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... 8/13/21 X 8/13/21 Running head: HEART DISEASE EDUCATION Implementation of Heart Disease Education for Women at an Obstetrics and Gynecology Clinic Megan L. Wright BSN, RN Doctor of Nursing Practice Program Family Nurse Practitioner Track Saint Marys College Faculty Team Leader: Dr. Linda Paskiewicz PhD, CNM, RN HEART DISEASE EDUCATION 3 Abstract Heart disease is the leading cause of morbidity and mortality worldwide (Saeed, Kampangkaew, & Nambi, 2017). There is a high prevalence of heart disease among women, especially those of postmenopausal women age. Although many risk factors for heart disease are preventable, controlling risk factors remains a challenge. Research emphasizes a need for improved heart disease knowledge and self-care practices among women to decrease heart disease risk. Assessment of baseline health literacy and heart disease knowledge is vital to improving health outcomes. The goals of this project were to increase awareness of heart disease risk factors and to improve heart disease knowledge among women 45 years and older. The project was implemented at UPMC Western Maryland Obstetrics and Gynecology clinic. Current knowledge was assessed utilizing the Heart Disease Knowledge Questionnaire (HDKQ) at scheduled office visits among women 45 years and older. After completion of the questionnaire, education from the American Heart Association (AHA), as well as, rationales to the HDKQ were provided to each participant. Participants were contacted by telephone one month after completion of the HDKQ to complete the questionnaire verbally for a second time. The results of a Wilcoxon Signed Ranks test (p = 0.0018) showed that there was a significant improvement in HDKQ scores after completion of the educational intervention. This study successfully identified knowledge gaps among women that can be used to make future teaching recommendations related to improving heart disease awareness and prevention at the individual and community level. Keywords: heart disease education, heart disease knowledge, post-menopausal women HEART DISEASE EDUCATION 4 Table of Contents Cover Page.....1 Practice Innovation Completion Form.....2 Abstract..........3 Table of Contents.......4 Introduction...6 Background.......7 Problem Statement....9 PICOT Question and Objectives.....10 Literature Review....11 Theoretical and Implementation Models........18 Social Entrepreneurship, Innovation, and Sustainability ....19 Ethical Considerations....20 Methods....22 Data Analysis.......28 Results..28 Discussion....31 Conclusion...34 References....35 Appendix A: Informed Consent..39 Appendix B: UPMC Western MD: Authorization to Use and Disclose Health History Form....41 Appendix C: Demographics and Health History Form.....44 Appendix D: Heart Disease Knowledge Questionnaire.....47 HEART DISEASE EDUCATION 5 Appendix E: HDKQ Rationales and American Heart Association Heart Disease Education.51 Appendix F: Gantt Charts: DNP Project Timeline....76 Appendix G: Operational Budget...78 Appendix H: Power Analysis..81 Appendix I: CITI Training.....82 Appendix J: Literature Synthesis Table.83 HEART DISEASE EDUCATION 6 Implementation of Heart Disease Education for Women at an Obstetrics and Gynecology Clinic Heart disease is the leading cause of morbidity and mortality among women (Pardhe et al., 2017). Feldman (2016) describes heart disease as an equal opportunity phenomenon, meaning that women have as great of a chance as men of dying from heart disease. Compared to men, women with heart disease have poorer health outcomes. Differences exist in the pathophysiology, symptoms, presentation, efficacy of diagnostic tests, and response to pharmacological interventions for heart disease among men and women. These variations have a direct effect on treatment and patient health outcomes (Saeed, Kampangkaew, & Nambi, 2017). Heart disease is most prevalent among women of post-menopausal age. After the onset of menopause, there is a decline in the level of protective estrogen in a womans body, resulting in an increased risk of heart disease. Decreased estrogen levels can result in long-term cardiovascular complications, including vasoconstriction and changes in a womans lipid profile (Peacock and Ketvertis, 2020). The risk of heart disease in post-menopausal women continues to be overlooked in the primary care setting (Feldman, 2016). Over the last few decades, interventions have been put in place to improve heart disease awareness; however, only 50% of women recognize heart disease as their most common killer (CDC, 2020). Research suggests that there is a need for improved knowledge and self-care practices related to heart disease among women, especially those of postmenopausal age (Saeed, Kampangkaew, & Nambi, 2017). The population of interest for this DNP Practice Innovation Project was women 45 years and older due to the increased risk of heart disease among women at this age. This project was tailored to meet the needs of women related to heart disease prevention, health literacy, and self-care. The purpose of this project was to contribute to the existing literature on women and heart disease. The DNP student utilized the HEART DISEASE EDUCATION 7 Heart Disease Knowledge Questionnaire (HDKQ) to assess current heart disease knowledge and provided educational materials to participants with the goal of improving health outcomes. The primary objective of this project was to develop an easily administered heart disease education program that can be used in the primary care setting to aid in improving health literacy, heart disease knowledge, and self-care practices among women 45 years and older. By acting as a change agent, the Advanced Practice Registered Nurse (APRN) is in the position to improve health care outcomes among the targeted population. This project allowed the DNP student to act as a leader and initiate the implementation of best practices in the outpatient setting by working directly with patients and health care professionals. Background Heart disease, a significant health problem in the United States, is the leading cause of death and is the cause of an enormous burden for communities, health care providers, and health systems. Approximately 13 million Americans have a diagnosis of heart disease (CDC, 2020). Heart disease generally refers to conditions that narrow or block blood vessels, leading to myocardial infarction (MI), angina, or cerebrovascular accident (Mayo Clinic, 2020). Modifiable risk factors for heart disease include hypertension (>140mmHg SBP and/or >90 mmHg DBP, depending on age), smoking, sedentary lifestyle, and hyperlipidemia. Diabetes mellitus, obesity, and stress also contribute to the development of heart disease (Dunphy, Winland-Brown, Porter, and Thomas, 2019). Non-modifiable risk factors related to the development of heart disease include age, post-menopausal status, family history of heart disease, and African-American ethnicity (Dunphy, Winland-Brown, Porter & Thomas, 2019). In the United States nearly as many women die as a result of heart disease compared to men. In 2017, heart disease was the cause of death of 299,578 women, accounting for 1 in 5 of all female deaths (CDC, 2020). In women, heart disease risk factors and a diagnosis of heart disease are more prevalent after the onset of menopause (Pardhe et al., 2017). Although menopause HEART DISEASE EDUCATION 8 typically begins between the ages of 50 and 52, around 5% of women experience early menopause between the ages of 40 and 45. According to Peacock and Ketvertis (2020) coronary artery disease rates are 2 to 3 times higher in post-menopausal women. Also, the in-hospital mortality rate following a myocardial infarction is over 50% higher in comparison to men (Feldman, 2016). Age-related cessation of ovarian follicle development, as well as, surgical removal of the ovaries result in a dramatic decline of circulating estrogen in a womans body (Naftolin, Friedenthal, Nachitigall & Nachtigall, 2019). Estrogen has a known positive impact on plasma lipid profiles, as well as antiplatelet and antioxidant effects (Naftolin, Friedenthal, Nachitigall & Nachtigall, 2019) Previous studies have shown that post-menopausal women experience increased arterial stiffening when compared to premenopausal women (Westendorp et al., 1999). Estrogen receptors are present in coronary artery endothelium and have profound action on muscles and insulin action that are necessary for maintenance of vessels. The lack of estrogen causes postmenopausal women to be more prone to diseases associated with estrogen deficiency, including heart disease, osteoporosis, and dyslipidemia (Peacock & Ketvertis, 2020). Heart disease has been linked to insufficiencies of estrogen receptors (Naftolin, Friedenthal, Nachitigall & Nachtigall, 2019). Although hormone replacement therapy is commonly and successfully used to treat the effects of decreased estrogen in post-menopausal women, it is still important to provide education about physiological changes for this population. In addition to physiological changes, limited health literacy can contribute to poor health outcomes. Health literacy can be defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions (U.S. Department of Health and Human Services, 2010). Adequate health literacy is mandatory for a person to improve their capacity and their ability to take responsibility for their health (Healthy People 2020). APRNs are in the position to develop and implement educational opportunities for women to decrease their risk of heart disease and improve their overall health. HEART DISEASE EDUCATION 9 APRNs can improve heart disease knowledge and self-care practices among women by focusing on evidence-based strategies that are tailored specifically for the target population. The DNPprepared APRN is largely focused on health promotion. However, for health promotion techniques to be effective in the improvement of patient health outcomes, it is important for primary care providers to be able to assess patients baseline health literacy level. It is the responsibility of the health care provider to offer additional resources and learning opportunities as needed. This is especially important for individuals with low health literacy to ensure that the patient understands their diagnosis and are able to participate in their plan of care (U.S. Department of Health and Human Services, 2010). Problem Statement Heart disease disproportionately affects post-menopausal women (Saeed, Kampangkaew, & Nambi, 2017). Physiological changes, decreased knowledge of heart disease, and inadequate self-care practices result in more health challenges for women. Data supports that postmenopausal women are at a greater risk of heart disease compared to men; however, women who present with heart disease risk factors are less likely to be treated appropriately (Feldman, 2016). In addition, women with heart disease are less likely to be properly diagnosed and are more likely to die of heart disease or related complications. Although these truths have been scientifically proven, proper identification of risk factors, diagnosis, and treatment of heart disease among postmenopausal women continues to be substandard (Feldman, 2016). A need exists for sufficient education and self-care practices related to heart disease among women. The purpose of this quality improvement project was to assess and meet the needs of women 45 years and older, especially those with low health literacy, who are at increased risk for the development of heart disease. This project addresses the problem of poor health literacy and self-care practices among women that increase their risk of heart disease. This project was designed to provide patient education that will aid in improving health outcomes among the target HEART DISEASE EDUCATION 10 population. The use of a heart disease knowledge screening tool in the primary care setting can be useful for assessing patients baseline heart disease knowledge. Although heart disease knowledge screening tools exist, screening for heart disease risk is not routinely performed in the primary care setting. APRNs are in the position to identify patients with low health literacy and provide them with needed resources and learning opportunities. This project aimed to improve heart disease knowledge and self-care practices through education provided by the American Heart Association focused on lifestyle changes and risk reduction (American Heart Association, 2020). Educational topics included: cholesterol, high blood pressure, diet, nutrition and well-being, physical activity, weight management, and smoking cessation (American Heart Association, 2020). This project contributes to nursing knowledge because the findings provide recommendations for education through the identification of knowledge gaps that currently exist among the target population. PICOT and Objectives In a population of women 45 years and older (P), what is the effect of heart disease lifestyle and risk reduction education (I) on patients heart disease knowledge (C) as measured by the Heart Disease Knowledge Questionnaire (HDKQ) over one month (T)? Project objectives were as follows: Assess the current heart disease knowledge and self-care practices of women 45 years and older at UPMC Western Maryland Obstetrics and Gynecology using the Heart Disease Knowledge Questionnaire (HDKQ) Identify gaps in current knowledge and self-care practices related to heart disease among the target population Analyze the impact of American Heart Association education on heart disease knowledge by comparing pre- and post- intervention scores Provide recommendations that can be used by the APRN in the primary care setting with the overall goal of improving health outcomes HEART DISEASE EDUCATION 11 Literature Review Heart Disease The terms heart disease and cardiovascular disease are often used interchangeably to describe a range of conditions that affect the heart. Heart disease generally refers to conditions that narrow or block blood vessels, leading to myocardial infarction (MI), angina, or cerebrovascular accident (Mayo Clinic, 2020). In coronary artery disease (CAD), optimal blood flow and dilation of the coronary arteries are hindered as a result of arteriosclerotic plaque formation along the inner vessel walls. Plaque buildup causes the coronary arteries to become obstructed, stiffened, and incapable of vasodilation. Ischemia of heart muscle develops as a result of coronary insufficiency if CAD, as a cause of coronary heart disease (CHD), is not treated. Ischemia of heart muscle will cause angina pectoris (chest pain due to cardiac ischemia) which can progress to a MI (Dunphy, Winland-Brown, Porter & Thomas, 2019). Atherosclerosis, also known as arteriosclerosis, is the main cause of CHD; however, once diagnosed, it is likely that atherosclerosis is also present throughout the entire arterial system, in addition to the coronary arteries. (Dunphy, Winland-Brown, Porter & Thomas, 2019). Menopause Menopause can be defined as the permanent cessation of menses for 12 months as a result of estrogen deficiency. Menopause is a normal part of aging and is not associated with a pathology. Most women experience vasomotor symptoms; however, menopause has an effect on many other body systems including urogenital, psychogenic, and cardiovascular. (Peacock and Ketvertis, 2020). Estrogen has a cardio-protective effect on the heart; therefore, the risk of heart disease increases immensely after the onset of menopause. As women grow older, the ovarian follicles diminish in number and fail to produce a sufficient amount of estrogen (Peacock and HEART DISEASE EDUCATION 12 Ketvertis, 2020). Hormonal changes that are associated with heart disease include low plasma estrogen, elevated Luteinizing Hormone (LH) and elevated Follicle Stimulating Hormone (FSH), which have significant effects on plasma lipid and lipoprotein metabolism (Pardhe et al., 2017). The hypothalamic-pituitary-ovarian axis is disrupted by the decline in estrogen levels, resulting in failure of endometrial development and irregular menstrual cycles. These physiological changes cause menstrual cycles to eventually stop altogether (Peacock and Ketvertis, 2020). In addition to the normal aging process, menopause can result from a hysterectomy with bilateral oophorectomy. Menopause can also result from the treatment of certain conditions, including endometriosis and breast cancer with antiestrogens, and some other cancers due to chemotherapy (Peacock and Ketvertis, 2020). Health Literacy Sufficient health literacy is necessary to improve a persons capacity and their ability to take responsibility for their health (Healthy People 2020). Health literacy can be defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions (U.S. Department of Health and Human Services, 2010). A concept map (Figure 1) that links heart disease to health literacy illustrates the relationship between social determinants of health, heart disease risk factors, health literacy, heart disease self-care and knowledge, and resultant outcomes. HEART DISEASE EDUCATION 13 Figure 1. Concept Map for Heart Disease and Health Literacy. A literature review was conducted and used various electronic databases, including CINAHL, PubMed, and Cochrane. The process involved searching databases using the following keyword search terms: heart disease, heart disease knowledge, heart disease self-care practices, heart disease education, health literacy, women, and post-menopausal women. The results of the literature review focus on heart disease knowledge and related self-care practices. Inclusion criteria for articles to be included in the literature review included: published in English and full text articles published since 2014. All articles included in the literature review are relevant to the PICOT question. All articles reviewed focus specifically on women. The following literature informs the project. Villablanca, Slee, Lianov, & Tancredi (2016) conducted a pre-post study with the aim of assessing baseline heart disease knowledge gaps and efficacy of a survey-based intervention. A convenience sampling method was used to recruit 472 women attending previously scheduled HEART DISEASE EDUCATION 14 appointments at five clinical sites in Northern California. Each participant completed a selfadministered Knowledge Awareness and Risk Assessment during their scheduled clinic visit. The survey assessed womens knowledge of heart disease, risk factors, heart attack/stroke symptoms, and taking appropriate actions to prevent heart disease. After completion of the pre-survey, individualized clinic-based education was delivered by a healthcare professional. The pre-post test change score analysis showed improvements in knowledge post-intervention. Knowledge change was compared by race, ethnicity, and urban/non-urban status. The results of the study concluded that baseline heart disease knowledge was low among all groups, especially American Indian women (p < 0.05). Most women were aware that heart disease is the leading killer. Awareness for taking appropriate action was low among 13% of Hispanic women, 13% of American Indian women, 29% of African American women, and 18% of nonurban women (p < 0.05). Among all women included in the study, 58% of participants had low knowledge of the major risk factors as well as knowledge of their personal risk factors. The change scores showed that the educational intervention was effective among all groups of women, especially for raising awareness (p < 0.01). The results of the change score analysis concluded that American Indian women had the greatest baseline deficit and achieved the greatest knowledge and awareness gains after participation in the educational intervention (p < 0.05). In addition, the change score for ethnicity revealed that Hispanic women had the greatest gains in overall awareness of heart disease risk factors compared to non-Hispanic women (p < 0.05). The change score analysis for urban/non-urban women showed that nonurban women had the greatest gains in awareness compared to urban women (p < 0.01). The results of the study conclude that there is a need for improved awareness and increased efforts to deliver education on heart disease prevention among women in the outpatient clinical setting. Altman, Ybarra and Villablanca (2014) developed and assessed the impact of a community-based education program for improving outcomes for knowledge and awareness of HEART DISEASE EDUCATION 15 heart disease, risk factors, and health behaviors among Latina women. The study was conducted by the Womens Cardiovascular Medicine Program at the University of California, Davis, and the Sacramento Latino Medical Association. Participants were recruited through community announcements and flyers. Thirty-five women completed a 4-month community-based bilingual cardiovascular prevention education program. Pre- and post- intervention analyses were performed for heart disease risk factors, symptoms, when to call 911, personal risk factors (smoking, physical inactivity, family history of heart disease), clinical parameters (weight, BMI, waist circumference, blood pressure, fasting lipids, and glucose), diagnosis of metabolic syndrome, and serum inflammatory markers (Altman, Ybarra & Billablanca, 2014). The results of the study found that womens baseline heart disease knowledge and awareness was relatively low. Post intervention, participants demonstrated significant (p < 0.05) improvements in symptom knowledge, risk factors for heart disease, calling 911, and knowledge and adoption of heart-healthy behaviors. Clinical health status also improved, especially for serum triglycerides (p < 0.05; 21% decline), prevalence of metabolic syndrome (from 43% to 37% of participants), and serum levels of the proinflammatory TNF- (from 16.91.11 pg/mL to 13.50.8 pg/mL, p <0 .05) (Altman, Ybarra & Billablanca, 2014). The study concluded that a community-based heart disease prevention program focused on health education can be effective in improving heart disease knowledge. Bourgette-Henry, Davis, Flood, Choi, and Bourgette (2019) conducted a pre-post study with the aim of improving identification of heart disease risk and to promote health literacy of the disease in Asian, Native Hawaiians, and other Pacific Islander women on Oahu. The study assessed current awareness of heart disease as the leading cause of death and involved implementation of a heart disease risk reduction program. A mixed methods approach was utilized and included a pre- and post- test heart disease awareness questionnaire, a screening process using the American Heart Associations Lifes Simple 7 matrix, and six educational sessions. The American Heart Associations Lifes Simple 7 matrix assessment tool was created using the HEART DISEASE EDUCATION 16 American Heart Association guidelines and is part of the organization's Life's Simple 7 program. The Lifes Simple 7 program identifies the 7 most significant predictors of heart health and shows users a pathway for achieving ideal cardiovascular health (Bourgette-Henry, Davis, Flood, Choi, and Bourgette, 2019). A convenience sampling method was used to recruit a sample of twenty women from the Makeke Market on the Leeward Coast of Oahu. The results of the project showed improved awareness of heart disease and self-care behaviors. Descriptive statistics were calculated to summarize study participants' characteristics. The pre-post intervention Risk Awareness Questionnaire test results were determined by comparing how many participants answered each item correctly and the overall mean score change. The pre and post Life's Simple 7 scores were analyzed both using both a continuous scale and a categorical scale (poor; intermediate; and ideal). Paired t-test (p < 0.05) and McNemar's test (p < 0.05) were performed to determine if there was a statistically significant difference in participants' Risk Awareness Questionnaire test scores and Life's Simple 7 scores pre-post intervention. The study concluded that participants had improved knowledge, awareness, and self-care behaviors to reduce the risk of heart disease. Villablanca, Warford, and Wheeler (2015) conducted a pilot study with a pre-post design with the aim of piloting and assessing the effectiveness of a 4-month pre- and post- heart disease prevention education intervention with the goal of improving knowledge, clinical risk profiles, adoption of heart-healthy behaviors, and cardiometabolic risk among African American women. In 2010, forty-two African American women enrolled in a 4-month educational Cardiovascular Disease Prevention Intervention Program in Sacramento, CA. Pre- and post- intervention knowledge-based surveys were completed by each participant. Participants also provided clinical measures (weight, waist circumference, BMI, blood pressure and blood samples for analysis of fasting glucose and lipids and inflammatory markers (Villablanca, Warford & Wheeler, 2015). The results of the study showed that post-intervention there were significant (p<0.05) HEART DISEASE EDUCATION 17 improvements knowledge for heart attack symptoms and calling 911, clinical risk parameters (waist circumference and low-density lipoprotein cholesterol (p<0.05)) and reductions in all the inflammatory markers assessed (p<0.05). Additionally, there was a 60% reduction in the number of participants with metabolic syndrome (p<0.05), as a result of reductions in triglycerides and glucose and a rise in high-density lipoprotein (HDL) cholesterol (Villablanca, Warford & Wheeler, 2015). The study confirmed the efficacy of a pilot community-based educational cardiovascular disease program for reducing cardiometabolic risk among high-risk African American women. Koniak-Griffin and Brecht (2015) conducted a study with the purpose of evaluating knowledge of heart disease among overweight Latinas. Ninety, Latinas aged 35-65 with low education were recruited to participate in the study. The educational intervention consisted of eight educational sessions focused on understanding risk factors and preventative measures for health disease through heart-healthy diets, physical activity, and weight control. Participants completed a heart disease knowledge questionnaire pre- and post- intervention which evaluated general heart disease knowledge and prevention measures (Koniak-Griffin & Brecht, 2015). The results of the study found that baseline heart disease knowledge was low and most participants did not recognize heart disease as the leading cause of death among women. A comparison of pre- and post- intervention scores showed a significant change (P < 0.001). The study concluded that educational interventions for heart disease knowledge may significantly improve heart disease knowledge and that there is a need for further heart disease health promotion efforts. Strengths of Current Literature The literature suggests that heart disease educational programs are effective in improving heart disease knowledge, awareness, and self-care practices among women (Villablanca, Slee, Lianov, & Tancredi, 2016; Altman, Ybarra and Villablanca, 2014; Bourgette-Henry, Davis, Flood, Choi, & Bourgette, 2019; Villablanca, Warford, & Wheeler, 2015; Koniak-Griffin & Brecht, HEART DISEASE EDUCATION 18 2015). The studies evaluated improvements in heart disease knowledge scores pre- and postintervention. Differences among studies included: educational tools, delivery of educational programs, length of intervention, and cultural and ethnic focus. Pre- and post- intervention studies used valid and reliable heart disease knowledge screening tools to assess heart disease knowledge (Villablanca, Slee, Lianov, & Tancredi, 2016; Altman, Ybarra and Villablanca, 2014; BourgetteHenry, Davis, Flood, Choi, & Bourgette, 2019; Villablanca, Warford, & Wheeler, 2015; KoniakGriffin & Brecht, 2015). Overall, strengths of the studies selected for review include improvements in heart disease knowledge, awareness, and self-care practices among women, feasibility of implementation, and generalizability for the target population. Limitations of Current Literature There were several limitations of the studies reviewed. Many of the studies utilized selfreported behaviors, which is prone to subjective bias. The results of the studies would be more reliable if the interventions were longer and participant follow up occurred long term. Villablanca, Slee, Lianov, and Tancredi (2016) utilized a pre- post- intervention design for measuring knowledge; however, the intervention lasted less than an hour and there was approximately only an hour between assessments. This study design poses a threat to internal validity. Additionally, this study lacked assessment of long-term retainment of knowledge. The study lacks long term follow up, as knowledge does not always translate to behavioral change. There is a need for long term follow up to assess health outcomes and retention of information. Theoretical and Implementation Models The theoretical framework for this DNP Practice Innovation Project was Nola Penders Health Promotion Model (HPM). Pender published A Conceptual Model for Preventive Health Behavior as a foundation for studying how individuals make decisions about their own health care in a nursing context (Pender, 1975). The HPM is a research tool that serves as a foundation for this practice innovation project. The Health Promoting Lifestyle Profile, that is derived from HEART DISEASE EDUCATION 19 the HPM, serves as the operational definition for health-promoting behaviors (Alligood, 2014). The goal of this DNP Practice Innovation Project was to improve education and promote healthy lifestyle changes related to heart disease among post-menopausal women. The key concept of the HPM is self-efficacy, which is directly related to this project. According to Bandura (1977), selfefficacy can be described as an individuals belief in his or her capacity to execute behaviors that are necessary to produce specific performance attainments. Self-efficacy is central to this project as the projects long-term success is directly dependent on a participants judgement of their personal capability to organize and perform a health-promoting behavior. Quality Improvement This DNP Practice Innovation Project can be best described as a quality improvement (QI) project. According to the U.S. Department of Health and Human Services Health Resources and Services Administration (2011) QI consists of actions that lead to improvements in health care service delivery with measurable health status of targeted patient groups. In health care, QI involves a combined effort of health care staff and stakeholders to identify and treat problems that exist in the healthcare system (Silver et al., 2016). This project is a QI project because the purpose was to assess the knowledge of post-menopausal women regarding heart disease risk and provide recommendations for implementation of education and self-care practices to improve health in the ambulatory care setting. Social Entrepreneurship, Innovation, and Sustainability Social entrepreneurs focus on improving social outcomes for a community or a group of stakeholders (Phillips et al., 2014). The goal of social entrepreneurship is the development of social value, rather than personal or shareholder wealth. This DNP project was in alignment with the social entrepreneurship framework because the goal was to improve the health of women and provide them with necessary education to care for themselves. The purpose of this project was HEART DISEASE EDUCATION 20 strictly to develop social value. There was no personal or shareholder profit involved in the implementation of this project. Social innovation can be defined as innovative activities and services that are motivated by the goal of meeting a social need (Phillips et al., 2014). This project is innovative because of all of the research reviewed, no studies were found that focus specifically on knowledge of heart disease among women 45 years and older. For a project to be sustainable it must be able to be maintained at a certain level indefinitely (Morfaw, 2014). Project sustainability is necessary for effective and efficient delivery of goods and services and is important for the success of the proposed project. A comprehensive analysis of social, economic, legal, cultural, educational, and political environments for project implementation has been performed. Additionally, the philosophy, mission, vision, goals, and objectives for the project have been analyzed prior to beginning the project. Input from key stakeholders and advocates during the planning process contributed to the logistical preparation for project implementation. A sustainability analysis was performed to determine the relevance, acceptability, political expediency, viability, and adaptability of the project. The projects funding requirements were assessed and analyzed to determine the projects ability to operate independently. This project will maintain sustainability if health care providers utilize the resultant educational recommendations from the project and incorporate education into practice. Primary care providers should continue to educate and reinforce teaching about eliminating heart disease risk as needed after the completion of the project. Ethical Considerations Risks and Benefits to Participants The benefits of this DNP Practice Innovation Project outweighed the potential risks. The project design did not pose any physical, privacy, or legal risks. Participation in this project posed no physical risk that could cause injury. The psychological risks of this project were comparable HEART DISEASE EDUCATION 21 to any other health screening questionnaire. Recruitment for this project took place during scheduled visits at UPMC Western Maryland Obstetrics and Gynecology. Patients who met inclusion criteria were asked to participate in the project. At the beginning of the project, participants were made aware that participation was completely voluntary and that they had the right to withdraw from the study at any time. Informed consent was obtained prior to participation (Appendix A), in addition to the UPMC Western Maryland Authorization to Use and Disclose Health Care Information Form (Appendix B). The patient was presented with the questionnaire and health screening forms at the beginning of their office visit, along with their routine paperwork. After the completion of the questionnaire, rationales to the questionnaire were provided as well as education from the American Heart Association (AHA). The primary investigator was the only person who had access to the results of the questionnaire, health history, and demographic data. In order to maintain confidentiality during the implementation phase and data analysis, the patient demographic form and pre- and post- intervention questionnaires were coded and stored in a locked file cabinet in which only the DNP student had access to. Anonymity and Confidentiality To protect the privacy of participants, confidentiality was maintained during all phases of this project. Any identifiable information was not displayed in the research results. Informed consent forms that included the participants name were locked in a filing cabinet over the duration of this project to eliminate all confidentiality risk involved in this project. Only the DNP student had access to the locked file cabinet during the duration of this study. Data was collected at UPMC Western Maryland Obstetrics and Gynecology. The DNP student collected all data for this project in the waiting room at the office while patients were completing routine paperwork. After completion of the informed consent, UPMC Western Maryland Authorization to Use and Disclose Health Care Information Form, and Heart Disease Knowledge Questionnaire, participants were given a copy of the informed consent and the UPMC Western HEART DISEASE EDUCATION 22 Maryland Authorization to Use and Disclose Health Care Information Form before leaving the office. Data was collected on printed questionnaires and was then entered into Microsoft Excel on a secured lap top with a password. Only the DNP student had access to the data. Informed Consent A thorough explanation of the study was provided to each participant by the DNP student prior to participation in the study. The informed consent form was presented to eligible participants upon arrival to their scheduled appointment. Informed consent was obtained by having the participant sign the informed consent form thereby stating that they are agreeable to participate in the study. Participants were made aware that they may choose to terminate their agreement to participate in the study at any time. In addition to completion of an informed consent form, UPMCs Authorization to Use and Disclose Health Information was obtained from each participant. Methods Overview This project utilized a pre- post- intervention design. A convenience sampling method was used for recruitment of participants who met inclusion criteria and who were patients at UPMC Western Maryland OB/GYN clinic. The DNP student actively engaged with participants upon check in to their scheduled appointment with the goal of providing participants with the American Heart Association educational intervention. Key Stakeholders The key stakeholders for this project included Dr. Linda Paskiewicz and the health care providers at the UPMC Western Maryland OB/GYN office. Dr. Paskiewicz was the faculty advisor from Saint Marys College who provided mentorship to the DNP student over the course of this project. Implementation in the OB/GYN clinic setting was beneficial to the project because HEART DISEASE EDUCATION 23 the providers at this clinic were experts in providing care to women across the lifespan, including those who are 45 years and older and/or post-menopausal status. Setting and Population UPMC Western Maryland Obstetrics and Gynecology is located in Cumberland, Maryland. The clinic offers health care services to women from early adolescence to mature adulthood. Patients at the clinic are primarily Caucasian. The clinic accepts Medicaid, Medicare, and private insurance. Participant inclusion criteria for this project included women 45 years and older, patients of UPMC Western Maryland OB/GYN, and English speaking. The participants may or may not have presented with modifiable and/or non-modifiable risk factors for heart disease. Exclusion criteria included males, cognitively impaired individuals who are unable to complete the questionnaire and learning materials, non-English speaking individuals, and women younger than 45. Recruitment Strategy Patients at the UPMC Western Maryland OB/GYN office who met inclusion criteria were invited to participate in this project by the DNP student. Recruitment occurred utilizing a convenience sampling method at the OB/GYN office in March and April 2021. Potential participants were informed about the current project and were provided with the opportunity to participate. Informed consent and UPMC Authorization to Disclose Health Information forms were completed and obtained from each individual prior to participation. Those who agreed to participate were provided with a copy of these forms and the DNP students contact information prior to leaving the office. Intervention Plan Prior to project implementation, the HDKQ and other pertinent materials were reviewed with key stakeholders to ensure that the purpose of the project and the project design were fully understood. During the pre-implementation phase, all data collection tools, consent forms, and HEART DISEASE EDUCATION 24 patient education material were printed and made ready to use. Saint Marys IRB approval was received on March 8, 2021. After IRB approval was received, the DNP student finalized the implementation process with the key stakeholders and data collection began. Data collection occurred in March and April 2021. Participants were recruited to participate in this project at the UPMC Western Maryland OB/GYN office by the DNP student. Patients who met the criteria were invited to participate in the project upon checking in to their scheduled appointment. If patients agreed to participate, the DNP student provided the participant with an overview of the project. If the patient still agreed to participate after receiving information about the project the patient was then provided with the informed consent form and the UPMC Authorization to Disclose Health Information form. After completing these forms, next the participant completed the demographic data sheet and the HDKQ while waiting to be seen by their healthcare provider. Prior to leaving the office, each participant was provided with a copy of the informed consent form, the UPMC Western Maryland Authorization to Disclose Health Information form, and the DNP students contact information. The DNP student recruited a total of 27 participants to participate in this project. After recruitment was complete, participants were sent AHA education, as well as rationales to the questions on the HDKQ. Each participant was given the opportunity to choose if they would like to receive their education by mail or email. Email reminders for one month follow up telephone interviews were sent to each participant who provided an email address. Follow up occurred one month after receiving the educational intervention. The DNP student contacted each participant for follow up via telephone and voicemail messages were left as needed. During telephone encounters, the HDKQ was completed for a second time. Participants who did not answer the phone were attempted to be contacted multiple times during the data collection phase. A total of 11 participants were successfully followed up with post-intervention. HEART DISEASE EDUCATION 25 Demographic Data Patient demographic data was collected using a tool designed by the DNP student based on the literature review. The patient demographic tool was targeted for women 45 years and older. The baseline data that was collected included age, race/ethnicity, educational level, past medical history, family history, activity level, smoking status, height, weight (Appendix C). Heart Disease Knowledge Questionnaire The Heart Disease Knowledge Questionnaire (HDKQ) (Appendix D) was selected as an appropriate data collection instrument for this project. The HDKQ was developed in 2011 with the goal of developing an easily administered and reliable heart disease knowledge questionnaire that could be used among a variety of patient populations (Bergman et al., 2011). The scale measures five knowledge domains related to heart disease, including: dietary knowledge, epidemiology, medical information, risk factors, and heart attack symptoms (Bergman et al., 2011). The five domains were derived from a literature review of previous heart disease knowledge scales, the self-regulatory model of illness, and the findings from an ad hoc expert panel of a board-certified internist, health psychologist, and psychometrician (Bergman et al., 2011). The process of the selection of existing items and development of new items was undertaken by the authors of the HDKQ, including a health psychologist, a research psychologist, and a psychometrician. Some items were used from existing, yet dated scales, such as the Cardiovascular Disease (CVD) Knowledge Test (Suminski et. al., 1999). Some items were developed using findings and information from the Pittsburgh Healthy Heart Study, American Heart Association, Harvard Center for Cancer Prevention, Women's Heart Foundation, Heart Healthy Women, National Heart, Lung and Blood Institute, National Center for Health Statistics, Department of Health and Human Services, United States Department of Agriculture, Centers for HEART DISEASE EDUCATION 26 Disease Control and Prevention, Mayo Clinic, University of Maryland Medical Center, Harvard Medical School, and Coalition of Labor Union Women (Bergman et al., 2011). The authors of the HDKQ chose a true/false item format for the current scale to decrease participant burden. The option I dont know was included to improve the scales reliability by reducing guessing that is often associated with true-false questions (Bergman et al., 2011). An ad hoc panel was created to address and review the content validity and face validity of the items. The ad hoc panel consisted of three experts in cardiovascular disease, health psychology, and psychometrics. The questionnaire was reviewed by the experts individually. The experts then checked the items independently to ensure that the questions had the correct response, fit under the pre-established domain, and were medically accurate and up to date (Bergman et al., 2011). Lim et al. (2016) conducted a cross-sectional study to determine the validity and reliability of the HDKQ. Cluster sampling was used to recruit 788 participants from a Malaysian university to complete the HDKQ. Item analysis and confirmatory factor analysis were performed and construct validity of the model was included. Several statistical softwares were used for the data analysis, including: Microsoft Excel and IBM SPSS. An item analysis, descriptive analysis, and confirmatory analysis were completed. Descriptive statistics were calculated to describe the characteristics of the sample and the item analysis (the index of difficulty and item discrimination) of the scale. The validity of the structure of HDKQ was tested using a confirmatory analysis, as well as construct validity (p < 0.05). The item analysis involved statistical analysis of each item on the questionnaire. The item analysis was performed to determine if some items should be discarded from the questionnaire. The difficulty index was calculated based on the number of correct responses to each item. The weighted least squares mean and variance adjusted estimator was used in the analysis. The correlation among constructs (r 0.85) was used to determine discriminant validity. The results of the study confirm that the HDKQ has adequate levels of HEART DISEASE EDUCATION 27 psychometric properties. It was concluded that the HDKQ covers a wide range of knowledge concepts, and is presently considered to be a reliable and validated scale (Lim et al. 2016). The HDKQ was reviewed with key stakeholders before implementation of the project to ensure that the screening procedure is fully understood. Heart disease education, as well as, rationales to the questionnaire were provided to participants after completion. An email reminder was sent to participants one week prior to follow up. Participants were then followed up with via phone interview one month after completion of the questionnaire. American Heart Association Heart Disease Education The primary patient education utilized to supplement the educational needs of this project was obtained from the American Heart Association (AHA, 2015). The AHA provides patient education handouts on their website for a variety of topics. The educational materials that were selected for this project were specific to the target population and the learning objectives of this project. The educational topics included information on heart disease, stroke, blood pressure, cholesterol, triglycerides, weight management, healthy diet, healthy lifestyle choices, exercise, and smoking cessation (AHA, 2015). Rationales to the heart disease knowledge questionnaire, as well as, educational materials utilized from the AHA are included in Appendix E. Timeline Saint Marys IRB approval was obtained on March 8, 2021. Data collection at the UPMC Western Maryland OB/GYN office was completed in mid-March and April 2021. After data collection at the office was complete, educational materials were sent to participants in late April 2021. Participants were then followed up with in late May and early June 2021. The original and revised Gantt Chart timelines for this project are included in Appendix F. Budget HEART DISEASE EDUCATION 28 The direct costs for this project included approximately $100 for printing and mailing materials to participants. Additionally, the cost of incentives for office staff cost approximately $50. The budget for this project is included in Appendix G. Data Analysis The desired sample size for this project was 34 participants based on the results of a power analysis that was conducted using the Ai Therapy Statistics online calculator. A t-test with a significance level of 0.05 and power of 0.8 lead to a suggested total sample size of at least 34 participants (Appendix H). Unfortunately, a needed sample size of 34 participants was not achieved. Although 27 participants were recruited to complete the pre-implementation questionnaire and received heart disease education, not all participants were able to complete the one-month post-implementation portion of the project. A total of 11 participants successfully completed all aspects of the study and these participants were used to determine the differences in pre- and post-implementation scores. Because of the pre- post intervention project design and the small sample size, the Wilcoxon signed rank test was best suited for data analysis. The paired scores from these 11 participants were entered into Microsoft Excel and the Wilcoxon signed rank test was performed by the DNP student using Persons StatCrunch software. Demographic data that was provided by participants was used to calculate descriptive statistics. Results Heart disease education was provided to participants (N = 27) with the purpose of improving heart disease knowledge. The major areas of focus of the heart disease education included diet, exercise, and smoking cessation. The pre- and post-implementation scores of 11 participants who completed all aspects of this project were used to determine if participants knowledge was improved after receiving educational intervention. Descriptive statistics, summary statistics and the results of the Wilcoxon signed rank test are included in the following sections. HEART DISEASE EDUCATION 29 Descriptive Statistics All participants who fully completed all aspects of this project were female patients at UPMC Western Maryland OB/GYN office, 45 years old or older, and identified as white (n = 11). Age ranges for participants are displayed in Figure 2. Patients education levels were assessed utilizing the demographic questionnaire designed by the DNP student. Education levels of participants are displayed in Figure 3. Of the 11 participants, two reported that they never exercise, two reported that they exercise one day a week, two reported that they exercise two or three days a week, and five reported that they exercise four or more days a week. Smoking status was also assessed and one participant reported a history of smoking with a 30-year pack life. Eight participants in the study reported a family history of heart disease. In addition, six participants in the study had a history of hypertension and four participants were currently taking medication for high blood pressure. Two participants in the study had a history of hypercholesterolemia. Figure 2. Age Range of Participants. HEART DISEASE EDUCATION 30 Figure 3. Education Levels of Participants. Heart Disease Knowledge Questionnaire Results Summary statistics were calculated using Persons StatCrunch to determine the average HDKQ score pre- and post- intervention. Of the total 27 participants who completed the pre- test and received heart disease education, the post- test was completed by 11 participants. The average score out of 30 True/False/I dont know questions on the pre- intervention HDKQ was 19.7 and the average score on the post- intervention HDKQ was 27.9. The variance for pre-intervention scores was 16.2 and 1.69 for post-intervention scores. The standard deviation was also calculated. The standard deviation for pre- intervention scores HDKQ was 4.03 and the standard deviation for post- intervention HDKQ scores was 1.30. Summary statistics are displayed in Table 1. HEART DISEASE EDUCATION 31 Table 1. Summary statistics for pre- and post- intervention HDKQ scores. The Wilcoxon signed rank test was used to assess if a significant difference exists between pre- and post- test scores. The results of the Wilcoxon signed rank test with a significance level of < 0.05 showed that p = 0.0018. The results of this test suggest that there is sufficient evidence to conclude that the heart disease knowledge scores improved from pre- to post- test, indicating that there was a significant improvement in HDKQ scores after the educational intervention (Table 2). Table 2. Wilcoxon signed rank test with a significance level of p = 0.0018. Discussion The DNP Practice Innovation Project focused on four main objectives. The first objective was to assess the current heart disease knowledge and self-care practices of women 45 years and older at UPMC Western Maryland Obstetrics and Gynecology using the Heart Disease Knowledge Questionnaire (HDKQ). This objective was met by recruiting participants to complete the HDKQ at their scheduled appointment. The second objective of this project was to identify gaps in current knowledge and self-care practices related to heart disease among the target population. After recruiting participants for the project, the DNP student then reviewed and scored the pre-test questionnaire with the purpose of comparing baseline heart disease knowledge and knowledge HEART DISEASE EDUCATION 32 gained after completion of the educational intervention. Knowledge gaps were identified and education related to mutual knowledge gaps among participants was highlighted in the educational intervention. The third objective was to analyze the impact of AHA education on heart disease knowledge by comparing pre- and post- intervention scores. This objective was met by completing a Wilcoxon Ranked Signs test (p = 0.0018) to compare pre- and post- intervention scores. The results of the Wilcoxon Ranked Signs test indicated that there was a significant improvement in scores after receiving rationales to the HDKQ and AHA education. The fourth objective of this project was to provide recommendations that can be used by health care providers in the outpatient setting with the overall goal of improving health outcomes. The DNP student plans to share the results of this study and subsequent recommendations for heart disease education with the office manager and the providers at UPMC Western Maryland OB/GYN office. The goal of this project, to improve heart disease knowledge among women 45 years and older, was met. The results of this study provide implications for clinical practice, quality and safety, and education. Implementation of this project can improve clinical practice through assessment of heart disease knowledge and identification of knowledge gaps. Clinical practice can be improved by providing patients with education to prevent heart disease and to improve health outcomes. This project improves quality and safety of patients by addressing heart disease risk and providing patients with preventative education and self-care recommendations that can be utilized to improve health. Ultimately, this project improves heart disease knowledge and awareness and improves health outcomes at the individual and community level. Project Strengths The main strength of this project was the result of the Wilcoxon Ranked Signs test (p = 0.0018) that showed a significant improvement in HDKQ scores after receiving AHA education. This study eliminated bias by utilizing a convenience sampling method to recruit participants. HEART DISEASE EDUCATION 33 Another strength was the use of the HDKQ, a valid and reliable tool. Implementation of this study is affordable and can be easily adopted by outpatient clinics. The implementation of this project can ultimately benefit patient health outcomes and decrease health care system costs associated with heart disease. Project Limitations The major limitations of this project were related to the sample size. Unfortunately, the desired sample size of 34 participants which was needed to utilize a paired t-test for data analysis was not met. Multiple factors likely led to the small sample size. The strict timeline set by the DNP student to complete the project likely impacted the sample size. Also, the original data collection plan with the office staff had to be modified during the data collection phase. The sample size for this project could have been improved if the DNP student had more time to recruit participants at the UPMC Western Maryland OB/GYN office. Additionally, advertisements for the project and incentives for participation may have improved the sample size of this study. Future Research Future research is warranted to continue to assess patients heart disease knowledge and to continue to find the most effective ways to provide appropriate education as needed. Heart disease education should be a priority for women 45 years and older at all primary care wellness exams and GYN annual visits. Patients at risk for heart disease or with a history of heart disease require continuing support from health care providers in order to effectively self-manage their health. Continued research is needed to improve patient engagement in heart disease educational opportunities that aide in making behavioral and lifestyle modifications for the prevention of heart disease. HEART DISEASE EDUCATION 34 Conclusion The expected goal of this project, to improve heart disease education among women 45 years and older, was met. Based on the findings of this study, the integration of heart disease education into the care of women 45 years and older is recommended to aide in the improvement of heart disease knowledge and self-care practices related to heart disease. APRNs are in the position to promote health and provide education for the prevention and management of heart disease. The design of this study aimed to supplement the provider who may be pressed for time during office visits. The aim of this intervention was to improve patient education at the clinic that serves to meet the gynecological needs of women by introducing a new easy to use screening tool and educational materials. Having tools readily available for use can help busy clinics meet educational needs while also meeting the demands of a busy work environment. The intervention is in alignment with the Health Promotion Theory because the main premise is to promote health by teaching patients how to properly care for themselves (Pender, 1975). Based on the results of this study, it can be recommended for outpatient clinics to utilize the HDKQ to assess heart disease knowledge among women 45 years and older. Also, women should be provided with AHA education as needed to improve heart disease knowledge and selfcare practices related to the prevention of heart disease. The project provides benefits at the individual and the community level. Implementation of this project in outpatient clinics can help fill heart disease knowledge gaps among individuals and improve health outcomes. HEART DISEASE EDUCATION 35 References Alligood, M.R. (2014) Nursing Theorists and Their Work (Vol. 8 edition). St. Louis, Missouri: Mosby retrieved from https://smcproxy1.saintmarys.edu:2138/login.aspx?direct=true&db=nlebk&AN=1105475 &site=ehost-live Altman, R., Nunez de Ybarra, J., & Villablanca, A. C. (2014). Community-based cardiovascular disease prevention to reduce cardiometabolic risk in Latina women: a pilot program. Journal of women's health (2002), 23(4), 350357. https://smcproxy1.saintmarys.edu:2166/10.1089/jwh.2013.4570 American Heart Association. (2020) Answers by Heart Fact Sheets: Lifestyle and Risk Reduction. Retrieved from https://www.heart.org/en/health-topics/consumer-healthcare/answers-byheart-fact-sheets/answers-by-heart-fact-sheets-lifestyle-and-risk-reduction American Heart Association. (2020). Limited health literacy is a major barrier to heart disease prevention and treatment. ScienceDaily. Retrieved from www.sciencedaily.com/releases/2018/06/180604112611.htm American Heart Association. (2015). What are Heart Disease and Stroke? Retrieved from https://www.heart.org/-/media/data-import/downloadables/d/c/0/pe-abh-what-are-heartdisease-and-stroke-ucm_300313.pdf Bandura, A. (1977). Self-efficacy: Toward a unifying theory of behavioral change. Psychological Review, 84(2), 191-215. Bergman, H. E., Reeve, B. B., Moser, R. P., Scholl, S., & Klein, W. M. (2011). Development of a Comprehensive Heart Disease Knowledge Questionnaire. American journal of health education, 42(2), 7487. https://doi.org/10.1080/19325037.2011.10599175 HEART DISEASE EDUCATION 36 Bourgette-Henry, S. J., Davis, A., Flood, J., Choi, S. Y., & Bourgette, A. (2019). The Wahine Heart Wellness Program: A Community Approach to Reducing Women's Cardiovascular Disease Risk. Hawai'i journal of health & social welfare, 78(11), 341348. Centers for Disease and Prevention (2020). Heart Disease: About Heart disease. Retrieved from https://www.cdc.gov/heartdisease/about.htm Dunphy, L.M., Winland-Brown, J.E., Porter, B.O. & Thomas, D.J. (2019). Primary Care: Art and Science of Advanced Practice Nursing. (5th ed.) Philadelphia, PA: F.A. Davis Company. Feldman R. D. (2016). Heart Disease in Women: Unappreciated Challenges, GPER as a New Target. International journal of molecular sciences, 17(5), 760. https://doi.org/10.3390/ijms17050760 Healthy People 2020 (n.d.) Heart Disease and Stroke. 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(2014). Fundamentals of project sustainability. Project Management Institute. Newtown Square, PA. https://www.pmi.org/learning/library/fundamentals-project-sustainability9369 Naftolin, F., Friedenthal, J., Nachtigall, R., & Nachtigall, L. (2019). Cardiovascular health and the menopausal woman: the role of estrogen and when to begin and end hormone treatment. F1000Research, 8, F1000 Faculty Rev-1576. https://doi.org/10.12688/f1000research.15548.1 Pardhe, B. D., Ghimire, S., Shakya, J., Pathak, S., Shakya, S., Bhetwal, A., Khanal, P. R., & Parajuli, N. P. (2017). Elevated Cardiovascular Risks among Postmenopausal Women: A Community Based Case Control Study from Nepal. Biochemistry research international, 2017, 3824903. https://doi.org/10.1155/2017/3824903 Peacock, K., Ketvertis, K.M. (2020). Menopause. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; Available from https://www.ncbi.nlm.nih.gov/books/NBK507826/ Pender N. J. (1975). A conceptual model for preventive health behavior. Nursing outlook, 23(6), 385390. Phillips, W., Lee, H., Ghobadian, A., ORegan, N., & James, P. (2014). Social Innovation and Social Entrepreneurship: A Systematic Review. Group and Organization Management. 40(3): 428-461. https://doi.org/10.1177/1059601114560063 Saeed, A., Kampangkaew, J., & Nambi, V. (2017). Prevention of Cardiovascular Disease in Women. Methodist DeBakey Cardiovasular Journal. 13(4): 185-192. doi: 10.14797/mdcj13-4-185 Silver, S. A., Harel, Z., McQuillan, R., Weizman, A. V., Thomas, A., Chertow, G. M., Nesrallah, G., Bell, C. M., & Chan, C. T. (2016). How to Begin a Quality Improvement Project. Clinical journal of the American Society of Nephrology : CJASN, 11(5), 893900. https://doi.org/10.2215/CJN.11491015 HEART DISEASE EDUCATION 38 Suminski R. R., Anding J., & Smoth, D. (1999). Risk and reality: the association between cardiovascular disease risk factor knowledge and selected risk-reducing behaviors. Fam & Community Health; 21:5162. U.S. Department of Health and human Services Health Resources and Services Administration (HRSA) (2011). Quality Improvement. Retrieved from https://www.hrsa.gov/sites/default/files/quality/toolbox/508pdfs/qualityimprovement.pdf Villablanca, A. C., Slee, C., Lianov, L., & Tancredi, D. (2016). Outcomes of a Clinic-Based Educational Intervention for Cardiovascular Disease Prevention by Race, Ethnicity, and Urban/Rural Status. Journal of women's health (2002), 25(11), 11741186. https://doi.org/10.1089/jwh.2015.5387 Villablanca, A. C., Warford, C., & Wheeler, K. (2016). Inflammation and Cardiometabolic Risk in African American Women Is Reduced by a Pilot Community-Based Educational Intervention. Journal of women's health (2002), 25(2), 188199. https://doi.org/10.1089/jwh.2014.5109 Westendorp, I.C., Bots, M.L., Grobbee, D.E., et al. (1999). Menopausal status and distensibility of the common carotid artery. Arterioscler Thromb Vasc Biol.19(3):7137. 10.1161/01.ATV.19.3.713 HEART DISEASE EDUCATION 39 Appendix A Heart Disease Knowledge Study Informed Consent Principal Investigator: Megan Wright MS, RN, DNP Student Contact Information: Phone: 301-268-5442 Email: mwright01@saintmarys.edu Faculty Advisor: Linda Paskiewicz PhD, CNM, RN Contact Information: Phone: 630-487-1225 Email: lpaskie@saintmarys.edu Academic Affiliation: Saint Marys College Statement of Purpose: You are invited to participate in the study of heart disease knowledge among women 45 years and older. We hope to learn about your current knowledge and practices related to heart disease risk. The goal of this project is to provide education about heart disease to help you improve your selfcare practices and overall health. You were selected as a possible participant because you meet the inclusion criteria for this study. Description, Including Risks and Benefits: Description: If you decide to participate, the principle investigator (or office staff) will provide an explanation of the study design, purposes of interventions, and the timeframe of the study. The study procedure includes completion of the Heart Disease Knowledge Questionnaire today during your office visit. After completion of the questionnaire, you will be provided with educational material on heart disease via email or mail (your preference). After receiving heart disease education, you will be followed up with via phone call in one month. The principal investigator will send you a reminder about the follow up phone call. At this time, you will speak with the principal investigator and verbally complete the questionnaire for a second time. At this time, you will have the opportunity to ask additional questions to the principal investigator if desired. Risks: There are no risks involved in the participation of this study. Benefits: The project will help educate patients and will provide guidance and recommendations for health care providers for heart disease education needs. Confidentiality: Any information obtained in connection with this study that can be identified with you will remain confidential and will be disclosed only with your permission. In any written reports or publications, no one will be identified or identifiable and only group data will be presented. This consent form, with your signature, will be stored separately from the data collected so that your responses will not be identifiable. Right to withdraw: Your participation is voluntary. Your decision whether or not to participate will not affect your future relations with WMHS OBGYN in any way. If you decide to participate, you are free to discontinue participation at any time without affecting such relationships. Whom to contact for answers to questions: HEART DISEASE EDUCATION 40 If you have any questions, please ask us. If you have any additional questions later, we will be happy to answer them. Contact Megan Wright (Phone: 301-268-5442 Email: mwright01@saintmarys.edu). You will be given a copy of this form to keep. Signature indicating Informed Consent: You are deciding about whether or not to participate in this study. Your signature indicates that you are at least 18 years of age, have read the information provided above, and have decided to participate. You may withdraw at any time without penalty after signing this form should you choose to discontinue participation in this study. Signature of Participant Date Signature of Witness (when appropriate) Date Signature of Investigator Date HEART DISEASE EDUCATION 41 Appendix B AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION: EDUCATION If the information is about a Mental Illness, Developmental Disability, HIV/AIDS Testing or Treatment Communicable Disease, Venereal Disease, Alcohol or Drug Abuse, Abuse of an Adult with a Disability, Sexual Assault, Child Abuse or Neglect, or Genetic Testing, then the patient must sign the Specific Consent Attachment Patients Name: Last First Middle Medical Record Number: Home Address: Home Telephone: Date of Birth: PURPOSE: When I sign this Authorization, I will allow UPMC Western Maryland Corporation, specifically ______________________________________________________(name of provider or group), to use and disclose the health information listed below for the following purpose (check those that apply): Create and present one or more case study(ies) Create and present one or more presentation(s) Create and publish one or more article(s), textbooks, internet publications, or other publications Other (be specific)____________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ SPECIFY INFORMATION TO BE DISCLOSED: The information that may be disclosed under this Authorization includes (be specific): Description of injury or condition Family History Test Results Patient Treatment Clinical History Patient Demographic (age, sex, etc.) Patient Diagnosis HEART DISEASE EDUCATION 42 Other: (explain)__________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ By putting my initials here, I give my permission to use and disclose photograph(s), videotape(s) or audiotapes(s) or other images such as an MRI of me, with or without my name, for the purposes listed on this Authorization. RECIPIENT: The following are the people to whom UPMC Western Maryland Corporation may disclose my health information: ______ Attendees at a public conference(s), seminar(s), or other educational session(s) Students who are performing research as part of their academic curriculum (with the understanding that the health information may be used as part of a class project/presentation Publishers and readers of a publication(s) Health Care providers at the following type of gatherings (be specific): Other (be specific): I understand that UPMC Western Maryland Corporation will/will not (circle one), directly or indirectly, receive any items of value from any third party in connection with the use or disclosure of the health information. TERM: This Authorization will remain in effect: From the date of this Authorization until the following date: Until the following event occurs (e.g. after the conference is over): , 20 Other (e.g. no expiration): Note: The Term for mental health records must be stated you may not use no expiration. Provide a copy of the signed Authorization to Patient I understand that once the health information is disclosed to the recipient, UPMC Western Maryland Corporation cannot guarantee that the recipients will not re-disclose the health information to third parties or as required by law. The third parties may not be required to comply with this Authorization or applicable federal and Maryland law governing the use and disclosure of the health information. I understand that I may refuse to sign this authorization and that my refusal to sign will not affect my ability to obtain treatment or payment or my eligibility for benefits at UPMC Western Maryland Corporation. I may inspect or copy any information used/disclosed under this Authorization. HEART DISEASE EDUCATION 43 I understand that I may change my mind and revoke this Authorization in writing at any time by notifying the UPMC Western Maryland Corporation Compliance Officer (see the information below), and changing my mind will not affect my treatment. The revocation will not apply to the extent that UPMC Western Maryland Corporation has already taken action where it relied on my permission. I have read and understand the terms of this Authorization and I have had a chance to ask questions about the use and disclosure of health information. I authorize UPMC Western Maryland Corporation to use or disclose my health information in the manner described above. Signature of Patient or Personal Representative* Name of Personal Representative* (if applicable) Date Relationship to Patient * The Personal Representative is the patients decision maker. It can be the parent if the patient is a minor, legal guardian, health care surrogate, or other person. Scott Borsuk Compliance Officer UPMC Western Maryland Corporation 12400 Willowbrook Road P.O. Box 539 Cumberland, Maryland 21502 Telephone: (240) 964-8105, Email: sborsuk@wmhs.com *Provide a copy of signed Authorization to Patient HEART DISEASE EDUCATION 44 Appendix C Demographics and Health History Form Please answer the following questions by filling in the blanks with the correct answers or by choosing the best answer. 1. Please provide your contact information so that you can receive educational material and be followed up with: Phone: ____________________________________________________ Email: _____________________________________________________ Address: ___________________________________________________ How would you like to receive your educational material? (check one box) Email Mail 2. Age: _______ 3. What is your ethnic origin/race? (check one box) White Black Hispanic Native American Asian or Pacific Islander Other 4. How much education have you completed? (Years of formal schooling completed) 8TH grade or less Some high school High school graduate or GED Some college or technical school College graduate HEART DISEASE EDUCATION Graduate degree 5. How tall are you? _________ 6. How much do you weigh? __________ 7. How many days per week do you exercise for at least 30 minutes or longer? _________ If you do exercise, what kind of exercise do you usually do? Endurance (ex: walking, jogging, running, biking) Strength (ex: lifting weights, using resistance bands) Flexibility (ex: stretching, yoga) 8. Do you smoke cigarettes? Yes No If yes, how long have you been smoking? ______________ How many cigarettes do you smoke per day? _____________ 9. Do you have a history of heart disease? Yes No 10. Does anyone in your family have a history of heart disease? Yes No 11. Have you ever been told your blood pressure is too high? (140/90mmHg or higher?) Yes No If yes, do you take any medications for high blood pressure? Yes 45 HEART DISEASE EDUCATION No 12. Have you ever been told that your cholesterol is too high? Yes No If yes, do you take any medications for high cholesterol? Yes No 13. Have you ever been told that you have diabetes? Yes No 46 HEART DISEASE EDUCATION 47 Appendix D Heart Disease Knowledge Questionnaire Instructions: Please respond to the following questions addressing your beliefs and knowledge about various aspects of heart disease. Answer each question by circling True or False. Feel free to circle I dont know if you are unsure of an answer. Your participation is this project greatly appreciated! 1. Polyunsaturated fats are healthier for the heart than saturated fats. True False I dont know 2. Women are less likely to get heart disease after menopause. True False I dont know 3. Having a history of chicken pox increases heart disease risk. True False I dont know 4. Eating a lot of red meat increases heart disease risk. True False I dont know 5. Most people can tell whether or not they have high blood pressure. True False I dont know 6. Trans-fats are healthier for the heart than most other kinds of fats. True False I dont know 7. The main cause of heart attacks is stress. True False I dont know 8. Walking and gardening are considered types of exercise that can lower heart disease risk. HEART DISEASE EDUCATION True False 48 I dont know 9. Most of the cholesterol in an egg is the white part of the egg. True False I dont know 10. Smokers are more likely to die from lung cancer than heart disease. True False I dont know 11. Taking an aspirin each day decreases heart disease risk. True False I dont know 12. Dietary fiber lowers blood cholesterol. True False I dont know 13. Heart disease is the leading cause of death in the United States. True False I dont know 14. The healthiest forms of exercise for the heart involve rapid breathing for a sustained period of time. True False I dont know 15. Turning pale or gray is a symptom of having a heart attack. True False I dont know 16. A healthy person's pulse should return to normal within 15 minutes after exercise. True False I dont know 17. Sudden trouble seeing in one eye is a common symptom of having a heart attack. True False I dont know HEART DISEASE EDUCATION 49 18. Cardiopulmonary resuscitation (CPR) helps to clear clogged blood vessels. True False I dont know 19. HDL refers to good cholesterol, and LDL refers to bad cholesterol. True False I dont know 20. Atrial defibrillation is a procedure where hardened arteries are opened to increase blood flow. True False I dont know 21. Feeling weak, lightheaded, or faint are common symptoms of having a heart attack. True False I dont know 22. Taller people are at higher risk for developing heart disease. True False I dont know 23. High blood pressure is defined as 110/80 (systolic/diastolic) or higher. True False I dont know 24. Women are more likely to die from breast cancer than heart disease. True False I dont know 25. Margarine with liquid safflower oil is healthier than margarine with hydrogenated soy oil. True False I dont know 26. People who have diabetes are at higher risk for heart disease. True False I dont know HEART DISEASE EDUCATION 50 27. Men and women experience many of the same heart attack symptoms. True False I dont know 28. Eating a high fiber diet increases heart disease risk. True False I dont know 29. Heart disease is better defined as a short-term illness than a chronic, long-term illness. True False I dont know 30. Many vegetables are high in cholesterol. True False I dont know HEART DISEASE EDUCATION 51 Appendix E Heart Disease Knowledge Questionnaire Rationales and American Heart Association Heart Disease Education Thank you for participating in this project! This packet contains some main takeaways and rationales to the Heart Disease Knowledge Questionnaire that you completed at the UPMC Western Maryland OB/GYN Office. I have also included education from the American Heart Association focused on heart disease, cholesterol, blood pressure, healthy diet, exercise, and smoking. I will follow up with you in a few weeks to see if you have any questions or need any more information. I also will be in contact with you to complete the questionnaire for a second time after viewing the education. This can be done either by email or over the phone. I have included my contact information below. Thanks! Name: Megan Wright Phone: 301-268-5442 Email: mwright01@saintmarys.edu Heart Disease Knowledge Takeaways 1. Heart disease is the leading cause of death in the United States. Heart disease is a significant health problem in the United States. Heart disease is the leading cause of death and is the cause of an enormous burden for communities, health care providers, and health systems. Approximately 13 million Americans have a diagnosis of heart disease (CDC, 2020). 2. Heart disease is a long-term disease. Heart disease generally refers to conditions that narrow or block blood vessels, leading to myocardial infarction (MI), angina, or cerebrovascular accident (Mayo Clinic, 2020). Harding of the arteries, or arthrosclerosis, is when the inner walls of arteries become narrower due to buildup of plaque (usually caused by high fat diet, cigarette smoking, diabetes or hypertension. This occurs over time. (AHA, 2021). 3. Smokers are more likely to die from heart disease than lung cancer. Smokers are at greatest risk for diseases that affect the heart and blood vessels (heart disease). Heart disease is associated with a higher rate of death among smokers than lung cancer (CDC, 2020). 4. People who have diabetes are at higher risk for heart disease. HEART DISEASE EDUCATION 52 Over time, high blood sugar can damage blood vessels and the nerves that control your heart. People with diabetes are also more likely to have other conditions that raise the risk for heart disease, including: high blood pressure, high cholesterol, and high triglycerides (CDC, 2020). 5. Women are more likely to die from heart disease than breast cancer. Heart disease is the leading cause of death among men and women! Only 50% of women correctly recognize heart disease as their most common killer (CDC, 2020). 6. Women are more likely to develop heart disease after menopause. Decreases in estrogen causes post-menopausal women to be more prone to diseases associated with estrogen deficiency, including heart disease, osteoporosis, and dyslipidemia (Peacock & Ketvertis, 2020). Coronary artery disease rates are 2 to 3 times higher in post-menopausal women. 7. Having a history of chicken pox does not increase heart disease risk. A history of chicken pox is not associated with increased risk of heart disease. 8. Taller people are not at higher risk for developing heart disease. Being taller is not associated with increased risk of heart disease. Modifiable risk factors for heart disease include hypertension (>140mmHg SBP and/or >90 mmHg DBP, depending on age), smoking, sedentary lifestyle, and high cholesterol. Non-modifiable risk factors related to the development of heart disease include age, postmenopausal status, family history of heart disease, and African-American ethnicity (Dunphy, Winland-Brown, Porter & Thomas, 2019). 9. HDL refers to good cholesterol, and LDL refers to bad cholesterol. HDL cholesterol is called good cholesterol. Having a higher level of HDL can lower your risk of heart attack and stroke. LDL cholesterol is known as bad cholesterol. The bodys tissues use some of this cholesterol to build cells. But when you have too much of it, LDL can build up in your arteries (AHA, 2021). 10. High blood pressure is a systolic pressure of 130 or higher, or a diastolic pressure of 80 or higher, that stays high over time. High blood pressure usually has no signs and symptoms. Thats why its so dangerous. But it can be managed (AHA, 2021). HEART DISEASE EDUCATION 53 11. Polyunsaturated fats are healthier for the heart than saturated fats. Polyunsaturated fats are found in vegetable oils and fish oils. These can improve blood cholesterol when eaten as part of a healthy diet and should be used to replace saturated or trans fats. Monounsaturated fats are found in olive, canola, peanut, and sunflower oils. As part of a healthy diet they may help improve blood cholesterol (AHA, 2021). 12. Saturated fats and trans fats are unhealthy for the heart. Saturated fat raises blood cholesterol, so too much is not good for you. Aim for a diet that has 56% or less of calories from saturated fat. Animal fats like lard and meat fat and some tropical oils like coconut oil, palm oil, and palm kernel oil contain saturated fats. Trans fat comes from adding hydrogen to vegetable oils and tend to raise blood cholesterol. Its used in commercial baking goods and for cooking in many restaurants and fast food chains. It is also found naturally in milk and beef. Eliminate trans fat by avoiding foods with hydrogenated oils (AHA, 2021). 13. Eating a high fiber diet decreases heart disease risk. Studies have shown that high-fiber foods may have heart-healthy benefits, such as reducing blood pressure and inflammation (Mayo Clinic, 2021). 14. Dietary fiber lowers blood cholesterol. 15. Vegetables do not contain cholesterol. Cholesterol is only found in foods that come from animals, there is no cholesterol in foods that come from plants (AHA, 2021) 16. Eating a lot of red meat increases heart disease risk. Limit red meats. If you choose to eat red meats, select lean cuts of meat. Trim all visible fat and throw away the fat that cooks out of the meat (AHA, 2021). 17. Most of the cholesterol in an egg is in the yellow part of the egg. One large egg has about 186 mg of cholesterol all of which is found in the yolk. If you like eggs but don't want the cholesterol, use only the egg whites. Egg whites contain no cholesterol but still contain protein. You may also use cholesterol-free egg substitutes, which are made with egg whites (Mayo Clinic, 2021). HEART DISEASE EDUCATION 54 Soluble fiber found in beans, oats, flaxseed and oat bran may help lower total blood cholesterol levels by lowering low-density lipoprotein, or "bad," cholesterol levels (Mayo Clinic, 2021). 18. Margarine with liquid safflower oil is healthier than margarine with hydrogenated soy oil. Focus on limiting foods that list the words hydrogenated oils in the ingredients (AHA, 2021). 19. The healthiest forms of exercise for the heart involve rapid breathing for a sustained period of time. Aerobic exercise improves circulation, which results in lowered blood pressure and heart rate. Aerobic exercise also reduces the risk of type 2 diabetes and, if you already live with diabetes, helps you control your blood glucose (John Hopkins Medicine, 2021). 20. Walking and gardening are considered types of exercise that can lower heart disease risk. Other examples include brisk walking, running, swimming, cycling, playing tennis and jumping rope. Heart-pumping aerobic exercise is the kind that doctors have in mind when they recommend moderate activity (John Hopkins Medicine, 2021). 21. A healthy persons pulse should return to normal within 15 minutes after exercise. Doing an average of 40 minutes of moderate to vigorous intensity aerobic activity 3 to 4 times per week can help lower heart disease risk (AHA, 2021). 22. Stress is not the main cause of a heart attack. Plaque buildup in the inner walls of the arteries (usually caused by a diet high in fat, cigarette smoking, diabetes, or hypertension) limits the flow of blood to the heart and brain. Sometimes plaque can break open. When this happens a blood clot forms and blocks blood flow in the artery. Heart attacks occur when the blood flow to a part of the heart is blocked, usually by a blood clot. This cuts off blood flow completely and part of the heart muscle supplied by that artery begins to die (AHA, 2021). 23. Feeling weak, lightheaded, or faint are common symptoms of having a heart attack. The main symptoms of having a heart attack include: Uncomfortable pressure, squeezing, fullness or pain in the center of your chest. It Lasts more than a few minutes, or goes away and comes back. Pain or discomfort in one or both arms, the back, neck, jaw, or stomach. Shortness of breath with or without chest discomfort. Other signs such as breaking out in cold sweat, nausea, or lightheadedness (AHA, 2021). 24. Turning pale or gray is a symptom of having a heart attack. HEART DISEASE EDUCATION 55 In addition to the other symptoms, people who are having a heart attack often look pale and sickly. 25. Sudden trouble seeing in one eye is not a common symptom of a heart attack. 26. Men and women experience many of the same heart attack symptoms. Men and women experience many of the same heart attack symptoms. As with men, womens most common heart attack symptom is chest pain or discomfort. But women are somewhat more likely than men to experience some of the other common symptoms, particularly shortness of breath, nausea/vomiting and back or jaw pain (AHA, 2015). 27. Taking an aspirin each day decreases heart disease risk. Daily aspirin therapy may lower your risk of heart attack, but daily aspirin therapy isn't for everyone. If you've had a heart attack or stroke, your doctor will likely recommend you take a daily aspirin unless you have a serious allergy or history of bleeding. If you have a high risk of having a first heart attack, your doctor will likely recommend aspirin after weighing the risks and benefits (Mayo Clinic, 2019). You shouldn't start daily aspirin therapy on your own, however. While taking an occasional aspirin or two is safe for most adults to use for headaches, body aches or fever, daily use of aspirin can have serious side effects, including internal bleeding. (Mayo Clinic, 2019). 28. Most people cannot tell if they have high blood pressure. The danger is that you usually cant tell if you have high blood pressure! There are no signs, so you must see a doctor every year. Also, no one knows exactly what causes it. Yet, high blood pressure can lead to hardened arteries, stroke, or heart attack (AHA, 2021). 29. Angioplasty is a procedure to open narrowed or blocked blood vessels to increase blood flow. Fatty deposits can build up inside the arteries and block blood flow. A stent is a small, metal mesh tube that keeps the artery open. Angioplasty and stent placement are two ways to open blocked peripheral arteries (MedlinePlus, 2021). 30. CPR is an emergency lifesaving procedure that is performed when the heart stops beating. CPR is useful in many emergency situations including a heart attack (Mayo Clinic,, 2018). HEART DISEASE EDUCATION 56 HEART DISEASE EDUCATION 57 HEART DISEASE EDUCATION 58 HEART DISEASE EDUCATION 59 HEART DISEASE EDUCATION 60 HEART DISEASE EDUCATION 61 HEART DISEASE EDUCATION 62 HEART DISEASE EDUCATION 63 HEART DISEASE EDUCATION 64 HEART DISEASE EDUCATION 65 HEART DISEASE EDUCATION 66 HEART DISEASE EDUCATION 67 HEART DISEASE EDUCATION 68 HEART DISEASE EDUCATION 69 HEART DISEASE EDUCATION 70 HEART DISEASE EDUCATION 71 HEART DISEASE EDUCATION 72 HEART DISEASE EDUCATION 73 HEART DISEASE EDUCATION 74 HEART DISEASE EDUCATION 75 HEART DISEASE EDUCATION 76 Appendix F Original Gannt Chart: DNP Project Implementation Timeline Submit IRB and Project Proposal. Defend project. Finalize educational materials Print questionnaire/ educational material. Collect Data Follow up phone calls Data Analysis Months Nov 2020 Dec 2020 Jan 2021 Feb 2021 MarchJuly 2021 HEART DISEASE EDUCATION 77 Revised Gannt Chart: DNP Project Implementation Timeline Submit Project Proposal and Defend Project Finalize materials / plan for project Submit IRB to Saint Marys College Saint Marys IRB Approval Collect Data Follow up phone interviews Data Analysis Months Nov 2020 Jan 2021 Feb March 2021 2021 MarchApril 2021 MayJune 2021 JuneJuly 2021 HEART DISEASE EDUCATION 78 Appendix G Operational Budget 2021 Implementation of Heart Disease Education for Women at an Obstetrics and Gynecology Clinic Cost Project Component Cost Category Determination of Cost Direct Cost Indirect Cost Total Cost Personnel NonMonetary Cost In-Kind Contribution 1. Key Stakeholder(s) $0 $0 $0 $0 2. DNP Student $0 $0 $0 $0 3. Office Staff $0 $0 $0 $0 $0 $0 $0 $0 Facilities OB/GYN Office Materials NonMonetary Cost In-Kind Contribution HEART DISEASE EDUCATION Printed informed consent, UPMC Authorization to Disclose Health Information, Demographics Form, HDKQ Monetary Cost 79 40 units X $1.25 $50.00 $0 $50.00 $50.00 $25.00 $0 $50.00 Monetary Cost $50.00 $50.00 $0 $50.00 NonMonetary Cost In-Kind Contribution $0 $0 $0 $0 Printing educational Monetary materials and price of Cost postage Incentives Doughnuts and lunch for office Equipment TOTAL COST $150.00 Costs Cost Category 2021 Budget Staff Incentives In-Kind Contribution $50.00 HEART DISEASE EDUCATION 80 Facilities In-Kind Contribution $0.00 Materials: In-Kind Contribution $100.00 Total Cost: $150.00 HEART DISEASE EDUCATION 81 Appendix H Power Analysis HEART DISEASE EDUCATION 82 Appendix I CITI Training HEART DISEASE EDUCATION 83 Appendix J Literature Synthesis Table HEART DISEASE EDUCATION 84 HEART DISEASE EDUCATION 85 HEART DISEASE EDUCATION 86 HEART DISEASE EDUCATION 87 HEART DISEASE EDUCATION 88 HEART DISEASE EDUCATION 89 HEART DISEASE EDUCATION 90 HEART DISEASE EDUCATION 91 HEART DISEASE EDUCATION 92 HEART DISEASE EDUCATION 93 HEART DISEASE EDUCATION 94 HEART DISEASE EDUCATION 95 HEART DISEASE EDUCATION 96 HEART DISEASE EDUCATION 97 HEART DISEASE EDUCATION 98 HEART DISEASE EDUCATION 99 HEART DISEASE EDUCATION 100 HEART DISEASE EDUCATION 101 HEART DISEASE EDUCATION 102 HEART DISEASE EDUCATION 103 HEART DISEASE EDUCATION 104 HEART DISEASE EDUCATION 105 HEART DISEASE EDUCATION 106 HEART DISEASE EDUCATION 107 HEART DISEASE EDUCATION 108 HEART DISEASE EDUCATION 109 HEART DISEASE EDUCATION 110 HEART DISEASE EDUCATION 111 HEART DISEASE EDUCATION 112 HEART DISEASE EDUCATION 113 HEART DISEASE EDUCATION 114 HEART DISEASE EDUCATION 115  ...

... 1 2 The Implementation of Mock Code Simulations Ellen M. Wray Adult-Gerontology Acute Care Nurse Practitioner Track Department of Nursing Science, Saint Marys College Doctor of Nursing Practice Program Faculty Team Leader: Dr. Annette Peacock Johnson 3 Acknowledgment This paper and the research behind it would not have been possible without the exceptional support of my advisor, Professor Annette Peackock-Johnson. Her support, knowledge, and attention to detail have helped carry me through all of the stages of my project. I would also like to thank the key stakeholders involved in this project, Janet Haw, Joe Canino, Megan Gross, and Jackie Corbett for their eagerness and willingness to assist me in this project. I would also like to thank my classmates for the peer reviews along with brilliant suggestions and comments allowing me to complete this project and my research to the best of my ability. As well as Saint Marys College as without their support, this project would not have been possible. Finally, I would like to my husband Evan and my family for their continuous support and understanding when completing my research and writing this paper. Their love, patience, and belief in me kept my spirits and motivation high during this project. 4 Abstract Medical emergencies are high-risk situations that occur infrequently. The patients outcome largely depends on the ability of the first responders and the effectiveness with which they provide emergency care. When healthcare providers are not confident in their ability to provide emergency care, this often leads to a delay in recognition of a deteriorating patient as well as action taken. Simulation-based learning can be utilized to improve healthcare workers confidence levels, thus improving their efficiency and effectiveness when responding to an emergency. The aim of this study was to improve the self-confidence levels of healthcare providers by implementing mock code simulations at routine 3-month intervals. The PICOT question for this project was: Do healthcare providers in the hospital have improved confidence from the implementation of mock code simulations at routine 3-month intervals? Simulation training allows participants to integrate knowledge learned while practicing skills without fear of patient harm. This practice innovation project was performed at Rush University Medical Center in the Interventional Services (IS) Department. It was implemented in three phases with the assistance of key stakeholders. The target population for this project was the healthcare providers participating in the mock code simulation scenarios. Sixteen participants completed two mock code simulation scenarios specific to the IS Department. Data collected by the DNP student shows an increase in self-confidence levels after mock code simulations. A paired t-test was used to analyze the pre-test and post-test simulation 1 data and showed a statistically significant increase (t = -10.894, n = 16, p = <0.001) in self-confidence as well as the pre-test and post-test simulation 2 data (t = -4.478, n = 16, p = 0.003) as scored by the participants using the VAS. Keywords: mock code simulation, confidence levels, healthcare providers 5 Contents Introduction .......................................................................................................................... 6 Background ........................................................................................................................... 7 Problem Statement ............................................................................................................... 8 PICOT Question..............................................................................................................................9 Objectives......................................................................................................................................9 Literature Review .................................................................................................................. 9 Concept Map ............................................................................................................................... 12 Scholarly Project and the Novice to Expert Theory ................................................................ 12 Implementation Model ........................................................................................................ 14 Social Entrepreneurship, Innovation, and Sustainability ....................................................... 15 Ethical considerations .......................................................................................................... 16 Risks and Benefits to Participants ................................................................................................. 16 Informed Consent and Confidentiality .......................................................................................... 17 Discussion of Methods ......................................................................................................... 18 Key Stakeholders ......................................................................................................................... 18 Participants Criteria and Recruitment ........................................................................................... 18 Interventional Plan ...................................................................................................................... 19 Demographic Qualitative & Quantitative Data .............................................................................. 19 Budget ......................................................................................................................................... 20 Data analysis....................................................................................................................... 21 Conclusion ........................................................................................................................... 26 Appendix A .......................................................................................................................... 27 Appendix B .......................................................................................................................... 29 Appendix C .......................................................................................................................... 30 Appendix D.......................................................................................................................... 31 Appendix E .......................................................................................................................... 32 Appendix F .......................................................................................................................... 33 References........................................................................................................................... 34 6 DNP Practice Innovation Project Proposal Paper Introduction Nurses are expected to have the ability to quickly and accurately notice when a patient is deteriorating and to intervene appropriately. Medical emergencies such as cardiac arrest are high-risk situations that occur infrequently. The patients outcomes are largely dependent on the ability of the first responders (most often nurses) to provide the emergency care required within the first few minutes of a cardiac arrest. In-hospital cardiac arrests (IHCA) in the U.S. have a 21% survival-to-hospital discharge rate (Adcock et al., 2020, p. 50). This outcome is often related to nurses hesitant and inadequate responses, leading to a delay in cardiopulmonary resuscitation (CPR). Not only do recent graduates respond with anxiety during a code situation, but experienced nurses respond with anxiety resulting in a delay in CPR initiation (Williams et al., 2016). It is vital to ensure that nurses are confident in their ability to provide high-quality CPR in emergency situations. Simulation-based education can improve nurses knowledge and communication skills when focusing on a deteriorating patient (Crowe et al., 2018). All nurses are required to be CPR certified, as CPR during a cardiac arrest is essential to restore blood flow to vital organs. Chu and Robilotto (2018) found that approximately 3 months after CPR training, nurses CPR skills decrease dramatically due to infrequent practice. Implementing simulation-based mock codes at routine intervals can improve nurses performance and self-confidence during code situations. Frequent practice opportunities for mock codes improved teamwork, response time, and confidence (McPhee, 2018). First responders must have the confidence and skill to take action during a cardiac arrest. In order to improve patient outcomes by increasing the self-confidence of healthcare providers, this Innovation Practice Project focused on the implementation of mock 7 code simulations in the Interventional Services (IS) Department at Rush University Medical Center (RUMC). Background An estimated 209,000 adult in-hospital cardiac arrests occur annually in the United States (Morton et al., 2019, p. 177). It is imperative for the patients survival that the nurses providing care to the patient react efficiently and effectively when performing lifesaving techniques such as CPR. Hospitals with active mock code programs and education achieved a higher percentage of defibrillation in less than two minutes (Josey et al., 2018). The American Heart Association (AHA) has added Booster Training to their updated 2020 CPR guidelines. These are frequent, brief sessions focused on the repetition of prior content (Merchant et al., 2020). Booster Training has been associated with improved CPR skill retention between certification classes (Merchant et al., 2020). The AHA has also encouraged the addition of in situ simulation training. In situ training occurs in actual patient-care areas and provides learners with a more realistic training environment. This DNP practice innovation project meets these two guidelines proposed by the AHA by providing in situ mock code training sessions at more frequent intervals. The target population for this project was the healthcare providers participating in the mock code simulation scenarios. The healthcare providers most likely to be involved in a code blue situation are registered nurses, health technicians, physicians and medical students, respiratory therapists, pharmacists, and nursing management (Dillion et al., 2018). When healthcare providers participate in mock code simulations, studies have demonstrated decreased fears and anxiety related to resuscitation, improved communication, and increased knowledge and familiarity with resuscitation guidelines (Hutcheson et al., 2020). More specifically, the 8 target population for implementation of this project was healthcare workers who provide direct patient care in the IS Department at RUMC who hold a current CPR certification. The implementation of mock code simulations is within the scope of the DNP-prepared APRN as the APRN, especially in critical care areas, will be leading and giving orders during a code and other emergency situations. The APRN should participate in all mock code simulations to ensure that all participants are on the same page and to provide education when necessary. It is imperative that the APRN work as a team with all participants to help increase participant knowledge and skills, thus increasing participants self-confidence levels. Debriefing should be performed during mock code simulations to review what participants believe went well and what did not during the simulation. The APRN should be well versed in debriefing as it is an essential aspect of providing education after medical emergencies. The doctorally prepared APRN plays a vital role during mock code simulations and has the ability to offer unique insights during training. Problem Statement When patients experience a medical emergency in the hospital, it is imperative for the healthcare provider to effectively and efficiently identify the deteriorating patient to provide the best possible outcome for the patient. This can be accomplished by increasing the confidence levels of healthcare providers through the implementation of mock code simulations. Simulation training provides clinical practice challenges while developing knowledge and skills in an open and trusting environment without the fear of harming patients, thus, reducing fear and anxiety (Ahmad et al., 2017). Through mock code simulation training, healthcare providers can develop an increase in confidence in their resuscitation skills, creating improved patient outcomes. 9 There is a need for increased research on the benefit of mock code simulations, as this is a relatively new phenomenon. With improved technology and the development of simulation labs with incredibly realistic simulation manikins, mock code simulations can create life-like emergency scenarios. The DNP project aims to explore the relationship between mock code simulations and participant self-confidence levels. Not only do mock code simulations improve participants self-confidence, but they contribute to nursing knowledge by providing education to all participants and reinforcing participant skills in emergency situations. Increasing awareness of patient safety and recent advances in technology are the main incentives to use simulation to teach and evaluate clinical competencies (Ahmad et al., 2017, p. 1). PICOT Question: Do healthcare providers in the hospital have improved confidence levels from the implementation of mock code simulations at routine three-month intervals? Objectives Implement mock code simulation scenarios in the IS department at RUMC to improve participant self-confidence levels. Increase awareness of the importance of mock code simulations at routine intervals to improve patient outcomes by deliberate practice, booster learning, and in situ education. Collaborate with key stakeholders at RUMC to identify the importance of mock code simulations and the need for evidence that can be translated into clinical practice. Literature Review During the last 20 years, simulations have become an essential part of education and training in healthcare (Al Gharibi & Arulappan, 2020). Simulation has evolved due to the increased demand of healthcare providers to deliver high-quality care to increasingly complex patients. Simulation training allows participants to integrate the knowledge learned while 10 practicing the skills. In situ mock code simulations significantly increase staff confidence levels (Herbers & Heaser, 2016). In their literature review of 11 articles, Al Gharibi & Arupallan (2020) examined the outcomes of repeated simulation experiences on self-confidence. The literature review results revealed a statically significant increase in the perceived level of participant self-confidence from baseline (63% increase). Lubbers & Rossman (2017) performed a quasi-experimental study using 61 undergraduate nursing students at a Midwestern college to evaluate the use of simulation by measuring novice learners' self-confidence and satisfaction levels. When implementing mock code simulations, Lubbers & Rossman (2017) suggest that the scenarios utilized be standardized, reproducible, clinically accurate, and mimic real-life situations. The students rated their selfconfidence and satisfaction levels using a 12-item Likert scale with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The study reported that the students experience yielded a high level of self-confidence with the simulation experience, thus suggesting that simulationbased learning can be utilized to improve participant self-confidence levels in emergency situations. A study performed by Kiernan (2018) was designed to demonstrate the use of simulation technology to improve clinical competency and confidence in nurses, thus improving patient outcomes. The sample group in this study consisted of 40 adult nursing students. The students were separated into three groups to complete the simulation scenarios. Each student was asked to complete a pre- and post-test comprised of a Likert scale to rate their confidence levels. It was found that most students underestimated their ability to perform basic clinical skills. The students expressed increased confidence once the skills were reinforced in a safe and judgment-free 11 environment. Nursing students exposed to deliberate practice utilizing simulation are highly likely to be competent and confident in safely performing skills when caring for patients. Crowe et al. (2018) implemented a quality improvement program at a large tertiary hospital in Canada. No patient identifiers were included in the data provided for the study. This study focused on the impact of simulation education on post-licensure nurses working in a general medicine unit. The Adult Learning Theory was utilized in this study as Crowe et al. (2018) states that adult education is most impactful when engaging learners in activities related to their own experience. A 12-item self-confidence scale was created and validated for the purpose of this study. The simulation education sessions were performed over a three-week period where participants attended seven sessions in groups of six. Three hundred thirty-one nurses participated in the simulation sessions. An overall improvement in confidence was measured immediately after completion of the simulation education and at a three-month followup. Due to the scenarios provided for the simulations, it is reasonable to conclude that simulation-based learning can increase nurses confidence related to the deteriorating patient. Hossino et al. (2018) performed a study to assess the effects of simulation scenarios focused on resuscitation to improve confidence in medical residents. The authors argue that in order to become proficient in resuscitation, it is essential for healthcare providers to participate in real-life events routinely. Simulation scenarios allow for the practice of real-life events without the fear or possibility of harming a patient. Twenty-six residents participated in the simulation scenarios, each taking turns in all of the designated roles. After the simulations were completed, the residents completed a Likert scale questionnaire to assess their self-reported confidence levels. The study results revealed that simulation training has significant positive improvements in the self-reported confidence of residents. 12 Concept Map Scholarly Project and the Novice to Expert Theory Patricia Benners Novice to Expert Model was the theoretical framework used for this study. The phenomena of interest for the DNP Practice Innovation Project was the implementation of mock code simulations to improve participant confidence levels. Tiitinen et al. (2020, p. 234) defines theory as a set of interrelated concepts, definitions, and propositions that explain events or situations by specifying relationships among variables. Theories such as Patricia Benners Novice to Expert Model are helpful when implementing a quality improvement project as all participants will begin in the novice stage with the goal to advance to the expert stage. This theoretical framework helped the facilitator to understand the goal and guide participants through the learning process. Theories play a crucial role in developing quality improvement interventions. 13 The Novice to Expert Theory served as the foundational building block for the DNP project as mock code simulations have been shown to increase nursing skills, knowledge, and confidence. The use of simulation allows students clinical reasoning skills to evolve as they are able to perform skills in a real-world problem-solving context. Studies have revealed that many new graduate nurses lack professional confidence upon entry into professional practice (Ortiz, 2016). As nurses go through the phases of Benners Novice to Expert Theory, they gained confidence as their knowledge increased. Once a nurse has reached the expert phase, they `have the ability to confidently assess and react to the patients needs without losing time. The use of simulation can help to advance the nurses through these phases without the worry of harming patients in the learning process. Previous research supports that with better quality practice environments, the greater the outcomes for nurses and patients (Papastavrou et al., 2015). By improving the practice environment, nurses can learn to facilitate care according to the individualized needs of the patient. Individualized nursing care is a significant indicator of quality nursing care and should be integrated into nursing practice. Benners Novice to Expert Model helps guide nurses in their care practices by providing the theoretical framework (Ozdemir, 2019). The APRN plays a significant role in applying theory to the mock code simulation education sessions. The APRN helps to facilitate the learning environment to effectively educate participants and guide them through the phases of Benners Novice to Expert Model. The utilization of theory-based design is key to conducting research so it can, in turn, guide development efforts and improve professional practice (Hill et al., 2020). 14 Implementation Model The implementation model was split into three phases, pre-implementation, implementation, and post-implementation. The focus of the pre-implementation phase was the development of the simulation program. This included the planning and designing of the simulation scenarios specific to the Interventional Services (IS) Department patient population. Four simulation scenarios were developed in collaboration with the key stakeholders utilizing the most commonly occurring emergency situations in the IS Department. The 4 simulation scenarios were determined by reviewing the safety reports within the IS Department. The most commonly occurring safety events were adapted for the mock code simulation scenarios. This objective was completed with advice and collaboration from the CNS in the IS department. This phase also included gaining support from key stakeholders such as the unit leadership, nurses, physicians, pharmacists, and advanced practice providers. During the pre-implementation phase, the participants were divided into groups for each simulation and assigned a specific role according to their job title. The Visual Analog Scale (VAS) was selected during the preimplementation phase as the assessment tool for measuring confidence levels. VAS allows more variability in measurements as participants are not limited to only a few responses in order to express how they feel. The VAS allows for fine-grained measurements thus preventing measurement errors (Sung & Wu, 2018). Once the aforementioned tasks and a timeline were completed, the implementation phase began. This project was implemented in multiple phases through two mock code simulations approximately 2 months apart. The 2-month time period as opposed to a 3-month time period was chosen by the key stakeholders involved due to time constraints within the institution. The Interventional Services Department has approximately sixty employees. It was projected that it 15 would take 2 months for each member to participate in the first mock code simulation. At the end of this 2-month period, the second round of mock code simulations began, starting with the first group of participants trained. At the completion of the mock code simulation training, participants were assessed for a change in their knowledge and confidence level during code blue situations. The post-implementation phase of this project included data collection and analysis. The DNP student met with a statistician to receive advice regarding the data analysis. The data collected using the VAS assessment tool was analyzed to determine an improvement in the selfconfidence levels of each of the participants. The data was measured before and after each simulation experience resulting in 4 different data points. Data for only the participants who completed two mock code simulations were included in the quantitative data analysis. The final goal of this quality improvement project was to increase participants self-confidence levels through the implementation of mock code simulations, potentially increasing response time and patient outcomes. Social Entrepreneurship, Innovation, and Sustainability Sustainable health systems have adequate resources to meet their objectives and are able to adapt and evolve in a continuously changing environment. One way to achieve sustainability is by implementing improvements, interventions, and change strategies (Braithwaite et al., 2017). This DNP project fits with sustainability as the implementation of simulation-based mock codes can be a sustainable project through continual utilization of mock code scenarios to provide education and keep providers aware of the most up-to-date guidelines. Successful innovations often possess two essential qualities: usability and desirability (Kelly & Young, 2017). The DNP project fits into this description of innovation; it is desirable since it can be used to improve 16 patient outcomes by improving staff confidence and knowledge in emergency situations. It is usable and can be easily implemented with routine education. Social entrepreneurs act as change agents by improving systems and creating sustainable solutions (Altman & Brinker 2016). Engaged nurses on the frontlines are central to achieving and sustaining change. The concept of social entrepreneurship can help support nurses leading change initiatives. Healthcare social entrepreneurs seek creative solutions to problems, utilize insights to identify and mitigate problems, and tackle challenges in the context of scarce resources (Altman & Brinker, 2016, p. 30). The implementation of mock code simulations aligns with social entrepreneurship as it is a creative solution in helping to identify and mitigate issues that occur when there is an emergency situation. This helps to improve patient outcomes by delivering high-quality care. In healthcare, a social entrepreneur provides high-quality care with positive patient outcomes. This is done by the implementation of innovative ideas. Ethical considerations Risks and Benefits to Participants The participants in this study can benefit in many ways. Hospital staff who are inexperienced in emergency situations may have anxiety and are hesitant to begin resuscitation for fear they may perform a wrong action, cause harm to the patient, or are unsure of their roles and responsibilities (Lee et al., 2021). Lee et al. (2020) showed that participants self-confidence and knowledge are improved through simulation-based training. Repeated mock code training may be an effective strategy in providing increased confidence in the healthcare providers when delivering chest compressions, assessing for a pulse and breathing, identifying dysrhythmias, and using a cardiac monitor/defibrillator. Not only will this project benefit the participants, but the patients who are receiving care during emergency situations. When those providing care can 17 effectively and efficiently deliver care in an emergency situation, patients have improved outcomes. Mock code simulations are a helpful way to enhance team performance and enhance the quality of cardiac resuscitation (Hazwani et al., 2020). There are minimal risks to the participants, such as anxiety during the mock code simulations or mild discomfort related to the assessment of the individuals performance during the simulation experiences. Informed Consent and Confidentiality Informed consent (Appendix A) was obtained from each of the participants in this study. The participants were provided with adequate information concerning the study and were provided a sufficient opportunity to consider all risks and benefits of the study. It is imperative to ensure the participants have comprehended all information regarding the study in order to make an informed decision before agreeing to participate. The documented consent serves as a guide for the verbal explanation of the study. Issues relating to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process (Kadam, 2017, p. 107). Respecting participants confidentiality and privacy is considered as the participants rights (Noroozi et al., 2017). Inappropriate disclosure of information relating to the participants may threaten the participants reputation, opportunities, and human dignity. The DNP student was the only person who had access to the participants personal information needed for the study. The data collected throughout the course of the project was seen by the key stakeholders as well as the faculty involved in the project. Participants should not be identified by individuals who are not involved in the data collection process. Data was placed in a secure file cabinet that only this investigator and the CNS could access. The file cabinet was kept in the office of the CNS and remained locked when the CNS was not present. All electronic data was 18 held on the investigators personal laptop, which was password protected. If the data needed to be transferred electronically, it was encrypted through the Rush email system. The data will be stored for three years per the request of the CNS. Discussion of Methods Key Stakeholders The key stakeholders for this performance improvement project were those involved directly in the projects development. At Rush University Medical Center (RUMC), where the project was implemented, the key stakeholders were Megan Gross, the Interventional Services (IS) CNS, Janet Haw, the Unit Director (UD) of the IS department who was responsible for approving and overseeing the budget for the project, and Joe Canino, the Assistant Unit Director (AUD) who helped to assign each participant to a group. Together with the key stakeholders and the IS education committee at RUMC, mock code simulations were implemented in order to improve participant confidence levels during emergency situations. Participants Criteria and Recruitment Healthcare providers who work at Rush University Medical Center (RUMC) in the Interventional Services (IS) Department were the main focus of the practice innovation project. A sample of convenience was used to select the participants. The healthcare providers most likely to be involved in a code blue situation are registered nurses, health technicians, physicians and medical students, respiratory therapists, and nursing management (Dillion et al., 2018). When healthcare providers participate in mock code simulations, studies have demonstrated decreased fears and anxiety related to resuscitation, improved communication, and increased knowledge and familiarity with resuscitation guidelines (Hutcheson et al., 2020). More specifically, the target population for the implementation of this project was healthcare workers 19 who provide direct patient care in the IS Department at RUMC. Inclusion criteria for this study were those who have undergone basic life support (BLS) and/or advanced care life support (ACLS) training and who hold an active certification. In the IS Department, there are approximately 40 staff members who provide direct patient care, including nurses, radiology technicians, residents, attending physicians, and respiratory therapists. No recruitment techniques were necessary as the key stakeholders involved have provided their full support for this project and required all eligible staff members in the IS Department to participate. Interventional Plan This quality improvement project was implemented using three phases: preimplementation, implementation, and post-implementation. The tasks in the pre-implementation phase have been completed. Tasks in the pre-implementation phase included collecting literature, collaborating with key stakeholders, developing the program, and research focused on data collection methods. Once IRB approval was obtained from RUMC, the implementation phase began. The implementation phase has been provided in detail using a Gantt chart in Appendix C. Once the implementation phase was completed, the post-implementation phase began. During this phase, data analysis utilized the data collected during the implementation phase to perform a statistical analysis. Demographic Qualitative & Quantitative Data Demographic data was collected from participants including their job title, any certifications they hold related to their job title, and if they are BLS or ACLS certified. If the participant holds a current certification related to their role, data will be collected on the date of their last certification. Each participant will be asked how long they have worked in their current job position in the IS department This may help to provide additional feedback into their pre- 20 simulation confidence level. An example of the demographic questionnaire can be found in Appendix E. Qualitative data was examined throughout the research process. This form of data that was collected through participant observation and interviews was described as nonnumerical, qualitative data. An interview was performed at the end of each simulation experience. The first and second rounds of simulations were held 2 months apart at the request of the key stakeholders in the IS department. The participants were asked questions such as what went well and what did not go well. They were also asked what they learned from the experience and how the experience can be improved utilizing a post simulation survey. Mock code simulation scenarios can effectively increase skill compliance and staff confidence (Hutcheson et al., 2020). The quantitative data collected for this study was any change in the confidence of the participants ability to provide effective and efficient care during an emergency situation. The quantitative data utilized in this study was measured using the VAS at the completion of the mock code simulations. Once all participants completed the VAS provided, a statistical analysis was performed in order to assess the outcome of the quality improvement project. Only those participants who completed 2 mock code simulations were included in the quantitative and qualitative data. Budget The costs related to this project were costs associated with the hourly wage of participants. Since the UD had approved this project in the IS Department, the mock code simulations were performed during scheduled work hours. The second Wednesday of each month was reserved for educational purposes. This was when the mock code simulations were performed, thus not creating any additional costs for the department. A grant was received that 21 was utilized to access the simulation lab when necessary. An operational budget was created and is listed in Appendix D. Data analysis The statistical analysis for this project was performed by analyzing the VAS completed by participants and comparing their responses before and after each mock code simulation. A ttest can be used to determine if there is a significant difference between the means of the groups. The dependent variable measured in this study was improved participant self-confidence levels. The independent variable in this study was the implementation of mock code simulation scenarios at two-month intervals. It was determined by conducting a power analysis that 16 participants were needed for the appropriate sample size for this project. For this power analysis, an error probability of 0.05 and a power of 0.95 was used. An effect size of 0.70 was calculated resulting in a sample size needed of 16 for this study. A trend analysis measures the changes in the self-confidence levels of participants over time. Due to the small sample size required for the project, a statistician was who provided insight and advice on data organization was consulted but not needed for this project. Demographic Data A total of 16 participants completed two consecutive rounds of the mock code simulation scenarios in the IS Department. Each participant completed a demographic questionnaire. The mean age of the 16 participants who completed 2 mock code simulations was 37.8 years of age with the average length in the participants current role as 11.2 years. This study included a wide range of healthcare professionals with ages from 27-58 and experience ranging from 4 months to 17 years in the current job title. A total of 27 participants completed one mock code simulation. Those who were unable to complete two simulations were not included in this study. Additional 22 participants were unable to complete two mock code simulations due to scheduling conflicts and a high turnover rate during the course of the simulations. Over half of the participants held a certification related to their job title and all individuals were BLS and/or ACLS certified. The participants included seven Registered Nurses (RN) and nine Radiology Technicians (RT). No Physicians or Respiratory Therapists completed two mock code simulations and therefore were not included in the data. Out of the seven RNs, four held a certification (three Critical Care Registered Nurse, one Emergency Certified Registered Nurse) and five of the nine RTs held a VI (Vascular Interventional) certification. A VI certification formally prepares the RT to work in a Vascular Interventional Radiology setting such as the IS department at RUMC. Certification signifies a commitment to lifelong learning and the expectation of staying up to date and implementing evidence-based practice in daily care. Results The quantitative data were analyzed by this DNP student utilizing SPSS (Statistical Package for the Social Sciences). This DNP project used a pretest/posttest design in order to evaluate the self-confidence levels of participants after completing two mock codes simulations approximately 2 months apart. The post-test scores from the VAS scale were compared to the pretest scores of the VAS rating participants self-confidence levels for the 16 individuals who completed two mock code simulations. A paired t-test was used for this data analysis to compare the pre-test and post-test scores of participants' self-confidence levels in the first simulation utilizing the VAS. There was a statistically significant increase in self-confidence levels from the pre-test (M = 7.41, SD = 0.88), t (16) = -10.89, p < 0.001. The mean increase in self-confidence levels was 1.56 with a 95% confidence interval ranging from 7.40 to 8.97. The eta squared statistic ( -2.72) indicated a small effect size. A paired t-test was used for this data analysis to 23 compare the pre-test and post-test scores of participants self-confidence levels in the second simulation utilizing the VAS. There was a statistically significant increase in self-confidence levels from the pre-test (M = 7.40, SD = 1.20), t (16) = -4.48, p < 0.001. The mean increase in self-confidence levels was .97 with a 95% confidence interval ranging from 7.41 to 8.97. The eta squared statistic ( -1.12) indicated a small effect size. A total of 16 participants completed two rounds of mock code simulations and each completed a pre-and post-test questionnaire rating confidence levels. The mean pretest score for simulation 1 was 7.01 compared to the post-test mean of 8.97. The pretest mean for simulation 2 was 7.41, compared to the mean post-test score of 8.37. A paired t-test was used to analyze simulation 1 data and showed a statistically significant increase (t = -10.894, n = 16, p = <0.001) in self-confidence levels as scored by the participants on using the VAS. A paired t-test was also used to analyze simulation 2 data and showed a statistically significant increase (t = -4.48, n = 16, p = 0.003) in self-confidence levels as scored by the participants using the VAS. Statistical data from SPSS can be found in Tables 1-3. Table 1: Paired Samples Statistics Table 2: Paired Samples Correlations 24 Table 3: Paired Samples Test Discussion The results of this study show that with the implementation of mock code simulations at routine intervals, there is an increase in healthcare providers self-confidence levels. Thus, the null hypothesis is accepted. The pretest scores were 7.40 and 7.41 with the post-test scores averaging 8.97 and 8.38. Appendix B depicts the VAS scale utilized by participants when rating their self-confidence levels. While there was an increase in self-confidence levels from each pretest to post-test, simulation 2 showed a lower overall scoring in self-confidence levels. The decrease is accounted for in the difficulty level of the scenarios presented during the mock code simulations. Four scenarios were created in collaboration with the key stakeholders related to the most common emergency situations in IS. Two scenarios were presented during each simulation, starting with the least difficult. The scenarios created for the second round of simulations were deemed to be more difficult and complex by the key stakeholders. The scenarios were created in collaboration with the key stakeholders and the IS education committee chair. A study by Chu & 25 Robilotto (2018) showed that participants CPR skills and knowledge decrease significantly within 10 weeks after training. The decrease in the participants confidence level from the completion of the first simulation to the start of the second simulation is attributed to the knowledge lost during the time between simulations when the participants did not experience emergency situations. Qualitative data was collected during post-simulation debriefing where the participants provided feedback. After completion of the first simulation, participants requested a visual aid showing the patients heart rhythm which was not provided for the first simulation but was added for the second round of simulations. It was also noted that participants were more likely to engage when roles were assigned ahead of the simulation as opposed to asking for volunteers. Finally, participants stated the mock code simulations were very helpful. The participants stated they were looking forward to completing the simulations at routine intervals. Overall, this study has shown the importance of routine mock code simulations to improve participant selfconfidence levels. When healthcare providers have increased confidence in their skills, the literature suggests that providers are able to react quickly and effectively in emergency situations thus creating improved outcomes for patients. The strengths of this study include an adequate sample size of 16 participants as indicated by the power analysis performed. Another strength of this study is the use of a valid and reliable tool, the VAS, that was used by participants to rate their self-confidence levels. The study was not without limitations. One limitation was the high turnover rate in the IS department making it difficult for all participants to complete two simulations thus excluding many participants from the data analysis. Another limitation is that this project was started during the COVID-19 pandemic thus delaying the start time of the simulations. Due to this, only two rounds of 26 simulations were able to be performed before the completion of this project. With the help of the key stakeholders and the education committee at RUMC, this project will continue with mock code simulations at routine intervals and further data will be collected and analyzed. Conclusion This DNP performance improvement project aimed to improve the confidence levels of healthcare workers such as nurses, physicians, and radiology technicians during emergency situations, thus increasing patient outcomes. This project was implemented in multiple phases, including two mock code simulation scenarios specific to the IS department. Improving selfconfidence during emergency situations provides value to the hospital or facility where the project is implemented. This value is created when providers self-confidence increases, allowing them to react appropriately and efficiently when patients are deteriorating, thus improving patient outcomes. This project received support from the internal resources provided by the IS department and RUMC. The key stakeholders in this department were excited and willing to implement this project. A study performed by Herbers and Heaser (2016) found that after participating in mock code simulations, nursing staff reported an increase in confidence when initiating first-responder interventions. The results from this performance improvement project show an improvement in staff self-confidence resulting in improved efficiency and effectiveness in staff response during emergency situations. 27 Appendix A Informed Consent The Implementation of Mock Code Simulations to Improve Participant Confidence Levels in Emergency Situations: A Quality Improvement Study Researcher: Ellen Wray: BSN, RN, DNP-FNP Student Supported By: Saint Marys College & Rush University Medical Center What is the purpose of this study? This study aims to improve healthcare provider self-confidence levels in emergency situations through the implementation of mock code simulations. What will I do if I choose to be in this study? If you join this study, you will be asked to participate in two mock code simulation educational sessions approximately two months apart with other healthcare providers. You will also be asked to complete a brief demographic survey before the simulation and a self-confidence assessment before and after each simulation. After completing the mock code simulations, you will complete a short survey assessing your confidence levels. After completion of the study, the data you have provided will be analyzed for quality improvement purposes. You will not have to share any private information with other providers. You can leave the group at any time. There will be no penalty if you leave the group. What are the possible risks or discomforts? Perceived risks to this study are anxiety and discomfort to the participant related to the pre and post-assessment required for each simulation experience. What are the possible benefits for me or others? You will increase your knowledge of actions to be performed during emergency situations. In turn, you will possibly have improved self-confidence levels resulting in increased efficiency and effectiveness during emergency situations. This will lead to improved patient outcomes. What alternatives are available? You may choose not to join this study. What happens if I dont want to participate anymore? 28 If you join this study, you may leave any time. There will be no penalty if you leave the study. Will it cost me anything to participate? It is free to join this study. Will I get paid anything if I participate? You will be paid your hourly wage during the time you participate in the study. What are my rights? You have the right to be treated with respect. You have the right to leave the study at any time. You have the right to answer or not answer our questions. You do not have to join this study. What about my confidentiality and privacy rights? You will not be asked to share private information with the other participants. Any information you write about yourself will be confidential. Your name will never be used in the study report. For additional questions or concerns, please contact Ellen Wray at ellen_wray@rush.edu. Consent I have read this form about the study or had it read to me. Any questions I have about this study have been answered. I understand the information about the study. I agree to join this study but can leave this study at any time. I will receive a copy of this form. ___________________________ Signature of Subject ___________________________ Date 29 Appendix B Visual Analog Scale 30 Appendix C Gantt Chart 31 Appendix D Program Budget Interventional Services Mock Code Simulation Program Budget Direct Fringe Costs Cost Category Units Rate Costs (22%) Facilities Simulation Lab 1 hour $29.36/hr $29.36 $0.00 IS Procedure Room 1 hour $0.00/hr $0.00 $0.00 Total Cost $29.36 $0.00 Personnel Radiology Techs (RT) 1 hour (RN x 20) 1 hour (RT x 20) Equipment Crash Cart Respiratory Supplies Documentation 1 cart 1 bag 1 computer $300 rental $25.00 per bag $0.00 $300.00 $25.00 $0.00 Educational Program Development 1 DNP Student 1 CNS in IS Department 30 hours 15 hours $40.00 $52.00 $1,200.00 $264.00 $780.00 $171.60 $1,464.00 $951.60 RN - $40.00/hr $1,200.00 $264.00 $1,464.00 RT - $30.00/hr DNP Student $40.00/hr CNS - $52.00/hr $780.00 $171.60 $951.60 $40.00 $52.00 $8.80 $11.44 $48.80 $63.44 Nurses (RN) $40.00/hr $800.00 $176.00 $976.00 $30.00/hr $600.00 $132.00 $732.00 $0.00 $0.00 $0.00 $300.00 $25.00 $0.00 Program Maintenance Routine 6-month intervals 1 hour (RN x 20) 1 hour (RT x 20) 1 hour 1 hour Total Cost $7,005.80 32 Appendix E Demographic Questionnaire 1. Age _____ 2. Job title: RN RT PHYSICIAN RESPIRATORY PHARMACY OTHER _______ 3. Do you hold any certifications? YES NO 4. What are they? _________ 5. Date you received your most recent certification ________ 6. Are you CPR or ACLS certified? YES NO 7. How long have you worked in your current role? _______ 8. How many years of experience do you have in your job title? _______ 33 Appendix F CITI Certificate 34 References Adcock, S., Kuszajewski, M. L., Dangerfield, C., & Muckler, V. C. (2020). Optimizing nursing response to in-hospital cardiac arrest events using in situ simulation. Clinical Simulation in Nursing, (2020). https://doi.org/10.1016/j.ecns.2020.05.006 Ahmad, A. A., Nannette, N., & Sheila, T. (2017). The use of simulation training to improve knowledge, skills, and confidence among healthcare students: a systematic review. Internet Journal of Allied Health Sciences and Practice, 15(3), 22. Al Gharibi, K. A., & Arulappan, S. J. (2020). 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... Saint Mary's College Doctor of Nursing Practice Program DNP Practice Innovation Project Completion Form AI:. the faculty team leader for this DNP Practice Innovation Project, I certify that this project was prepared, implemented, and evaluated under my direction. I have read the paper that was prepared by Kaitlyn Williams titled Type 2 Diabetes Mellitus Education in the Primary Care Setting to Improve Patient Self-Management and recommend that it be accepted as fulfilling the DNP Practice Innovation Project requirement for the Doctor ofNursing Practice degree at Saint Mary's College. Date: July 27, 2021 Sue Anderson PhD, RN, FNP-BC Faculty Team Leader I hereby certify that I have carried out this project in its entirety under the direction of my team leader. My signature indicates that this document is presented truthfully and in alignment with the Academic Honor Code of Saint Mary's College. ~u)Jfuw Date: '11 oO I2-l Kaitlyn Williams DNP Practice Innovation Projects are stored with the student's pennission in the online repository at the Cushwa-Leighton Library. The projects are available to the public for viewing. I do / do not _ _ grant my permission for my project to be stored in the repository. ~~WillinvYVa: Kaitlyn Williams Date: 1 I,;j 1-I Type 2 Diabetes Mellitus Education in the Primary Care Setting to Improve Patient SelfManagement Kaitlyn Williams, BSN, RN, DNP Student Doctor of Nursing Practice Program Family Nurse Practitioner Track Saint Marys College Faculty Team Leader: Dr. Sue Anderson, PhD, RN, FNP-BC Type 2 Diabetes Mellitus Self-Management Education 2 Abstract Problem Statement: Type 2 Diabetes Mellitus (T2DM) is a complex condition that requires diligent self-management. T2DM is becoming an economic burden in the United States facilitated by increasing rates of prevalence and poor self-management. National rates of prevalence of T2DM are 8.6%, however, prevalence in medically underserved communities, such as rural Appalachia, is 15% (de Groot et al., 2017). Literature Review: Diabetes Self-Management Education (DSME) is beneficial and effective in improving self-management of those diagnosed with T2DM. Previous studies have suggested that increased knowledge and confidence in patients with T2DM have been associated with decreased HgbA1c and therefore decreased rates of complications (Powers et al., 2017). PICOT Question: In adults aged 45-75 with T2DM in rural Appalachia North Carolina in a Federally Qualified Health Center (FQHC) primary care setting (P), will education using The Diabetes Placemat from the American Diabetes Association and an assessment utilizing the LMC Skills, Confidence, and Preparedness Index (I) (LMC SCPI) when compared to previous assessments utilizing the LMC SCPI (C) lead to an improvement in patient self-management of T2DM in the form of knowledge, confidence, and preparedness (O)? Results: Statistically significant results were noted following the paired t-test with an increase in skills, confidence, preparedness, and understanding of healthy eating among the 18 participants. The Diabetes Placemat could enhance glucose control to prevent complications of T2DM through its refinement of self-management by improving knowledge, skills, confidence, and preparedness in self-management of T2DM. Prevention of complications could decrease the health and financial burden of T2DM. Type 2 Diabetes Mellitus Self-Management Education Keywords: Rural Appalachia, Diabetes Self-Management Education, Diabetes Placemat, LMC SCPI, Primary Care T2DM Education 3 Type 2 Diabetes Mellitus Self-Management Education 4 Table of Contents Abstract .................................................................................................................................................. 2 Background ............................................................................................................................................ 7 Problem Statement ............................................................................................................................... 11 PICO .................................................................................................................................................... 12 Objectives ............................................................................................................................................ 13 Definition of Terms.............................................................................................................................. 13 Type 2 Diabetes Mellitus ................................................................................................................. 13 Glycated Hemoglobin (HgbA1c/HbA1c) ........................................................................................ 13 Diabetes Self-Management Education ............................................................................................. 14 Informed Decision Making .............................................................................................................. 14 Medically Underserved .................................................................................................................... 15 Numeracy ......................................................................................................................................... 15 Self-Regulation Theory and Social Cognitive Theory ..................................................................... 15 Food Insecurity................................................................................................................................. 16 Retrieval Process/Forward Effect .................................................................................................... 16 Literature Review................................................................................................................................. 16 Theme One: Economic Burden of T2DM Facilitated by Increasing Prevalence................................. 17 Theme Two: Benefits of DSME .......................................................................................................... 18 Benefits to the Participants............................................................................................................... 18 Cost-Effectiveness of DSME ........................................................................................................... 19 Theme Three: Effectiveness of Various Forms of DSME ................................................................... 19 Theme Four: Barriers to DSME ........................................................................................................... 20 Lack of Access to DSME ................................................................................................................. 20 Type 2 Diabetes Mellitus Self-Management Education 5 Medically Underserved Communities.............................................................................................. 21 Theme Five: Adult Learning ................................................................................................................ 22 Retrieval Practice and Forward Effect ............................................................................................. 22 Health Illiteracy................................................................................................................................ 23 Strengths .............................................................................................................................................. 25 Limitations and Gaps in Research ....................................................................................................... 25 Concept Map ........................................................................................................................................ 27 Figure 1. ........................................................................................................................................... 27 Theoretical Framework ........................................................................................................................ 27 Social Entrepreneurship and Innovation .............................................................................................. 28 Sustainability........................................................................................................................................ 30 Implementation Model ......................................................................................................................... 31 Ethical Considerations ......................................................................................................................... 33 Risk and Benefits to Participants ..................................................................................................... 33 Recruitment ...................................................................................................................................... 34 Anonymity and Confidentiality........................................................................................................ 34 Informed Consent ............................................................................................................................. 35 Educational Presentation .................................................................................................................. 36 Data Collection and Security ........................................................................................................... 36 Methods................................................................................................................................................ 37 Key Stakeholders ............................................................................................................................. 37 Participant Inclusion Criteria ........................................................................................................... 38 Intervention Plan .............................................................................................................................. 39 Type 2 Diabetes Mellitus Self-Management Education 6 Data collection ................................................................................................................................. 41 Timeline ........................................................................................................................................... 42 Budget .............................................................................................................................................. 42 Data Analysis ................................................................................................................................... 44 Results .................................................................................................................................................. 45 Figure 2 ............................................................................................................................................ 46 Table 1.............................................................................................................................................. 46 Discussion ............................................................................................................................................ 47 Strengths........................................................................................................................................... 49 Limitations ....................................................................................................................................... 50 Conclusion ........................................................................................................................................... 50 References ............................................................................................................................................ 51 APPENDIX A ...................................................................................................................................... 58 APPENDIX B ...................................................................................................................................... 59 APPENDIX C ...................................................................................................................................... 61 APPENDIX D ...................................................................................................................................... 62 APPENDIX E ...................................................................................................................................... 64 APPENDIX F....................................................................................................................................... 65 APPENDIX G ...................................................................................................................................... 66 APPENDIX H ...................................................................................................................................... 67 APPENDIX I ....................................................................................................................................... 70 Type 2 Diabetes Mellitus Self-Management Education 7 Type 2 Diabetes Mellitus Education in the Primary Care Setting to Improve Patient Self-Management Diabetes continues to be the 7th leading cause of death in the United States (U.S.) (Dawson et al., 2017). An increased prevalence rate has been noted in Type 2 Diabetes Mellitus (T2DM) with the disease affecting more people each subsequent year. The current prevalence of T2DM is 8.9% in the U.S. (Bullard et al., 2018). Increased healthcare spending has been associated with decreased glycemic control, increased rates of prevalence, and increasing rates of complications. In 2012, the U.S. spent $245 billion on diabetes and complications related to diabetes (Powers et al., 2017). Appropriate glycemic control can prevent diabetes associated complications, thus, decreasing healthcare spending (Dawson et al., 2017). Education of patients with T2DM improves self-management of the disease by assisting in knowledge of skills related to self-care and understanding of the disease (Dawson et al., 2017). Previous studies have suggested that increased patient knowledge and confidence in management of T2DM has been associated with improved glycemic control (Powers et al., 2017). The DNP Practice Innovation Project assessed the effect of the Diabetes Placemat diabetes education tool from the American Diabetes Association (A.D.A.) in rural Appalachia on patient knowledge, confidence, and preparedness in self-management of their T2DM. Background Patients with T2DM have an insufficient amount of insulin to maintain homeostasis of glucose levels due to defects in insulin secretion or insulin resistance by tissues (American Diabetes Association, 2019). Defects in insulin secretion can be related to inflammation and metabolic stress. Excess weight, particularly located in the abdominal region, can cause insulin resistance (American Diabetes Association, 2019). Many patients can slow disease progression and obtain glycemic control through appropriate diet and exercise. Some patients will require the Type 2 Diabetes Mellitus Self-Management Education 8 use of oral medications or insulin injections to obtain glycemic control (Bullard et al., 2018). Glycemic control is currently the strongest predictor of T2DM progression and complications related to T2DM (Chrvala, Sherr, & Lipman, 2016). It has been estimated that by 2050, approximately one out of every three individuals will develop T2DM (Powers et al., 2017). This increases the need for research regarding evidence-based practice in T2DM disease management (Powers et al., 2017). According to the Health Resources and Services Administration (HRSA), the medically underserved face barriers related to education, income, race, and other social or economic factors (Wang et al., 2018). These barriers contribute to why only 5% of those with Medicare or Medicaid are receiving education about diabetes self-management (Chrvala et al., 2016). The Practice Innovation Project educated participants using The Diabetes Placemat to improve self-management through further understanding of T2DM and the significance of food choices on T2DM. Participant recruitment for this project was done through a Federally Qualified Health Center (FQHC) in rural Appalachia to assess the medically underserved and the effect T2DM education had on their disease self-management. Increased rates of prevalence of T2DM are seen in rural Appalachia where individuals are 1.4 times as likely to develop T2DM compared to those who do not reside in rural Appalachia (Carpenter & Smith, 2018). The medically underserved communities of rural Appalachia experience prevalence rates between 13-15% (Carpenter & Smith, 2018; de Groot et al., 2017). The Appalachian culture historically has been exploited for natural resources and labor, making them reluctant to seek support outside of their community (Carpenter & Theeke, 2018). Many within the Appalachia region report a general mistrust of outsiders and fear of being taken advantage of by healthcare systems, these individuals will reach out to friends, Type 2 Diabetes Mellitus Self-Management Education 9 family, and church members before medical professionals (Carpenter & Theeke, 2018). This contributes to poor glycemic control within the region. The rural Appalachia region spans numerous states and is characterized by its aging population, low level of educational attainment, and high poverty level (Carpenter & Smith, 2018). In a previous research study conducted in rural Appalachia, 59% of participants had an annual household income between $10,000 and $19,000 (Schoenberg, Ciciurkaite, & Greenwood, 2017). Up to 40% of adults in Appalachian counties do not possess basic literacy skills. Specifically, in Appalachian North Carolina, 15.7% of those 25 and over have less than a high school diploma, this is greater than the 13.3% seen nationally (Pollard & Jacobsen, 2017). Non-modifiable risk factors for T2DM include age, first-degree relative diagnosis, hypertension, women with a history of gestational diabetes, and certain racial or ethnic groups (American Diabetes Association, 2019). For residents of Appalachian North Carolina, the median age is 42.2 which is remarkably higher than the national median age of 37.6 (Pollard & Jacobsen, 2017). The increased age in the population of rural Appalachia is a non-modifiable risk of T2DM. Those residing in rural areas such as Appalachia have a higher prevalence of chronic diseases including hypertension, heart disease, cancer, stroke, and Chronic Obstructive Pulmonary Disease (COPD) (Hodges, 2017; Robinson, 2015). Concerning race, the largest percentage of patients diagnosed with T2DM are non-Hispanic African Americans, who account for 32% of all patients with T2DM. The second largest percentage of people diagnosed with T2DM are Hispanic at 25.6% of cases (Bullard et al., 2018). For asymptomatic patients, testing for T2DM begins at 45 years old (American Diabetes Association, 2019). The highest proportion of non-Hispanic African Americans with T2DM are Type 2 Diabetes Mellitus Self-Management Education 10 50-60 years of age and the highest proportion of non-Hispanic Whites with T2DM are ages 6070 (Lee et al., 2019). However, limited ethnic diversity is exhibited in rural Appalachia North Carolina with 80.5% of individuals identifying as White compared to 62.3% nationally (Pollard & Jacobsen, 2017). The next largest category for race in Appalachian North Carolina is African American which accounts for 8.7% of residents compared to 12.3% nationally (Pollard & Jacobsen, 2017). For this DNP Practice Innovation Project, the target population age range was 45-75 to include the largest number of T2DM patients across various ethnic groups and races. The disease prevalence between genders only differs 1-2% for ages 40-75; therefore, this project will include males and females (Lee et al., 2019). Some modifiable risk factors include physical activity, obesity, and dyslipidemia (American Diabetes Association, 2019). Those residing in rural areas have a higher prevalence of obesity with over a third of residents in West Virginia, Kentucky, Alabama, Mississippi, and Tennessee being obese, making them more at risk for T2DM (Hodges, 2017). Another modifiable risk factor is diet. By decreasing and monitoring carbohydrate intake, one can improve glycemic control (Wang et al., 2018). Many rural Appalachian counties are considered food deserts. The United States Department of Agriculture (USDA) looks at the percentage of residents that have low access to vehicles, low income, and low access to supermarkets to determine which areas are deemed food deserts. Low access to supermarkets in rural Appalachia can mean more than 10 miles from a supermarket. Living in these areas results in a lack of fresh and healthy foods which increases rates of obesity, dyslipidemia, and T2DM (Hodges, 2017). This Practice Innovation Project educated participants on carbohydrates and the amount to consume per meal through the Diabetes Placemat which can be applied to diet regardless of food deserts. Type 2 Diabetes Mellitus Self-Management Education 11 The goal of nursing scholarship within the role of the Advanced Practice Registered Nurse (APRN) is to improve health care and the health of the patient. Scholarship for the APRN includes translation and application of evidence (American Association of Colleges of Nursing, 2018). This DNP Practice Innovation Project translated current research about T2DM disease management into daily evidence-based practice for the APRN with the Diabetes Placemat. The implementation of this project following the assessment of available evidence improves delivery of care and patient outcomes, both are goals of translation science. Translation science takes the language of scientific research and applies it to the care of the patient and their health (Titler, 2018). The gap between theory and practice is closed by the APRN using translation science (Zaccagnini & Pechancek, 2019). Problem Statement In the U.S., 21 million adults are currently diagnosed with T2DM (Bullard et al., 2018) with a prevalence rate of 8.9% nationally (Carpenter & Smith, 2018) Within rural Appalachia, those rates of prevalence are vastly higher at up to 15% (Carpenter & Smith, 2018). The Appalachia region is a 205,000 square mile region from southern New York to northern Mississippi and is federally designated. This region is characterized by low income, low educational attainment, lack of access to healthcare, limited health literacy, challenging geography, and being largely rural in nature (Carpenter & Theeke, 2018). Improved T2DM management is called for within the primary care setting as the financial burden of the disease on the U.S. healthcare system continues to rise due to increasing prevalence of the disease. In the U.S., 13% of the total national healthcare expenditures and 30% of Medicare expenditures are spent on those with diabetes (Sohn et al., 2016). The DNP Practice Innovation Project aimed to improve self-management of T2DM through education within the primary care setting. Diabetes Type 2 Diabetes Mellitus Self-Management Education 12 Self-Management Education (DSME) has been associated with decreased hospital admissions, decreased readmissions, and lowered risk of complications related to diabetes (Powers et al., 2017). Proper glucose control delays and prevents diabetes-associated complications. Blood glucose levels can be better controlled through weight loss, a healthy diet, and physical activity (Chong, Ding, Byun, Comino, Bauman, & Jalaludin, 2017). Implementation of the Diabetes Placemat education within the primary care setting was hypothesized to increase patient knowledge, confidence, and preparedness of disease self-management. Advancement of nursing knowledge was achieved as the project examined the Diabetes Placemat, available through the A.D.A., and its effect on patient confidence, knowledge, and preparedness in disease self-management through analysis with the LMC Skills, Confidence, and Preparedness Index (LMC SCPI). The results of the project yielded further evolution of evidence-based practice within the primary care setting in relation to management of T2DM. The project contributed to general research knowledge in its central concept of adult education and examined retrieval practice within adult learning and education. Retrieval practice is the recollection of information and testing of what one knows to enhance learning through focusing on what one doesnt know. Retrieval practice uses a pre-test and post-test method of education. Retrieval practice suggests that adults learn best by being tested on knowledge before the information is presented as this assists them in focusing on what needs to be learned. Increased information retention has been associated with adults educated using the retrieval practice method when compared with traditional education methods (Pastotter & Bauml, 2019). PICO In adults aged 45-75 with T2DM in rural Appalachia North Carolina in the primary care setting at a FQHC (P), will education using the Diabetes Placemat from the A.D.A. and an Type 2 Diabetes Mellitus Self-Management Education 13 assessment utilizing the LMC SCPI (I) when compared to previous assessments utilizing the LMC SCPI(C) lead to an improvement in patient self-management of T2DM in the form of knowledge, confidence, and preparedness (O)? Objectives The objectives for the DNP Practice Innovation Project were: 1. Sustainable implementation of T2DM education within the rural primary care setting based on current research to further future daily evidenced-based practice and improve patient self-management of T2DM. 2. Gather data on the effect of T2DM education in relation to patient knowledge, confidence, and preparedness using the LMC SCPI. Definition of Terms Type 2 Diabetes Mellitus When carbohydrates are consumed, the body converts food to energy in the form of glucose. Insulin helps break down glucose in the blood. Patients with T2DM do not produce enough insulin to maintain homeostasis of blood sugar (Bullard et al., 2018). Often, the blood glucose level of these patients is controlled through limitation of carbohydrate consumption (Bullard et al., 2018). Some patients will require oral medications for glycemic control or even insulin injections (Bullard et al., 2018). Those with T2DM often have defects in insulin secretion related to inflammation and metabolic stress (Bullard et al., 2018). Excess weight can also cause insulin resistance, specifically those patients with increased percentages of body fat distributed mainly in the abdominal region (American Diabetes Association, 2019). Glycated Hemoglobin (HgbA1c/HbA1c) Type 2 Diabetes Mellitus Self-Management Education 14 Glycated Hemoglobin is also known as HgbA1c or HbA1c. HgbA1c measures glycemic control exhibited by the patient the previous 3 months (Sherwani et al., 2016). HgbA1c analyzes hyperglycemia through the predicted half-life of the red blood cells and is completed through a blood test (Sherwani et al., 2016). As glucose increases within the blood, the amount of HgbA1c in the blood increases as well (Sherwani et al., 2016). HgbA1c is represented as a percentage. For patients with T2DM, the goal HgbA1c is <7.0%, though many patients do not attain this goal (American Diabetes Association, 2019). Diabetes Self-Management Education Diabetes self-management education (DSME) is the utilization of various methods of teaching and activities to facilitate understanding of disease process and proficiency of skills vital to adequate diabetes self-care that can potentially improve glycemic control (Powers et al., 2017; Chrvala et al., 2016). Studies show implementing DSME with primary care providers improves clinical, psychosocial, and behavioral outcomes (Powers et al., 2017). DSME has a positive effect on dietary habits, increases physical activity, and improves rates of smoking cessation (Chong et al., 2017). Research suggests DSME decreases hospital admissions and readmissions (Powers et al., 2017). DSME is cost-effective and associated with an increase in knowledge, improved clinical outcomes, improved quality of life, and other psychosocial outcomes (Chrvala et al., 2016). Informed Decision Making Informed decision making is collaboratively created through a relationship between the provider of DSME and the individual with T2DM (Chrvala et al., 2016). Informed decision making is defined as the process involved in individually tailoring goals in one or more areas of self-management to the client receiving the DSME (Chrvala et al., 2016). Type 2 Diabetes Mellitus Self-Management Education 15 Medically Underserved Medically underserved populations are defined by the HRSA as older or facing barriers to good health (Wang et al., 2018). Barriers can include income, education, race, ethnicity, food insecurity, or other social and economic factors (Wang et al., 2018). Lee et al. (2019) found that specific communities are noted to have worse health outcomes, increased morbidity and mortality, and an increased financial burden from T2DM. The annual household income of 59% of those residing in rural Appalachia is between $10,000 to $19,000 (Schoenberg, Ciciurkaite, & Greenwood, 2017). The seclusion seen in rural Appalachia due to mountainous terrain stunts economic growth (Hodges, 2017). These areas may have primary care physicians but often lack specialists causing many patients to fail to follow up with specialists due to distance and accessibility as well as financial burden (Hodges, 2017). Numeracy Numeracy is the ability to use numbers in daily life (Bowen et al., 2016). An individual with low numeracy struggles to understand and comprehend numbers and their interactions within daily life (Bowen et al., 2016). People with lower numeracy scores tend to struggle to read food labels and have poorer glucose control (Bowen et al., 2016; Young et al., 2018). Within the U.S., 110 million adults have limited numeracy skills (Young et al., 2018). Self-Regulation Theory and Social Cognitive Theory Self-regulation theory hypothesizes that the monitoring of behaviors and their associated outcomes result in a behavior change due to self-awareness of the effects of certain activities on the health of the individual (Wang et al., 2018). Self-regulation following the education provided using the Diabetes Placemat assists the participants in improving knowledge, confidence, and preparedness needed for proper self-management of T2DM. Social Cognitive Theory posits adult Type 2 Diabetes Mellitus Self-Management Education 16 learners will act and behave according to their expectations of outcomes from behaviors (Merriam & Bierema, 2014). Food Insecurity Food insecurity describes a situation where an individual has limited access to nutritionally adequate foods (Young et al., 2018). These individuals report difficulty affording healthy food options. Often, non-chain supermarkets are more expensive; low-income communities report 75% fewer chain supermarkets than average (Young et al., 2018). Food insecurity has been correlated with a two to three times increase in prevalence of T2DM and obesity (Young et al., 2018). Retrieval Process/Forward Effect The retrieval process refers to the learning that takes place following being tested on an item (Pastotter & Bauml, 2019). Retrieval process does not involve studying the information again. Increased information retention has been associated with adults educated using the retrieval practice method when compared with traditional education methods. The forward effect describes the increase of retention of subsequently studied information gathered following the retrieval process and testing of the participant (Pastotter & Bauml, 2019). Literature Review A literature review was conducted using articles from 2015-2020 in the following databases: CINAHL, MedLine, PubMed, NIH, and PSYCHInfo. The inclusion criteria for articles is as follows: published in 2015 or later, available in English, and including one of the keywords utilized during searches. During database searches the following keywords were utilized: Type 2 Diabetes, Type 2 Diabetes Mellitus, Education in Primary Care, Adult Education and Learning, Type 2 Diabetes Mellitus Education, Diabetes Self-Management Type 2 Diabetes Mellitus Self-Management Education 17 Education, and DSME in Primary Care. The level of research included ranged from I-V with 2 Level Is, 6 Level IIs, 5 Level IIIs, 4 Level IVs, and 2 Level Vs. The review of the current literature uncovered five themes: economic burden of T2DM facilitated by increasing prevalence, benefits of DSME, effectiveness of DSME, barriers to DSME, and adult learning. The interaction of these five themes within the project and the concept map created the overarching objective of the DNP Practice Innovation Project. Theme One: Economic Burden of T2DM Facilitated by Increasing Prevalence Diabetes continues to be the 7th leading cause of death in the U.S (Dawson et al., 2017). An article examined during the literature review by Powers et al., found that in 2012 the U.S. spent $245 billion on T2DM and related complications (2017). Thirteen percent of total national healthcare expenditures are spent on those with diabetes and 30% of all Medicare expenditures (Sohn et al., 2016). Of the money spent on diabetes, 86% of diabetes related healthcare expenditures are spent treating diabetes related complications which can often be prevented by glycemic control (Sohn et al., 2016). Powers et al. reviewed the literature regarding DSME and reimbursement available from the Centers for Medicare and Medicaid Services for DSME (2017). Recommendations from this research encouraged the implementation of DSME within the primary care setting with an algorithm for providing DSME effectively (Powers et al., 2017) to prevent detrimental complications. Damage and complications from T2DM are noted in the eyes, kidneys, nerves, heart, and blood vessels (Wang et al., 2018). Some common complications include: Myocardial Infarction (MI), Cerebrovascular Accident (CVA), end-stage renal disease, and non-traumatic lower extremity amputations (Lee et al., 2019). Diabetes also negatively effects blood pressure (BP) (Chong et al., 2017). Glycemic control predicts complications of T2DM (Chrvala et al., 2016). Type 2 Diabetes Mellitus Self-Management Education 18 However, less than half of patients attain the recommended HgbA1c of <7.0% (Young et al., 2018; Chrvala et al., 2016). Glycemic control is an issue worldwide with Canada and Europe reporting poor glycemic control within their T2DM populations (Aronson, Brown et al., 2018). Globally, the number of people diagnosed with T2DM in 2014 was 422 million (Dawson et al., 2017). Research suggests that by 2050, one out of every three individuals in the United States will develop T2DM if prevalence rates continue to rise (Powers, et al., 2017). Bullard et al., investigated increasing prevalence of T2DM by analyzing the National Health Interview Survey (2018). Currently in the U.S., 21 million adults have T2DM with a prevalence rate of 8.9% (Bullard et al., 2018), however, those in Appalachia are 1.4 times as likely to have diabetes compared to those that do not reside in Appalachia (Carpenter & Smith, 2018). Increasing prevalence of T2DM continues to increase healthcare costs. Theme Two: Benefits of DSME Benefits to the Participants Education of patients about self-management of T2DM assists them to make decisions and participate in activities that improve health outcomes (Powers et al., 2017). DSME benefits all participants with T2DM, regardless of baseline HgbA1c (Chrvala et al., 2016). Chrvala et al. published a systematic review of DSME by analyzing 118 interventions with 61.9% reporting significant changes in HgbA1c (2016). The information from this systematic review found that engagement in DSME results in statistically significant decreases in HgbA1c (Chrvala et al., 2016). Powers et al., concluded that DSME improves HgbA1c by up to 1% (2017). DSME positively affects dietary habits, increases physical activity, and improves rates of smoking cessation (Chong et al., 2017). Powers et al. (2017) also examined benefits to T2DM management using DSME. Improvement in DSME behaviors that create healthy eating patterns Type 2 Diabetes Mellitus Self-Management Education 19 and regular physical activity led to increased healthy coping and empowerment of the patient. This can decrease T2DM related depression (Powers et al., 2017). DSME has been associated with positive improvements in other clinical, psychosocial, and behavioral aspects (Powers et al., 2017). Many participants report improved quality of life following DSME (Powers et al., 2017; Bowen et al., 2016). Residents of rural Appalachia diagnosed with T2DM report difficulty going to family gatherings for fear of not being able to eat food their families have prepared (Beverly et al., 2017). The utilized DSME assists participants in attending family gatherings while still eating appropriately utilizing the Diabetes Placemat to self-manage their T2DM. Cost-Effectiveness of DSME DSME decreases hospital admissions and readmissions (Powers et al., 2017). Effective glycemic control improvement is exhibited through DSME within the current research (Phillips et al., 2015). By achieving glycemic control, complications of T2DM can be prevented. Utilization of DSME decreases estimated lifetime health care spending costs due to decreased risk of complications (Powers et al., 2017). Appropriate glycemic control can decrease healthcare spending and the financial burden of T2DM (Dawson et al., 2017). With the projected increasing rates of prevalence, DSME is a cost-effective tool to decrease the burden of T2DM on the U.S. economy (Chrvala et al., 2016). Better health outcomes continue to be associated with the amount of time spent receiving DSME (Powers et al., 2017). Theme Three: Effectiveness of Various Forms of DSME Chrvala et al. utilized informed decision making within DSME to assist in individualizing patient goals and strengthening the patient-provider relationship (2016). Bowen et al. (2016) found that HgbA1c improved when patients were educated by a Certified Diabetes Educator (CDE) using the Diabetes Placemat with p-values of <0.001. This author used analyzation of Type 2 Diabetes Mellitus Self-Management Education 20 HgbA1c in a three-arm randomized controlled trial. The control group did not show significant improvement in HgbA1c, however, the group provided with the Diabetes Placemat of DSME in three 30-60 minutes face-to-face meetings had improved HgbA1c at the 3-month and 6-month reassessments (Bowen et al., 2016). The participants educated using the Diabetes Placemat reported significant satisfaction in education method (Bowen et al., 2016). Another study found that using the Diabetes Placemat of DSME had the highest retention rate for participants (Mottalib et al., 2018). This study was a randomized 3-arm study that compared the Diabetes Placemat with structured dietary planning in a 16-week study (Mottalib et al., 2018). For the participants assigned to the structured dietary planning, the individuals had to utilize measuring cups and record weights/volumes of food (Mottalib et al., 2018). Due to rates of low numeracy within the desired project population, usage of structured dietary planning with measuring cups may be ineffective. Up to 40% of those in Appalachia do not possess basic literacy skills making various forms of DSME ineffective, however the use of the Diabetes Placemat, with its pictures and diagrams, will be effective in educating this population (Carpenter & Theeke, 2018). This project used the Diabetes Placemat to provide DSME to medically underserved populations. The research suggests the Diabetes Placemat leads to increased overall satisfaction in treatment plan and can significantly decrease HgbA1c in participants with T2DM (Bowen et al., 2016). Theme Four: Barriers to DSME Lack of Access to DSME DSME is pivotal to effective management of T2DM. Most T2DM care is performed by the patient. Without effective DSME, the patient may be less able to manage T2DM properly (Bowen et al., 2016). Though crucial to the management of T2DM, few patients have access to Type 2 Diabetes Mellitus Self-Management Education 21 or receive DSME. Medicare did not begin to cover DSME until 1997 (Chrvala et al., 2016). Currently, the Medicare policy allots 10 hours of DSME during the first year of engagement, following the first year of engagement the patient is allotted only 2 hours of DSME per year (Chrvala et al., 2016). The first year of engagement sometimes is confused to mean the first year of diagnosis, however, the first year of engagement is meant to mean the first year the patient engages in any form of DSME (Chrvala et al., 2016). Lack of access contributes to why only 5% of those with Medicare or Medicaid are receiving DSME (Chrvala et al., 2016). The burden of T2DM education and DSME is often assumed by the primary care provider when patients do not receive formal DSME from a CDE (Devchand et al., 2018). The Appalachia culture historically has been exploited for natural resources and labor. Many within the Appalachia region report a general mistrust of outsiders and fear of being taken advantage of by healthcare systems (Carpenter & Theeke, 2018), this may account for their lack of utilization of CDE. Medically Underserved Communities People who are defined as medically underserved face barriers to health maintenance in the form of income, education, race, ethnicity, or other social and economic factors (Wang et al., 2018). Lee et al. (2019) found that specific communities are noted to have worse health outcomes, increased morbidity and mortality, and an increased financial burden from T2DM (2019). This study included a sample size of 576,306 patients in New York City with T2DM and compared the areas they lived, their ages, race/ethnicity, and how frequently they visited the emergency department in 5 years from 2011-2015. Patients with T2DM who experienced complications and adverse outcomes were more likely to live in disadvantaged areas and reported more psychosocial distress (Chong et al., 2017). Ongoing DSME assists patients in overcoming barriers to proper T2DM self-management (Powers et al., 2017). One barrier the Type 2 Diabetes Mellitus Self-Management Education 22 medically underserved face in T2DM self-management is numeracy. Young et al. (2018) investigated numeracy and food insecurity in relation to T2DM. Currently, 110 million adults within the U.S. have limited numeracy scores. Individuals with T2DM that exhibit lower numeracy scores are noted to have poorer glycemic control. Young et al. (2018) gathered data through the Diabetes Numeracy Test-15, the Spoken Knowledge in Low Literacy Diabetes Scale, and the U.S. Department of Agriculture Food Security Questionnaire. The authors found the prevalence of T2DM increases by two to three times as food insecurity increases (Young et al., 2018). Patients with food insecurity purchase lower-quality, higher calorie foods which leads to their weight gain and poor control of T2DM. Many rural Appalachian counties are considered by the USDA to be food deserts (Hodges, 2017). Living in these areas increases rates of obesity from lack of fresh and healthy foods leading to high rates of chronic disease (Hodges, 2017). Another barrier the medically underserved face in T2DM self-management is level of educational attainment. The prevalence of T2DM decreases as level of educational attainment increases (Bullard et al., 2018). One third of patients with T2DM have not completed a high school education (Chong et al., 2017). The DNP Practice Innovation Project took place in rural North Carolina Appalachia, this is a mountainous region in North Carolina. High rates of T2DM are noted in rural Appalachia (de Groot et al., 2017). Theme Five: Adult Learning Retrieval Practice and Forward Effect Pastotter and Bauml (2019) found that middle aged adults show benefits in the utilization of retrieval practice and the forward effect in long-term memory retention. Research recommends the use of pre-test and post-test methods when educating middle aged adults to Type 2 Diabetes Mellitus Self-Management Education 23 achieve retrieval practice (Pastotter & Bauml, 2019). The project utilized a pre-test and post-test method to achieve the retrieval practice and create a forward effect. Long-term retention of DSME skills and knowledge is important to self-management of T2DM and sustainability of change. With research suggesting the usage of a pre-test and post-test method to educate adults ages 45-75, this Practice Innovation Project tested participants on their knowledge, confidence, and preparedness of T2DM self-management before and after the education was provided. By testing before the information was provided, the retrieval practice was utilized because adults are more likely to pay attention to new information if they recently have been tested on it (Pastotter & Bauml, 2019). The forward effect is the utilization of long-term memory following the installment of retrieval practice, meaning that once an individual has utilized the retrieval practice to focus on information after being tested on it, the individual is more likely to remember the information for future testing (Pastotter & Bauml, 2019). This means the project used the retrieval practice by having a pre-test before educational session and the forward effect by educating between the pre-test and post-test. Health Illiteracy Literacy is the ability to read and write (Merriam-Webster, 2021). When one is illiterate it means they have an inability to read and write, often this term also means they have little to no education (Merriam-Webster, 2021). Merriam and Bierema found that internationally, 16.3% of individuals over the age of 15 are illiterate and only 1% of adults in the world obtain a college education (2014). Not only are illiterate members of the population a concern in adult education, but there has been an increasing focus within the available research on low health literacy (Merriam & Bierema, 2014). Health literacy according to the U.S. Health Resources and Services Administration is ones ability to acquire, process, and comprehend essential health Type 2 Diabetes Mellitus Self-Management Education 24 information to make appropriate decisions regarding their health (HRSA, 2019). Research indicates that 14% of the overall population in the U.S. has below basic health literacy, which causes difficulty during education and comprehension of disease processes (Imoisili et al., 2017). People with lower rates of health literacy are more highly represented in the Medicare and Medicaid populations at 27% and 30% respectively (Imoisili et al., 2017). Older adults, medically underserved communities, minorities, and those of low socioeconomic status have more prevalent rates of low health literacy (HRSA, 2019). Low health literacy has been associated with increased health care costs including increased emergency department utilization and increased hospitalizations (Imoisili et al., 2017). Nationally, 13.3% of those 25 and over have less than a high school diploma, however in Appalachian North Carolina, 15.7% of the population has less than a high school education (Pollard & Jacobsen, 2017). In Central Appalachia only 12% of individuals 25 and over have a bachelors degree compared to the 27% nationwide (Robinson, 2015). Joint Commission recommends that patient education be written at a 5th grade reading level to account for patients with decreased levels of educational attainment and low health literacy (Imoisili et al., 2017). The Centers for Medicare and Medicaid Services recommends using the Simple Measure of Gobbledygook (SMOG) Readability Formula; however, the FleschKincaid grade is more widely used to evaluate reading level (Imoisili et al., 2017). Imoisili et al. investigated readability of patient education materials related to DSME (2017). With 175 participants, the study utilized the SMOG and the Flesch-Kincaid metrics (Imoisili et al., 2017). This study found that literacy of 17.1% of the participants was at or below a 6th grade reading level (Imoisili et al., 2017). The results of this study reinforced the use of the Diabetes Placemat due to its use of pictures, rather than verbiage alone, to educate the participants. Type 2 Diabetes Mellitus Self-Management Education 25 Strengths T2DM is a topic with a large amount of research available. Numerous articles were available regarding various methods of DSME. The articles included in this literature review had large sample sizes and utilized validated tools. The literature review included a wide range of locations where the studies were completed. Some studies were completed in urban settings such as New York City while others were completed in rural communities. Reviewing articles that included both indicates the positive DSME effects can be seen both in urban and rural settings. Another strength of the literature examined was the various settings in which the studies took place. Some research settings utilized included primary care, endocrinologist offices, dieticians, nutritionists, and with community based CDEs. Within the literature some studies had been completed at FQHCs, however the project was still novel in its use of the LMC SCPI tool and the Diabetes Placemat education together. The LMC SCPI tool has been tested for reliability and validity, though it was not specified if this was done in a rural environment or not. The literature reviewed also included various forms of DSME including two articles that specifically examined the usage of the Diabetes Placemat. Two systematic reviews were included in the literature review. Limitations and Gaps in Research The LMC SCPI was only used in one research study prior to the Practice Innovation Project, this could be a potential limitation in the tool utilized for analyzation of knowledge retention and change in confidence and preparedness following education. One limitation in the literature review conducted was that only studies in English were examined. Information from other countries not published in English could have provided more information regarding the global impact of T2DM and methods of education found to be effective within other cultures. Type 2 Diabetes Mellitus Self-Management Education 26 Some of the studies examined interventions that would be unsustainable within a FQHC setting long-term. An example being one study provided patients with smart phones so they could participate in a mobile app and Bluetooth enabled glucometers (Wang et al., 2018). Another example was providing the patients with meal replacements for 16 weeks free of charge (Mottalib et al., 2018) Providing a smart phone to utilize a mobile app, a Bluetooth enabled glucometer, or meal replacements were too much of a financial burden for the student and FQHC selected. Utilization of mobile apps, Bluetooth enabled glucometers, or meal replacements are not feasible for the rural Appalachia population regarding sustainability. Minimal information is available regarding testing patients for skills, confidence, and preparedness to self-manage their T2DM. This gap within the research was addressed by the DNP Practice Innovation Project. While the Diabetes Placemat of education has been suggested in previous research as a form of DSME that improves T2DM self-management skills and HgbA1c, this method had not been tested before for its effect on patient confidence and preparedness to self-manage. Based on the literature examined and the evidence available, the Practice Innovation Project took place in a Rural Appalachia primary care setting in North Carolina. Prior to and following the DSME presented, the participants were tested using the LMC SCPI to assess skills, confidence, and preparedness before and after the DSME. During the intervention, T2DM participants were provided with DSME in the form of the Diabetes Placemat. This method of education is easily understood regardless of health literacy and numeracy with its pictures of food and easily understood diagrams of a plate. Participants in the project were able to take the placemat home with them to place on their table and visualize during meals. Participants could make multiple copies of the placemat for reference as well. The project is sustainable, and the Type 2 Diabetes Mellitus Self-Management Education 27 intervention is easily applied to various locations. A primary care provider can easily keep a few copies of the placemat in their office and provide them to patients with T2DM. The Diabetes Placemat comes in 7 different cuisine options making it applicable to various cultures. Concept Map The concept map (Figure 1) connects the topic of interest, the target population, and phenomenon of interest to the DNP Practice Innovation Project: T2DM Education in the Primary Care setting to improve self-management. The topic of interest is T2DM. DSME includes an understanding of the disease, the target population, and adult learning and education. The target population are males and females ages 45-75 at a FQHC. The phenomenon of interest is adult learning. Utilizing the information available surrounding this phenomenon will allow the student to accomplish the proposed project. Within the concept map are the themes revealed in the literature review and their relation to the proposed project. Figure 1. Theoretical Framework The Chronic Care Model (CCM) was utilized as the theoretical framework for the DNP Practice Innovation Project. The CCM focuses on improving chronic disease management Type 2 Diabetes Mellitus Self-Management Education 28 through the examination of the organization of health systems, self-management support, decision support, community resources and policies, clinical information systems, and delivery system design (Russell et al., 2017; Baptista et al., 2016). The CCM provides patients with chronic diseases, such as T2DM, with self-management skills (Baptista et al., 2016). The DNP Practice Innovation Project focused on T2DM, a chronic disease, and improvement of delivery of education to improve self-management. The project utilized components of the CCM through providing self-management support, while assessing and improving delivery of education. The CCM advocates for changes in the management of chronic disease (Barr et al., 2003) through utilization of existing resources (Baptista et al., 2016). The project utilized the existing resource of the primary care office to promote the empowerment of the participant in their selfmanagement (Baptista et al., 2016). The multi-pronged strategy of the CCM will assisted the project in being successful in sustainment of long-term changes in T2DM management (Barr et al., 2003). Evidence indicated the CCM provides support for the primary care provider and interdisciplinary team to affect the care of T2DM patients in a positive manner (Barr et al., 2003). The CCM focuses on self-care support by assisting patients in understanding self-care and monitoring by providing strategies for management, education, and emotional support (Baptista et al., 2016). The use of the Diabetes Placemat provides education and a strategy for selfmanagement. Social Entrepreneurship and Innovation The social entrepreneur creates opportunities to achieve valuable solutions. The goal of the social entrepreneur is to see a return on investment and a return to society. Compared to general entrepreneurs who capture value and have a goal of return on investment, the social entrepreneur combines profit with altruism to address social problems (Betts et al., 2018). Type 2 Diabetes Mellitus Self-Management Education 29 Entrepreneurs and social entrepreneurs alike use discovery and various innovation strategies to obtain opportunities. The definition of social entrepreneur by Betts et al., in their article on social entrepreneurship, is that social entrepreneurs use profit making enterprises to address social, environmental, and other problems that were traditionally entrusted to governmental and nonprofit organizations (2018, p. 2). The social entrepreneur uses principles of entrepreneurship to innovatively achieve valuable solutions to social issues while crafting a return on investment both for themselves and society (Betts et al., 2018). Innovation is what makes a project sustainable. The definition of innovation is fluid, often changing depending on the countrys culture. For most modern cultures, innovation is something new that can create value. Social entrepreneurship utilizes innovation to foster sustainability for a project (Reaiche et al., 2016). The DNP Practice Innovation Project did not generate a profit, but rather anticipates a decrease in healthcare costs related to T2DM. The project proposes a generation of improved self-management by patients as a profit from the education provided. Improved self-management suggests a decrease in the financial burden of T2DM on society (Powers et al., 2017). The project used the innovation of education from the primary care provider to the patient on improved diabetes self-management with the underlying theory of adult learning. Often, T2DM education is provided by an endocrinologist; however, utilization of a primary care provider that the patient potentially already has a relationship with is part of the innovation the project presents. Access to education is improved, many in medically underserved communities face barriers when attempting to attend appointments with specialists such as Endocrinologists, dieticians, or CDE. Education of patients with T2DM is a social issue due to the strain of this disease on the patient financially and disease rates in medically underserved communities. The Type 2 Diabetes Mellitus Self-Management Education 30 complications seen with T2DM also create a financial strain on the health care systems within the U.S. (Power et al., 2017). Utilization of attributes of social entrepreneurship including innovation will assist in the completion of the project. Sustainability Sustainability is an important aspect of implementation science and is defined as when the project officially ends, the intervention continues to be delivered, lasting effects are achieved, or the behavior changes are maintained (Moore et al., 2017). For the Practice Innovation Project, which belongs within implementation science, the intervention was implemented over a period of 2 months. The intervention or behavior changes may continue to adapt, but if it has been sustained, the change continues to bring benefit to society (Moore et al., 2017). Sustainability is exhibited by the DNP Practice Innovation Project if the education and information provided to participants on T2DM self-management continues to positively affect the participants behaviors and disease management following program completion. Sustainability was exhibited by the Practice Innovation Project as once the student completed the implementation process, HVMC providers continue to utilize the intervention, the Diabetes Placemat to educate patients with T2DM. The project served the population of interest, individuals diagnosed with T2DM, by educating them on behaviors that can prevent long term complications. For society, the DNP Practice Innovation Project provided efficient, cost-effective, superior quality healthcare for patients regarding self-management education and their T2DM (Cantiell et al., 2016). Improved self-management of T2DM can prevent complications and decrease disease financial burden on society (Powers et al., 2017). The project improved provider knowledge and skill in educating Type 2 Diabetes Mellitus Self-Management Education 31 patients with T2DM. Providers can assist and enhance their patients ability to understand T2DM and proper self-management of it (Cantiell et al., 2016). Implementation Model The implementation model that was utilized during the Practice Innovation Project was the Plan, Do, Study, Act (PDSA) model. Many similar projects have utilized this implementation model. Modeled after a similar study by Harris (2017), the DNP Practice Innovation Project PDSA model was: Plan Definition of DSME through research of current literature including methods of education, and plan for collection of data utilizing the LMC SCPI Do implement the intervention within Happy Valley Medical Center (HVMC) Study analyze the outcomes of the intervention and its effects; examine effectiveness of implementation process Act based on results of DNP Practice Innovation Project, plan to spread the project through education of fellow providers if positive results occur. Russell et al. found that the PDSA model allowed for rapid implementation and concurrent evaluation (2017). Due to limited time for implementation of the project, the ability for rapid implementation using the PDSA model made it desirable. To appropriately use the PDSA cycle, the student asked the following 3 questions: 1. What are we trying to accomplish? 2. How will we know that a change is an improvement? 3. What changes can we make that will result in improvement? (Girdler et al., 2016). Type 2 Diabetes Mellitus Self-Management Education 32 Research suggests that definition of goals assists in the effectiveness of the PDSA model. Measurable metrics for improvement assists in continual improvement of process outcomes (Girdler et al., 2016). In similar studies, dedication of time from those on the interdisciplinary team contributed to successful use of the PDSA (Waller et al., 2018). In the study by Waller et al., monthly meetings between program leaders were conducted during the duration of the program to review progress and data (2018). Similarly, the student for the Practice Innovation Project met with providers at HVMC daily during the implementation process and barriers were be discussed. The student continued analyzing the implementation process and outcomes of the intervention with the faculty advisor and key stakeholders at HVMC. The feedback mechanisms that were utilized by the student were part of the PDSA model and facilitated the adaptation of the project to the needs of the facility. Adaptation through the continuous improvement available in the PDSA design assisted in project sustainability and longevity. Similar studies that did not use the PDSA model for the implementation model lacked feedback from providers, key stakeholders, and nurses. Without feedback from pivotal members of the implementation team, there is a possibility of resistance to and negative reactions from the change that can hamper the effectiveness of implementation (Jolin, 2017). By using the PDSA model, the student obtained feedback from members of the implementation team to address concerns to project implementation. Utilization of the PDSA model leads to continuous quality improvement and can improve compliance long-term (Girdler et al., 2016). Type 2 Diabetes Mellitus Self-Management Education 33 Ethical Considerations Risk and Benefits to Participants Participating in the project can benefit individuals by causing them to feel virtuous for assisting in the advancement of nursing knowledge. Another benefit of participation is structured education with the student using certified education tools. The hypothesis was with structured education, the participant will gain knowledge and confidence while feeling more prepared to self-manage their T2DM. The survey tools utilized may assist participants in understanding areas of self-management that they are less knowledgeable. Improved overall health due to proper diet management is another benefit available to participants. The DNP Practice Innovation Project assessed the effect of the diabetes education tool, the Diabetes Placemat, on patient knowledge, confidence, and preparedness related to selfmanagement of T2DM. Previous studies have suggested that increased knowledge and confidence in patients with T2DM has been associated with decreased HgbA1c (Powers et al., 2017). Appropriate glycemic control can assist in prevention of T2DM associated complications and decrease healthcare spending (Dawson et al., 2017). There was no known physical or psychological risk for those participating in the Practice Innovation Project. The risk of breach of privacy is minimized by reminding participants to not include personal information that could identify them on the demographic form. Participants were reminded that participation is optional and that they could leave the project and educational offering at any time. The student does note that research suggests a social stigma exists within the culture of rural Appalachia regarding a diagnosis with T2DM; those with T2DM are viewed as lazy, irresponsible, and overindulgent (Della, Ashlock, & Basta, 2015). Patients in rural Appalachia report guilt and shame related to a T2DM diagnosis for this reason (Della, Ashlock Type 2 Diabetes Mellitus Self-Management Education 34 & Basta, 2015). Participants may be hesitant to participate due to guilt and shame related to diagnosis or embarrassment related to low literacy levels. Recruitment The population was recruited from a FQHC within the West Caldwell Healthcare system, HVMC, that assists medically underserved patients in North Carolina. Participants were recruited by using a Recruitment Flyer (Appendix E) that was posted at the patient check-in and lobby on the days the student was present at the clinic. HVMC staff assisted with recruitment, staff were informed about the days the student was present at the facility. Anonymity and Confidentiality To maintain anonymity, participants were instructed not to include names, birthdays, medical record numbers, or any other identifying information on the pre-tests, post-tests, and demographic form. The only form with any type of identification on it was the Informed Consent form. To maintain confidentiality, this form was stored in a separate file folder and kept in a locked briefcase until the end of the day when the information was locked in a file cabinet at the intervention site, HVMC. Staff collecting the documents were educated about the importance of anonymity and removing any identifying information from the patients demographic form. Staff at West Caldwell Health and HVMC saw minimal data as it was collected from the patients. The staff members who had access to the information include providers, nurses, and medical assistants involved in direct patient care and study administration. These individuals already have access to these patients information and have engaged in HIPAA training for employment with HVMC prior to project implementation to protect patient privacy. The student saw all the data. While data were being collected, all electronic information was stored within a password protected application on the students computer. The electronic information was shared Type 2 Diabetes Mellitus Self-Management Education 35 with the students advisor. The participants will not be identifiable due to the information they shared in the demographic form or the LMC SCPI utilized in the pre-test and post-test evaluations. For the project, the principal investigator is a student, therefore, the faculty supervisor must keep all records of research for three years at a minimum (Saint Marys College, 2020). The data will be reported by the student following the completion of the intervention in a formal paper to Saint Marys College. Informed Consent One potential confounding variable for this project was the lack of understandability for many participants when reading consent forms (Simonds et al., 2018). Up to 40% of adults in Appalachian counties do not possess basic literacy skills (Carpenter & Theeke, 2018). Many consent forms utilize verbiage that is complex in nature, much like the standard expectations found in a research document, possibly making it difficult for participants to understand the proposed research (Simonds et al., 2018). The Informed Consent form (Appendix B) was adapted to improve readability through utilization of simplified words or explanations where possible within the document. Also, to improve participant understanding of the Informed Consent form, the participants signed a concise summation of the information included in the Informed Consent form. Readability scores were determined using the SMOG index; the Informed Consent form has a readability score of the 10th grade. The Consent Form Signature Page, (Appendix C) is the concise summation of Informed Consent form and had a SMOG index readability score of 7.8th grade. The participants were educated verbally on the project and had the opportunity to read the informed consent form or have it read to them. At that time, the student answered any questions the participant had, and the participant had the opportunity to Type 2 Diabetes Mellitus Self-Management Education 36 sign the informed consent form and participate in the project. No compensation was provided to individuals for their participation. Educational Presentation The educational session included information about the Diabetes Placemat available through the American Diabetes Association (Appendix D). The Diabetes Placemat is available in seven different versions, each addressing a different form of cuisine, using a mixture of pictures, words, and easy to understand diagrams to assist in portion control for diabetics. The Diabetes Placemats used were the classic and southern version. Lipari et al. (2019) examined understandability, actionability, and readability of current diabetes tools available from the American Diabetes Association, Association of Clinicians for the Underserved, and the National Diabetes Education Initiative. All items had readability scores of between a 6th grade and 9th grade reading level, above the standard 5th grade reading level. The high readability scores seen in this study were another reason why the Diabetes Placemat, that primarily uses pictures and diagrams, is important in its utilization within this project for future applicability to evidencebased practice changes in primary care. Data Collection and Security Data were collected from participants individually. The Informed Consent form signature page was collected and stored in a separate locked location from the other data collected to ensure confidentiality. After the Informed Consent had been signed, the participant completed the demographic form (Appendix G). The demographic form was stored in a sealed folder with the student. The demographic data were entered into a password protect laptop. All de-identified paper documents were stored in a locked file cabinet at the end of the day. Type 2 Diabetes Mellitus Self-Management Education 37 Next, the participant completed the LMC SCPI (Appendix H) pre-test evaluation to determine their level of skills, confidence, and preparedness in relation to self-management of T2DM. This was completed using hard copies of the LMC SCPI to prevent potential cross contamination between participants as the project took place during the COVID-19 pandemic. These were stored in a folder similar to the demographic form folder. All information was entered into the online password protected application available from the creators of the tool immediately by the student. Each participant had an individualized random code to link their pretest LMC SCPI with their post-test LMC SCPI. The paper copies of the tool were shredded. The results of the pre-tests were stored through the online application by the creators of the tool and within excel on the students laptop, both are password protected. After completing the pre-test, the participant was then educated utilizing the Diabetes Placemat tool (Appendix D). Following the educational session, the participant completed the LMC SCPI as a post-test. Information from this was stored in the same manner as the pre-test. Methods Key Stakeholders A key stakeholder at HVMC, Kathrine Teague, acted as a liaison between the student and the Medical Director and CEO of West Caldwell Health. Katherine also met with the management team at HVMC to assess implementation feasibility. Another key stakeholder at HVMC was Dr. Sonya Suttle, a DNP-FNP within the organization. Dr. Suttle assisted in implementation planning for the project with her background working in a designated rural county providing care to the medically underserved. Dr. Sue Anderson, a faculty member at Saint Marys College, served as the faculty team leader for the project and is another key stakeholder. Type 2 Diabetes Mellitus Self-Management Education 38 Participant Inclusion Criteria Due to recommendations for testing to begin at age 45 and that T2DM is most prevalent in people older than 29, people younger than 45 years of age were not included in this Practice Innovation Project (American Diabetes Association, 2019; Bullard et al., 2018). The age range of the target population was 45-75 to include the largest number of patients with T2DM. Male and female patients were both included in this project since the difference in prevalence between genders is 1-2% for ages 40-75 (Lee et al., 2019). Less than 7% of patients with private insurance and less than 5% of patients with Medicare are actively participating and receiving diabetes self-management education (Chrvala et al., 2016). Patients with private insurance and those with Medicare/Medicaid were included in this DNP Practice Innovation Project. To participate in the project, patients must exhibit a diagnosis of T2DM by fasting plasma glucose, 2-hour plasma glucose testing during a 75g oral glucose tolerance test, or HgbA1c (American Diabetes Association, 2019). Current practice guidelines suggest a goal HgbA1c of less than 7.0% in patients with T2DM, however, research has shown that 50% of these patients do not achieve or maintain that goal (Chrvala et al., 2016). Patients with T2DM were recruited for this project because the Practice Innovation Project hypothesized improved self-management following the education. Improved self-management has been suggested to decrease HgbA1c in those with T2DM (Powers et al., 2017). Inclusion criteria for the project were men and women between the ages of 45-75, who had been diagnosed with T2DM. Participants had to be able to read or understand spoken English. Participants were patients at HVMC where they were recruited from. Based off the power analysis conducted for the project, the students goal is to recruit 16 participants. Type 2 Diabetes Mellitus Self-Management Education 39 Exclusion criteria for the project included: pregnant women or women in the post-partum period; people diagnosed with sickle cell anemia, or human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS); people receiving hemodialysis, glucose-6-phosphate dehydrogenase deficiency, erythropoietin therapy; recent blood loss or transfusion in the last 6 months; multiple sclerosis; traumatic brain injuries; Alzheimers disease, or any other significant learning deficits. Exclusions were due to the altered relationship these conditions or situations cause between HgbA1c, glycemia, and dietary restrictions. In these patients, HgbA1c is not a reliable measurement of blood glucose (American Diabetes Association, 2019). Minimal testing has been done with patients diagnosed with multiple sclerosis, traumatic brain injuries, Alzheimers disease, or significant learning deficits in retrieval practice and the forward effect (Pastotter & Bauml, 2019). These patients were excluded from the study due to the education method being utilized. Prior to participant consent to the study, the student asked if the possible participant had any of the disorders, diseases, or conditions that would exclude them from participation. If they did, they were informed they do not meet the requirements to participate. Intervention Plan The project was implemented over a 2-month time-period. Initially, the student intended to implement for 4-months as exhibited in the Gantt Chart (Appendix F) to increase probability of achieving optimal sample size. However, due to the COVID-19 pandemic, the student was limited in implementation. Implementation began once IRB approval was gained from Saint Marys College. After IRB approval, the student educated the HVMC staff members who assisted with the project about the purpose of the project, its implementation, and their role. After staff had been educated and the student received approval from HVMC, the projects intervention began, and data were collected from participants. Type 2 Diabetes Mellitus Self-Management Education 40 As potential participants checked in at the clinic, there was a recruitment flyer posted in the waiting area and check-in area the days the student was at the facility. If the potential participant exhibited interest while checking in, the student was notified and communicated with the nurse or medical assistant caring for that patient to determine if the patient met criteria. When the registered nurse (RN) or certified medical assistant (CMA) escorted the patient to an exam room, he or she screened the individual for their ability to participate in the project. If the patient met the inclusion criteria, the RN or CMA offered the participant to meet with the student after their visit with their provider. If the patient verbally expressed an interest in participating, he or she was directed to the students education area following the visit with the primary care provider. The student determined if the patient met the rest of the qualification criteria. The student asked the participant about the exclusion criteria. If no exclusion criteria were identified, the student provided the participant with the Informed Consent Form and the Consent Form Signature Page. During this time, the participant was encouraged to ask the student any questions regarding the project and the student provided answers. After obtaining informed consent, the participant was given the demographic form (Appendix G). The participant then completed the LMC SCPI as a pre-test. Following completion of the pre-test, the participant was provided with the Diabetes Placemat education. For education, the student went over the foods and portion sizing exhibited on the Diabetes Placemat and answered any questions the participant had. The participant then completed the LMC SCPI as a post-test. The project exhibited retrieval practice through pre-test and post-test education by being tested on the information prior to being educated on it. Increased information retention has been associated with utilizing this method (Pastotter & Bauml, 2019). The forward Type 2 Diabetes Mellitus Self-Management Education 41 effect was exhibited in the increase of retention of knowledge following the retrieval process and testing of participant on knowledge presented (Pastotter & Bauml, 2019). Data collection Participants answered questions about their age, gender, ethnicity, and highest level of education achieved when completing the demographic form (Appendix G). Age and ethnicity are important as prevalence of T2DM differs depending on age and ethnicity. Gender is also included within the demographic form to inform future studies about appropriate selfmanagement education depending on gender. Information gathered through the project related to participant highest level of education achieved can inform future studies and providers on the management and education of those with T2DM (Wang et al., 2018). The data gathered was quantitative in nature. The age, ethnicity, gender, and highest level of educational attainment from the demographic form can all be manipulated in a quantitative manner. The tool used to measure the effect of the education provided is the LMC SCPI in Appendix H (Aronson, Li, et al., 2019). The creators of the tool were contacted, and the student obtained their approval for usage of the tool prior to implementation. The tool was administered to one person at a time. In a previous study with 518 participants in Ontario, the instrument was administered electronically and took 6 minutes to complete (Aronson, Brown, et al., 2018). The student was present while each LMC SCPI is administered to read the questions to the participant to decrease the barrier of illiteracy. Feeling shame related to illiteracy may be prevent individuals from participating in the project, therefore the barrier of illiteracy cannot be fully eliminated. In the previous study, the scale was utilized at an endocrinology specialty clinic to assess patient knowledge, confidence, and preparedness in diabetes self-management (Aronson, Brown, Type 2 Diabetes Mellitus Self-Management Education 42 et al., 2018). For the DNP Practice Innovation Project, the tool was implemented in a primary care setting. During the previous study, participants were both Type 1 and Type 2 diabetics, however the data were analyzed separately between the cohorts. The student only assessed participants with T2DM. During the previous study, the tool was only administered once, and no prior specific education was provided to the patient (Aronson, Brown, et al., 2018). The student utilized this specific tool as the pre-test and post-test in the Practice Innovation Project. The purpose of this tool was to assess the confidence, knowledge, and preparedness of the participants before and after the administration of education in the primary care setting. Timeline The included Gantt Chart (Appendix F) was a proposed implementation guideline as data collection dates were contingent on IRB approval from Saint Marys College and the COVID-19 pandemic policies at the implementation site, HVMC. The student collected data over 2 months. The yellow highlighted areas are completed steps of implementation, the blue highlighted areas were part of the initial proposed implementation guideline, and the green highlighted area is what is currently being completed. Budget HVMC provided the space and staff free of charge to the student. The student incurred expenses during project implementation. The student was projected to spend $127.30 in travel expenses and did incur $92 in travel expenses. Additional expenditures included printing the Recruitment Flyer, Informed Consent form, Consent Form Signature Page, demographic form, LMC SCPI, and the Diabetes Placemat. Fifty copies of the LMC SCPI were printed to avoid cross contamination between participants due to the COVID-19 pandemic. Printing these documents cost an estimated $250, which was similar to the budgeted amount. The student Type 2 Diabetes Mellitus Self-Management Education 43 decreased her hours at work, monetarily decreasing income by $1,000/month equivalent to $2,000 for the entirety of the project. The student had a decrease in free time worth $30/hour valued at $1,800 for the entirety of the project. The student determined her free time at this value by averaging the cost to pay an individual of her education for an hour worth of work as a nanny, maid, laundress, and chef as these are tasks completed in her free time. The student incurred added stress with an estimated cost of $100/visit, which is the equivalent for $700 for the entirety of the project. This cost was determined by averaging the cost of therapy, massages, facials, and gym memberships in the Charlotte, NC area where the student resides as these are means of stress relief. The total cost to the student for project implementation is $4,842 which was supplied by the student. Access to the LMC SCPI is available online free of charge from the creators of the tool. No direct profits were derived from the products and services provided. Individuals with diabetes incur an average of $9,601 per year in expenses related to their diabetes; these expenses are paid by the individual and the healthcare system (American Diabetes Association, 2018). The student proposes the education provided to patients may collectively save up to $1,000 per year per participant through the decrease in adverse outcomes and complications that lead to additional costs in T2DM self-management. With the 18 participates that is an estimated $18,000 in savings for the participants and healthcare system. Glycemic control improvement has been seen through effective DSME (Phillips et al., 2015), by achieving glycemic control, complications of T2DM can be prevented (Powers et al., 2017). Appropriate glycemic control can decrease healthcare spending and financial burden of T2DM (Dawson et al., 2017). The project was potentially a worthwhile investment and should be further evaluated as a realistic long-term opportunity. Type 2 Diabetes Mellitus Self-Management Education 44 Data Analysis The information gathered from the demographic form was quantified for data analysis. Participant gender and ethnicity were treated as nominal scales. Participant highest level of educational attainment was an ordinal level of measurement. Participant age was a ratio level of measurement. No qualitative data were gathered from participants. The information gathered from the demographic form was analyzed by the student. The LMC SCPI is an ordinal level of measurement that assesses knowledge, confidence, and preparedness. For the DNP Practice Innovation Project, the results of the LMC SCPI for the pre-test and the post-test are compared against each other using a paired T-test with a two tailed hypothesis to determine if the education provided increased the patients knowledge, confidence, and preparedness. The necessary sample size for the study was 16 participants. The sample size was determined using a power of 0.80, an effect size of 0.8, and an alpha of 0.05 with the intention of using a paired T-test. There were 18 initial participants with 17 participants completing both the pre-test and post-test. A pre-test and post-test analysis was conducted of the participants knowledge retained from the education. No maximum sample size was determined. Data were entered into Social Science Statistics Paired T-test calculator without identifiable characteristics and analyzed by the student. The statistical analysis used in the previous study with the LMC SCPI was an ANOVA. The LMC SCPI has a high internal consistency with the individual subscales exhibiting a Cronbachs alpha score ranging from 0.81-0.95. The LMC SCPI was compared against the Michigan Knowledge Test and Diabetes Empowerment Scale when assessing external validity. An interclass correlation for the LMC SCPI was determined to be 0.94. The scale also had a test- Type 2 Diabetes Mellitus Self-Management Education 45 re-test reliability of 0.84 with a p-value of less than 0.001. Testing of reliability was done with 61 participants who completed the questionnaire a second time (Aronson, Brown, et al., 2018). The LMC SCPI is a 25-item tool with a Flesch Kincaid readability score of 8th to 9th grade. Strengths of the scale include a high internal consistency, strong external validity, and significant reliability. Most scales solely assess knowledge. In comparison, this scale assesses knowledge, confidence, and preparedness. Providing the three subcategories within the scale helps in individualization of support strategies and care plan management for patients. An inverse relationship was observed between LMC SCPI scores and HgbA1c, suggesting improved confidence, knowledge, and preparedness is correlated with a decrease in HgbA1c (Aronson, Brown, et al., 2018). The Practice Innovation Project is applicable to future studies in its assessment of knowledge, confidence, and preparedness following the Diabetes Placemat education. Results Information gathered from the demographic form was analyzed by the student. Analysis of participant race can be found in Figure 2 with 72% of participants identifying as White. There were equal percentages of individuals who identified as African American, Hispanic, and Native American at 11% each. Participants could identify as more than one race on the demographic form. Type 2 Diabetes Mellitus Self-Management Education 46 Figure 2 Race White African American Hispanic Native American All participants had finished the 6th grade, however 6% didnt finish 8th grade and 22% didnt finish high school. Further breakdown of educational attainment as reported by participants can be found in Table 1. The average age of the participant was 63. There was an equal ratio of male and female participants with 9 male and 9 female. Table 1 Educational Attainment Percentage of Sample Size Finished 6th Grade 100% Finished 8th Grade 94% Finished High School 78% Obtained a College Degree 44% Obtained a Graduate Degree 6% Type 2 Diabetes Mellitus Self-Management Education 47 The paired t-tests for each subcategory of the LMC SCPI were run as two tailed hypotheses. The paired t-test results for the skill category had a t-value of 4.96 and showed a statistically significant increase in skill with the p-value of 0.00014. The paired t-test results for confidence showed a t-value of 3.125 and a statistically significant increase in confidence with a p-value of 0.00654. The paired t-test results for preparedness revealed a t-value of 2.225 and a statistically significant increase with a p-value of 0.0408. The paired t-test results for the healthy eating sub-category revealed a t-value of 3.553 and a statistically significant increase with a pvalue of 0.00266. Education using the DSME the Diabetes Placemat improved patient knowledge, confidence, and preparedness related to self-management of their T2DM as exhibited by the change between LMC SCPI pre-test and post-test scores. HgbA1c was not a measurement used within this study due to time constraints as this would have required a followup 3 months after education. HgbA1c was also not used to measure change within this project because previous studies using the LMC SCPI had observed an inverse relationship between LMC SCPI scores and HghA1c (Aronson, Brown, et al., 2018). One can infer that if improvements were noted in participants skills, confidence, and preparedness exhibited by the LMC SCPI that their HgbA1c would decrease as self-management improves. The goal of this Practice Innovation Project was to assess the Diabetes Placemat as a method of education within the medically underserved population in rural Appalachia, this was accomplished a yield results that can be used to inform future studies. Discussion Increased ethnic diversity was exhibited within the Practice Innovation Project compared to what is commonly seen in rural Appalachia North Carolina. Other studies had found that in rural Appalachia North Carolina, 80.5% of individuals identify as White compared to the 72% Type 2 Diabetes Mellitus Self-Management Education 48 exhibited in this study and 62.3% seen nationally (Pollard & Jacobsen, 2017). In rural Appalachia North Carolina, the next largest category for race is African American at 8.7% compared to the 11% seen in this study which is similar to the 12.3% seen nationally (Pollard & Jacobsen, 2017). The DNP Practice Innovation Project did see differences in educational attainment compared to other studies. Appalachian North Carolina has 15.7% of residents who have not received a high school diploma, this is greater than the 13.3% seen nationally (Pollard & Jacobsen, 2017). Within the Practice Innovation Project, 22% of participants had not received a high school diploma. This is similar to the research that suggests that the prevalence of T2DM decreases as educational attainment increases with 1/3 of patients with T2DM not completing high school education (Chong et al., 2017). Recommendations for Practice The Diabetes Placemat could enhance glucose control to prevent complications of T2DM through its refinement of self-management by improving T2DM knowledge, confidence, and preparedness. The statistically significant improvement in knowledge and confidence is notable as previous research found correlation between increases in knowledge and confidence and a decrease in HgbA1c (Powers et al. 2017). Appropriate glycemic management exhibited by HgbA1c delays and prevents diabetes-associated complications (Dawson et al., 2017). Therefore, the increases in knowledge, confidence, and preparedness following the DSME as exhibited by this study suggests that education with the Diabetes Placemat could decrease HgbA1c and prevent or delay diabetes-associated complications. The results of this project suggest that DSME in the primary care setting can successfully promote increases in patient knowledge, confidence, and preparedness regardless of level of Type 2 Diabetes Mellitus Self-Management Education 49 educational attainment when using the Diabetes Placemat. Providers at FQHCs in medically underserved areas should consider usage of the Diabetes Placemat when discussing selfmanagement with their patients. The results of this study will be shared with the FQHC where implementation took place, due to the statistically significant results, the implementation site intends to continue this method of education as a means of quality improvement. Although the impact of this education was not measured through HgbA1c levels, future research could examine the effects of increased preparedness on HgbA1c long term, as it is unknown how increasing participant preparedness affects future HgbA1cs. Future research should also look at sustainability of the intervention on the participants actions and self-management long term. Also, investigation should be made on the difference in DSME when one on one, such as in this study, and in groups of various sizes. Currently, only 10 hours of DSME is allowed during the first year of engagement for Medicare patients; following the first year only 2 hours of DSME are allotted for the Medicare patient yearly (Chrvala et al., 2016). Only 5% of those with Medicare and Medicaid are receiving DSME (Chrvala et al., 2016). A policy change is needed not only to provide these patients with more allotted time for DSME in subsequent years, but also an improvement of access to DSME for these patients. Strengths A strength of the DNP Practice Innovation Project was the necessary sample size needed based off the power analysis was surpassed. Strong communication was also found between providers, staff, the director of quality improvement, and the student at the implementation site. This strong communication was instrumental in the Plan, Do Study, Act implementation model. Type 2 Diabetes Mellitus Self-Management Education 50 Limitations Though the necessary sample size was met, the sample size remained small at 18. This partially can be due to the limited available number of participants in a rural FQHC. Another factor contributing to small sample size was the global COVID-19 pandemic that limited the amount of time the student was permitted at the implementation site and patient willingness to participate or attend their appointments. A mistrust of outsiders or fear of being taken advantage of by the healthcare system is a viewpoint found within the Appalachia region and may have contributed to the small sample size (Carpenter & Theeke, 2018). Another limitation was the implementation timeline was limited due to this being a doctoral Practice Innovation Project and having to be completed prior to graduation. Conclusion The current prevalence of T2DM is 8.9% in the U.S. (Bullard et al., 2018). Increased healthcare spending is associated with increasing rates of prevalence and complications with decreased rates of glycemic control (Powers et al., 2017). Appropriate glycemic control can prevent T2DM complications and healthcare spending (Dawson et al., 2017). Education of patients with T2DM improves self-management of the disease, which can improve glycemic control (Powers et al., 2017). The DNP Practice Innovation Project assessed the effect of the Diabetes Placemat on patient skill, confidence, and preparedness in self-management of T2DM evident by the LMC SCPI. The data was analyzed using a paired t-test. A statistically significant improvement was noted during data analysis between the pre-test and post-test LMC SCPI in the areas of knowledge, confidence, preparedness, and healthy eating. The data gathered from the project informs future studies on usage of the Diabetes Placemat DSME in medically underserved communities similar to the population of interest, rural Appalachia. The utilization Type 2 Diabetes Mellitus Self-Management Education 51 of principles of entrepreneurship in an innovative manner achieved a valuable solution to the social issues raised by T2DM (Betts et al., 2018). References American Association of Nurse Practitioners, (2019). NP Fact Sheet, AANP. American Diabetes Association. (2019). 2. 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A., Sherr, D., & Lipman, R. D. (2016). Diabetes self-management education for adults with type 2 diabetes mellitus: a systemic review of the effect on glycemic control. Patient Education and Counseling, 99(6), 926-943 Dawson, A. Z., Walker, R. J., & Egede, L. E. (2017). Differential relationships between diabetes knowledge scales and diabetes outcome. The Diabetes Educator, 43(4), 360-366 De Groot, M., Doyle, T., & Averyt, J. (2018). Program ACTIVE: Cognitive Behavioral Therapy to treat depression in adults with Type 2 Diabetes in rural Appalachia. Journal of cognitive psychotherapy, 31(3), 158-170 Della, L. J., Ashlock, M. A., & Basta, T. B. (2015). Social constructions of stigmatizing discourse around type 2 diabetes diagnoses in Appalachian Kentucky, Health Communication. Devchand, R., Nicols, C., Gallivan, J. M., Tiktin, M., Krause-Steinrauf, H., Larkin, M., Tuncer, D. M., & the GRADE research group. (2017). Assessment of a national diabetes Type 2 Diabetes Mellitus Self-Management Education 54 education program diabetes management booklet: The GRADE experience. Journal of the American Association of Nurse Practitioners, 29(5); 255-263 Girdler, S. J., Glezos, C. D., Link, T. M., & Sharan, A. (2016). The science of quality improvement. JBJS, 4(8). Harris, A. N. (2017). Diabetes Self-Management Education Provision by an Interprofessional Collaborative Practice Team: A Quality Improvement Project. (Electronic Thesis). Hodges, G. (2017). Diagnostic prevalence of diabetes among older adults in rural Appalachia. (Electronic Thesis). HRSA. (2019). Health Literacy. U.S. Health Resources & Services Administration. Imoisili, O. E., Levinsohn, E., Pan, C., Howell, B. A., Streiter, S., & Rosenbaum, J. R. (2017) Discrepancy between patient health literacy levels and readability of patient education materials from an electronic health record. Health Literacy Research and Practice, 1(4): 203-207. Jolin, J. (2017). Increasing exercise for patients with Diabetes using a mobile app- a quality improvement project. (Electronic Thesis). Lee, D. C., Young, T., Koziatek, C. A., Shim, C. J., Osorio, M., Vinson, A. J., Wall, S. P. (2019). Age disparities among patients with type 2 diabetes and associated rates of hospital use and diabetic complications. Preventing Chronic Disease, 16. Lipari, M., Berlie, H., Saleh, Y., Hang, P., & Moser, L. (2019). Understandability, actionability, and readability of online patient education materials about diabetes mellitus. American Journal of Health-System Pharmacists, 76(3); 182-186 Merriam, S. B., & Bierema, L. L. (2014). Adult Learning: Linking theory and practice. San Francisco: John Wiley & Sons. Type 2 Diabetes Mellitus Self-Management Education 55 Merriam-Webster. (2021). Literacy. In Merriam-Webster.com dictionary. Moore, J. E., Mascarenhas, A., Bain, J., & Straus, S. E. (2017). Developing a comprehensive definition of sustainability. Implementation Science, 12. Mottalib, A., Salsberg, V., Mohd-Yusof, B., Mohamed, W., Carolan, P., Pober, D. M., Hamdy, O. (2018). Effects of nutrition therapy on HgbA1c and cardiovascular disease risk factors in overweight and obese patients with type 2 diabetes. Nutrition Journal, 17, 42 Pasttter, B. & Buml, K.T. (2019). Testing enhances subsequent learning in older adults. Psychology and Aging, 34(2); 242-250 Phillips, L. S., Barb, D., Yong, C., Tomolo, A. M., Jackson, S. L., Olson, D. E., Long, Q. (2015). Translating what works a new approach to improve diabetes management, Journal of diabetes Science and Technology, 9(4), 857-864 Pollard, K., & Jacobsen, L. A. (2017). The Appalachian region: a data overview from the 20112015 American Community survey chartbook; Population Reference Bureau; 1-108 Powers, M. A., Bardsley, J., Cypress, M., Dukers, P., Funnell, M. M., Fischl, A. H., Vivian, E. (2017). Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American diabetes association, the American association of diabetes educators, and the academy of nutrition and dietetics. The Diabetes EDUCATOR, 43(1). Reaiche, C., Corral de Zubielqui, G., & Boyle, S. (2016). Deciphering innovation across cultures, The Journal of Developing Areas, 50(6). Type 2 Diabetes Mellitus Self-Management Education 56 Robinson, C. (2015). An exploration of poverty in central Appalachia: questions of culture, industry, and technology. KOME An international Journal of Pure Communication Inquiry, 3(2); 75-89 Russell, N. M., Vess, J., Durham, C., & Johnson, E. (2017). Text-messaging to support diabetes self-management in a rural health clinic: a quality improvement project. Online Journal of Nursing Informatics, 21(2). Saint Mary's College. (2020). Institutional Review Board Statements of Responsibility of the Investigator, Supervisor, and Institution. Retrieved from https://www.saintmarys.edu/portal/institutional-review-board/statements-responsibilityinvestigator-supervisor-institution Schoenberg, N. E., Ciciurkaite, G., & Greenwood, M. K. (2017). Community to clinic navigation to improve diabetes outcomes. Preventive Medicine Reports, 5: 75-81 Seol, H., Thompson, M., Kreider, K. E., & Vorderstrasse, A. (2017). Diabetes self-management quality improvement initiative for medically underserved patients, Journal of Nursing Care Quality, 32(3); 272-279 Sherwani, S. I., Khan, H. A., Ekhzaimy, A., Masood, A., & Sakharkar, M. K. (2016). Significance of HbA1c test in diagnosis and prognosis of diabetic patients, Sage Journals: Biomarker Insights. Simonds, V. W., Garroutte, E. M., & Buchwald, D. (2018). Health literacy and informed consent materials: Designed for documentation, not comprehension of health research. Journal of Health Communication, 22 (8), 682-691. Sohn, M. W., Kang, H., Park, J. 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Correlations between A1c and diabetes knowledge, diabetes numeracy, and food security in a vulnerable type 2 diabetes population. Diabetes Spectrum, 31(2), 177-183 Type 2 Diabetes Mellitus Self-Management Education APPENDIX A Citi Program Certificate 58 Type 2 Diabetes Mellitus Self-Management Education 59 APPENDIX B Informed Consent Form Adult Education on Diabetes Self-Management in the Primary Care Setting You are being asked to participate in a research project conducted by Kaitlyn Williams, a Doctorate of Nursing Practice-Family Nurse Practitioner student at Saint Marys College. PURPOSE: The purpose or reason for this project is to determine the effect of teaching adults with Type 2 Diabetes about self-management in the primary care setting on HgbA1c (3-month blood sugar), knowledge of self-management, and the Type 2 Diabetes Mellitus disease process. Self-management is how you are taking care of yourself. PROCEDURE: You are being asked to complete a demographic form, the about me form. You are also being asked to complete a test before and after being taught by the student, Kaitlyn Williams. Once you have completed these items you have no further commitment to the project. The student, Kaitlyn Williams, can answer any questions you may. VOLUNTARY PARTICIPATION: Taking part in this project is voluntary, meaning you are not required to do so. Your decision to participate in no way will affect your current relationship with your provider (Doctor or Nurse Practitioner), the staff, or the student. You have the right to leave or stop participating in the project at any time without any penalty. Leaving the project will not negatively affect your health. Participation is free. You have the right to not answer any questions in the test. CONFIDENTIALITY: Kaitlyn, the student, is asking you to complete the test anonymously please do not write your name or birthday on the papers. Please do not disclose any identification on the papers. All research data will be stored by West Caldwell Health and Saint Marys College or within a locked briefcase by the student, Kaitlyn. Any electronic information on the students computer will be password protected. RISKS AND BENEFITS: There are no direct risks associated with helping this study. Benefits of this study include participating in structured education today in the primary care office. Benefits also include learning more about how to take care of yourself and your Type 2 Diabetes Mellitus. If you have any questions, want more information, or have suggestions please contact Kaitlyn Williams who may be reached at 704-890-8978 or at ksmith07@saintmarys.edu. You may also contact the study advisor, Dr. Sue Anderson. If you have any concerns about your rights, how you are being treated, or complaints regarding this study, benefits, or risks associated with being in this project, please contact the Institutional Review Board for Saint Marys College. Type 2 Diabetes Mellitus Self-Management Education 60 CONSENT TO PARTICIPATE: Please keep this copy of the consent form for you records. By completing the tests, filling out the demographic form, and signing the attached document you are voluntarily consenting to participating or taking part in this research project. If you choose not to participate in this project, please discard the consent form and inform staff. Type 2 Diabetes Mellitus Self-Management Education 61 APPENDIX C Consent Form Signature Page Adult Education on Diabetes Self-Management in the Primary Care Setting I agree to take part in this project. I am 18 years old. The reason for the project has been explained to me. I understand the information I give will be confidential. I have been told the benefits and risks of taking part in this project. I know who to contact for more information or questions. I know that my participation is voluntary and that I can refuse to participate with no penalty. I know that I may leave the project at any time. Signature of Participant Date Type 2 Diabetes Mellitus Self-Management Education APPENDIX D Classic Diabetes Placemat 62 Type 2 Diabetes Mellitus Self-Management Education Southern Cuisine Diabetes Placemat 63 Type 2 Diabetes Mellitus Self-Management Education APPENDIX E Recruitment Flyer Volunteers Needed for Research Project on Type 2 Diabetes Education 64 Type 2 Diabetes Mellitus Self-Management Education 65 APPENDIX F Gantt Chart Project Time-Line Research educational interventions and pretest/post-test assessment tools Identify location for project implementation Write up and submit IRB proposal and Project Proposal Print off tools X X X X Introduce intervention and assessment tools to location and educate staff Collect Data Final Project Write Up Months X * * X X * X June and Before July December Feb November Jan March April May and Onward *Intended implementation timeline, however these are not when these objectives were achieved Type 2 Diabetes Mellitus Self-Management Education 66 APPENDIX G Demographic Form Adult Education on Diabetes Self-Management in the Primary Care Setting AGE: . Gender: Please circle MALE FEMALE PREFER NOT TO ANSWER Race: Please circle all that apply Caucasian/White African American/Black Native American Alaskan Immigrant Asian American Hispanic/Latino Pacific Islander Middle Eastern Prefer not to answer Which Describes Your Education Best? Please circle one. No School/Some Grade School Finished 6th Grade Finished 8th Grade Some High School Graduated High School/GED Some College Technical Degree Associates Degree Bachelors Degree Some Graduate School Graduate Degree (Masters, PhD, Doctorate) Type 2 Diabetes Mellitus Self-Management Education APPENDIX H 67 Type 2 Diabetes Mellitus Self-Management Education 68 Type 2 Diabetes Mellitus Self-Management Education 69 Type 2 Diabetes Mellitus Self-Management Education 70 APPENDIX I Literature Synthesis Table Authors Year Title Bralic Lang, V. & Bergman Markovic, B. 2016 Prevalence of comorbidity in primary care patients with type 2 diabetes and its association with elevated HgbA1c: a crosssectional study in croatia Burden of illness in type 2 diabetes mellitus Cannon, A., 2018 Handelsman Y., Heile M., & Shannon, M. Bullard, K. M., 2018 Cowie, C. C., Lessem, S. E., Savdah, S. H., Menke, A., Geiss, L. S., Imperatore, G. Huang, X., Pan, 2016 J., Chen, D., Chen, J., Chen, F., Hu, T. Grontved, A., Pan, A., MeKarv, R. A., Stampefer, M., Willett, W. C., Manson, J. E., & Hu, F. B. Larsen, B. A., Martin, L., & Strong, D. R. 2014 2015 Odgers-Jewell, 2017 K., Isenring, E., Thomas, R., & Source, Journal, Volume/Edition, Page Scandinavian Journal of Primary Health Care, 34(1): 66-72 Level of Strength III Journal of Managed Care & Specialty Pharmacy, 24(9): S5-S13 IV Prevalence of diagnosed diabetes in adults by diabetes type- United States, 2016 Morbidity and Mortality Weekly Report; 67(12): 359-361 III Efficacy of lifestyle interventions in patient with type 2 diabetes: a systematic review and meta-analysis Muscle-strengthening and conditioning activites and risk of type 2 diabetes: a prospective study in 2 cohorts of US women European Journal of Internal III Medicine; 27: 37-47 Public Library of Science Medicine, 11(1) II Sedentary behavior and prevalent diabetes in nonlatino whites, non-latino blacks, and latinos: findings from the National Health Interview Survey Process evaluation of a patient-centered, patient directed, group-based Journal of Public Health, 37(4), 634-640 III CINAHL-FT; Nutrition & Dietetics; The Journal of the II Type 2 Diabetes Mellitus Self-Management Education Reidlinger, D. P. McNeill, D. B. & Herbst, R. 2018 Roberts, D. P., Ward, B. M., Russell, D. J., & O'Sullivan, B. G. Matthews, A., Jones, N., Thomas, A., van den Berg, P., & Foster, C. 2017 Newell, E. 2017 Ellis, K., Mulnier, H., & Forbes, A. 2018 Mulquiney, K. J., Tapley, A., van Driel, M. L., Morgan, S., Davey, A. R., Henderson, K. M., Spike, N. A., Kerr, R. H., Watson, J. F., Catzikiris, N. F., & Magin, P. J. Devchand, R., Nicols, C., Gallivan, J. M., Tiktin, M., KrauseSteinrauf, H., Larkin, M., Tuncer, D. 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... Running head: DOCUMENTATION IN RURAL HEALTHCARE Initiation of Documentation Standards in a Rural Ugandan Health Clinic Kayla T. Wilkerson DNP/FNP student, BSN, RN, CEN, SANE Saint Marys College Faculty team leader: Sue Anderson PhD, RN, FNP-BC Faculty reader: Patricia Keresztes PhD, RN, CCRN Faculty content expert: Tracy Anderson DNP, CNM Date of Submission: June 20, 2020 1 DOCUMENTATION IN RURAL HEALTHCARE 2 Abstract Sub-Saharan Africa hosts 12% of the worlds population and 27% of the words total disease burden while lacking health information technology (HIT) innovation and use, making it difficult for medical providers to collect high quality patient data, leading to a decreased quality of patient care and poorer patient outcomes (Odekunle, Odekunle, & Shankar, 2017). Currently, rural Ugandan health clinics are not utilizing evidence-based documentation standards, further leading to disjointed, ineffective, incomplete, and low-quality care (Gimbel et al., 2017). Additionally, rural areas have unique barriers, such as differing population statistics and limited resources, that can be combated with the utilization of HIT and evidence-based interventions to enhance patient care (Odekunle et al., 2017). This project implemented evidence-based documentation standards in a rural Ugandan health clinic and noted the positive impact the documentation standards had on quality and continuity of care to patients using both qualitative and quantitative data analysis. DOCUMENTATION IN RURAL HEALTHCARE 3 Table of Contents Abstract ........................................................................................................................................... 2 Background ..................................................................................................................................... 5 Problem Statement .......................................................................................................................... 7 PICO(T) Question and Objectives .................................................................................................. 7 Definition of Terms......................................................................................................................... 8 Literature Review............................................................................................................................ 9 Theoretical Framework ................................................................................................................. 20 Implementation Model .................................................................................................................. 21 Integration of Social Entrepreneurship and Innovation ................................................................ 23 Sustainability................................................................................................................................. 24 Ethical Considerations .................................................................................................................. 25 Methods......................................................................................................................................... 26 Data Analysis ................................................................................................................................ 32 Results ........................................................................................................................................... 32 Discussion ..................................................................................................................................... 41 Conclusion .................................................................................................................................... 43 References ..................................................................................................................................... 45 DOCUMENTATION IN RURAL HEALTHCARE 4 Initiation of Documentation Standards in a Rural Ugandan Health Clinic In the Kyenjojo District of Uganda there are numerous small, rural villages with Ugandan health clinics serving as critical-access medical centers to the people within the District that provide services such as primary and urgent care, inpatient hospitalizations, and womens health services including labor and delivery. The Ugandan Ministry of Health requires health clinics to only report the prevalence of certain diseases encountered via monthly reports. Additionally, the Ugandan health clinics have not followed evidence-based documentation guidelines, leading to disjointed, inefficient, and incomplete care. Although advances have been made in the medical field regarding new treatments, innovative technology, and disease prevention, there remain varying standards for medical documentation, which have been even more pronounced in developing nations such as Uganda. Lack of documentation standards have led to decreased quality of care, poor decision-making, inefficient resource allocation, a lack of continuity of care, incomplete care, and negatively impacted patient outcomes (Gimbel et al., 2017; Nguyen, Bellucci, & Nguyen, 2014). Furthermore, rural areas and developing nations have higher incidence of poverty, slow growing or declining populations, and decreased ability to pay for medical services (Olson, & Anderson, 2018). Rozich et al. (2014) found rural medical clinics that implemented documentation standards increased safety for patients and staff, reduced costs to the clinic, and increased the uniformity of practice. This DNP Innovation Project implemented an evidence-based documentation standard and template in a rural Ugandan Health Clinic in the Kyenjojo District of Uganda in order to improve the quality and continuity of care to patients who sought health care services at the womens health unit of the clinic. Ten of the 2018 National Committee for Quality Assurance DOCUMENTATION IN RURAL HEALTHCARE 5 (NCQA) core components of documentation were used to construct the evidence-based medical record template utilized in the Ugandan Health Clinic. Quantitative and qualitative data were collected to measure quality and continuity of care post-intervention via the Emblem Health Adult Medical Record Review Tool for Primary Care Providers (2014) and interviews with the providers, respectively. Background Sub-Saharan Africa hosts approximately 12% of the worlds population and roughly 27% of the total disease burden in the world is concentrated in this region as well (Odekunle, Odekunle, & Shankar, 2017). Unfortunately, this region also lacked health information technology (HIT) innovation and use, which made it difficult for medical providers to collect high quality patient data, which lead to a decreased quality of patient care and poorer patient outcomes (Odekunle, et al., 2017). In addition to a high disease burden, rural areas, such as those served by the Ugandan Health Clinic in the Kyenjojo District, faced additional challenges, like high rates of poverty, a shortage of health care providers, civil unrest, and lack of monetary resources (Kiberu, Mars, & Scott, 2017). However, technology such as computers, cell phones, and internet services have increased in availability in Uganda and the price of each have dropped significantly. This allows Ugandan health clinics the unique opportunity to bypass paper-based medical documentation interventions and utilize electronic HIT to improve the quality of care and continuity of care to their patients (Kiberu, et al., 2017). Electronic health records (EHRs) and electronic templates can be utilized to reduce medical errors and health care costs to facilities, lead to better coordination of care, and improve the quality of care patients receive (Cifuentes et al., 2015; Hillestad et al., 2005). In rural areas of Uganda, EHR systems that have been implemented have also been found to improve follow-up DOCUMENTATION IN RURAL HEALTHCARE 6 care of patients who are generally lost in the follow-up process, assist in trending medication use and shortages, and combat environmental factors, such as rain, that pose a threat to paper-based documentation in poor storage conditions (Liang, Wiens, Lubega, Spillman, & Mugisha, 2018). Although initial costs of a computer-based documentation system may seem high in comparison to a paper-based option, Nguyen, Bellucci, and Nguyen (2014) found EHRs may be a more costeffective option in rural areas and developing nations when compared to the continued costs of paper documentation for printing, shipping, ink, and storage. Thus, the benefits of an EHR outweighed the barriers to implementation, such as cost and differences in cultural values. The target population for the evidence-based documentation intervention was adult women who sought care at the womens health ward of the Ugandan Health Clinic. In Ugandan culture, women are viewed as subordinate to men and are frequently equated to the value of livestock, as Ugandan culture is classified as masculine-focused (Campbell, 2017; Rarick et al., 2013; Tembo, 2019). Rarick et al. (2013) found Uganda is a collectivist culture in which people will identify with and rely on group membership for protection and resources instead of being individualist in nature where people only look out for their own individual interests. Based on the masculine and collectivist culture, Ugandan women are in a unique position in which they could benefit from a project focused on improving their health and quality of care in order to document their individual life stories and medical histories. Furthermore, Ugandan culture views time as moving and rotating backward and focuses on the past rather than the future, which was addressed through education regarding the benefits of medical documentation on each patients future state of health (Onyango, 2017). Although the aforementioned cultural aspects were potential barriers to the implementation of electronic, evidence-based documentation templates in Uganda, the benefits of documentation standards helped the Ugandan Health Clinic become a DOCUMENTATION IN RURAL HEALTHCARE 7 leader in innovative care in the rural Kyenjojo District of Uganda. Furthermore, this project fell within the scope of the Doctor of Nursing Practice (DNP) prepared advanced practice registered nurse (APRN) who was trained to provide culturally competent and sensitive care while implementing the latest evidence-based practice (EBP) regarding medical documentation. Problem Statement Health care clinics in Uganda were not utilizing evidence-based documentation standards which led to disjointed, ineffective, incomplete, and low-quality care provided to patients (Gimbel et al., 2017). Rural areas had unique barriers and considerations not present in urban areas, such as differing population statistics and limited resources, that were minimized with the utilization of HIT to enhance patient care (Odekunle, et al., 2017). Due to the current growth and availability of technology and infrastructure, even in rural areas, health care clinics should utilize electronic, evidence-based documentation standards in order to improve the quality and continuity of care and become an innovative leader in Uganda. This DNP Innovation Project improved the quality and continuity of care patients received at the Ugandan Health Clinic by implementing evidence-based documentation standards per the NCQA (2018) core components of documentation. The intervention utilized HIT and a computer-based documentation template program to help the clinic overcome barriers that affect rural health clinics. Furthermore, the Ugandan Health Clinic is now a leader in the utilization of HIT and evidence-based documentation standards in the Kyenjojo District of Uganda and can assist neighboring clinics in implementing similar standards and templates. PICO(T) Question and Objectives For providers at the Kyembogo Holy Cross Health Centre, how did the implementation of evidence-based documentation standards, compared to current documentation methods and DOCUMENTATION IN RURAL HEALTHCARE 8 practices, impact quality of care and continuity of care to patients within a three-month time period? The primary objective of this project was to evaluate if the initiation of documentation standards based on national guidelines improved the quality and continuity of care through the completeness of medical records for patients seeking care at the Ugandan Health Clinic via medical record audits using the Emblem Health Adult Medical Record Review Tool (2014). The secondary objective of this project was to capture qualitative accounts of the provider perspective regarding the effects the new documentation standards had on the care provided to patients through recorded interviews. Definition of Terms Quality of Care The term quality of care has been the focus of numerous articles since the Institute of Medicine (IOM) Crossing the Quality Chasm (2001) report that focused on the standards of care patients should receive within the United States health care system. This report deepened the definition and understanding of quality of care for both health care providers and patients seeking health care services. Numerous researchers have attempted to summarize the complex nature of the quality of care provided to patients by combining traditional definitions, such as the dictionary definition of the term quality, with the IOMs recommended definition. Based on a systematic review by Allen-Duck, Robinson, and Stewart (2017), quality of care was comprehensively defined as safe and effective care that is culturally competent resulting in the desired or optimal outcome. This definition encompasses the concepts of safety, effectiveness of care, cultural considerations, and the desired outcomes, which provides a truly holistic definition of quality of care for patients within the health care system. DOCUMENTATION IN RURAL HEALTHCARE 9 Continuity of Care The concept of continuity of care within the health care industry goes beyond the Merriam Webster (2019) definition of continuity as a connection that is uninterrupted. The World Health Organization (WHO) (2018) defined continuity of care as a series of health care related events that are coherent, interconnected, and consistent with their health goals. In order to further define continuity of care, the American Academy of Family Physicians (AAFP) (2015) stated continuity of care is cooperative teamwork between a provider and a patient with ongoing health management toward a common goal. Although these differing definitions appear complex, elements of both the AAFP and WHO definitions were combined to define continuity of care as the repeated interactions forming a relationship between a provider and patient as they work together to achieve a common health goal. Electronic Health Record (EHR) As popularity and use of EHRs has increased, the definition of an EHR became more comprehensive in nature. Traditional definitions stated an EHR holds a patients demographic information, diagnoses, and treatment details in an electronic format (Clark, et al., 2016). Alsadi and Saleh (2019) further defined EHRs as a method to digitally and securely store retrospective, current, and prospective patient information in order to support holistic, efficient, and quality integrated health to a given population. This comprehensive definition highlights the fact that an EHR is more than just a document, it is a tool for health care providers to utilize when delivering safe, effective, and quality care to their patients. Literature Review A literature review was completed for articles published via CINAHL, PubMed, the Cochrane Database, and Google Scholar. Search terms included documentation or charting or DOCUMENTATION IN RURAL HEALTHCARE 10 medical records and rural health or healthcare. Inclusion criteria included: published in 2014 or later, English language, and full text articles. After the articles were noted to meet all inclusion criteria, they were sorted and evaluated for relevance; duplicate articles, those in other languages, and those not pertaining to documentation were removed which resulted in a total of 19 systematic reviews and randomized controlled trials, 11 quasi-experimental, case control or cohort studies, and 10 qualitative studies. All articles were evaluated and graded using the Johns Hopkins Nursing Evidence-Based Practice Synthesis and Recommendations Tool (Dang & Dearholt, 2018). The main concept present in the articles that met inclusion criteria was the concept of medical documentation. In health care, medical documentation is used as a tool to ensure standards for safety, quality, and continuity of care are met for every patient while also improving the communication between medical providers and patients (Alsadi & Saleh, 2019). Further, standards and expectations for medical documentation must be in place in order for critical patient information, such as medical history, laboratory test results, and diagnoses, to be consistently collected and documented, leading to a positive impact on patient care delivery. The review of current literature regarding the concept of medical documentation revealed recurring themes within the research: barriers and facilitators to implementation of documentation practices, improved documentation and data quality, and EHR implementation and use in various health care settings. Theme One: Barriers and Facilitators to Documentation Implementation Barriers. Clarke et al. (2016) conducted a qualitative study to determine if there are any perceived risks from health care workers regarding EHR use and found two common themes throughout DOCUMENTATION IN RURAL HEALTHCARE 11 their interviews with 19 participants: social factors and technical factors. Social factors included the potential of inputting errors from staff due to lack of computer literacy, newer staff members joining during the implementation period, and a lack of confidence with the EHR system. The technological factors that posed as barriers to the EHR system included difficulty finding needed information within the program, the EHR being hard to navigate, perceived patient privacy concerns, and the lack of flexible data entry. Clarke et al. suggested administrators combat these barriers for future EHR implementation, by engaging front-line staff in the planning stages, ensuring sufficient infrastructure and hardware, and providing adequate training and support. Farzianpour, Amirian, and Byravan (2015) conducted a review of 19 studies and noted common barriers to EHR implementation. These barriers included startup costs, lack of participation from end users in the planning and implementation processes, insufficient training, concerns about patient privacy, and denial and resistance from health care workers regarding the disruption of workload and current practices. Similarly, Scantlebury et al. (2017) noted barriers such as a lack of understanding as to why an EHR was implemented, staff reluctance to change, and staff not being involved in the decision-making or planning process during an attempt to implement an EHR in a maternity unit. Kiberu, Mars, and Scott (2017) found common barriers to EHR implementation in Uganda included poor planning, no readiness assessments of health care workers or practices, inadequate infrastructure, and inadequate training on the EHR system, which led the authors to recommend further EHR projects address barriers prior to implementation. An additional study found barriers specific to sub-Saharan African nations included high implementation and maintenance costs, limited computer skills, and unreliable electricity and internet in certain areas (Odekunle, Odekunle, & Shankar, 2017). DOCUMENTATION IN RURAL HEALTHCARE 12 Kruse, Kothman, Anerobi, and Abanakas (2016) systematic review of the current literature found a total of 23 common barriers to EHR implementation, with the most prevalent barriers being cost, time consuming documentation, and negative user perception. An additional systematic review found 39 common barriers with the most frequently mentioned being cost, technical support or concerns, and resistance to change (Kruse, Kristof, Jones, Mitchell, & Martinez, 2016). Facilitators Alsadi and Saleh (2019) completed a systematic review of 17 studies in order to decipher the best methods to assess readiness for change prior to an EHR implementation and found when readiness assessments were done prior to the intervention, administrators and stakeholders were able to ensure a smooth transition through the implementation period. Although there were many different methods to assess the readiness for change of staff, Alsadi and Saleh (2019) found if front-line staff readiness was not assessed, the EHR implementation was more likely to fail. Additionally, the perceived support from administrators by completing a readiness assessment helped address perceptions or concerns and thus staff felt more involved in the implementation and were more willing to view the change to an EHR positively (Alsadi & Saleh, 2019). Cucciniello, Lapsley, Nasi and Pagliari (2015) sought to discover what factors positively impacted EHR implementation and found involving stakeholders in the adoption, implementation, and evaluation process, highlighting the positive impacts on the quality of work, and identifying super users all greatly benefited a health system in Scotland. Super users are a group of individuals who receive advanced training and education prior to the implementation of a new process, such as an EHR, and can be utilized to train other staff or serve as a resource throughout the implementation period. Cucciniello et al. used the Actor Network Theory to DOCUMENTATION IN RURAL HEALTHCARE 13 highlight the social processes and elements that help influence the success of technology. Ultimately, Cucciniello et al. recommended the implementation of EHRs should be viewed as a long-term initiative that should include end-users in every stage of the process via the use of super-users in addition to showing end-users how the EHR will improve their workflow and quality of work. Kruse, Kothman, Aberobi, and Abanaka (2016) conducted a systematic review to determine facilitators to EHR adoption and found a total of 25 factors that were repeatedly discussed in the literature. The most discussed facilitators were EHR efficiency, practice size, improved quality, and perception of usefulness (Kruse, Kothman, Aberobi, & Abanaka, 2016). A similar study by Odekunle, Odekunle, and Shankar (2017) found in sub-Saharan African nations, the most significant facilitators to EHR adoption was adequate planning, training, support, and a phased implementation process, which allowed providers to adjust to small changes and better prepare for the next step toward complete automation. Theme Two: Improved Documentation and Data Quality Gimbel et al. (2017) sought to determine if EHR implementation improved the data quality, supported provider decision making, and improved clinical care in resource-limited settings, such as in Mozambique, Rwanda, and Zambia. This study found that audits of EHR documentation helped educate providers regarding documentation standards and improved the quality of data and documentation in the EHR, which ultimately led to an improvement in clinical care for their patients (Gimbel et al., 2017). Furthermore, they found consistent quality improvement initiatives and documentation audits with both management and end-user support helped cement the improved data quality and assist in creating tools within the EHR to help provide decision making support to the providers (Gimbel et al., 2017). DOCUMENTATION IN RURAL HEALTHCARE 14 Hamade, Terry, and Malvankar-Mehta (2019) conducted a systematic review and metaanalysis of 12 studies regarding potential interventions to improve the use and quality of documentation within EHRs in the primary care setting. In order to improve compliance with documentation standards and increase the use of EHR systems, Hamade et al. suggested several features be added to EHRs, such as Clinical Decision Support (CDS) tools, customizable templates, and guidelines for use in order to improve documentation quality and patient care. Haskew et al. (2015) sought to improve the quality and compliance of the antenatal record documentation and implemented a cloud-based EHR system in a Kenyan health clinic. By implementing a cloud-based EHR, Haskew et al. found a statistically significant improvement in the completeness of the antenatal record, more consistent documentation practices by the providers, and a reduction in missing data. Additionally, the use of a cloud-based EHR eliminated the need for permanent clinic infrastructure, such as storage of paper charts, and allowed enhanced access to data, such as compliance, trends, analysis, and reporting. Similarly, Scantlebury et al. (2017) noted EHR use was positively correlated with more compliant documentation audits and more accurate data collection, trending, and analysis which provided the clinic with improved quality improvement possibilities. Jones, Talebi, Littlejohn, Bosnic, and Aprile (2018) sought to decipher factors that enhanced the use of EHR systems and found having on-site support, analyzing ways to improve EHR efficiency and workflow, and performing audits to ensure high quality data entry were all noted to improve documentation practices, provider perceptions, and quality of patient care. Theme Three: EHR Implementation and Use Abiy et al. (2018) compared 250 patient records in both EHR and paper-based documentation format in a low-resource anti-retroviral therapy (ART) clinic in Ethiopia to DOCUMENTATION IN RURAL HEALTHCARE 15 decipher which method had higher documentation completeness of the national ART data elements. The study found although the paper-based documentation completeness was 2% higher than the EHR method, the result was not statistically significant (p-value = 0.369) (Abiy, et al., 2018). Abiy et al. concluded the reason for the paper-based method having higher compliance was due to the lack of support and attention during the implementation of the EHR, as well as the fact that staff were double-documenting, which led to fatigue and documentation burnout, per structured interviews with staff. Abiy et al. recommended providing adequate training and support during EHR implementation and for administrators to decide to use only one method, paper or electronic based documentation, to minimize dual documentation. Alocer Alkureishi et al. (2016) conducted a systematic review to determine the effects of EHR use on patient-provider communication and relationships due to the belief that use of EHRs decreased these interactions. However, there was no significant change in patient satisfaction or patient-provider communication and they found EHRs actually facilitated communication and were used as a guide to prompt communication between the provider and patient (Alocer Alkureishi, et al., 2016). Arndt et al. (2017) found primary care providers spent approximately six hours of their workday interacting with an EHR system. In order to diminish provider burnout, reduce workload, and improve provider satisfaction, there should be adequate technical support offered, customizable templates, and the ability to delegate appropriate work should be implemented with EHR use (Arndt et al., (2017). Carlson, McFadden, and Barkin (2015) found the use of structured data entry forms and templates within an EHR system helped to reduce provider stress and improved job satisfaction. Further, Carlson et al. noted when templates were utilized, EHR documentation time decreased DOCUMENTATION IN RURAL HEALTHCARE 16 giving providers more time to spend with patients. An additional study found problem-oriented templates helped improve the quality of provider documentation without a significant difference in the amount of time needed for documentation (Mehta et al., 2016). Feldstein et al. (2017) conducted a randomized controlled trial to decipher the impact on computer-based clinical prediction rules (CPRs) and CDS tools versus paper-based documentation and the impact on patient care. The goal of this study was to determine if the providers care, such as tests ordered or diagnoses given, were impacted based on the use of CPRs and CDS tools that are automatically triggered based on the documentation of the provider (Feldstein et al., 2017). Additionally, Feldstein et al. utilized the RE-AIM framework for this study, which helped provide a significant and lasting impact after an intervention was initiated. The RE-AIM framework will guide this DNP Practice Innovation Project. This study is currently ongoing with results pending. Fritz, Tilahun, and Dugas (2015) conducted a systematic review of 47 articles regarding best practices for implementing an EHR in low-resource areas that either did not have any documentation practices or were using paper-based methods. Fritz et al. found seven themes of success criteria for an EHR system, which in order of most frequently discussed to least were: functionality of the EHR system, organization/project management, technical support, adequate training, political attitudes and policies, ethics, and financial resources. Based on this study, the most important factors for a successful EHR implementation include the functionalities and userfriendliness of the system, structured project management, and adequate technical support and training for end-users. Jones, Koziel, Larsen, Bery, and Kabatka-Willms (2017) conducted a survey of 4,214 clinicians using EHR systems in order to assess the progress of EHR use within the Canadian DOCUMENTATION IN RURAL HEALTHCARE 17 health care system. Jones et al. found a direct correlation between the years of EHR use and EHR optimal use of features as well as a positive correlation between the years or EHR use and the perception that EHRs improve clinical practice. Additionally, Jones et al. found the use of an EHR assisted them in providing better continuity of care, quality of care, improved patient experience, and higher levels of patient safety. Kershaw et al. (2018) conducted a large cohort study to determine the impact of EHR reminder prompts on patient screening for HIV testing. The study found use of EHR reminders increased the rates of HIV screening for patients in all age, gender, racial, language, and income groups, which led the authors to conclude the added EHR feature of practice standard reminder prompts assisted providers in following national guidelines for screening and treatment. Kroth et al. (2018) found although there were benefits to EHR use, such as improved communication, patient safety, and quality of care, there can also be factors that led to provider burnout and increased stress. The factors that correlated with provider burnout included ergonomic problems, inadequate time allotted for documentation, or a lack of EHR proficiency (Kroth, et al., 2018). Additionally, pressure from management for perfect documentation led to increased provider frustration (Kroth, et al., 2018). Liang, Wiens, Lubega, Spillman, and Mugisha (2018) implemented an EHR system, Stre@mline, in a rural village in Uganda and found not only were the providers satisfied with the implementation, they stated the EHR was easy to use, learn, and helped improve both clinical efficiency and patient care. This EHR system was tailored to this specific region of Uganda and functioned without internet access, did not require international funding, and had local technical support available, all things that helped the EHR implementation go smoothly. DOCUMENTATION IN RURAL HEALTHCARE 18 Nguyen, Bellucci, and Nguyen (2014) noted EHR implementation was associated with improved documentation standards and quality, improved patient safety, and improved coordination and quality of care. However, the initial EHR implementation period was often viewed negatively by providers due to the disruption of workflow, and could cause a delay of the benefits associated with EHRs. Noureldin, Mosallam, and Hassan (2014) compared paper-based documentation to EHRs and found a higher compliance and completion rate in the paper-based method, although the EHRs were noted to be easier for administrators to use. Noureldin et al. attributed the higher compliance to the fact that the clinic was already using the paper-based method and providers had limited training in the EHR method. A similar study by Tanner, Gans, White, Nath, and Pohl (2015) also compared paperbased documentation to EHR use but found that clinics using EHRs outperformed paper-based clinics in every aspect, such as patient education, documentation compliance, patient-provider communication, and patient and medication safety. Additionally, Vaghefi et al. (2016) noted clinics utilizing EHRs were better prepared than paper-based clinics to provide practice-based population health management and patient-centered care. Tilahun and Fritz (2015a) surveyed 384 health professionals in Ethiopia and found that better EHR quality, training, and user-friendliness positively correlated with user satisfaction, EHR use and compliance, and sustainability. However, a follow-up study conducted by Tilahun and Fritz (2015b) noted physicians were more likely to be dissatisfied with the EHR system than nursing staff, which led to decreased use by physicians. Tilahun and Fritz (2015b) combated this dissatisfaction by providing user support, offering more trainings, and increased presence in order to keep staff motivated to use the EHR system. DOCUMENTATION IN RURAL HEALTHCARE 19 Concept Map The Concept Map (Figure 1) summarizes the relationship between the concepts and themes found in current research throughout the literature review. Figure 1. Concept Map Strengths of Current Literature There were numerous systematic reviews that touched on the facilitators and barriers to EHR implementation, which helped better prepare those looking to implement this change into practice. Further, as technology has advanced, the research focus was on the ways providers can utilize EHR systems to better their current practice, quality of care, and continuity of care. DOCUMENTATION IN RURAL HEALTHCARE 20 Weaknesses of Current Literature There was ample literature and research conducted regarding established EHR systems in developed nations and limited literature regarding implementation in resource-limited or developing nations. Additionally, few studies focused on the overall sustainment strategies of EHR systems in resource-limited settings, thus limiting the available knowledge for current practice. There were also a limited number of randomized controlled trials and quantitative studies regarding the impact and effects of documentation implementation, which led providers to rely on more qualitative studies for research conclusions. Theoretical Framework Madeleine Leininger is credited with starting the transcultural nursing specialty due to her research and work to determine the impact of culture on overall health and the healing process (McEwen & Wills, 2017). Leiningers Culture Care Theory of Diversity and Universality combines concepts from anthropology and nursing in order to provide culturally congruent care to all patients (Alligood, 2014, p. 420). Leiningers theory discussed the importance of discovering the meanings, patterns, and processes that help predict the health and well-being of a given population while ensuring the cultural needs of the patient are met as care is provided (Leininger, 1988). The major concepts of Leiningers theory include culture, culture care, culture care differences (diversities) and similarities (universals) (McEwen & Wills, 2017). The theory defined culture as the patterns and values of people that influence their actions and decisions (Alligood, 2014, p. 421). Based on that definition, the base of Leiningers theory urged nurses and health professionals to uncover their motivations and consider their culture when providing DOCUMENTATION IN RURAL HEALTHCARE 21 care. The concept of culture care encompassed a broad, holistic view of human life and included factors such as social structure, environmental factors, and history (Alligood, 2014, p. 421). Ultimately, Leiningers theory is used as a guide for health care providers to provide culturally congruent care in a world full of diverse cultures where the cultural norms and values of the patient differ from those of the health care provider. This theory was used to guide this DNP Practice Innovation Project to ensure the cultural values and needs of both the staff and patient population were met while also ensuring culturally congruent care was provided. In order to do so, aspects of Ugandan culture were researched in order to gain further understanding into the cultural values, norms, and the potential impact. For example, Ugandan culture places little emphasis on punctuality or schedules and views time as rotating backward and forward, with a focus to look to the past rather than into the future (Onyango, 2017). In order to incorporate the cultural view of time into this project, education was provided to the clinic staff on how evidence-based electronic documentation can help to capture events in the past and guide current and future care for patients. By understanding this aspect of Ugandan culture, the documentation intervention was tailored to incorporate the Ugandan importance on the past, while also highlighting how the past can impact the future. Implementation Model The RE-AIM framework was developed in 1999 and has proved very effective in assisting researchers in identifying and overcoming barriers prior to or during the implementation of an evidence-based intervention. The RE-AIM framework focused on five domains of intervention implementation that go beyond traditional outcome analysis (Holtrop, Rabin, & Glasgow, 2018). The five domains of the RE-AIM framework are reach, effectiveness, adoption, implementation, and maintenance (Titler, 2018). Through assessing different aspects of DOCUMENTATION IN RURAL HEALTHCARE 22 the domains, the RE-AIM framework helps guide both the planning, implementation, data collection, and evaluation of an implemented intervention. Additionally, the RE-AIM framework incorporates both quantitative and qualitative evaluation methods to each domain in order to get a comprehensive view of potential barriers and results within each domain (Holtrop et al., 2018). By focusing on each of the aforementioned domains, the RE-AIM framework assists health professionals in translating evidence-based research into practice by asking specific questions about each of the domains in order to best prepare for the implementation period (Titler, 2018). The RE-AIM framework was utilized in order to prepare for each of the five domains in relation to the implementation of the electronic evidence-based documentation system. The reach of the DNP Practice Innovation project was determined to focus internally on the providers at the Ugandan Health Clinic and externally on the patients who sought care in the womens health ward of the Ugandan Health Clinic. The goals of the DNP Practice Innovation Project were to achieve a 100% participation rate of the providers (participants), meaning all of the providers in the womens health ward would utilize the electronic documentation system to document patient encounters. An additional goal was set to reach at least 100 documented encounters, thus at least 100 patients would have electronically documented patient encounters. The effectiveness, which according to Glasgow and Estabrooks (2018) measures the impact on health outcomes, of the intervention was assessed via quantitative compliance audits with the Emblem Health Audit Tool (2016) and qualitative interviews with participants in order to assess the result on quality and continuity of care, which is further discussed in the results section. Adoption, which measures the number of staff members or practices willing to initiate the program based on the results, is also discussed in detail in the results section via feedback from the qualitative interviews (Glasgow & Estabrooks, 2018). Implementation focuses on the delivery and degree of the DOCUMENTATION IN RURAL HEALTHCARE 23 implementation as well as any changes that had to be made in order to ensure a smooth implementation period. For example, in this DNP Practice Innovation Project, education was provided throughout the implementation period regarding compliance and use of the electronic documentation method in order to ensure a seamless transition. The final part of the RE-AIM framework, maintenance, was addressed during the qualitative interviews with participants and focused on continuing to use the electronic documentation method in the future as well as expanding the use, which is further discussed in the sustainment section. Additionally, while assessing each of the domains, Leiningers theory was utilized to ensure culturally competent care was being provided. Furthermore, the RE-AIM framework was used to anticipate potential barriers that may exist throughout the EHR implementation period and helped uncover solutions that eliminated the barrier. Integration of Social Entrepreneurship and Innovation The concept of social entrepreneurship was first coined in the 1960s by Bill Drayton as he attempted to enact social change within the business world (Altman & Brinker, 2016). However, the definition of social entrepreneurship evolved as social entrepreneurs came into the spotlight as governments or large corporations failed to provide basic needs for disadvantaged populations (Lim & Chia, 2016). Social entrepreneurs focus on fulfilling the needs of the underserved, while understanding that underserved does not correlate with helplessness or dependence (Lim & Chia, 2016). Additionally, social entrepreneurs work to create systematic, sustainable, practical solutions when addressing issues that will ultimately yield long-term benefits to society (Kickul & Lyons, 2016). Social entrepreneurs in health care work to deliver high-quality health care to disadvantaged populations through the use of innovative ideas and solutions (Altman & Brinker, 2016). DOCUMENTATION IN RURAL HEALTHCARE 24 The definition of social innovation has been contested and has been a concept many have struggled to define. Avelino et al. (2019) stated social innovation ultimately drives societal change while empowering key stakeholders to deal with any barriers that arise. Additionally, the Stanford Centre for Social Innovation defined social innovation as a process used to invent, gain support, and implement solutions to current social needs (Brandsen, Cattacin, Evers, & Zimmer, 2018). Based on this definition of social innovation, the concepts of social entrepreneurship and social innovation were used to guide this DNP Practice Innovation Project. This DNP Innovation Project addressed the concepts of social entrepreneurship and social innovation by addressing a need within an underserved area while working to create a lasting and sustainable solution through the use of an innovative, electronic evidence-based documentation system. This project provided the opportunity for an underserved area and population to further their own knowledge and skillsets by using an evidence-based and sustainable solution to the problem of not having a standardized method of medical documentation. The electronic evidence-based documentation intervention created a lasting impact on the Ugandan Health Clinic as well as improve the medical care for those within the surrounding community. Additionally, through the DNP Practice Innovation Project, the providers at the Ugandan Health Clinic acted as pivotal change agents and helped the concepts of social entrepreneurship and social innovation grow within Uganda. Sustainability The results of this DNP Practice Innovation Project were shared with the key stakeholders as well as other staff members at the Ugandan Health Clinic. The key stakeholders at the Ugandan Health Clinic plan to continue to use the documentation intervention in the womens health ward and disseminate the standardized documentation method to all other areas DOCUMENTATION IN RURAL HEALTHCARE 25 of the clinic in order to have patient records for every patient seeking care at the clinic. This would be accomplished by the key stakeholders and participants of this project acting as leaders and superusers for dissemination to the rest of the clinic. Additional projects to further the scope of electronic evidence-based documentation use at the Ugandan Health Clinic were discussed and planned by the DNP student and the key stakeholders at the Ugandan Health Clinic. The results were shared with peers in the nursing and medical community through publication, presentations, and word of mouth. Ethical Considerations Institutional Review Board (IRB) approval was obtained from Saint Marys College on November 4, 2019, prior to implementing this project. The Ugandan National Council for Science and Technology (2016) did not require additional approval for projects or research posing minimal risk to human participants that had obtained IRB approval from the home institution. All responses by participants during the recorded interviews were deidentified in order to maintain confidentiality. Following the completion of the data collection period of this project, both quantitative and qualitative data records were double locked and stored, within a lock box and a locked filing cabinet, and will be stored for to two years then the records will be destroyed. Risks of this project included the potential of slowing down the efficiency of the Ugandan Health Clinic during the initial implementation phase. Additionally, the providers at the Ugandan Health Clinic could have felt overwhelmed by the new documentation practices and the reduced efficiency. In order to combat these risks, ample education and practice were provided to staff of the Ugandan Health Clinic prior to the go-live date. DOCUMENTATION IN RURAL HEALTHCARE 26 Benefits of this project included the Ugandan Health Clinic becoming more cost effective as they are able to collect and trend data regarding disease incidence, medication use, and supply use. Additionally, the providers and patients seeking care at the Ugandan Health Clinic experienced improved continuity and quality of care due to the fact that each patient now have their own record in the electronic evidence-based documentation system. Methods Key Stakeholders Key stakeholders for this DNP Innovation Project included Dr. Tracy Anderson, who served as the Saint Marys College faculty overseeing this project. At the Ugandan Health Clinic, Sr. Angelica and Sr. Jacinta oversaw the implementation and the midwives who utilized the electronic documentation intervention. Additionally, Edward Grosser served as a cultural content expert. Setting & Population The Ugandan Health Clinic is located in the Kyenjojo District of Uganda near the rural village of Kyarusozi and provides services such as primary care, urgent care, inpatient wards for children, women, and men, and womens health to the surrounding community. The target population of this DNP Practice Innovation Project focused on the providers at the Ugandan Health Clinic who will use the electronic documentation system while working in the womens health ward treating Ugandan women, aged 18 years and older. Recruitment Recruitment focused on the providers at the Ugandan Health Clinic providing care to women in the womens health ward between November 2019 and February 2020. The participants were the medical providers using the electronic documentation intervention when DOCUMENTATION IN RURAL HEALTHCARE 27 caring for the women. The participants received education regarding the scope of the project, risks, and benefits from the DNP student or one of the key stakeholders. Each participant signed an informed consent form and received a copy to keep for their own records, while the DNP student also kept a copy of the signed consent form (Appendix A). Data Collection Instruments Data were collected through the electronic documentation system and was evaluated through medical record audits completed by the DNP student using the Emblem Health Adult Medical Record Review Tool (2014) (Appendix C). The goals of the Emblem Health Tool audits were to assess the medical record for completeness and ensure the documentation by the providers at the Ugandan Health Clinic. The goals of this DNP Practice Innovation Project align with the current evidence-based practice standards from the NCQA (2018) core components (Appendix B). The electronic documentation system was constructed by the DNP student with input from the key stakeholders at the Ugandan Health Clinic in order to ensure it was user-friendly for the participants during the implementation period. The DNP student looked at numerous EHRs, both in the United States and other countries, to assess the format and user-friendliness, while also considering the feedback available from end users regarding the pros and cons of each EHR. The DNP student designed a few potential templates via Microsoft Excel for the electronic documentation system and presented each format to the key stakeholders to provide feedback prior to the implementation period. The final design (Appendix D) chosen by the DNP student and key stakeholders used the feedback provided and reduced the number of free text boxes on standardized entries, such as provider/participant name, patient age, or gestational age, and was built in an encrypted, password protected Microsoft Excel spreadsheet to ensure patient privacy. DOCUMENTATION IN RURAL HEALTHCARE 28 Additionally, the documentation system was organized in a horizontal format for each encounter since this is what the participants would be most familiar with due to current medical documentation format norms in Uganda, such as the prevalence reporting forms which are reported to the Ministry of Health each month. This horizontal format meant that one patients information was all placed on a single row of the document. The final password protected system was transposed into a Google Sheets Excel document, in order to utilize a cloud-based platform to minimize the storage space on the laptops and tablets being used. Furthermore, the DNP student shared the document and password to the document with the key stakeholders and participants so that all of the aforementioned parties could access the documentation system via Google Sheets with the provided password. The password was also changed at the end of the implementation period to ensure only the DNP student had access to the data. Furthermore, the DNP student ensured the electronic documentation system (Appendix D) included all of the NCQA (2018) criteria for core components of medical documentation. The Emblem Health Adult Medical Record Review Tool (2014) was created specifically to audit adult medical records to assess for compliance with the United States national documentation guidelines, which is why only charts of women aged 18 years and older seeking care at the womens health ward of the Ugandan Health Clinic were used in this project. The Emblem Health Tool is currently used by the Emblem Health Organization to audit the charts for their outpatient facilities within the state of New York. The tool was chosen for this project because it is used when performing audits for quality improvement, quality assurance, and has also been accepted as a valid tool for use by the State of New York, Centers for Medicare and Medicaid Services, and the Joint Commission (Emblem Health, 2019). Although the tool was initially constructed in 2012 and updated in 2014, the Emblem Health Organization has ensured DOCUMENTATION IN RURAL HEALTHCARE 29 the tool continues to align with the national documentation guidelines and standards within the United States per organizations, such as those mentioned above, in addition to the NCQA standards. Data Collection During the pre-implementation phase, the providers at the Ugandan Health Clinic received education and training on how to use the electronic documentation system. Each participant received one-on-one training with the DNP student that focused on how to use the laptops and tablets provided and how to access, use, an input patient data into the electronic documentation system. The participants were given multiple practice patient scenarios to input into the electronic documentation system and were able to ask questions during the education sessions. Additionally, education was provided regarding the latest evidence-based practice for medical documentation by sharing the NCQA (2018) standards with the providers and highlighting the impact comprehensive documentation can have on patient care. During the implementation phase, data from the electronic documentation records were collected for auditing by the DNP student through accessing the password protected Google Sheets could-based platform. Confidentiality was maintained via the password protection of the documentation system and patient names being omitted and instead numbers being used for patient encounters. The data included the overall number of medical records created in addition to the completeness/compliance of the records with the NCQA (2018) standards according to the Emblem Health Adult Medical Record Review Tool (2014). Additional data that were collected included demographic data, diagnoses and disease trends, interventions performed, and treatment trends. In order to collect an adequate sample, the goal was to have at least 100 charts from the Ugandan Health Clinic between November 12, 2019 and February 29, 2020 to audit and analyze DOCUMENTATION IN RURAL HEALTHCARE 30 through descriptive statistical analysis. The DNP student obtained access to the electronic documentation records during visits to the Ugandan Health Clinic as well as through the secure, encrypted, cloud-based platform of the electronic documentation system. In order to protect patient confidentiality and privacy, the electronic records were deidentified and provided an automated chart number as they were audited, which ensured secure patient information was not shared via the audit process. Additionally, qualitative data were collected in the implementation phase through faceto-face interviews with the participants in order to describe their experience with the electronic, evidence-based documentation system and the impact on quality and continuity of care. The interviews were performed by the DNP student and the key stakeholders at the Ugandan Health Clinic. The interviews were recorded with a tape recorder, transcribed by the DNP student, and then coded to evaluate for recurring themes. The use of written questionnaires was not considered because the Ugandan Health Clinic providers stated they were more comfortable with face-to-face interviews instead of written questionnaires due to varying levels of writing skills. The face-to-face interviews between the DNP student and each participant took place twice during this project, once midway through the implementation period in December 2019 via Skype and after the data collection period had ended in March 2020 when the DNP student was in Uganda. The providers were de-identified via coding in order to protect their privacy when giving responses to the interview questions. The same providers were used for both sets of interviews, due to no turnover in providers at the Ugandan Health Clinic throughout the implementation phase. During the interviews, the providers were asked the following questions: 1. How has the use of the electronic documentation system affected the quality of the care you provide to your patients? DOCUMENTATION IN RURAL HEALTHCARE 31 2. How has the use of the electronic documentation system impacted the continuity of care for your patients? 3. What barriers did you experience with the electronic documentation system? 4. What was the most beneficial part of using an electronic documentation system? The post-implementation phase included completing the data analysis for the electronic documentation chart audits in order to ensure at least the target number of medical records were audited. Additionally, during this time the recordings from the face-to-face interviews were evaluated and coded for recurring themes. The timeline for each of the phases of the DNP project is shown in the Gannt Chart below. Gannt Chart 24-Jul-19 28-Aug-19 2-Oct-19 6-Nov-19 11-Dec-19 15-Jan-20 19-Feb-20 25-Mar-20 29-Apr-20 3-Jun-20 Pre-Implementation Education/Training Data Collection Qualitative Interview 1 Qualitative Interveiw 2 Data Analysis Project Budget This DNP Innovation Project required monetary funds for the initial implementation and sustainment time periods. The money was raised through crowd-funding as the DNP student raised awareness of this project within the community as well as personal funding from the DNP student. The money was needed in order to account for laptop computers for the participants to DOCUMENTATION IN RURAL HEALTHCARE 32 use, Wi-Fi and electricity services at the clinic, and travel costs. Additionally, discounts were obtained for the cost of the laptops and travel costs. Table 1 shows the projected budget and final budget costs for this project, with a cost savings of $522 US Dollars. Table 1. DNP Practice Innovation Project Budget Supply Cost per Unit Units Needed 3 Projected Cost (US Dollars) $597.00 Final Cost (US Dollars) $375.00 Chromebook Laptop Monthly Wi-Fi Service Monthly Electricity Service Travel Costs Total Costs $199.00 $20.00 4 $80.00 $80.00 $15.00 4 $60.00 $60.00 $1800.00 1 $1800.00 $2537.00 $1500.00 $2,015.00 Data Analysis Descriptive statistical analysis via Microsoft Excel was used to highlight the compliance of the electronic documentation record to the audit tool and national standards, as well as assist in describing the trends discovered through the medical records. This was conducted through chart audits on every documentation record used during the implementation period. Each documentation record received an overall audit compliance score in addition to detailed compliance scores for each of the elements in the NCQA (2018) documentation standards. Additionally, the recorded interviews were transcribed by the DNP student and analyzed for recurring themes. The statements from participants were compared to those of others for similarities and differences during each round. Furthermore, the themes from both the midway and final interviews were further analyzed for recurring themes. Results DOCUMENTATION IN RURAL HEALTHCARE 33 Throughout the implementation period of this DNP Practice Innovation Project, five participants signed the informed consent form and were educated on how to use the electronic, evidence-based documentation intervention. Image 1 (below), shared with permission from the participant, shows one of the participants practicing using the electronic documentation system during a one-on-one training session. Image 1. Education/training session for participant. All five of the participants who signed the consent forms participated in the implementation phase and the midway and final interviews. During the implementation period, November 12, 2019 to February 29, 2020, the participants used the electronic documentation for 210 patient encounters, which far exceeded the goal of 100 charts. Each of the 210 charts collected during the implementation period were audited using the Emblem Health Adult Medical Record Review Tool (2014) for compliance with the NCQA (2018) 10 core components of documentation criteria using descriptive statistical analysis in Microsoft Excel. The records were accessed by the DNP student via the password protected Google Sheets cloud-based system, which as previously stated, maintained patient confidentiality by the names of patients being omitted and replaced with numbers. The table below summarizes DOCUMENTATION IN RURAL HEALTHCARE 34 the compliance for each of the NCQA (2018) core documentation components during the implementation period. Table 1. Documentation Compliance of NCQA (2018) Core Components NCQA Core Component Address/Village Identification number (in lieu of name) Contact phone number Marital status documented Significant illnesses Medication allergies Past medical history History and physical findings Laboratory tests and results Working diagnoses Treatment plans Immunization history Preventative screening No. of Perfect Charts (n=210) 209 197 185 165 148 148 148 180 170 208 190 180 184 Compliance % 99.52% 93.81% 88.10% 73.33% 70.48% 70.48% 70.48% 85.71% 80.96% 99.05% 90.48% 85.71% 87.62% The participants were least compliant with the significant illnesses, medication allergies, and past medical history of patients, which the participants attributed to the lack of documentation standards in Uganda. This data was collected via the participants verbally asking each patient for their past medical history, allergies, or significant illnesses. The participants stated that due to the lack of standardized documentation, a lot of patients may not be aware of past diagnoses or illnesses, with the same being true regarding allergies or past allergic reactions. Additionally, Ugandan culture has more of a focus on the past, which one would think would benefit patients knowing their past medical history (Onyango, 2017). However, the participants pointed out that the literacy rates in Uganda are low and patients may not be aware of the diagnostic names for illnesses they have had in the past. Thus, the participants stated patients would be able to discuss a time when they were sick in the past, but not necessarily recall the exact diagnosis. Furthermore, although the literacy rate in Uganda is slowly climbing, the literacy rate among DOCUMENTATION IN RURAL HEALTHCARE 35 females in Uganda is a mere 36.1%, and is even lower among rural areas with less access to educational resources (Knoema, 2020). To compound the low literacy rate among women, medical documentation in Uganda is done in the English language, and women may only be literate in their native language, thus leading to low rate of awareness for past medical history, illnesses, or allergies. However, the participants were most compliant with documenting the working diagnoses and village of residence for each patient. Table 2 (below) shows the top 10 working diagnoses that were documented by the participants. Table 2. Top 10 Working Diagnoses of Patients Working Diagnosis Full-Term Labor Pre-Term Labor Amenorrhea Vaginal Bleeding Abdominal Pain Antenatal Visit Postpartum Hemorrhage Malaria Pelvic Pain Hyperemesis Gravidarum No. of Patients 119 54 8 6 6 5 5 3 3 1 % of Patients 56.67% 25.71% 3.81% 2.56% 2.56% 2.38% 2.38% 1.43% 1.43% 0.48% The participants were unable to document the working diagnosis for two patients, both of which were transferred to other facilities and the participants stated they did not complete the documentation since that information would not transfer with the patient. The ability to analyze the top 10 diagnoses seen at the Ugandan Health Clinic can help administrators better prepare the clinic for the most-common patient situations by ensuring adequate supplies to manage those types of patients. Additionally, this provides the Ugandan Health Clinic information regarding where education and training should be focused for the providers in order to ensure they have the knowledge and skills to be prepared for these situations. DOCUMENTATION IN RURAL HEALTHCARE 36 The participants stated the village of residence was one of the easiest measures to document since everyone knew the name of the village closest to their home, for the more rural areas, or the village their home was in. Figure 2 below shows the most prevalent villages the patients came from in order to receive care at the Ugandan Health Clinic. Figure 2. Villages of Patients. Most Common Villages of Patients Nyaruzigati Nyabusozi Mparo Kyembogo Kitugutu Kirinda Kinoni Kigoyera Kigando Kibangali Katambale Kasaba Kajuma Igoma Galilaya 0 5 10 15 20 25 30 35 Although Figure 2 only shows the most prevalent villages, patients were noted to come from 49 surrounding villages or cities, some as far as 413 kilometers (256.6 miles) away from the Ugandan Health Clinic. Furthermore, the participants documented a contact phone number for 185 patients (88.10%), while also notating reasons in the documentation system when they were unable to note a contact phone number. The most common reason for not documenting a phone number was that the patient did not have the money to pay their phone bill and thus would not have DOCUMENTATION IN RURAL HEALTHCARE 37 access to their mobile phone for much longer. Even in a developing nation, the vast majority of people were able to have access to technology, such as mobile phones, which is most likely aided by the Ugandan use of Mobile Money. The utilization of Mobile Money helps increase access to personal funds since formal institutions such as banks, are scattered throughout the nation (Bongomin, Ntayi, Munene, & Malinga, 2018). Additionally, the participants noted that a large number of Ugandans have multiple mobile devices, which can be due to the strategy to decrease costs of mobile services across multiple carriers or be used as burner/disposable phones (Bongomin, et al., 2018). Additional data were collected regarding diagnoses, medications and indications, and outcomes specific to the patient population of the womens health ward, such as birth outcomes for women who presented to give birth at the Ugandan Health Clinic. Table 3 shows the compliance rates for the various data points that were also collected and analyzed in the electronic documentation system. Table 3. Documentation Compliance for Additional Measures Documentation Variable HIV Status Documented HIV Positive Status HIV Treatment for HIV Positive Patients Malaria Status (within the past year) Documented Positive Malaria During Pregnancy Birth Outcome Charted Birth Outcome: Alive Birth Outcome: Dead Twin Births APGAR (1 min) APGAR (5 min) Transferred to Higher Level of Care Provider Name on Chart Medications Charted No. of Compliant Charts (n=210 unless noted otherwise) 175 12 10 (n=12) 171 Compliance % 1 (n=171) 173 (n=189) 170 (n=173) 3 (n=173) 4 168 (n=173) 168 (n=173) 21 189 171 0.48% 91.53% 98.27% 1.73% 1.90% 97.11% 97.11% 10% 90% 81.43% 83.33% 6.86% 83.33% 81.43% DOCUMENTATION IN RURAL HEALTHCARE Indications for Medications Charted 0 (n=171) 38 0% The participants were noted to document patients HIV status for 83.33% (175 patients) of the patient encounters charted using the electronic documentation system. Although there are only 12 HIV positive patients noted, the rate of 6.86% in this sample is higher than the general HIV prevalence in Uganda which is approximately 5.7% (UNAIDS, 2020). Of those 12 patients that were documented as HIV positive, 10 (83.33%) were currently receiving treatment for HIV, which is higher than the national average of 79% of women with HIV receiving treatment (UNAIDS, 2020). The higher compliance with HIV treatment is likely aided by the AntiRetroviral Treatment (ART) Clinic on site at the Ugandan Health Clinic, which has a robust treatment and follow-up team that provides treatment for all HIV patients in the surrounding communities. Additionally, the participants documented that they assessed for the presence of malaria for 81.43% (171) of the patient encounters during the implementation period. Of those charts, only one patient (0.48%) was noted to have had malaria within the past year. According to the Ugandan Ministry of Health (2020), Uganda has some of the highest malaria transmission rates in the world and has the sixth highest number of deaths annually due to malaria. Furthermore, the World Health Organization (WHO) World Malaria Report (2019) found the prevalence of malaria during pregnancy in Uganda is approximately 30%, which is disproportionate to the 0.48% reported at the Ugandan Health Clinic. The participants documented the one- and five-minute APGAR scores for 97.11% of the births that occurred during the implementation period. The Ugandan Health Clinic also was found to have three infant deaths (1.73%) during the implementation period, which when calculated, equates to an approximate infant mortality rate of 17.63 per 1,000 births. DOCUMENTATION IN RURAL HEALTHCARE 39 Unfortunately, Uganda has numerous disparities in infant mortality due to socioeconomic status, living in a rural area, age of mother, and education level of the mother. The average infant mortality rate in a rural area of Uganda is approximately 30 deaths per 1,000 live births and 26 deaths per 1,000 live births in the poorest socioeconomic class (UNICEF, 2020). Although the rate at the Ugandan Health Clinic was found to be substantially lower than the average infant mortality rate in rural Uganda, the participants noted that 10% of their patients were transferred to a higher level of care due to their unique circumstances which could contribute to the clinic having a lower infant mortality rate. Furthermore, the participants only documented the provider name on the charts of patients who were not transferred to another facility, meaning only 90% (189) of the charts had a provider noted. Medications were given to 171 patients (81.43%) who visited the Ugandan Health Clinic, although zero charts stated any indications for the medications that were given. The participants stated they had never documented indications for medication previously and had trouble remembering to do so during the implementation period. Furthermore, the participants stated that Ugandans seeking any medical care expect to be given medication, regardless of if it is truly needed, and if they did not give any medications it could hurt the reputation of the Ugandan Health Clinic by patients stating they did not give them any treatment. Thus, the participants standard practice had been to always give medication regardless of need. Additionally, qualitative data were obtained via face-to-face interviews with the participants at the midway point and completion of the implementation period to capture the participants experiences using the electronic, evidence-based documentation system. The overarching themes of both the midway and final interviews are summarized in Table 4. Table 4. Themes of Participant Interviews. DOCUMENTATION IN RURAL HEALTHCARE 40 Themes from Participant Interviews Midway Interview Final Interview Improved knowledge of patient Distinguishes clinic from others in the situations. area due to improved care. Overcoming barriers (i.e. WiFi). Resolution of previous barriers. Organization of electronic Provides more information about documentation system. patients and the care provided at the clinic. Organization and user-friendliness of electronic documentation system. During the midway interviews, the participants stated they felt the quality of their care improved, felt more comprehensive, and was better when using the documentation intervention. During the final interviews, they stated their quality of care had gotten even better, had improved the quality of care, and had helped set the clinic apart in the quality of care provided when compared to other clinics in the area. The second question during the participant interviews addressed if the electronic documentation system impacted the continuity of care for patients seen at the Ugandan Health Clinic. Both the midway and final interviews revealed the participants felt the documentation intervention greatly improved continuity of care. Additionally, the participants stated they knew more about their patients and were able to give more complete care during return visits since aspects of the patients history were previously documented. During the midway interviews, the participants voiced barriers to the electronic documentation system, which included inconsistent WiFi service during weather, such as rain and the laptop trackpads stopped working making it difficult to use the laptops. Luckily, a result of information gained from the midway interviews enabled the DNP student to provide wired mice for the malfunctioning laptops. Additionally, the DNP student was able to provide a WiFi booster to the clinic in order to strengthen the WiFi signal. During the final interviews, the DOCUMENTATION IN RURAL HEALTHCARE 41 participants stated that barriers during the second half of the implementation period included misplacing the power cords to the laptops, from one participant while the others did not state any barriers during the final interviews. The participants stated the most beneficial part of the documentation intervention was having click-boxes with pre-set options to limit the amount of necessary free-typing, the way the documentation system was organized made it easy to use, and the fact that the participants were able to use any of the provided laptops or tablets and access the documentation system made it easy to access. During the final interview, one participant stated: I think it gives more information; more information for us about the patient and their reason for coming here. I feel more organized; the click boxes in the system reduce my worry of spelling errors and help me know what questions I should ask, I feel like continuing to use it will help us and our patients. If we use a computer system in the whole clinic, just think of all of the good we can do for every patient (Participant 3, 2020). Overall, the participants felt the quality and continuity of care both improved through the use of the evidence-based, electronic documentation system and would be beneficial to continue use in the Ugandan Health Clinic and even expand the use to other wards of the clinic. Discussion The results of this DNP Practice Innovation Project show how implementing evidencebased documentation standards can have a positive impact on quality and continuity of care for patients and patient safety, even in a resource-limited area of a developing nation. The recommendation from the literature and the DNP student are to implement evidence-based documentation standards in all health clinics and provide ample education and training for DOCUMENTATION IN RURAL HEALTHCARE 42 providers prior to the go-live date. The education should not only focus on how to document in the system, but also the rationale for why medical documentation is important and the impact it can have on patient care. Furthermore, HIT should be utilized, even in resource-limited areas, in order to streamline and standardize medical documentation. For example, by utilizing an electronic documentation system, the risk of misinterpreting information in the medical record due to not being able to read handwriting is minimized. Furthermore, the time and research by the DNP student to investigate Ugandan cultural norms and values positively impacted the success of the intervention and the overall DNP Practice Innovation Project. This allowed the DNP student to gain understanding of past and current cultural practices and expectations and how they relate to health care providers as they treat patients in various settings. Additionally, the DNP student found the key stakeholders and participants were more receptive to education, training, and the implementation of this DNP Practice Innovation Project since the DNP student had taken the time to learn about their Ugandan culture. Furthermore, this helped foster good rapport between the DNP student, key stakeholders, and participants which positively impacted the implementation of this project. Additionally, government health organizations, such as the Ministry of Health, and health care clinics or hospitals, should work together to enact policies to create and ensure standards for medical documentation across all aspects of health care. By creating policies at both the individual organizational level and national government level, the care provided to patients will improve as health care records and communication must rise to meet the minimum standards. Finally, once documentation standard policies have been put in place, health care providers should receive education on the rationale for the documentation standards and training on how to use the medical record system in order to ensure truly standardized care is achieved. DOCUMENTATION IN RURAL HEALTHCARE 43 Project Strengths and Limitations Strengths of this DNP Practice Innovation Project include the use of a validated tool, the Emblem Health Adult Medical Record Review Tool (2014) to audit the electronic documentation system for the NCQA (2018) core components of documentation. Additionally, the number of charts obtained during the implementation period were over double the goal set by the DNP student, thus providing more data for analysis. Furthermore, a strength of this DNP Practice Innovation Project is the use of a cultural assessment regarding cultural norms and expectations in Uganda. By completing a cultural assessment, the DNP student was able to ensure this project aligned with cultural norms as well as tailor education to the participants that included how Ugandan culture was addressed and preserved through the intervention. Limitations of this DNP Practice Innovation project include the fact that only one ward of the clinic was used during the implementation phase, which limits the generalizability of the results. Additionally, due to budget restrictions, an EHR software system was not utilized for the intervention, which could limit the replication of the intervention to other clinics or areas. Future Study Areas Future projects or research should focus on expanding the use of electronic, evidencebased documentation systems into the other wards of the Ugandan Health Clinic as well as further expanding use to other clinics as well. Additionally, implementation of a formal EHR software system could produce further positive impacts on quality and continuity of care to patients in rural areas of Uganda. Furthermore, future study should be done to build an interlinked health care network through HIT, such as an EHR system, to improve the coordination of care of patients within rural Uganda across numerous clinics. Conclusion DOCUMENTATION IN RURAL HEALTHCARE 44 This DNP Practice Innovation Project implemented an evidence-based, electronic documentation system that highlighted the impact of documentation standards on quality and continuity of care in a rural health clinic in a developing nation. The NCQA (2018) core components were used as the evidence-based documentation standards to guide the critical aspects of the electronic documentation system. Quantitative statistical analysis was conducted using descriptive statistics via chart audits, while qualitative analysis was completed using the coded themes from the provider interviews to assess the impact on quality and continuity of care post-intervention at the Uganda Health Clinic. This DNP Practice Innovation Project found the participants felt implementing an evidence-based documentation system improved both the quality and continuity of care provided to the patients they serve. Additionally, this DNP Practice Innovation Project helped identify the strengths and weaknesses in the documentation at the Ugandan Health Clinic, and sought to provide a foundation to build upon with future study and collaboration. 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Modeling antecedents of electronic medical record system implementation success in low-resource setting hospitals. BMC Medical Informatics and Decision Making, 15(61), doi: 10.1186/s12911-015-0192-0 DOCUMENTATION IN RURAL HEALTHCARE 52 Tilahun, B., & Fritz, F. (2015b). Comprehensive evaluation of electronic medical record system use and user satisfaction at five low-resource setting hospitals in Ethiopia. JMIR Medical Informatics, 3(2), e22. Titler, M. G. (2018). Translational research in practice: An introduction. OJIN: The Online Journal of Issues in Nursing, 23(2), manuscript 1. Uganda Ministry of Health. (2020). National malaria control program. Retrieved from https://www.health.go.ug/programs/national-malaria-controlprogram/#:~:text=Uganda%20has%20the%20sixth%20highest,and%20over%2010%2C5 00%20deaths%20annually. Uganda National Council for Science and Technology (UNCST). (2016). Research registration and clearance policy and guidelines. Kampala, Uganda: UNCST. Retrieved from https://www.uncst.go.ug/guidelines-and-forms/ UNAIDS. (2020). Uganda: Overview. Retrieved from https://www.unaids.org/en/regionscountries/countries/uganda#:~:text=In%20Uganda%20 in%202018%3A,49%20years)%20was%205.7%25. UNICEF. (2020). Maternal and newborn health disparities: Uganda. Retrieved from https://data.unicef.org/country/uga/ Vaghefi, I. et al. (2016). Understanding the impact of electronic medical record use on practicebased population health management: A mixed-method study. JMIR Medical Informatics, 4(2): e10 World Health Organization. (2018). Continuity and coordination of care; A practice brief to support implementation of the WHO Framework on integrated people-centered health services. Geneva: World Health Organization. DOCUMENTATION IN RURAL HEALTHCARE World Health Organization. (2019). World malaria report: 2019. Geneva: World Health Organization. 53 DOCUMENTATION IN RURAL HEALTHCARE 54 Appendix A: Consent Form You are invited to participate in a project designed to implement a standardized method for documentation of patient records at the Ugandan Health Clinic in Kyarusozi, Uganda. You have been chosen to participate in this project because you are a person who provides care to patients at the Ugandan Health Clinic. If you decide to participate, you will receive education regarding the new method of documenting patient records at the Ugandan Health Clinic. You will be trained on how to document things such as a patients demographic information, medical history, allergies, medications, history of present illness, laboratory tests and results, and pharmacologic and nonpharmacologic treatments. At the end of the project, you will be asked to provide your thoughts and feedback regarding the standardized method of documenting patient records. Because we value your opinions and want to learn from you and your perspective, this discussion will be tape recorded. The tape recording makes sure we are able to take every comment into consideration. After the conversation is over, the comments made will be typed into a report, and the tape recording will be destroyed. In the typed report, no ones name will be revealed. Each person will be assigned a number, and the identity of those who made comments will not be revealed. Any information obtained in connection with this project that can identify you will remain confidential and will be disclosed only with your permission. In any written reports or publications, no one will be identified or identifiable and only group data will be presented. This consent form, with your signature, will be stored separately from the data collected so that your responses will not be identifiable. Your decision whether or not to participate will not affect your future relations with Saint Marys College or the Ugandan Health Clinic in any way. If you decide to participate, you are free to discontinue participation at any time without affecting such relationships. If you have any questions, please ask us at any time before, during or after the project. Contact Kayla Wilkerson (Phone/WhatsApp: +1-517-945-4620, email: kwilkerson01@saintmarys.edu). You will be given a copy of this form to keep. You are deciding whether or not to participate. Your signature indicates that you are at least 18 years of age, have read the information provided above, and have decided to participate. You may withdraw at any time without penalty after signing this form should you choose to discontinue participation in this project. _______________________________________________________ Signature of Participant ________________ Date _______________________________________________________ Signature of Investigator ________________ Date DOCUMENTATION IN RURAL HEALTHCARE 55 Appendix B. NCQA (2018) Documentation Core Components The following are the ten critical components that will be utilized in the Kyembogo Holy Cross Health Centre documentation intervention: 1. Personal biographical data include the address, mobile telephone number, and marital status. 2. Significant illnesses and medical conditions listed on the problem list. 3. Medication allergies/adverse reactions; if there are no allergies/history of adverse reactions it is also noted in the chart. 4. PMH (past medical history) is easily identified and includes operations, illnesses, and accidents. 5. History and physical examination identify subjective and objective information pertinent to patients chief complaint(s). 6. Denotes laboratory and other tests/studies ordered with results. 7. Working diagnoses are consistent with findings. 8. Treatment plans are consistent with diagnoses. 9. Immunization history is noted. 10. There is evidence of preventive screening and services are offered. DOCUMENTATION IN RURAL HEALTHCARE 56 Appendix C. Emblem Health Adult Medical Record Review Tool Adult Medical Record Review Tool Primary Care Provider Member Name: Provider Name: Product: DOB: Date of Review: Member ID#: Provider I.D. #: Initials of Reviewer: The Medical Record contains the following patient information: 1. Patient Identification. Each page within the Medical Record contains the patients name or ID number on both sides of the page. 2. Personal Biographical Data. Mark off each data element found in the medical record: DOB Gender Address Home telephone number(s) Employer Occupation Work telephone number(s) Marital status Name of next of kin/significant other/proxy Telephone number(s) of next of kin/significant other/proxy 3. All entries in the medical record contain the authors identification. Author identification may be a handwritten signature, initials, an initials-stamped signature or a unique electronic identifier. 4. All entries in the medical record are dated. 5. The medical record is legible to someone other than the writer. Is the record an Electronic Medical Record (EMR)? Page 1 of 9 Updated 5/30/14 DLD DOCUMENTATION IN RURAL HEALTHCARE Member Name: 57 Member ID#: PCP Adult Medical Record Review Tool (continued) 6. Allergies and Adverse Reactions are prominently noted in the record, or NKA is noted. Prominently noted refers to: on the front of the chart or inside the front cover of the chart or on a designated problem list or medication page or at the time of each office visit. Updated at a minimum of annually (preferably during a physical). 7. Medication Record A medication record/list includes dosages and dates for initial and refill prescriptions. Discussion of medication side effects and symptoms are reviewed with the member and documented. Medication Adherence Review for compliance for maintenance medications for members with chronic conditions. Documentation of drug samples. (NO SCORE) 8. Significant illnesses and medical conditions are indicated on the problem list. The Medical Record contains a problem list that can either be a separate form or listed in the progress notes, is updated as appropriate and contains significant illnesses and medical conditions Or For those patients without chronic, serious or disabling conditions and/or active (acute) medical or psychosocial problems, the list should either indicate well visit or no problems/complaints. Page 2 of 9 Updated 5/30/14 DLD DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) 9. The history and physical exam identifies appropriate subjective and objective information pertinent to the patients presenting complaints. The baseline history and physical is comprehensive and includes a review of: Baseline History: Family history, psychosocial and medical-surgical history must contain at least one qualifier. Family history - including pertinent medical history of parents and/or sibling(s) Psychosocial history - including occupation, education, ethnicity, primary language, living situation, mental health issues/problems, socioeconomic issues/problems, risk behaviors Medical-surgical history - including serious accidents, injuries, operations, illnesses/diseases (acute or chronic), and mental health/substance abuse issues Baseline Physical: A comprehensive review of systems with an assessment of presenting complaints (as applicable). A comprehensive assessment of health and development (physical and psychosocial). The periodic history and physicals are comprehensive and include a review of: Periodic History and Physicals: Should be repeated in accordance with age-appropriate preventive care guidelines Periodic History: Family history, psychosocial and medical-surgical history must contain at least one qualifier. An updated family history An updated psychosocial history An updated medical-surgical history Periodic Physical must contain: A comprehensive review of systems with an assessment of presenting complaints, as applicable. An updated assessment of health and development (physical and psychosocial). Page 3 of 9 Updated 5/30/14 DLD 58 DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) 10. High-Risk Behaviors and Anticipatory Guidance. There is appropriate notation regarding the inquiry and/or teaching of specific topics and appropriate notation concerning high-risk behavior inquiry. Tobacco/cigarette query At every encounter yes no Alcohol misuse Substance abuse query HIV/STD/Hepatitis risk query Safe sex practices Nutrition guidance/obesity/exercise query if BMI >30 Violence/Injury/safety prevention query/discussion Abuse query/discussion (i.e., Domestic abuse for women of child-bearing age, elder abuse, etc.) Social/emotional health query/depression Illness prevention And Is the patient counseled regarding high-risk behavior(s) or referred to appropriate treatment? 11. Laboratory and other studies are ordered, as appropriate. Laboratory and other diagnostic studies are appropriate for the clinical findings and/or diagnoses stated consistent with preventive care guidelines. 12. Communicable Disease(s) are reported to appropriate regulatory agency and documented in the MR. (Reference list of NYS/NYC reportable communicable diseases). Document Communicable Disease and Regulatory Agency: ______________________________________________________________________________________________________ Page 4 of 9 Updated 5/30/14 DLD 59 DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) 13. Routine or follow-up visits must include: A focused review of systems based upon presenting complaints, active (acute) medical or psychosocial problems, or management of a chronic, serious or disabling condition. Unresolved problems from previous office visits are addressed in subsequent visits. 14. Working diagnoses/impressions are consistent with subjective and objective findings. 15. Treatment plans are consistent with diagnoses. Addresses each chief complaint (subjective/objective) and clinical finding with a plan of care consistent with standards of care and clinical practice (including further diagnostic testing, procedures, medication, referrals, etc.). The PCP documents discussion(s) and agreed upon decision(s) with the member/guardian of potential treatment options that are available to them regarding their health care needs. 16. Follow-Up Notation Encounter forms or notes have a notation, when indicated, regarding follow-up care, calls or visits. The specific time of return is noted in days, weeks, months, or as needed. Page 5 of 9 Updated 5/30/14 DLD 60 DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) 17. Follow-up after an ED visit or hospitalization. Date(s) listed for ED and/or hospitalizations: _______________________________________________________ ________________________ An office visit, written correspondence or telephone follow-up intervention is clearly documented in the PCP record regarding the ED or IP LOS. 18. Continuity of care. Indicate whether a specialist consultation: Name/Specialty: __________________________ Or If whether a diagnostic study: Name of Diagnostic Study: _____________________ ______ If a consultation or diagnostic study is requested, there is a note or report from the consultant in the record. The ordering health care provider initials consultation and diagnostic study reports filed in the chart. Abnormal consultation and diagnostic study results have an explicit notation of follow-up plans in the record. 19. Immunization. An appropriate immunization history has been made with notation that immunizations are up to date (See Adult Immunization Schedule). Immunizations administered after May 1992 contain lot number and manufacturers name. (Must have 100% compliance) Page 6 of 9 Updated 5/30/14 DLD 61 DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) 20. The Medical Record reflects an appropriate utilization of Consultants. Review of Medical Record for Under- or Over-Utilization of Referrals to Consultants Evidence of Under-Utilization: Yes or No Definition: Unresolved acute or chronic illness(es) and/or symptoms are being actively treated or monitored by the PCP without referral(s) to an appropriate specialist/consultant. Evidence of Over-Utilization: Yes or No Definition: A consistent pattern of referrals to a consultant without PCP formulating a treatment plan based on assessment of presenting symptoms. 21. Care rendered is medically appropriate/Follows Clinical Practice Guidelines, Standard of Care. * NO SCORE* YN (If this standard is not met, the case is immediately referred to the Medical Director for a quality of care review). Definition: There is evidence that the patient may be placed at inappropriate risk by an inadequate(ly), incorrect(ly) or inappropriate(ly): Performed physical examination or assessment Performed procedure Performed diagnostic studies, including but not limited to lost specimens, poor film quality, misread results, or delayed turnaround time Diagnosed the member Prescribed, dispensed, or administered medication Developed and/or implemented treatment plan Other errors, delays or omissions in the delivery of care 22. Advance Directives Documentation in the Medical Record of all patients at least 45 years and older (if younger as appropriate) that advance directives have been discussed. If the patient chooses to make an advance directive, there should be a copy of it in the MR and the records should be flagged. Updated 5/30/14 DLD 62 DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) 23. Preventive Health Guidelines. Indicate: Male______ Female______ and Age: _______ There is evidence that preventive screening and services are offered in accordance with the organizations practice guidelines. (Reference: Adult Preventive Services) (Refer to high-risk behaviors for additional screening not included in this section.) Measurements Blood Pressure Every 1-2 years (Repeat if elevated?) Pulse/Respirations and Temperature (as appropriate) Weight Height BMI Annual Date of Service____________________ Procedures/Screening Cholesterol Starting at 20 years of age, obtained once every 5 years Referral Date of Service:___________________ EKG Test to be done for patients at high risk. Diabetes Screening Starting at age 45 every 3 years Abdominal Aortic Screening One-time screening by U/S for men 65-75 years who smoked TB Skin testing for asymptomatic high-risk patients Osteoporosis Screening/Testing women age 65 and older, and men 70 and older testing recommended every two years. Date of Service:_____________________ Preconception Screening for all women of childbearing age (NO SCORE) Rubella Testing Routine screening for all women of childbearing age and health workers Menopause Screening Vision Screening Annual Glaucoma Screening - Annual Hearing Screening Annual Dental Health Screening Regular checkups twice a year or as advised Chlamydia All sexually active females < 26 years annually, as well as others at risk Referral Date of Service:_________________________ Cancer Screening Examinations Breast Exam/Mammography Annually for ages 40 and older Referral Date of Service:_________________________ Pap Smear Women ages 21-29 every three years; women ages 30-65 every three years or a Pap test plus HPV testing every five years. Referral Date of Service:_________________________ Colonoscopy every 10 years/Sigmoidoscopy every 5 years/Fecal Occult Blood testing annually starting at age 50 Referral Date of Service:_________________________ Prostate Examination/PSA Discussion of benefits and risks of screening Referral Date of Service:_________________________ Skin Cancer Routine checkup Referral Date of Service:_________________________ Aspirin for Prevention of CHD As PCP advises Page 8 of 9 Updated 5/30/14 DLD 63 DOCUMENTATION IN RURAL HEALTHCARE Member Name: Member ID#: PCP Adult Medical Record Review Tool (continued) Prevention Aspirin for Prevention of CHD As PCP advises Hormone replacement therapy As PCP advises Discussion of exercise or physical therapy and Vitamin D supplementation for community-dwelling adults ages 65 or older 24. No shows or missed appointments. Missed appointments should be documented Follow-up efforts to reschedule appointment 25. Medical Record reflects documentation of care for older adults (66 years and greater). Evidence of Pain Assessment (should be performed at every visit): Yes or No Can include documentation of either of the following: Notation of the presence or absence of pain Notation of the results of a screening using a standardized tool Evidence of a Functional Assessment: Yes or No Can include documentation of any of the following: Functional independence Loss of independent performance Activities of daily living (ADLs) Social activities Instrumental ADLs (IADLs) Level of assistance needed to accomplish various tasks Result of assessment using a standardized functional status assessment tool Evidence of Medication Review: Yes or No Definition: The percentage of older adults who had the presence of a medication list in the medical record AND a medication review during the measurement year. Evidence of Advance Care Planning: Yes or No Definition: Notation of a discussion about preferences for resuscitation, life-sustaining treatment, and end-of-life care or a patients refusal to discuss advance care planning. End of PCP Adult Medical Record Review Tool Page 9 of 9 Updated 5/30/14 DLD 64 DOCUMENTATION IN RURAL HEALTHCARE Appendix D. Electronic Documentation System (with examples of click-box selections to minimize free text) 65 DOCUMENTATION IN RURAL HEALTHCARE 66 DOCUMENTATION IN RURAL HEALTHCARE Appendix E. Signed DNP Practice Innovation Project Proposal Defense 67 DOCUMENTATION IN RURAL HEALTHCARE Appendix F. CITI Completion Documentation 68 DOCUMENTATION IN RURAL HEALTHCARE 69 Appendix G. Literature Synthesis Table No. Citation Design Sample/Setting Variables & Definitions Compa 250 medical Paper-based 1. Abiy, R., et al rative, records (both and (2018). cross- electronic and electronicA section paper-based based health compari al versions) at the records (both son of study. University of adult and electroni Gondar Referral pediatric). c Hospital in NW Completenes medical Ethiopia. s of records record was data to compared paper (via records checklists) as in well as antiretro qualitative viral remarks therapy regarding the clinic in challenges r/t Ethiopia the quality of : What the medical is records (via affectin interviews). g the quality of the data? Online Journal of Public Health Informat ics, 10(2): e212 Communicat 2. Alcocer System N= 53 studies Alkureis atic ion and the hi, M. et review relationship al. between (2016). patients and Impact doctors using of EHRs. Study Findings Limitations Evidence /Strengths Level It is important Specific to Level II to improve the ART clinic. quality of the Study paper-based conducted documentation in Ethiopia method prior to (resourcemoving to an limited, EHR. Paperdeveloping based methods nation were found to setting). be more Highlights complete than barriers and EHR, but the methods to result was not counter statistically barriers to significant in EHR every category. system Barriers implementat included ion. increased workload and double charting. No change in patient satisfaction or patient-doctor communication, EHR use encouraged as a Majority of Level II studies used were adult primary care settings, limiting DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions electroni c medical record use on the patientdoctor relations hip and commun ication: A systemat ic review. Journal of General Internal Medicin e, 31(5): 548-560 NA 3. Alligoo Summa NA d, M. R. ry of (2014). Nursin Nursing g Theorist Theorie s and s Their Work (vol. 8). St. Louis, Missoiu ri: Mosby. Retrieve d from http://s mcprox y1.saint marys.e du:2048 70 Study Findings Limitations Evidence /Strengths Level communication generalizabi tool. EHR used lity to to guide pediatric communication, settings. No inviting pts to analyzing look at screen done encouraged regarding communication. age of pt population correlating with satisfaction (millennial effect). Various theories discussed, including Leiningers Theory of Culture Care Diversity and Universality Comprehen Level IV sive review of nursing theories and how they apply to numerous aspects of nursing. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions /login?u rl=http:/ /search. ebscoho st.com/l ogin.asp x?direct =true&d b=nlebk &AN=1 105475 &site=e host-live The differing 4. Alsadi, System 17 Studies M., & atic readiness Saleh, Review assessment A. without tools and (2019). metatechniques Electron analysi prior to EHR ic health s implementati records on. impleme ntation readines s: An integrati ve review. Open Journal of Nursing, 9: 152162. Retrosp N=142 Time and 5. Arndt, B. G., et ective physicians usage al. cohort patterns of (2017). study physicians Tethere with an d to the EHR, direct EHR: vs indirect pt Primary care, within care or outside of physicia clinic work 71 Study Findings Limitations Evidence /Strengths Level Assessing the readiness for EHR implementation is highly recommend using a valid and reliable tool. Readiness target areas include culture, leadership/man agement, training, workflows, accountability, IT infrastructure, strategy. Contains Level II definition of EHR, review of current evidence, no intervention . PCPs spend more than half the work day (6 hours) in the EHR, many of the tasks could be delegated, increased need for IT support. Conducted Level III at a large academic center in the USA. Limitations in data accuracy for time with telephone DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions n workhours, tasks load time was assessm spent on. ent using EHR event log data and timemotion observat ions. Annals of Family Medicin e, 15(5): 419426. Physician 6. Carlson, Longit Convenience K. L., udinal sampling from satisfaction McFadd study Childrens and stress en S. E., Hospital level related & Primary Care to Barkin, Clinic documentati S. (Vanderbilt), 74 on (pre-and (2015). residents and 17 postImprovi attendings. surveys), ng implementati docume on of ntation structured timeline data entry ss: A forms based brighte on age of r future patient. for the electroni c medical record in resident clinics. 72 Study Findings Limitations Evidence /Strengths Level encounters. Hard to decipher time spent actively in EHR vs passive time with EHR open on the desktop. Improvement in satisfaction and stress related to documentation for both residents and attendings. SelfLevel I reporting of satisfaction and stress can lead to potential bias. Conducted in an academic medical center which limits ability to generalize results. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Academi c Medicin e, 90(12): 16411645. 7. Cifuente Observ 11 practices (8 Practice s, M., ational, primary care characteristic Davis, cross- and 3 mental s, challenges M., case health) to EHR Fernald, study documentati D., on, solutions Gunn, to barriers, R., observation Dickins of EHR in on, P., use, & interviews Cohen, describing D. J. experiences, (2015). number of Electron EHR ic health systems record used. challeng es, workaro unds, and solution s observe d in practice s integrati ng behavior al health and primary care. Journal of the 73 Study Findings Limitations Evidence /Strengths Level Decreased amount of double documentation, moved from workarounds to documentation to HIT permanent solutions. Integrates Level III primary care and behavioral health documentati on. EHR use can decrease cost and improve quality of care. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions America n Board of Family Medicin e, 28. Doi: 10.3122 /jabfm.2 015.S1. 150133 Qualitative 8. Clarke, Qualita N = 19 A., et al. tive descriptions (2016). study of any The experiences impact or perceived of increased electroni risk to c patient safety records due to EHR on use. patient safety: A qualitati ve study. BMC Medical Informat ics and Decisio n Making, 16(62): doi: 10.1186 /s129110160299-y Documentati 9. Cuccini Mixed Teaching ello, M., method hospital in on analysis, Lapsley, s: Scotland interviews I., Nasi, Qualita with 74 Study Findings Limitations Evidence /Strengths Level Two key themes identified: computer literacy issues and system design. Increased potential for errors during initial implementation and 12 months after, when new staff started, or when computer literacy was low. Initially harder to find information compared to paper charts. Only one Level III unit was used, small sample size, results may not be generalizabl e to other practices. Involvement in planning prior to EHR implementation No Level III intervention , study does not discuss DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions G., & tive/ob N=19 providers Pagliari, servati and key C. onal stakeholders. (2015). study Underst anding key factors affectin g electroni c medical record impleme ntation: A sociotec hnical approac h. BMC Health Services Researc h, 15: doi: 10.1186 /s129130150928-7 Nation Outpatient and NA 10. Departm 5 ent of al primary care Health Guideli settings and ne for Human Docum Services entatio : n Centers Standar for ds. Medicar e& Medicai d Services 75 Study Findings Limitations Evidence /Strengths Level helped educate its own people and get limitations. them on board for EHR implementation . EHR was viewed positively when providers noted it eased their workload and improved the quality of their work. Identifying superusers and having support staff were crucial to success. NA Specific for Level IV outpatient practices Limitation: for US practices, no evidence how well it works in other countries. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Study Findings Definitions . (2016). Evaluati on and manage ment services. Retrieve d Novemb er 26, 2018, from https://w ww.cms .gov/Ou treachandEducati on/Medi careLearnin gNetwork MLN/M LNProd ucts/Do wnloads /evalmgmtservguideICN006 764.pdf Audit Primary care Completenes NA 11. Emblem 6 Health. Tool settings s of medical (2014). record. Adult medical record review tool Primary care 76 Limitations Evidence /Strengths Level Specific to outpatient practices. Nine-page tool. Level IV DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions provider s. Retrieve d from https://w ww.emb lemhealt h.com/p roviders /manual/ medicalrecordsguidelin es Facilitators 12. Farzianp Literat 19 our, F., ure studies/articles and barriers Amirian review to EHR , S., & implementati Byravan on , R. (2015). An investig ation on the barriers and facilitat ors of the impleme ntation of electroni c health records (EHR). Health, 7: 16651670. 33 Primary care Impact of 13. Feldstei RCT n, D. A., clinics CPR et al. associated with (clinical (2017). the University prediction 77 Study Findings Limitations Evidence /Strengths Level Most important factors for facilitators are planning with end users, motivation, and perceived usefulness. Barriers include cost, lack of preparation, and infrastructure. Must evaluate the readiness for adoption and implementation . Only Level V included studies from 2008 and after. None at this time study still in process. Uses the RE-AIM framework (that I am Level I DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Design of Wisconsin rules) on pt and and University care. impleme of Utah medical Focused on ntation centers. respiratory of tract electroni infections. c health Rate of chest record xray integrate ordering, d rapid strep, clinical throat predicti culture, and on rules antibiotic (iCPR): use. a randomi zed trial in diverse primary care settings. BioMed Central, 12(37): doi: 10.1186 /s130120170567-y Success and 14. Fritz, F., System 47 Tilahun, atic articles/studies. challenges of B., & Review implementati Dugas, on of EHR M. systems (2015). according to Success the DeLone criteria and McLean for model electroni (information c quality, medical system record quality, impleme service 78 Study Findings Limitations Evidence /Strengths Level using for my DNP Innovation Project). Study still in process, no results yet. Success criteria include functionality of the implemented system, organizational structure, support for the implementation , and availability of technical resources. Studies Level II were from 1999 and after. Lowincome areas produce less research, limiting results and availably publications . DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions ntations quality, use, in lowintention to resource use, user settings: satisfaction, A net benefits) systemat in addition to ic ethical, review. financial, Journal functionabilit of y, America organization n al, political, Medical technical, Informat and training. ics Associat ion, 22: 479488. How to 15. Gimbel, Qualita N= 3 S., tive (countries) improve the Mwanza Study Mozambique, data quality , M., Zambia, and of health Nisingiz Rwanda) care data we, M. collected via P., EMR, QI Michel, initiatives, C., etc. Hirschh orn, L., & AHI PHIT Partners hip Collabor ative. (2017). Improvi ng data quality across 3 subSaharan African 79 Study Findings Limitations Evidence /Strengths Level Financial concerns were not among the major success criteria noted. EMRs improved data quality and supported decision making and clinical care improvements. Better when management and leadership are involved. Better when staff feel a sense of ownership and are involved. Continuous education and training are important. Audits are a must. Looked at Level III three countries, didnt differentiate between rural versus urban settings and if there were differences. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions countrie s using the consolid ated framew ork for impleme ntation research (CFIR): Results from the African health initiativ e. BMC Health Services Researc h, 17(suppl 3):828. DOI 10.1186 /s129130172660-y EMR 16. Hamade System 12 studies , N., atic features and Terry, Review outcomes A., & with affected by Malvan Metathe use of karAnalysi EMR Mehta, s functions. M. (2019). Interven tions to improve the use of EMRs in 80 Study Findings Limitations Evidence /Strengths Level EMR add ons (such as customized templates, clinical decision support systems, educational materials, and financial incentives) improve data quality. All studies included were conducted in developed nations (USA, UK, Ireland, Finland, Canada). Level I DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions primary health care: A systemat ic review and metaanalysis. BMJ Health & Care Informat ics, 29, doi: 10.1136 /bmjhcl2019000023. Implementati 17. Haskew, Experi 5 J. et al. mental Maternal/child on of a (2015). study, health cloud-based Implem preoutpatient EMR entation post clinics in system, of a interve Western Kenya studied cloudntion 946 women completeness based method of antenatal electroni . records. c medical record for maternal and child health in rural Kenya. Internati onal Journal of Medical Informat 81 Study Findings Limitations Evidence /Strengths Level Significant improvements in completeness of antenatal record; reduction in missing data. Doing a cloudbased implementation eliminates the need for clinic infrastructure and enhanced data access. Utilized the Level I antenatal booklet as a guide for information to include. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions ics, 84: 349354. System Information Cost of 18. Hillesta 1 d, atic from Healthcare documentati 1 R., Bigelow Review Information and on, effects , J., of Management on budget Bower, RCTs Systems management, A., and Society cost savings, Girosi, quasi- (HIMSS); cost of F., experi health care prevention Meili, mental facilities in the and R., studies USA. preventative Scoville therapies, , R., & cost of Taylor, chronic R. disease (2005). management. Can electroni c medical record systems transfor m health care? Potentia l health benefits, savings, and costs. Health Affairs 24(5), p. 11031117. Non4214 clinicians Practice 19. Jones, M., experi completed the management, Koziel, mental, EMR progress information C., observa report survey management, Larsen, tional patient D., study. results 82 Study Findings Limitations Evidence /Strengths Level Having documentation standards improves cost savings and effectiveness Focuses on EHR systems Level II Direct correlation b/w years of EMR use and EMR maturity, positive SelfLevel III reporting via surveys, concerns regarding ability to DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Berry, management, P., & diagnosis Kubatka support, treatment Willms, planning E. support, (2017). patient Progress engagement in the and enhance communicati d use of on, electroni evaluation c and medical monitoring. records: Data from the Ontario experien ce. JMIR Medical Informat ics, 5(1), e5. Mixed Ontario Canada Data quality, 20. Jones, M., method medical Talebi, s record R., completeness Littlejoh , quality of n, J., patient care, Bosnic, and the O., & effect/impact Aprile, of support J. personnel on (2018). EMR use An and quality. optimiza EPEP tion current state program assessment, to help analysis of practice data quality s assess and data workflow, 83 Study Findings Limitations Evidence /Strengths Level correlation b/w generalize years of EMR results to all use and practices. perception that it improves clinical care, further evidence of ongoing improvement as years of use increase. On-site support to assess EMR knowledge, use, efficiencies, workflow, and data quality greatly benefit EMR use and patient care. Mixed Level III methods but mainly observation al study leading to possibility of subjectivity bias. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions quality customized and action plan, workflo postw with engagement their evaluation. electroni c medical records: Observa tional study. JMIR Human Factors, 5(4): e30 Rates of HIV 21. Kersha Retrosp Cohort 1: w, C. et ective 27,729 screening al. cohort and testing (2018). study Cohort 2: pre and post Use of 20,640 reminder in an EHR. electroni c medical record reminde r improve s HIV screenin g. BMC Health Services Researc h, 18(14): doi: 10.1186 /s129130172824-9. 84 Study Findings Limitations Evidence /Strengths Level EHR reminder increased rates of HIV screening (doubled rates) in all age, gender, racial, language, and income groups. Setting was Level III in USA. Large sample/coh ort sizes. Data didnt capture all HIV tests done at the healthcare system due to alterations in ordering practices. Unable to discern practitionerrelated factors other than level of training. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Articles 22. Kiberu, Literat N=48 articles V. M., ure regarding Mars, Review implementati M., & on of Scott, R. electronic E. based health (2017). programs Barriers were and utilized. opportu nities to impleme ntation of sustaina ble ehealth program mes in Uganda: A literatur e review. African Journal of Primary Health Care & Family Medicin e, 9(1), https://d oi.org/1 0.4102/ phcfm.v 9i1.127 7 Mixed 41 physicians Assess 23. Kroth, P. J. et method factors, such al. s study as HICT and (2018). EHRs The associated 85 Study Findings Limitations Evidence /Strengths Level Needs No studies Level V assessments are mention a a must prior to needs implementation assessment. . Uganda has a lot of the 8 of the infrastructure articles necessary for reviewed EMRs. focused on Solutions that EMR do not increase systems in workload or Uganda. hinder patient care are a must. Highlights the DHIS2 charting system that is available in Uganda. Benefits to having all of patients information in one place, Included MDs, NPs, and PAs in study. Level II DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions electroni with burnout c and identify elephant coping in the strategies via room: focus groups. Physicia ns and the electroni c health record. Journal of America n Medical Informat ics Associat ion, 1(1): 49-56. System 31 Facilitators 24. Kruse, C.S., atic articles/studies and barriers Kothma review regarding to EMR n, K., implementation adoption. Anerobi of , K., & documentation Abanak in the a, L. healthcare (2016). setting. Adoptio n factors of the electroni c health record: A systemat ic review. JMIR Med Inform., 86 Study Findings Limitations Evidence /Strengths Level electronic messaging capabilities increase communication between providers, access to biomedical research leads to evidencebased care. Stressors include pressure for perfect documentation, too many clicks, increased practice burden. Identified recurring themes of 25 adoption facilitators and 23 barriers to adoption. Interrater Level II reliability is a potential factor. Only identified studies between 2012-2015, could have missed valuable studies. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions 4(2): e19 System 27 articles Barriers to 25. Kruse, C. S., atic EMR Kristof, review adoption C., Jones, B., Mitchell , E., & Martine z, A. (2016). Barriers to electroni c health record adoption :a systemat ic literatur e review. J Med Syst, 40(252). Doi: 10.1007 /s109160160628-9 Summa NA NA 26. Leining 1 er, ry of 4 M. M. Nursin (1988). g Leining Theory ers theory of nursing: Cultural care 87 Study Findings Limitations Evidence /Strengths Level Identified 39 common barriers to EMR adoption most frequently mentioned are cost, technical concerns, technical support, and resistance to change. Assesses Level II barriers in the United States only. Comprehensive review of rationale, methods, and techniques to use the Cultural care diversity and universality theory in practice. Strengths: Level IV theory is meant to be implemente d with different cultures. Studies used were from 20112016. Risk of selection and publication bias noted by authors. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions diversity and universa lity. SAGE Journals , doi: 10.1177 /089431 8488001 00408. Quantit N=28, Ugandan Survey 27. Liang, L., ative health care studying Wiens, study workers usability and M. O., performance Lubega, (Likert P., scale). Spillma n, I., & Mugisha , S. (2018). A locally develop ed electroni c health platform in Uganda: Develop ment and impleme ntation of Stre@m line. JMIR Formati ve Researc 88 Study Findings Limitations Evidence /Strengths Level 96% report it is easy to learn and 100% report easy to use. Stre@mline was useful in improving clinical efficiency and enhancing pt care. Set in Level II Uganda, selfreported survey, potential for bias, no data on cost savings or patient safety. Hospital based EHR DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions h, 2(2): e20 Use/advanta 28. Mehta, Rando N = 10 R., et al. mized hospitalist ges of, and (2016). cohort attendings in a quality of The use study large academic problemof center oriented evidenc templates as e-based, a clinical problem decision support tool. oriented template s as a clinical decision support in an inpatient electroni c health record system. Applied Clinical Informat ics, 7:790802. System Hospitals and Assessed 29. Nguyen, 1 L., atic clinics around impacts 9 Bellucci Review the world (both , E., & implementing positive and Nguyen, EHR systems negative) of L. T. within a 10EHR (2014). year period implementati Electron on, user ic health satisfaction, records service impleme quality, ntation: information An quality, evaluati system on of quality, 89 Study Findings Limitations Evidence /Strengths Level Use of problemoriented templates increased the quality of documentation. No significant difference in charting time. Physicians kept using the problemoriented templates after the study ended, per a 3 month follow up. Large Level II academic center, results not necessarily generalizabl e. Before/after design could lead to bias. Measureme nt of time included all time the chart was open, leading to potential inaccurate time stamps. Technology and EHRs help improve administrative efficiency, mixed reviews on quality, adaptation and satisfaction. Negative impacts include change in workflow and work disruption Looks at Level II implementat ion of electronic health records Incorporates numerous health centers and hospitals across the world in DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions informat intention of ion use and system actual usage. impact and continge ncy factors. Internati onal Journal of Medical Informat ics, 83(11), 779-96. 30. Noureld Mixed 350 records and Quality of in, M., method 31 providers documentati Mosalla s: within 7 on in m, R., & Qualita primary health electronic vs Hassan, tive, clinics in paper S. Z. retrosp Alexandria methods, (2014). ective Egypt provider Quality study. feedback on of barriers and docume facilitators to ntation the of electronic electroni system. c medical informat ion systems at primary health care units in Alexand ria, Egypt. Eastern 90 Study Findings Limitations Evidence /Strengths Level various settings Higher completion rate in paper based documentation than electronic. Electronic methods were easier to discern administrative data and identify providers. Providers report higher workload with electronic records. Set in primary care clinic in a low resource setting. Level III DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Mediter ranean Health Journal, 20(2): 105111. 31. Odekunl Literat 15 articles and Factors/strate e, F. F., ure studies gies to Odekunl review improve e, R. O., adoption of & EHR Shankar systems in , S. sub-Saharan (2017). African Why nations. subSaharan Africa lags in electroni c health record adoption and possible strategie s to increase its adoption in this region. Internati onal Journal of Health Sciences , 11(4), 59-64. Works Rural and Numerous 32. Olson, 2 S., hop outpatient (age, race, 1 & Anderso Summa settings health 91 Study Findings Limitations Evidence /Strengths Level Found the following barriers: high implementation and maintenance costs, limited computer skills, lack of prioritization of EHR, lack of electricity and internet. Does not Level V incorporate studies from all subSaharan African nations, no statistical analysis completed. Facilitators: implementation planning, training and education, financial support, appropriate EHR selection, phased implementation Numerous Only done Level IV inequities noted in USA, did in race, age, not look at DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions n, K. M. ry of conditions, (2018). Roundt economic, Achievi able health ng rural data of related, etc.) health rural equity health; and system wellatic being: review Proceedi ngs of a worksho p. The National Academi es of Sciences , Enginee ring, Medicin e. The National Academ ies Press, Washin gton DC. Quasi- Ugandan Assessing 33. Rarick, 2 C., experi University Ugandan 3 Winter, mental cultural G., study themes Nickers on, I., Falk, G., Barczyk , C., & Asea P. K. (2013). An investig ation of 92 Study Findings Limitations Evidence /Strengths Level sex, specific socioeconomic resource status, etc.) present in each rural practice. Shows strong evidence of disparities and discusses techniques to overcome them. Masculinity, power, individualism vs collectivism, uncertainty avoidance, long-term and time orientation Assesses Level II numerous components of Ugandan culture, compares to differing nations, both developed and undevelope d DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Uganda n cultural values and implicat ions for manager ial behavior . Global Journal of Manage ment and Business Researc h, XIII(IX: I). Quality Inpatient setting Number of 34. Rozich, 2 J. Improv errors, 4 D., Howard, ement, medication R. J., Case dosages, Justeson Report implementin , J. M., g a new Macken, standard of P. D., practice for Lindsay, medication M. E., administratio & n. Resar, R. K. (2004). Standar dization as a mechani sm to improve safety in health care. 93 Study Findings Limitations Evidence /Strengths Level Improved uniformity of practice and improved patient safety (reduction in errors) Inpatient Level IV setting, implemente d a new standardize d practice. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Joint Commis sion Journal on Quality and Safety, 30(1): 5-14. Benefits, 35. Scantleb Qualita N=19 ury, S., tive barriers, and et al. Study disadvantage (2017). s to an EHR Explorin in a g the maternity impleme unit. ntation of an electroni c record into a maternit y unit: A qualitati ve study using Normali sation Process Theory. BMC Medical Informat ics and Decisio n Making, 17(4): doi: 10.1186 /s12911- 94 Study Findings Limitations Evidence /Strengths Level Mixed understanding of participants regarding why an EHR was implemented, willingness to use EHR depended on training and support received. Adequate training, support, and cognitive participation is needed for an EHR implementation to be successful. Barriers included reluctance to EHR and change, not being involved in decision making. Benefits: more accurate data collection and clinical audits. Maternity Level III unit was the setting (same setting as the proposed DNP Innovation Project). Not necessarily generalizabl e to other units. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions 0160406-0 Patient 36. Tanner, Quasi- 209 primary C., experi care practices education, Gans, mental (92 use EHRs, communicati D., study 117 use paper on, practice White, records) management/ J., Nath, culture, R., & personnel, Pohl, J. qualification (2015). s, Electron competency, ic health handoffs and records transitions, and medication patient safety, data safety. overview. Applied Clinical Informat ics, 6: 136147. Survey to 37. Tilahun, Experi 5 hospitals in B., & mental Ethiopia (health identify Fritz, F. Cross- professionals satisfaction (2015a). Section N= 384) and use. Modelin al study Assesses use g of D&M antecede model for nts of implementati electroni on and effect c of computer medical skills to use, record satisfaction, system and quality impleme of EHR. ntation success in lowresource setting hospital s. BMC 95 Study Findings Limitations Evidence /Strengths Level Practices with EHRs outperformed clinics with paper-based documentation in every aspect. Does not Level II define if health care clinics were associated with hospital systems or support provided to EHR implementat ion or use. EHR system quality, information quality, and service quality have a significant impact on EHR use, user satisfaction. User satisfaction has an influence on use. EHR use and satisfaction influence perceived benefit. Computer literacy is correlated with SelfLevel I reported answers by participants, potential for respondent bias. Large sample size in a low resource setting. Highlights the importance of EHR implementat ion being evidencebased and well planned. DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions Medical Informat ics and Decisio n Making, 15(61), doi: 10.1186 /s129110150192-0 Usage 38. Tilahun, Experi 5 hospitals in B., & mental Ethiopia (health pattern, user Fritz, F. Cross- professionals satisfaction, (2015b). Section N=422) and Compre al study determinants hensive of health evaluati professional on of s satisfaction electroni with an c EHR. medical record system use and user satisfact ion at five lowresource setting hospital s in Ethiopia . JMIR Medical Informat ics, 3(2), e22. Eviden NA Definition of 39. Titler, 2 M. ce translational 7 G. 96 Study Findings Limitations Evidence /Strengths Level service quality, use, and satisfaction. Use of EHR decreased after implementation , high dissatisfaction rate (physicians more than nurses), correlation between dissatisfaction and use. Future implementation should work to improve service quality, user support, trainings and keep staff motivated to use. Setting is Level I lowresource country (Ethiopia), large sample size. High response rate (96.2%) for provider surveys. Short data collection period (1 month). NA Not an Level V experimenta DOCUMENTATION IN RURAL HEALTHCARE No. Citation Design Sample/Setting Variables & Definitions (2018). obtaine research, Translat d from examples in ional literatu practice research re in reviews practice: An introduc tion. OJIN: The Online Journal of Issues in Nursing, 23(2), manuscr ipt 1. 40. Vaghefi, Mixed 11 primary care Capacity of I. et al. method clinics in clinics (2016). s Canada utilizing Underst EHRs and anding paper-based the documentati impact on in of preparedness electroni to provide c practicemedical based record population use on health practicemanagement. based What populati facilitates on clinics to be health ready for manage PBPH. ment: A mixedmethod study. JMIR Medical 97 Study Findings Limitations Evidence /Strengths Level l study, well defines translational research Clinics using EHRs were more prepared to provide PBPH, more efficient, and more confident than paperbased clinics. Tool used was not rigorously validated. Level III DOCUMENTATION IN RURAL HEALTHCARE No. 98 Citation Design Sample/Setting Variables & Study Findings Limitations Evidence Definitions /Strengths Level Informat ics, 4(2): e10 Evidence Synthesis Table (based on the Johns Hopkins Research Synthesis Table (Dang & Dearholt, 2018)) Category (Level Type) Level I Experimental study, RCT, Systematic Review of RCTs with or without meta-analysis Level II Quasi-experimental studies, systematic review of a combination of RCTs and quasi-experimental studies, or quasi-experimental studies only, with or without meta-analysis Level III Non-experimental study, systematic review of a combination of RCTs, quasi-experimental, non-experimental studies with or without metaanalysis, qualitative study or systematic review of qualitative studies with or without meta synthesis Level IV Opinion of respected authorities and/or reports of nationally recognized expert committees/consensus panels based on scientific evidence Level V Evidence obtained from literature reviews, quality improvement, program evaluation, financial evaluation, case reports, opinion of nationally recognized experts based on experimental evidence Total number of sources 6 13 11 7 3  ...

... Saint Marys College Doctor of Nursing Practice Program DNP Practice Innovation Project Completion Form As the faculty team leader for this DNP Practice Innovation Project, I certify that this project was prepared, implemented, and evaluated under my direction. I have read the paper that was prepared by Kathryn Vera titled Impact of Formal Education Regarding Breaking Bad News on Self-Efficacy and recommend that it be accepted as fulfilling the DNP Practice Innovation Project requirement for the Doctor of Nursing Practice degree at Saint Marys College. __________________________________ Date: 8/2/2022 Sue Anderson PhD, RN, FNP-BC Faculty Team Leader I hereby certify that I have carried out this project in its entirety under the direction of my team leader. My signature indicates that this document is presented truthfully and in alignment with the Academic Honor Code of Saint Marys College. __________________________________ 8/2/2022 ___________________________________ Students Signature Date DNP Practice Innovation Projects are stored with the students permission in the online repository at the Cushwa-Leighton Library. The projects are available to the public for viewing. X I do_____ do not _____ grant my permission for my project to be stored in the repository. __________________________________ 8/2/2022 ___________________________________ Students Signature Date Running head: IMPACT OF FORMAL EDUCATION Impact of Formal Education Regarding Breaking Bad News on Self-Efficacy Kathryn Vera, MSN, RN, FNP-BC Doctor of Nursing Practice Program Master of Science APRN to DNP Track Department of Nursing Science, Saint Mary's College Faculty Team Leader: Sue Anderson, Ph.D., RN, FNP-BC 1 IMPACT OF FORMAL EDUCATION 2 Abstract Breaking bad news in a clinical setting can lead to a negative experience for the healthcare provider when delivered inappropriately (Gorniewicz et al., 2017). This Doctor of Nursing Practice (DNP) Practice Innovation Project seeks to discover if healthcare providers who receive formal education in breaking bad news to patients have increased self-efficacy in breaking bad news compared with healthcare providers not formally educated in a DNP Program. This comparison was analyzed using a pre-test/post-test format. The purpose of this DNP Practice Innovation Project is to improve the healthcare provider's self-efficacy in breaking bad news to a patient through an educational module outlining the SPIKES protocol, ultimately improving the experience for the healthcare provider. Participants included students enrolled in the DNP program in the Saint Mary's College Department of Nursing Science. The SE-12 self-efficacy tool (Axboe et al., 2016) measured the participants' self-efficacy utilizing a pre-test/post-test method that measured self-efficacy before and after the presentation of the educational module. The data from the pretest and posttest were analyzed using a two-tailed paired samples t-test. The result was significant, suggesting the difference in the mean overall score of the SE-12 pretest and the mean overall score of the SE-12 posttest was significantly different from zero. The mean overall score of the SE-12 pretest was significantly lower than the mean overall score of the SE-12 posttest. IMPACT OF FORMAL EDUCATION 3 Table of Contents Impact of Formal Education Regarding Breaking Bad News on Self-Efficacy ........................................... 6 Background ................................................................................................................................................... 6 Problem Statement ........................................................................................................................................ 8 PICO(T) and Objectives ............................................................................................................................... 9 Literature Review........................................................................................................................................ 10 Definition of Terms..................................................................................................................................... 10 Table 1 .................................................................................................................................................... 11 Definition of Terms ............................................................................................................................. 11 Themes and Concepts in the Literature....................................................................................................... 13 Breaking Bad News ................................................................................................................................ 13 Impact of Breaking Bad News on the Healthcare Provider .................................................................... 13 Education ................................................................................................................................................ 14 Education for Oncology Healthcare Providers ....................................................................................... 15 Communication ....................................................................................................................................... 16 Self -Efficacy .......................................................................................................................................... 17 Quality Improvement .............................................................................................................................. 17 SPIKES Protocol..................................................................................................................................... 18 Table 2 .................................................................................................................................................... 18 Definition and Implementation of SPIKES protocol .......................................................................... 18 Concept Map ............................................................................................................................................... 20 Figure 1 ................................................................................................................................................... 21 .................................................................................................................................................................... 21 Critical Appraisal of Literature ................................................................................................................... 22 Strengths ................................................................................................................................................. 22 Weaknesses ............................................................................................................................................. 22 Gaps ........................................................................................................................................................ 23 Description of the Intervention ................................................................................................................... 23 Theoretical and Implementation Models .................................................................................................... 24 Florence Nightingale's Environmental Theory ....................................................................................... 24 Alfred Bandura's Social Cognitive Theory ............................................................................................. 25 Implementation ........................................................................................................................................... 26 Quality Improvement .............................................................................................................................. 26 Project Implementation ........................................................................................................................... 27 Innovation and Social Entrepreneurship ..................................................................................................... 27 IMPACT OF FORMAL EDUCATION 4 Sustainability............................................................................................................................................... 28 Ethical Considerations ................................................................................................................................ 29 Participation Risks .................................................................................................................................. 29 Participation Benefits and Nursing Knowledge ...................................................................................... 30 Informed Consent.................................................................................................................................... 30 Discussion of Methods ................................................................................................................................ 31 Key Stakeholders .................................................................................................................................... 31 Participant Sample Information .............................................................................................................. 32 Implementation Plan ............................................................................................................................... 33 Participant Duties .................................................................................................................................... 33 Reliability and Validity of Instrument .................................................................................................... 34 Power Analysis ....................................................................................................................................... 36 Budget ..................................................................................................................................................... 37 Timeline .................................................................................................................................................. 37 Data Analysis .............................................................................................................................................. 37 Two-Tailed Paired Samples t-Test.......................................................................................................... 38 Assumptions....................................................................................................................................... 38 Results ................................................................................................................................................ 38 Table 3 .................................................................................................................................................... 39 Two-Tailed Paired Samples t-Test for the Difference Between Pre_Overall and Post_Overall ........ 39 Figure 2 ................................................................................................................................................... 39 The means of Pre-Overall and Post-Overall with 95.00% CI Error Bars ........................................... 39 Discussion ................................................................................................................................................... 40 Implications............................................................................................................................................. 40 Strengths and Limitations ....................................................................................................................... 41 Conclusion .................................................................................................................................................. 41 References ................................................................................................................................................... 43 Appendix A ................................................................................................................................................. 56 CITI Completion Document ................................................................................................................... 56 Appendix B ................................................................................................................................................. 57 DNP Defense Completion Form ............................................................................................................. 57 Appendix C ................................................................................................................................................. 58 Literature Synthesis Table ...................................................................................................................... 58 Appendix D ............................................................................................................................................... 109 Informed Consent Document ................................................................................................................ 109 IMPACT OF FORMAL EDUCATION 5 Appendix E ............................................................................................................................................... 112 Survey Instrument ................................................................................................................................. 112 Appendix F................................................................................................................................................ 117 IRB Approval Letter ............................................................................................................................. 117 Appendix G ............................................................................................................................................... 118 Poster Presentation ................................................................................................................................ 118 Appendix H ............................................................................................................................................... 119 SPIKES Protocol Educational Module ................................................................................................. 119 IMPACT OF FORMAL EDUCATION 6 Impact of Formal Education Regarding Breaking Bad News on Self-Efficacy Breaking bad news in a clinical setting can lead to a negative experience for the healthcare provider when the news is delivered inappropriately (Gorniewicz et al., 2017). Bad news is defined as "any news that drastically and negatively alters the patient's view of her or his future" (Buckman, 1984, p. 1597). Poor healthcare provider outcomes resulting from breaking bad news include an increase in stress (Fallowfield, 1993), anxiety (Sykes, 1989), emotional exhaustion, and a lower sense of personal accomplishment (Ramirez et al., 1995). Formal education to improve the process of breaking bad news to patients resulted in increased confidence in the healthcare provider (Baile et al., 2000; Moura Villela et al., 2020). Additionally, formal education in breaking bad news led to a more satisfying and less uncomfortable experience for the healthcare provider, the patient, and the patient's family members (Baile et al., 2000; Moura Villela et al., 2020). The phenomenon of breaking bad news is both a health promotion and a health system issue. When bad news is not delivered appropriately, the healthcare provider risks developing negative consequences (Fallowfield, 1993; Ramirez et al., 1995; Sykes, 1989). This is a health promotion issue because the inappropriate delivery of bad news can change the outlook and interpretation that the patient and their family members have about the illness (Mostafavian & Shaye, 2018). It is a health system issue because formal training leads to better health outcomes for patients and healthcare providers (Gorniewicz et al., 2017). Background Breaking bad news in a clinical setting can negatively impact the healthcare provider responsible for delivering the bad news if not delivered appropriately (Fallowfield, 1993; Sykes, 1989; Ramirez et al., 1995). Education focused on communication skills has improved healthcare IMPACT OF FORMAL EDUCATION 7 provider communication and self-efficacy in breaking bad news to patients (Axboe et al., 2016; Gorniewicz et al., 2017). Increased self-efficacy leads to improved confidence in clinical communication, which results in an improved experience for the healthcare provider (Axboe et al., 2016). The phenomenon of breaking bad news to patients is within the scope of the DNPprepared Advanced Practice Registered Nurse (APRN) because it directly affects the care the ARPN provides to the patient. The target population for this project is the healthcare providers responsible for breaking the bad news to patients in a clinical setting. This project is healthcarefocused, with the exchange of bad news from a healthcare provider to a patient in a clinical setting. Strong communication is key to breaking bad news effectively (Kebede et al., 2020) and is highlighted in Healthy People 2030 through the goal of "Health Communication" (U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion [HHS ODPHP], 2020). This objective recognizes and acknowledges the importance of clear communication between healthcare providers and patients so that the information received can be utilized to its maximum potential (HHS ODPHP, 2020). Education about communicating bad news to patients improved the providers skill set and self-efficacy (Axboe et al., 2016; Servotte et al., 2019). Healthcare providers that were surveyed felt unprepared to break the bad news to patients and appreciated education and training about the subject (Brouwers et al., 2018; Goncalves et al., 2017) The need for formal education about breaking bad news to patients is apparent in several research studies. Historically, education concerning breaking bad news is deferred to training through experience with patients instead of formal training in a classroom environment because the subject matter is tedious, and there is often a lack of resources required to provide formal IMPACT OF FORMAL EDUCATION 8 education on breaking bad news (Bagacean et al., 2020; Baile et al., 2000; Cvengros et al., 2016; Vandekeift, 2001). Yip et al. (2018) found that a group of family medicine residents ranked education about breaking bad news as one of the most important topics. Patients that were surveyed found it essential for the healthcare professional to be empathetic, a good communicator, and knowledgeable about treatment choices (Bagacean et al., 2020). This directly relates to formal training on breaking bad news because this training emphasizes empathy and communication in breaking bad news. Problem Statement Strong communication is paramount to breaking bad news (Kebede et al., 2020). Education and training about breaking bad news and patient communication led to an improvement in the skill set of breaking bad news, communication skills of the health care providers, and improvement in confidence levels in delivering bad news to patients (Servotte et al., 2019). Education in clinical communication skills has also increased self-efficacy in interactions between patients and healthcare providers (Axboe et al., 2018). This led to a better experience for the healthcare provider because of improved confidence in communication (Axboe et al., 2016). This concept is relevant and critical in the healthcare field, as it can affect the well-being of the healthcare provider (Gorniewicz et al., 2017). The purpose of this DNP Practice Innovation Project is to improve the healthcare provider's self-efficacy in breaking bad news to a patient through an educational module, ultimately improving the experience for the healthcare provider. Self-efficacy is described by psychologist Albert Bandura (1986) as one's personal belief in their ability to execute a particular task successfully. This project contributes to the general nursing knowledge because educational interventions for healthcare providers about breaking bad news to patients have improved self- IMPACT OF FORMAL EDUCATION 9 efficacy and confidence in the healthcare provider (Chung et al., 2016; Gorniewicz et al., 2017; Johnson & Panagioti, 2018). This DNP Practice Innovation Project focuses on the healthcare provider's perspective and how educating the healthcare provider about breaking bad news can improve the healthcare provider's experience. PICO(T) and Objectives The PICOT question for this DNP Practice Innovation Project asks: Do healthcare providers who receive formal education in breaking bad news to patients have increased selfefficacy in breaking bad news compared with healthcare providers not formally educated in a Doctor of Nursing Practice Program? The first objective of this DNP Practice Innovation Project was to improve the healthcare provider's self-efficacy in breaking bad news to patients through an educational module, which ultimately enhances the experience for the healthcare provider. Education focused on communication skills has been shown to improve healthcare provider communication in breaking bad news (Gorniewicz et al., 2017) The second objective was to offer this training in a classroom environment. Formal training in a safe and controlled classroom environment is preferable in improving the experience of breaking bad news for healthcare providers compared to learning in unpredictable clinical situations (Cvengros et al., 2016; Brouwers et al., 2018). This DNP Practice Innovation Project focused on the perspective of the healthcare provider and how education about breaking bad news can lead to a better experience for the provider through improved self-efficacy and confidence in the healthcare provider (Chung et al., 2016; Gorniewicz et al., 2017; Johnson & Panagioti, 2018). IMPACT OF FORMAL EDUCATION 10 Literature Review A literature review was conducted using articles published from 2016 to 2021. The databases Cochrane Central Register of Controlled Trials, Cochrane Clinical Answers, Cochrane Database of Systematic Reviews, Cochrane Methodology Register, EBSCO Management Collection, Ovid, and MEDLINE with Full Text were searched, and 671 articles were retrieved and reviewed. Ultimately, 75 articles were used in this DNP Practice Innovation Project. Inclusion criteria for these articles included peer-reviewed articles written in English. Only articles from the last five years were used, except for 10 sentinel articles. Melynk and Finehout's Grading System (2014) was used to grade all articles. These databases were searched using the keywords "breaking bad news to patients," "diagnosis delivery," "breaking bad news," "breaking bad news in health care," "breaking significant news," and "delivering a difficult diagnosis." The search was narrowed to include only peer-reviewed articles within the last five years. This literature search allowed the concept of breaking bad news to be discovered in various health care settings, including oncology, women's health, neurology, and the emergency department. The concept of breaking bad news is relevant and critical in the healthcare field, as it can affect how the patient copes with their circumstances (Bumbe et al., 2017; Warnock et al., 2017). A literature review identified what is known and unknown about this concept. While the concept of breaking bad news has been thoroughly studied for decades in various settings among different cultures, there are specific areas needing exploration and additional research, such as education to healthcare providers regarding breaking bad news. Definition of Terms Several terms were commonly used in the literature regarding breaking bad news that are critical to understand. The complete understanding of these terms is essential because it allows IMPACT OF FORMAL EDUCATION 11 for a comprehensive understanding of the literature regarding breaking bad news. These terms are defined according to their use in the literature about breaking bad news. Table 1 Definition of Terms Term Bad News Definition Bad news is defined as information that will likely change a person's perception of their future (Buckman, 1984). This definition is used widely in the research regarding breaking bad news and is used in this DNP Practice Innovation Project when referring to breaking bad news. This concept is relevant and critical in healthcare as it can affect how patients cope with their circumstances (Warnock et al., 2017). Blackboard Blackboard is the online learning management system used by Saint Marys College that connects students and teachers to educational content and facilitates connections with other students and teachers within the interface (Blackboard, 2022). Emotional Emotional empathy is defined as the ability of the healthcare provider to feel Empathy what the patient is feeling (Powell & Roberts, 2017). This allows the healthcare provider to assess and monitor the patient's state of mind, react appropriately, and customize the encounter accordingly (Hurst et al., 2015; Mishelmovich et al., 2016). Self-efficacy Self-efficacy is a concept derived from Albert Bandura's Social Cognitive Theory (Bandura, 1986). Self-efficacy is defined as one's belief in the ability to perform a particular skill through the skill set that one possesses IMPACT OF FORMAL EDUCATION 12 under varying circumstances (Bandura, 1997). Successful functioning must incorporate skill competency and the confidence to use the skill (Bandura, 1997). Cognitive, social, emotional, and behavioral attributes are necessary for facilitating self-efficacy because each attribute contributes to one's perceived confidence in performing a specific skill (Bandura, 1997). Bandura (1990) concluded that improved self-efficacy leads to increased goal attainment. Communication Communication is defined as how information is shared and is an essential attribute of the concept of breaking bad news (Bumbe et al., 2017). The method in which the bad news is shared with the patient affects how decisions are made about a care plan, the patient's perception of control over the circumstances, and the appropriateness of a treatment plan (Bumbe et al., 2017; Warnock et al., 2017). In addition, the element of clear communication is viewed as the highest level of importance in an exchange between the healthcare provider and the patient (Krohn et al., 2017; Ong et al., 1995). Education Education is the formal learning process about a specific subject in which the presenter instructs and advises the student on specific aspects of a topic using clear communication (Markowitz & Reid, 2018). In this DNP Practice Innovation Project, education refers to the formal teaching given to healthcare providers regarding breaking bad news to patients. Quality Quality improvement is defined as the methodical and organized way that a Improvement process is enhanced to better meet the goal of the purpose that the process IMPACT OF FORMAL EDUCATION 13 serves (Moran et al., 2020). The DNP Practice Innovation Project is a quality improvement project because it examines the current literature about breaking bad news to patients and describes an intervention to improve this process. SPIKES Discussed in detail later in this paper, the SPIKES protocol refers to Setting, Protocol Perception, Invitation, Knowledge, Emotion, and Summary Themes and Concepts in the Literature The emerging theme found in the literature about breaking bad news is education and the importance of having a formal education in breaking bad news (Moura Villela et al., 2020; Setubal et al., 2017; Yip et al., 2018; and Zwingman et al., 2017). Communication and selfefficacy are the major concepts influencing the main concept of education in breaking bad news. Breaking Bad News The concept of breaking bad news is relevant and critical in the healthcare field, as it can affect how patients cope with their circumstances (Bumbe et al., 2017; Warnock et al., 2017). A literature review identified what is known and unknown about this concept. While the concept of breaking bad news has been thoroughly studied for decades in various settings among different cultures, there are specific areas needing exploration and additional research, such as education to healthcare providers regarding breaking bad news. Impact of Breaking Bad News on the Healthcare Provider When bad news is not delivered appropriately, the healthcare provider is at risk of experiencing negative consequences, including an increase in stress (Fallowfield, 1993), anxiety (Sykes, 1989), emotional exhaustion, and a lower sense of personal accomplishment (Ramirez et al., 1995). Daffalah et al. (2020) focused on the SPIKES protocol (Baile et al., 2000), a sentinel IMPACT OF FORMAL EDUCATION 14 study used to break bad news to patients. Many healthcare professionals are not formally trained in their educational curriculum to break bad news to their patients because the subject matter is tedious and requires a significant amount of effort (Baile et al., 2000; Vandekieft, 2001). Additionally, Hoffman et al. (2018) highlighted the importance of training nurse practitioners to give patients bad and difficult news and found that this training is often lacking during the orientation period. Education The literature refers to the concept of education when discussing the concept of breaking bad news. Servotte et al. (2019) found education and training in breaking bad news to patients led to an improvement in the skill set of breaking bad news, communication skills of the health care providers in the emergency department, and improvement in confidence levels in delivering bad news to patients. Similarly, Goncalves et al. (2017) found that most physicians surveyed in the study felt the need for more training and felt unprepared to break bad news to patients. Students who have undergone training in breaking bad news appreciated feedback from simulated patients and clinicians in their technique and ultimately found it helpful (Brouwers et al., 2018). Computerized conversational assistants known as virtual human software, was shown to be beneficial and valuable in assessing the competence of healthcare professionals in breaking bad news (Guetterman et al., 2017). When bad news is not delivered appropriately, the healthcare provider risks experiencing negative consequences. Healthcare providers reported symptoms of depression after giving bad news to patients in an oncology center (Alshmmary et al., 2017). Daffalah et al. (2020) provided evidentiary support that formal training in breaking bad news to patients allows for a more IMPACT OF FORMAL EDUCATION 15 successful encounter with the patient than healthcare providers who did not have any training. Daffalah et al. (2020) focused on the SPIKES protocol (Baile et al., 2000). Education for Oncology Healthcare Providers The need for training regarding breaking bad news is urgent in the oncology setting due to an increase in people surviving cancer, an aging population in the United States, and enhancement in healthcare coverage for previously uninsured people (Coombs et al., 2016). The number of nurse practitioners currently practicing in the oncology workforce is increasing; therefore, the education regarding breaking bad news should be improved (Coombs et al., 2016). Education regarding breaking bad news in the oncology setting is complex because a delicate balance of realism and optimism is necessary (Vakada et al., 2018). When receiving a breast cancer diagnosis, women who were optimistic about their diagnosis had better coping skills when compared with women in the same situation who were not optimistic (Vakada et al., 2018). An appropriate amount of optimism may be an essential tool for the provider to incorporate when breaking bad news to the patient (Vakada et al., 2018). Physicians and APRNs have indicated that they are not properly trained in delivering bad news to patients and often have a negative experience personally when delivering bad news to the patient (Rosenzweig, 2012). However, research has shown that training within the medical provider educational programs regarding communication skills has become protocol. In contrast, this type of training still lacks in the training of the APRN (Corey & Gwyn, 2016). Corey & Gwyn (2016) promoted an educational training program for APRNs regarding communication with oncology patients, in which five nurse practitioners were educated about the SPIKES protocol. After this education, they were asked to implement the SPIKES protocol in their practice for 30 days and then were interviewed about their experiences using the SPIKES IMPACT OF FORMAL EDUCATION 16 protocol (Corey & Gwyn, 2016). Corey & Gwyn (2016) stated that the APRNs found that using the SPIKES protocol was helpful in breaking bad news and improved the experience for both the patient and the provider. DNP-prepared APRNs play an integral part in caring for oncology patients, as oncology interfaces with many other disciplines to ensure that the patient has a comprehensive plan of care. Communication In the literature regarding breaking bad news, the concepts of communication and education are closely linked. The literature suggests the advancement of robust, formal education regarding the communication of bad news between the healthcare provider and the patient (Bagacean et al., 2020; Chung et al., 2016; Cvengros et al., 2016; 2020; Kron et al., 2017). The SPIKES protocol (Baile et al., 2000) is discussed in much of the literature as a template for guiding difficult conversations. Specifically, the SPIKES protocol (Baile et al., 2000) was discussed by Wolfe et al. (2016) when used to formally educate health care providers in delivering bad news to the family members of pediatric patients. Communication is an essential attribute of the concept of breaking bad news and is the foundation of the SPIKES protocol (Baile et al., 2000). The method in which the information is communicated to the patient affects the way decisions are made about a plan of care by both the patient and the healthcare provider. The method of communication also affects the patient's perception of control over the circumstances and the appropriateness of a treatment plan (Bumbe et al., 2017; Warnock et al., 2017). In addition, the element of clear communication is viewed as the highest level of importance in an exchange between the healthcare provider and the patient (Krohn et al., 2017; Ong et al., 1995). The attribute of communication must consider communication with the entire family. Rao et al. (2016) conducted a study about the presence of IMPACT OF FORMAL EDUCATION 17 family members when a cancer diagnosis is delivered to a patient. The study concluded that most patients prefer the involvement of family members during the delivery of a cancer diagnosis (Rao et al., 2016). In considering the concept of a healthcare provider breaking bad news to a patient, the healthcare provider has information that must be expressed. Giving accurate information in a way that the patient and patient's family understand and prefer is paramount to the patient's quality of life (Rozveh et al., 2017). Interventions to improve breaking bad news have increased confidence in the healthcare provider responsible for breaking bad news (Johnson & Panagioti, 2018). Self -Efficacy Psychologist Albert Bandura (1986) described self-efficacy as one's personal belief in their ability to execute a particular task successfully. Educational interventions for healthcare providers about breaking bad news to patients have been shown to improve healthcare provider self-efficacy and confidence (Chung et al., 2016; Gorniewicz et al., 2017, Johnson & Panagioti, 2018). Self-efficacy requires the knowledge or skills to successfully achieve a goal and the selfconfidence to achieve the goal under varying circumstances (Bandura, 1997). Axboe et al. (2016) developed a tool using self-efficacy to determine the impact of a training module aimed at teaching communication skills to healthcare providers. The SE-12 tool was found to be reliable and valid in measuring self-efficacy before and after the training module (Axboe et al., 2016). Quality Improvement This DNP Practice Innovation Project is a quality improvement project. The goal is to improve the education that healthcare providers receive regarding breaking bad news to patients, which will improve the experience for the healthcare provider. Evidence shows formal training IMPACT OF FORMAL EDUCATION 18 to enhance the process of breaking bad news to patients leads to increased confidence in the healthcare provider and an overall more satisfying and less uncomfortable experience for the healthcare provider, the patient, and the patient's family members (Moura Villela et al., 2020). Strong communication is paramount to breaking bad news, and strategies in the communication of bad news are helpful to the healthcare provider (Kebede et al., 2020) SPIKES Protocol The phenomenon being researched is breaking bad news to patients in a clinical setting. The SPIKES protocol (Baile et al., 2000) is often utilized in the framework to break bad news to patients. The majority of the literature regarding breaking bad news mentions the SPIKES protocol (Baile et al., 2000). Table two summarizes the central concepts of the SPIKES protocol. Table 2 Definition and Implementation of SPIKES protocol Steps Definition Implementation Setting The physical space in which the bad Ensure a private space, engage the news is exchanged from provider to other people that the patient brought patient (Baile et al., 2000). along, minimize interruptions, connect with the patient by maintaining eye contact, and be seated (Baile et al., 2000). Perception Assess the patient's knowledge and Assess the patient's perception by thoughts of their medical situation and asking open-ended questions about possible results (Baile et al., 2000). IMPACT OF FORMAL EDUCATION 19 their understanding of the situation (Baile et al., 2000). Invitation Obtain the patient's consent to give Asking permission to go over the the results and information, and do not results with the patient is a way to assume they would like to know all obtain consent. If the patient does not the details (Baile et al., 2000). want to know the results, the conversation can begin by asking them if they have any questions about the information or the results (Baile et al., 2000). Knowledge An initial preamble that warns the This can be unaccomplished by saying, patient that bad news is coming can "unfortunately, this isn't the news we help decrease the shock when the were hoping for" (Baile et al., 2000). news is disclosed (Baile et al., 2000). Using words that are easier to While giving the information, speak understand but still convey the same with words and phrases that are meaning is essential, such as using the understandable to the patient, word "spread" instead of avoiding technical terms, bluntness, "metastasized" (Baile et al., 2000). and medical jargon (Baile et al., 2000). Give the information in small, understandable pieces, checking for understanding throughout the conversation (Baile et al., 2000). IMPACT OF FORMAL EDUCATION Emotion 20 Empathetic responses to address the Observing the emotion, identifying the patient's emotions are paramount to emotion, identifying the reason for the breaking bad news (Baile et al., 2000). emotion, and connecting the emotion with the reason for the emotion, are essential steps in giving an empathetic response to the patient (Baile et al., 2000). Summary Discussion of main points of the Begin by asking if the patient would conversation, with the ultimate goal of like to discuss the next steps so that a constructing a plan of care so that the treatment plan can begin (Baile et al., patient will have a more precise way 2000). Discuss the next steps, including to progress with their new information planning and decision making, (Baile et al., 2000) checking along the way to ensure that the patient understands all of the information that has been presented (Bail et al., 2000). Concept Map This concept map depicts how educating healthcare providers about communication strategies regarding breaking bad news using evidence-based practice leads to an improved experience for the healthcare provider (Gorniewicz et al., 2017). Educational interventions for healthcare providers about breaking bad news to patients have been shown to improve selfefficacy and confidence in the healthcare provider (Chung et al., 2016; Gorniewicz et al., 2017; IMPACT OF FORMAL EDUCATION 21 Johnson & Panagioti, 2018). An essential part of this education is teaching healthcare providers effective communication strategies when breaking bad news to patients (Kebede et al., 2020). Education given to healthcare providers in communication strategies about breaking bad news has been shown to increase selfefficacy in the healthcare provider, resulting in an improved experience for the healthcare provider when breaking bad news to the patient (Axboe et al., 2016; Gorniewicz et al., 2017). Figure 1 The phenomenon of healthcare providers breaking bad to news to patients in a clinical setting. Healthcare provider selfefficacy in breaking bad news to patients is key in the ability to perform this skill effectively. Education given to healthcare providers about the best way to break bad news to patient, based on evidence. Improved experience for healthcare providers in breaking bad news to patients. Learning communication strategies is key for healthcare providers to effectively break bad news to patients. IMPACT OF FORMAL EDUCATION 22 Critical Appraisal of Literature Strengths A major strength in the literature is the various ways the concept of breaking bad news was analyzed. For example, McElroy et al. (2019) examined giving bad news over the phone and what that means for both the patient and the healthcare provider. Rouge-Bugat et al. (2016) discussed the partnership between primary care physicians and oncologists in delivering bad news. Many articles went into depth in analyzing the need for healthcare providers to have formal education and training regarding the concept of breaking bad news. Yip et al. (2018), Setubal et al. (2017), Moura Villela et al. (2020), and Zwingman et al. (2017) discuss the importance of formal education in breaking bad news. Several high-level research articles were used, including randomized controlled trials (Gorniewicz et al., 2017; Kron et al., 2017), systematic reviews (Elf et al., 2017; Licqurish et al., 2019), and meta-analyses (Chung et al., 2016; Johnson & Panagioti, 2018) were included in the research regarding the phenomenon of breaking bad news. Another strength of the literature is that all of the literature used the same definition of "bad news," taken from a sentinel study by Buckman (1984). The SPIKES protocol (Baile et al., 2000) was also used uniformly throughout the articles. Weaknesses A weakness noted in the literature is the primary focus on physicians and medical students regarding breaking bad news, and there is no significant focus on APRNs. Examples of such articles that only discuss physicians and medical students include Johnson & Panagioti (2018), Aminiahidashti et al. (2016), Zielinska et al. (2017), Monden et al. (2016), Mostafavian & Shaye (2018), and Gorniewicz et al., (2017). IMPACT OF FORMAL EDUCATION 23 Most current research uses the SPIKES protocol (Baile et al., 2000) to identify and describe evidence-based guidelines for breaking bad news. Although the SPIKES protocol (Baile et al., 2000) is widely used and accepted, it is 21 years old. This is a weakness because evidence-based practice in healthcare is constantly changing, evolving, and integrating new research into the SPIKES protocol (Baile et al., 2000) may be beneficial. Buckman (1984) defined bad news in his sentinel article, which is widely used in the literature regarding breaking bad news. However, it is 37 years old and is an opinion piece, making it a low level of evidence. Gaps Only one article specifically discussed educating APRNs about breaking bad news, and it was a low level of evidence, as it was an exploratory, descriptive design (Corey & Gwyn, 2016). No articles about educating APRN students about breaking bad news to patients were found. Additionally, most articles about breaking bad news to patients focus on the patient experience (Baun et al., 2020; Brazeal et al., 2017; Ghoshal et al., 2019; Gonalves et al., 2017). Fennimore et al. (2018) recommended that oncology palliative care should be integrated into the standard DNP curriculum to meet the needs of the growing number of patients in this situation. It is possible for breaking bad news to be integrated into a curriculum regarding palliative care and oncology, as they are often linked. Description of the Intervention The purpose of this DNP Practice Innovation Project was to improve the healthcare provider's self-efficacy in breaking bad news to a patient through an educational module, ultimately improving the experience of the healthcare provider. This project contributes to the general nursing knowledge because educational interventions for healthcare providers about breaking bad news to patients have been shown to improve self-efficacy in the healthcare IMPACT OF FORMAL EDUCATION 24 provider (Chung et al., 2016; Gorniewicz et al., 2017; Johnson & Panagioti, 2018). This DNP Practice Innovation Project focused on the healthcare provider's perspective and how education about breaking bad news can improve the healthcare provider's experience. The intervention implemented in this DNP Practice Innovation Project was the presentation of an educational module to the Saint Mary's College graduate APRN students enrolled in the Department of Nursing Science. The educational module discussed breaking bad news in a clinical setting using the SPIKES protocol (Baile et al., 2000). Educational modules about breaking bad news effectively teach students how to break bad news to patients (Brighton et al., 2018; Rat et al., 2018; Reed & Sharma, 2016; Papadakos et al., 2016). The pretest/posttest method to measure self-efficacy in quality improvement projects is an effective method of measuring self-efficacy (Axboe et al., 2016; Papadakos et al., 2020; Rat et al., 2018; Reed & Sharma, 2016). The SE-12 self-efficacy tool (Axboe et al., 2016) utilized a pretest/posttest method that measured the participants' self-efficacy before and after the presentation of the educational module. The Calgary-Cambridge guide was used as a framework to structure the self-efficacy questionnaire (Axboe et al., 2016). Theoretical and Implementation Models Florence Nightingale's Environmental Theory The key concepts of Florence Nightingale's Environmental Theory are clearly defined in her publication, Notes on Nursing (Nightingale, 1969), as ventilation, warmth, diet, cleanliness, light, and noise. These concepts remain relevant in nursing practice today. Elf et al. (2017) identified instruments to assess the physical healthcare environment, as the physical healthcare environment is critical in measuring healthcare quality. Similarly, the fundamental concepts of Nightingale's Environmental Theory were applied to another study conducted by Anaker et al. IMPACT OF FORMAL EDUCATION 25 (2018) in identifying the physical environment on stroke units. Stroke can be a major cause of death and disability. Therefore, stroke units must promote wellness so that the patients can reach their maximum potential (Anaker et al., 2018). Although simplistic, the fundamental concepts of Nightingale's Environmental Theory can be applied in various, diverse, present-day healthcare settings to promote a favorable experience for the healthcare provider when breaking bad news to patients. The SPIKES protocol (Baile et al., 2000) incorporates the framework of Nightingale's Environmental Theory. The first step in the SPIKES protocol is "setting up the interview" (Baile et al., 2000, p. 305). Nightingale's Environmental Theory applies to this critical step in breaking bad news to patients. As Baile et al. (2000) described the first step in the SPIKES protocol, he stated that the setting in which the exchange of information occurs is essential. A private, quiet room where no interruptions will happen is the ideal setting for breaking bad news to patients. This relates to Nightingale's (1969) concepts of ventilation, cleanliness, light, and noise. A quiet, clean, well-lit, well-ventilated room allows the patient and family members to focus on exchanging complex, life-altering information while being as comfortable as possible in the given circumstances. An example of this is found in a study by Pouyesh et al. (2018). This study concluded that calming environmental factors had a calming effect and decreased anxiety in patients in a waiting room before coronary angiography (Pouyesh et al., 2018). Similarly, Ergin & Yucel (2019) found that influencing the environment of a nursing home by playing soothing music led to a decrease in anxiety in the residents of the nursing home. This is another example of applying the environmental theory in present-day healthcare to achieve favorable results. Alfred Bandura's Social Cognitive Theory IMPACT OF FORMAL EDUCATION 26 Axboe et al. (2016) discussed the work of Albert Bandura (1997) in constructing the selfefficacy tool developed to measure 12 points of self-efficacy related to the self-evaluation of clinical communication strategies. Bandura's Social Cognitive Theory (Bandura, 1986) hypothesized that people have the ability to influence their environment, as well as be influenced by their environment. Additionally, the behaviors that people observe in their environment can be learned and reproduced, furthering the notion that a person has the ability to impact their environment, just as the environment can impact the person (Bandura, 1986). Self-efficacy is a major component of Bandura's Social Cognitive Theory because a person's belief in self-efficacy affects the ability to mirror an observed behavior (Bandura, 1986). Bandura described self-efficacy as one's personal belief in their ability to execute a particular task successfully. Goncalves et al. (2017) found that most physicians surveyed felt the need for more training and were unprepared to break bad news to patients. Students who have undergone training in breaking bad news appreciated feedback from simulated patients and clinicians in their technique and ultimately found it helpful (Brouwers et al., 2018). Educational interventions for healthcare providers about breaking bad news to patients have improved self-efficacy and confidence in the healthcare provider (Chung et al., 2016; Gorniewicz et al., 2017, Johnson & Panagioti, 2018). Bandura's social cognitive theory is essential to this DNP Practice Innovation Project because improved healthcare provider self-efficacy has been shown to enhance the experience of breaking bad news to a patient (Axboe et al., 2016). Implementation Quality Improvement The quality improvement (QI) model was the best fit for this DNP Practice Innovation Project because it intended to improve the experience of breaking bad news to patients. A IMPACT OF FORMAL EDUCATION 27 specific aspect of this DNP Practice Innovation Project that supported the use of the QI design is healthcare provider education in breaking bad news. This allowed for an improved encounter between patient and provider. Ultimately, in improving the experience of breaking bad news, the healthcare provider is equipped to deliver the bad news in a patient-centric way and provide an overall better experience for the healthcare provider (Gorniewicz et al., 2017). Project Implementation This DNP Practice Innovation Project was implemented using a virtual pretest/posttest design constructed in SurveyMonkey. The pretest/posttest consisted of the SE-12 self-efficacy tool (Axboe et al., 2016). The educational module, which was the intervention, was presented virtually using the Blackboard format to the DNP graduate students at Saint Marys College. The presentation was given during the Spring 2022 Saint Marys College DNP immersion program on March 18, 2022. Innovation and Social Entrepreneurship Project funding, acceptance, and applicability to improving current processes rely on a project's innovative potential, as innovation is a crucial part of research (Villarruel, 2018). This DNP Practice Innovation Project is innovative because it focused on the APRN healthcare provider. In contrast, most of the literature utilizing the SPIKES protocol (Baile et al., 2000) focuses on the patient. The literature regarding breaking bad news to patients has shown how the experience of breaking bad news can negatively affect healthcare workers (Fallowfield, 1993; Gorniewicz et al., 2017; Ramirez et al., 1995; Sykes, 1989;). Utilizing an educational module to improve the experience of breaking bad news for healthcare workers can promote enhanced interaction (Chung et al., 2016; Gorniewicz et al., 2017; Johnson &Panagioti, 2018). IMPACT OF FORMAL EDUCATION 28 Social entrepreneurship is defined as a movement in which social change is inspired through sustainable and innovative ideas (Ngatse-Ipangui & Dassah, 2019). Traditionally, the goal of social entrepreneurship is to promote change, whereas the purpose of traditional entrepreneurship is to earn a monetary profit (Ngatse-Ipangui & Dassah, 2019). This DNP Practice Innovation Project fits within the social entrepreneurship framework because it is intended to support healthcare providers by educating them on a tool that can be used to break bad news to a patient. Sustainability Villarruel (2018) defined sustainability as the capacity to support an idea's key elements and infrastructure after its implementation. Interventions that are brief, targeted, and sensitive to the target population's culture have been suggested to show improved sustainability (Tan et al., 2018). This DNP Practice Innovation Project aligns with the definition of sustainability because the intervention of an educational module regarding breaking bad news to patients is relevant to the graduate nursing student population. The intervention also introduced the SPIKES protocol (Baile et al., 2000), an understandable and applicable model for patient encounters. This DNP Practice Innovation Project addresses the lack of current protocol in breaking bad news to patients in a clinical setting related to the APRN healthcare provider experience. Many articles about breaking bad news to patients focus on the patient experience (Baun et al., 2020; Brazeal et al., 2017; Ghoshal et al., 2019; Gonalves et al., 2017). This DNP Practice Innovation Project focused on the APRN provider experience when delivering the bad news to the patient. The DNP plays an integral part in collaborative care for the patient, which often includes breaking bad news regarding test results or other studies that have revealed an unfavorable outcome (Corey & Gwyn, 2016). IMPACT OF FORMAL EDUCATION 29 Fennimore et al. (2018) recommended that oncology palliative care be integrated into the standard DNP curriculum to meet the needs of the growing number of patients in this situation. This is an example of an educational module used with students to teach patients the best approach to breaking bad news. The problem addressed by this DNP Practice Innovation Project is significant because it directly affects the care that the DNP-prepared APRN is providing to the patient. The method in which bad news is delivered to the patient is paramount to the encounter in its entirety. The existing research on this subject must be analyzed and translated into practice for necessary improvements in advancing opportunities and strategies related to breaking bad news. Although the audience of APRN students participating in the educational module for this DNP Practice Innovation Project may not specialize in oncology, they will likely be responsible for breaking bad news to a patient at some point in their career. Therefore, the information about breaking bad news will be valuable for their practice as an APRN. Ethical Considerations Participation Risks Risks to the participants of this project were minimal. There were no physical risks, as this project was designed to be viewed as a PowerPoint presentation, with a pre-test/post-test survey to be completed. The psychological risks were minimal. The content of this project concerned breaking bad news to patients, and the assessment questions included in the SE-12 tool asked about the participant's ability to communicate difficult information (Axboe et al., 2016). While answering the questions on the assessment tool and viewing the educational module, participants may be reminded of times when they had to break bad news to another person or when they received bad news in the past. Reflecting on these experiences may elicit unpleasant memories and feelings. To minimize this risk, the participant will be informed that IMPACT OF FORMAL EDUCATION 30 they can leave the presentation at any time. There are no legal risks, as the demographic information was kept confidential, and no personal information is collected. Participation Benefits and Nursing Knowledge The participants in this DNP Practice Innovation Project were not paid. They were asked to participate because the information offered in the presentation served as an educational opportunity to learn how to break bad news to patients appropriately. When the Saint Mary's College graduate students become APRNs, they will likely have to break bad news to a patient at some point in their career. This can be an intimidating responsibility. The educational module presented in this DNP Practice Innovation Project gave the graduate students tools to break bad news to a patient. Gaining the knowledge of evidence-based practice techniques in breaking bad news to patients allows for the expansion of nursing knowledge and provides for implementation of evidence-based practices. Informed Consent The SurveyMonkey platform was used for the informed consent presentation and completion and data collection for this DNP Practice Innovation Project. The option to include informed consent before opening the assessment tool in SurveyMonkey was utilized. This was how and when informed consent was obtained. To maintain anonymity and confidentiality, the anonymity feature in SurveyMonkey was activated for the participants ("Making Responses Anonymous," n.d.). Thorough communication of the risks and benefits of this study were discussed with the participants to ensure a proper consent process. This was done through the informed consent letter at the beginning of the presentation (see Appendix A) (Lika et al., 2017). Dr. Sue Anderson and the DNP student researcher have access to the data and reports of data. The DNP student IMPACT OF FORMAL EDUCATION 31 researcher has been certified through the CITI training program (See Appendix A). Data were stored on the SurveyMonkey server and the student's password-protected personal computer. The participants were not identifiable because the anonymity feature was activated on SurveyMonkey ("Making Responses Anonymous," n.d.). Stanley et al. (2017) conducted a study in which a similar format was used regarding a questionnaire and data collection, and the SurveyMonkey platform was successful in data collection. Discussion of Methods Key Stakeholders Barbara Schmidtman, Ph.D., MAOL, CNMT, Director of Oncology Services at Spectrum Health Lakeland (SHL), is a key stakeholder in the DNP Practice Innovation Project. She believes this project is a good fit with SHL because it will provide necessary education in cancer diagnosis delivery and breaking bad news. Together, we discussed the idea of presenting an education module to the physicians in the residency program at SHL and any other APRNs, APPs, and physicians who desire to attend. If necessary, I would bring this project proposal and presentation to the IRB at SHL to be approved. Dr. Schmidtman stated that this project would have many benefits to SHL, such as a better understanding of who exactly is responsible for giving bad news to patients within the organization, a better overall experience for both the patient and the provider, and higher retention of patients in the organization because of the better patient experience. When discussing barriers to this project, Dr. Schmidtman did not foresee any barriers or financial concerns. She thought the educational module presented in my DNP Practice Innovation Project could be used within the residency program to educate the residents on the SPIKES protocol. IMPACT OF FORMAL EDUCATION 32 Jamie Birris, PsyD, is the clinical psychologist for Lakeland Cancer Specialists. She is a key stakeholder in this DNP Practice Innovation Project because she often has difficult conversations with patients and is consulted when a healthcare provider has to break bad news to a patient. She agrees that implementing this program at SHL would be beneficial to the healthcare providers. Dr. Birris stated that this is an interesting and important topic and will ultimately lead to improved experiences for the healthcare provider and the patient. Successfully engaging in difficult conversations is part of Dr. Birris's training as a clinical psychologist. Participant Sample Information For this DNP Practice Innovation Project, the population sample consisted of graduate students enrolled in the Department of Nursing Science at Saint Mary's College. This population is currently learning evidence-based practice techniques to implement in practice as an APRN. The APRN is often responsible for breaking bad news to patients; therefore, this educational module will be helpful and relevant. Inclusion criteria includes an age range between 18 years old to 65 years old. This study was intended only for adults, so the lower limit of 18 years old was chosen. Axboe et al. (2016) did not include participants over the age of 65 in the study. Therefore, the upper limit of 65 was chosen for this project. A power analysis indicated that 34 participants were needed for this project. This number was used as the minimum number of participants. Other inclusion criteria included access to a smartphone or computer and experience with direct patient care. Exclusion criteria included an age under 18 years old or over 65 years old, no experience with direct patient care, no access to a smartphone or computer, and no evidence of enrollment in the graduate program of the Department of Nursing Science at Saint Mary's College. IMPACT OF FORMAL EDUCATION 33 This population was chosen because, in similar projects, students in professional healthcare programs and residencies were most often studied (Cvengros et al., 2016; Gorniewicz et al., 2017; Reed & Sharma, 2016; Setubal et al., 2017). In another similar study, only healthcare providers with direct patient care were included (Dafallah et al., 2020). Completing this training before independent practice will be beneficial in implementing this knowledge throughout their entire career. Implementation Plan This DNP Practice Innovation Project was presented virtually using the Blackboard platform during the Spring 2022 Immersion Program at Saint Marys College on March 18th, 2022. A brief description of the purpose of this DNP Practice Innovation Project was given. After this, the presenter's screen was shared to view the educational module on Blackboard. A link to the informed consent and pretest was shared in the chat feature on Blackboard, and the participants were instructed to click on it. This link took the participants to the SurveyMonkey platform and automatically generated the informed consent (Appendix B) and the pretest. The narrated educational module PowerPoint presentation (Appendix H) was then presented virtually in real-time. After the presentation was complete, another link was shared in the Blackboard chat feature for the participants to click on, and a posttest was generated for the participants to complete. After completing the posttest, the participants were free to leave the presentation. The data in SurveyMonkey was accessed after the data collection, and a paired samples t-test was utilized to analyze the data. Participant Duties The participants in this project were asked to click a SurveyMonkey link in the Blackboard chat feature that automatically populated the informed consent through the IMPACT OF FORMAL EDUCATION 34 SurveyMonkey platform. The participants were required to complete the consent form before moving forward with the next step. The participants were then asked to complete a pretest using the SE-12 self-efficacy tool. After filling out the pretest, each participant watched an educational presentation about breaking bad news to a patient and the communication skills needed to improve these difficult conversations. After the educational presentation, the participant was asked to click another link in the Blackboard chat feature and fill out the post-test form to assess if they felt more confident in breaking bad news to patients than how they felt before watching the educational presentation. The posttest was also the SE-12 self-efficacy tool. The participant was also asked to provide a unique identifier in the SurveyMonkey platform so that their pretest and posttest could be matched up. The unique identifier suggestion was the participants birth month and the last four digits of their phone number. Reliability and Validity of Instrument There were no qualitative data collected from the participants for this DNP Practice Innovation Project. All data were quantitative in nature. The questions found in the SE-12 tool (Appendix C) asked the participants to rate the answers on a scale from 1 to 10, with 1 being "very uncertain" and 10 being "very certain". (Axboe et al., 2016). These responses were analyzed through a paired samples t-test. The instrument used in this DNP Practice Innovation Project was the SE-12, a selfefficacy questionnaire used to evaluate the communication skills of healthcare providers. A testretest procedure was used to assess the reliability of the SE-12 tool (Axboe et al., 2016). Four departments were included, with two departments not having had a communication course and two having a communication course (Axboe et al., 2016). Completed questionnaires were received from 292 of the 787 staff members surveyed, a 37% response rate (Axboe et al., 2016). IMPACT OF FORMAL EDUCATION 35 Out of the 787 staff members surveyed, 195 (25%) completed both questionnaires and rated their skills in communication as stable (Axboe et al., 2016). The questionnaire was completed on two separate occasions using an intra-class correlation coefficient (Axboe et al., 2016). The test-retest reliability was acceptable for the entire SE-12 tool, with 0.71 (0.66-0.76) being the ICC agreement (Axboe et al., 2016). When comparing the two departments with clinicians previously educated in the communication course (n=98), a higher reliability was found with an ICC agreement of 0.77 (range 0.67-0.84). Reliability was shown to be fair to good in the two departments, with staff not having previously attended the course on communication (n=97), with 0.64 (range, 0.49-0.79) being the ICC agreement (Axboe et al., 2016). Evaluation of the 12 self-efficacy questions showed a high internal consistency, with a Cronbach's of 0.95 (range, 0.94-0.95) (Axboe et al., 2016). This is indicative of high correlations between the elements in the scale. Loevinger's H was high in the Mokken Analysis, showing a total scale coefficient of 0.71 (range, 0.63-0.75). This indicates rank-ordered, nonoverlapping items, making the data additive (Axboe et al., 2016). The SE-12 tool was found to be partially valid, as only two out of the three hypotheses of the study were confirmed due to a ceiling effect (Axboe et al., 2016). The first hypothesis revealed higher scores in all the questions regarding self-efficacy in group 1, which was the group with the two departments with the staff having previously participated in the course. The mean sum score in group 1 (n = 152) was 101.27 (SD = 15.84), while the mean sum score in group 2 (n = 140) was 96.99 (SD = 13.5) (Axboe et al., 2016). The t-test was found to be t = 2.47 (P = 0.01), which confirmed the first hypothesis that the department with previous participation in a communication course would have high scores on questions regarding self-efficacy (Axboe et al., 2016). The second hypothesis found a higher IMPACT OF FORMAL EDUCATION 36 self-efficacy sum score in the participants with the most experience within their field compared to less experienced participants (Axboe et al., 2016). An equality-of-populations Kruskal-Wallis rank test was completed (chi-square = 12.94 with 5 degrees of freedom; P = 0.024), confirming the notion that self-efficacy is highly correlated to field experience (Axboe et al., 2016). In the third hypothesis, the difference in self-efficacy sum scores among professions found that the higher mean sum score (mean=100.20, SD 15.08) belonged to nurses, while physicians had a lower mean sum score (mean=98.80, SD=12.33); however, the difference was not statistically significant (t=0.72, P=0.47) (Axboe et al., 2016). Adjustments were made for the length of service, which showed higher physician self-efficacy sum scores, but still not statistically significant (Axboe et al., 2016). When comparing nurses and nursing assistants, nurses had higher self-efficacy sum scores (mean = 100.20, SD = 15.08 compared to mean = 93.42, SD = 20.42, respectively); however, the difference was not statistically significant (t = 1.81, P = 0.07). These findings neither supported nor rejected the hypothesis of physicians having the highest self-efficacy scores, with nurses coming in second (Axboe et al., 2016). A ceiling effect was observed in 9 of the 12 self-efficacy questions, which went over the set limit of >15% (Axboe et al., 2016). Regarding the floor effect, >15% was not exceeded in the self-efficacy questions (Axboe et al., 2016). Despite the ceiling effect, nothing was changed in the self-efficacy questions (Axboe et al., 2016). Power Analysis This DNP Practice Innovation Project required a paired samples t-test, in which the mean scores for the same group of people at two different times was compared (Manfei et al., 2017). The G*Power software was used (Faul et al., 2009). Two tails, effect size of 0.5, error probability of 0.05, and Power (1- err prob) 0.8 was used. This calculation revealed that a total IMPACT OF FORMAL EDUCATION 37 sample size of 34 participants for this DNP Practice Innovation Project was needed to capture the effect of this project at the 0.05 significance level. Budget SurveyMonkey is $70/month, which was necessary to disseminate the informed consent, the pre-test, and the post-test to the participants. PowerPoint is provided to Saint Mary's College students and did not need to be purchased. The pre-post test was conducted in a virtual platform. The PowerPoint presentation was presented in a virtual platform through the learning management system Blackboard, which is provided to each student and faculty member with enrollment at Saint Marys College. The pretest/posttest and PowerPoint presentation did not incur any cost. Intellectus Statistics software was purchased for $179. This software was used to analyze the data collected for this DNP Practice Innovation Project. Timeline The DNP Practice Innovation Project proposal was approved by the Saint Marys Institutional Review Board on January 18, 2022. Data collection took place at the Spring 2022 Immersion Program at Saint Marys College on March 18, 2022. Data analysis was completed on May 1, 2022. The academic poster presentation of this DNP Practice Innovation Project was completed on June 25, 2022. The final paper for this DNP Practice Innovation Project was submitted on July 22, 2022. Data Analysis The SE-12 self-efficacy tool pre-test and post-test were completed by 35 participants during the Spring 2022 Immersion Program at Saint Marys College on March 18th, 2022. The pre-test and post-test scores were entered into the Intellectus Statistics software. A twotailed paired samples t-test was conducted to examine whether the mean difference of the pre-test IMPACT OF FORMAL EDUCATION 38 (Pre-Overall) and post-test (Post-Overall) was significantly different from zero. This determined if there was a statistically significant improvement in the scores on the SE-12 self-efficacy tool after the participant viewed the educational module on breaking bad news. Two-Tailed Paired Samples t-Test Assumptions Normality. A Shapiro-Wilk test was conducted to determine whether the differences in Pre-Overall and Post-Overall could have been produced by a normal distribution (Razali & Wah, 2011). The results of the Shapiro-Wilk test were not significant based on an alpha value of .05, W = 0.98, p = .800. This result suggests the possibility that the differences in Pre-Overall and Post-Overall were produced by a normal distribution cannot be ruled out, indicating the normality assumption is met. Homogeneity of Variance. Levene's test was conducted to assess whether the variances of Pre-Overall and Post-Overall were significantly different. The result of Levene's test was not significant based on an alpha value of .05, F(1, 68) = 0.11, p = .741. This result suggests it is possible that Pre-Overall and Post-Overall were produced by distributions with equal variances, indicating the assumption of homogeneity of variance was met. Results The result of the two-tailed paired samples t-test was significant based on an alpha value of .05, t(34) = -12.23, p < .001. This confirms that healthcare providers who receive formal education in breaking bad news to patients have increased self-efficacy in breaking bad news compared with healthcare providers not formally educated in a Doctor of Nursing Practice Program. This finding suggests the difference in the mean of Pre-Overall and the mean of Post- IMPACT OF FORMAL EDUCATION 39 Overall was significantly different from zero. The mean of Pre-Overall was significantly lower than the mean of Post-Overall. The results are presented in Table 1. A bar plot of the means is presented in Figure 2. Table 3 Two-Tailed Paired Samples t-Test for the Difference Between Pre_Overall and Post_Overall Pre_Overall Post_Overall M SD M SD t P 6.29 1.25 8.10 1.06 -12.23 < .001 Note. N = 35. Degrees of Freedom for the t-statistic = 34. d represents Cohen's d. Figure 2 The means of Pre-Overall and Post-Overall with 95.00% CI Error Bars d 2.07 IMPACT OF FORMAL EDUCATION 40 Discussion Implications The data analysis from this DNP Practice Innovation Project indicated that self-efficacy is improved in APRN student healthcare providers who are formally educated about the topic in a DNP Program compared with those who had not been formally educated. Improved selfefficacy regarding breaking bad news has been shown to improve the experience in which bad news is shared for both the healthcare provider and the patient (Baile et al., 2000; Moura Villela et al., 2020). Improvement in self-efficacy regarding breaking bad news decreases the healthcare providers risk of experiencing negative consequences, including stress (Fallowfield, 1993), anxiety (Sykes, 1989), emotional exhaustion, and a lower sense of personal accomplishment (Ramirez et al., 1995). Additionally, the inappropriate delivery of bad news can change the outlook and interpretation that the patient and their family members have about the illness (Mostafavian & Shaye, 2018). Formal training leads to better health outcomes for patients and healthcare providers (Gorniewicz et al., 2017). In terms of healthcare policy, implementing a course or seminar in breaking bad news within the standard accredited APRN curriculum would benefit students. The American Association of Colleges of Nursing (AACN) (2021) delineates an educational framework citing the domain of Person-Centered Care in its professional nursing education competencies. The evidence obtained from this DNP Practice Innovation Project fits within this domain and can be used to support the policy of this curriculum change to demonstrate the importance of formal education regarding breaking bad news. IMPACT OF FORMAL EDUCATION 41 Strengths and Limitations Strengths of this DNP Practice Innovation Project include the use of recent and pertinent high quality, evidence-based studies to support the DNP Practice Innovation Project study and the utilization of highly researched nursing theory. Anonymity was preserved in this DNP study to maintain authentic responses of the participants. The data from this DNP Practice Innovation Project were analyzed using Intellectus Statistics to ensure the accuracy of the data outcomes. Limitations for this project include a homogenous sample, as the participants consisted only of APRN students at Saint Marys College. Additionally, the sample size can be considered small, with 35 participants. This DNP Practice Innovation Project was presented virtually to the APRN students due to the restrictions that the Covid-19 pandemic presented. The statistically significant findings in a virtual platform indicate the impact of virtual learning, which has the potential to reach a larger audience with ease. Although this can be considered a strength of this DNP Practice Innovation Project, there is no way to know if a more considerable impact may have been had if the ability to present the project in person was available and utilized. The results of the paired samples t-test in this DNP Practice Innovation Project showed statistically significant results, which further demonstrates the importance of formal education regarding breaking bad news and its impact on the self-efficacy of healthcare providers. Plans for future study include implementation of formal education regarding breaking bad news with larger groups of learners and application to diverse healthcare settings. Conclusion This DNP Practice Innovation Project explored improvement in the APRN healthcare provider's self-efficacy in breaking bad news to a patient using an educational module to enhance the experience of healthcare providers. This project contributes to the general knowledge IMPACT OF FORMAL EDUCATION 42 because educational interventions for healthcare providers about breaking bad news to patients have been shown to increase self-efficacy and confidence in the healthcare provider (Gorniewicz et al., 2017, Chung et al., 2016 Johnson & Panagioti, 2018). This DNP Practice Innovation Project focused on the perspective of the APRN student healthcare provider and how education about breaking bad news can lead to an improved experience for the healthcare provider, ultimately improving health outcomes. IMPACT OF FORMAL EDUCATION 43 References Alshammary, S., Hamden, A., Tamani, J., Alshuhil, A., Ratnapalpan, S., Alharbi, M. (2017). Breaking bad news among cancer physicians. Journal of Health Specialties, 5(2) DOI 10.4103/jhs.JHS_10_17 American Association of Colleges of Nursing. (2021). 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Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia, 39(10), 552559. https://doi.org/10.1055/s-0037-1604490 Tan, J. Y. S., Lam, K. F. Y., Lim, H. A., Chua, S. M., Kua, E. H., Griva, K., & Mahendran, R. (2018). Post-intervention sustainability of a brief psycho-educational support group intervention for family caregivers of cancer patients. Asia-Pacific Psychiatry: Official Journal of the Pacific Rim College of Psychiatrists, 10(3), 12305. https://doi.org/10.1111/appy.12305 U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2020). Health Communication: Decrease the proportion of adults who report poor communication with their health care provider HC/HIT-02. In Healthy People 2030. https://health.gov/healthypeople/objectives-and-data/browseobjectives/health-communication/decrease-proportion-adults-who-report-poorcommunication-their-health-care-provider-hchit-02 Villarruel, A. M. (2018). Building innovation and sustainability in programs of research: innovation and sustainability. Journal of Nursing Scholarship, 50(1), 510. https://doi.org/10.1111/jnu.12357 Vakada, S., Bachmann, G. A., & Lu, C.W. (2018). Breaking bad news to patients with breast cancerthe benefits of hope and optimism [9l]. Obstetrics & Gynecology, 131(1), 131. https://doi.org/10.1097/01.AOG.0000533548.61068.25 IMPACT OF FORMAL EDUCATION 54 VandeKieft G. K. (2001). Breaking bad news. American Family Physician, 64(12), 19751978. Warnock, C., Buchanan, J., & Tod, A. M. (2017). The difficulties experienced by nurses and healthcare staff involved in the process of breaking bad news. Journal of Advanced Nursing, 73(7), 16321645. https://doi.org/10.1111/jan.13252 Wolfe, A. D., Denniston, S. F., Baker, J., Catrine, K., & Hoover-Regan, M. (2016). Bad news deserves better communication: A customizable curriculum for teaching learners to share life-altering information in pediatrics. MedEdPORTAL : The Journal of Teaching and Learning Resources, 12, 10438. https://doi.org/10.15766/mep_2374-8265.10438 Yip, S. M., Meyers, D. E., Sisler, J., Wycliffe-Jones, K., Kucharski, E., Elser, C., TempleOberle, C., Spadafora, S., Ingledew, P. A., Giuliani, M., Kuruvilla, S., Sumar, N., & Tam, V. C. (2020). Oncology education for family medicine residents: A national needs assessment survey. BMC Medical Education, 20(1), 283. https://doi.org/10.1186/s12909020-02207-0 Zielinska, P., Jarosz, M., Kwiecinska, A., & Betkowska-Korpala, B. (2017). Main communication barriers in the process of delivering bad news to oncological patientsmedical perspective. Folia medica Cracoviensia, 57(3), 101-112. Zylner, I. A., Lomborg, K., Christiansen, P. M., & Kirkegaard, P. (2019). Surgical breast cancer patient pathway: experiences of patients and relatives and their unmet needs. Health Expectations: An International Journal of Public Participation in Health Care and Health Policy, 22(2), 262272. https://doi.org/10.1111/hex.12869 Zwingmann, J., Baile, W. F., Schmier, J. W., Bernhard, J., & Keller, M. (2017). Effects of IMPACT OF FORMAL EDUCATION 55 patient-centered communication on anxiety, negative affect, and trust in the physician in delivering a cancer diagnosis: A randomized, experimental study. Cancer, 123(16), 31673175. https://doi.org/10.1002/cncr.30694 IMPACT OF FORMAL EDUCATION 56 Appendix A CITI Completion Document IMPACT OF FORMAL EDUCATION 57 Appendix B DNP Defense Completion Form IMPACT OF FORMAL EDUCATION 58 Appendix C Literature Synthesis Table Article Design & Melnyk Level Sample Alshammary, S., Hamden, A., Tamani, J., Alshuhil, A., Ratnapalpan, S., Alharbi, M. (2017). Breaking bad news among cancer physicians. Journal of Health Specialties, 5(2) DOI 10.4103/jhs.JHS_10_17 "There have been accounts in the history of medicine, during the earlier era, that Hippocrates recommended hiding any information that would cause despair to patients and may worsen situations. This scenario is in concurrence with the first ethical code in medicine (1847) that states that doctors should not disclose bad news to the patients as this has a greater possibility of shortening their life span. Level III, quality B Physicians (n = 75) who are currently working in a university teaching hospital in the Middle East. The study population comprised of all (oncology, haematology, paediatric, radiation and palliative) physicians working in CCC. Those who were not directly in contact with patients, were excluded from the study Aminiahidashti, H., Mousavi, S. J., & Darzi, M. M. (2016). The purpose of this investigation was to 130 patients were evaluated (61.5% Variables & Measurements 13 variable were assessed about breaking bad news to patient and the physicians comfort level in doing so. 130 patients were evaluated Outcomes Sixtyeight percent responded to the survey. Eightyfour percent were comfortable with breaking bad news, and 70% had training in breaking bad news. Eightysix percent of responders stated that patients should be told about their cancer. Almost 30% of the respondents stated that they would still disclose the diagnosis to patients even if it would be against the preference of the relatives. Nearly 61% said that they would only tell the details to the patients if asked while 67% of them disagreed that patients should be told about the diagnoses only if the relatives consent. About 51% of physicians wanted to discuss the bad news with the family members and patient together, whereas 24% stated that the patient alone should be involved in the discussion. Based on the results of the present study, most participants believed IMPACT OF FORMAL EDUCATION Patients' attitude toward breaking bad news; a brief report. Emergency (Tehran, Iran), 4(1), 3437. Anaker Anna, Koch, L., Sjostrand Christina, Heylighen, A., & Elf, M. (2018). The physical environment and patients' activities and care: a comparative case study at three newly built stroke units. Journal of Advanced Nursing, 74(8), 19191931. explore the patients preferences and attitudes toward being informed about the bad news. This cross-sectional study was done on patients admitted to Imam Khomeini Hospital, Sari, Iran, Patient attitude regarding breaking bad news was evaluated using a reliable and valid questionnaire. The evidence is moderate to strong. Evidence level II, quality B male, mean age = 46.21 12.1 years). 118 (90.76%) participants believed that the patient himself/herself should be informed about the diseases condition. 120 (92.30%) preferred to hear the news from a skillful physician and 105 (80.76%) believed that emergency department is not a proper place for breaking bad news. To explore and compare Patients (N = 55) the impact of the physical who had a environment on patients' confirmed activities and care at diagnosis of three newly built stroke stroke were units. This work is a recruited from comparative descriptive three newly built case study. case studystroke units in Level 3, Quality B Sweden 59 (61.5% male, mean age = 46.21 12.1 years). that the most experienced and skillful physician should inform them completely regarding their medical condition. At the same time they declared that, it is best to hear bad news in a calm and suitable place and time rather than emergency department or hospital corridors during teaching rounds. The units were examined by non-participant observation using two types of data collection: behavioral mapping analysed with Patients' activity levels and interactions appeared to vary with the design of the physical environments of stroke units. Stroke guidelines focused on health status assessments, avoidance of bed-rest and early rehabilitation require a supportive physical environment. IMPACT OF FORMAL EDUCATION 60 https://doi.org/10.1111/jan.1369 0 Axboe, M. K., Christensen, K. S., Kofoed, P. E., &Ammentorp, J. (2016). Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals. BMC medical education, 16(1), 272. https://doi.org/10.1186/s12909016-0798-7 Baile, W. F., Buckman, R., Lenzi, R., Glober, G., Beale, E. A., & Kudelka, A. P. (2000). Spikesa six-step protocol for delivering bad news: application to the patient with cancer. The Oncologist, 5(4), 302311. "The questionnaire was developed on the basis of the theoretical approach applied in the communication course, statements from former course participants, teachers, and experts in the field. The questionnaire was initially validated through face-to-face interviews with 9 staff members following a test-retest including 195 participants." (Axboe et al., 2016) Level III, quality B Sentinel article about SPIKES protocol for delivering bad news to patients in a clinical setting. a protocol for disclosing unfavorable informationbreaking bad newsto cancer " 787 clinicians affiliated with four departments at three different hospitals; 292 responded to the initial questionnaire and 195 responded to both the first and the second questionnaire." ( Axboe et al., 2016). N/A descriptive statistics and field note taking analyzed with deductive content analysis. variables include the participants perceptions of self-efficacy and confidence in breaking bad news. N/A After minor adjustments, the SE-12 questionnaire demonstrated evidence of content validity. An explorative factor analysis indicated onedimensionality with highly correlated items. A Cronbach's of 0.95 and a Loevinger's H coefficient of 0.71 provided evidence of statistical reliability and scalability. The test-retest reliability had a value of 0.71 when evaluated using intraclass correlation. Expected relations with other variables were partially confirmed in two of three hypotheses, but a ceiling effect was present in 9 of 12 items Oncologists, oncology trainees, and medical students who have been taught the protocol have reported increased confidence in their ability to disclose unfavorable medical information to patients. Directions for continuing assessment of the protocol are suggested. IMPACT OF FORMAL EDUCATION https://doi.org/10.1634/theoncol ogist.5-4-302 Bandura, A. (1986). Social Foundations of Thought and Action: A Social Cognitive Theory. Upper Saddle River, NJ: Prentice Hall 61 patients about their illness. Straightforward and practical, the protocol meets the requirements defined by published research on this topic. Level V, quality A. Explanation of Banduras N/A theory: Social Foundations of Thought and Action: A Social Cognitive Theory. N/A N/A Bandura, A. (1990). Perceived self-efficacy in the exercise of personal agency. Journal of Applied Sport Psychology, 2(2), 128163. https://doi.org/10.1080/1041320 9008406426 Explanation of Banduras N/A theory: Social Foundations of Thought and Action: A Social Cognitive Theory. N/A N/A Bandura, A. (1997). Selfefficacy: The exercise of control. W H Freeman/Times Books/ Henry Holt & Co. https://doi.org/10.1136/bmj.288. 6430.1597 Explanation of Banduras N/A theory: Social Foundations of Thought and Action: A Social Cognitive Theory. N/A N/A Baun, C., Vogsen, M., Nielsen, M. K., Hilund-Carlsen, P. F., & Hildebrandt, M. G. (2020). We conducted a prospective mixed methods study in a sequential design at our closed ended demographic questions, questions A total of 46 patients received the questionnaire (median age 66, SD 11.8, range 34-84 years). Of these women, 38 (83%) completed the 53 white women with metastatic breast cancer who were invited to IMPACT OF FORMAL EDUCATION The perspective of patients with metastatic breast cancer on electronic access to scan results: a mixed-methods study. Journal of Medical Internet Research, 22(2), 15723. https://doi.org/10.2196/15723 Blackboard: About us. (2022). https://www.blackboard.com/ab out-us. Brazeal, H. A., Holley, S. O., Appleton, C. M., & Lee, M. V. (2018). Patient preferences for breast biopsy result notification. The Breast Journal, 24(3), 448450. https://doi.org/10.1111/tbj.12940 institution during 2018. Participants were women with metastatic breast cancer who were having scans every 3 months (combined positron emission tomography and computed tomography or computed tomography alone) to monitor treatment effects. Participants first received an online questionnaire about their knowledge and use of online access to scan results. We then conducted semi structured interviews with 4 women who used the online access to view their scan results. Level III, quality B N/A 62 participate in this study were already enrolled in a larger retrospective diagnostic study at the department, analyzing the use of computed tomography (CT) and positron emission tomography with computed tomography (PET/CT) for response monitoring in metastatic breast cancer. regarding knowledge of electronic health system, questions regarding feelings towards use of the electronic health system. survey (median age 69, SD 10.7, range 42-84 years). Most patients (34/38) were aware of the opportunity to access their reports online, but only 40% (15/38) used this access to read their scan results. N/A N/A N/A IMPACT OF FORMAL EDUCATION Brighton, L. J., Selman, L. E., Gough, N., Nadicksbernd, J. J., Bristowe, K., MillingtonSanders, C., & Koffman, J. (2018). 'Difficult Conversations': evaluation of multiprofessional training. BMJ supportive & palliative care, 8(1), 4548. https://doi.org/10.1136/bmjspcar e-2017-001447 "the workshop commences with an interactive seminar, video examples and group work covering the principles of breaking bad news, and introducing the SCARS communication framework. The SCARS acronym presents an aide memoire to help navigate difficult conversations: Setting, Communicate with kindness, Ask, Respond and reflect and Summary and plan"(Brighton et al., 2017). Brouwers, M., van Weel, C., Laan, R., & van WeelBaumgarten, E. (2019). Training undergraduates skills in breaking bad news: how students value educators' feedback. Journal of Aim was to investigate students opinions on the provided feedback by different educators (surgeons, psychologists, and simulated patient 63 Of 886 workshop participants, 655 completed baseline questionnaires and 714 postworkshop questionnaires; 550 were matched pairs. Participants were qualified or trainee general practitioners (34%), community nurses and care coordinators (32%), social care professionals (7%), care home staff (6%), advanced practice/specialist nurses (5%), care workers (5%) and allied health professionals (3% Five hundred twenty students at the Radboud University Medical Center where students Self-assessed confidence, knowledge and skills "Difficult Conversations workshops were associated with improvements in participants selfassessed confidence, knowledge, and skills. Our findings identify workshop characteristics that are acceptable to multidisciplinary trainees. Further testing is warranted to determine effectiveness and accurately identify workshop components leading to change" (Brighton et al., 2017). (1) perceived safety of the atmosphere, (2) perceived positive feedback, (3) Feedback ratings of the SP were the same as for the surgeon and valued higher than for the psychologist. An unsafe atmosphere, or not receiving positive, specific, or useful feedback was mostly related to the IMPACT OF FORMAL EDUCATION cancer education: the official journal of the American Association for Cancer Education, 34(6), 11031106. https://doi.org/10.1007/s13187018-1415-8 Buckman R. (1984). Breaking bad news: why is it still so (SP)) during BBN skills training. We developed a questionnaire investigating provided feedback by the surgeon, psychologist, and SP (yes or no statements), a questionnaire investigating provided feedback by the surgeon, psychologist, and SP (yes or no statements), regarding (1) perceived safety of the atmosphere, (2) perceived positive feedback, (3) perceived specific feedback, and (4) perceived usefulness for improvement during BBN skills training. Five hundred twenty students returned the questionnaire after BBN skills training. Most students rated the feedback as positive, specific, and useful. Also, the atmosphere was considered safe. Level III, quality B sentinel article about breaking bad news to patients. Gives the 64 followed a 3-year pre-clinical curriculum of followed by 3 years with clinical clerkships. The curriculum included a longitudinal, helical communication skills program on BBN. perceived specific feedback, and (4) perceived usefulness for improvement during BBN skills training. Descriptive statistics (SPSS 22.0) and www.openepi.c om were used to calculate percentages and 95% confidence limits for the proportions (Wilson). Questionnaires were analyzed for each statement separately. psychologists feedback. Feedback on BBN skills training by surgeons and SPs is rated equally helpful by students and is regarded specific, useful, and positive. When designing a BBN training, it is worth to consider involving SPs as well as clinicians. N/A N/A The author suggests that, with only minor changes in the curriculum, instruction in communication can be IMPACT OF FORMAL EDUCATION 65 difficult?. British medical journal (Clinical research ed.), 288(6430), 15971599. definition of bad news. expert opinion, Level V, quality A. Sentinel article integrated into orthodox medical education. Bumb, M., Keefe, J., Miller, L., & Overcash, J. (2017). Breaking bad news: An evidence-based review of communication models for oncology nurses. Clinical journal of oncology nursing, 21(5), 573 580. https://doi.org/10.1188/17.CJON .573-580 https://doi.org/10.1136/bmj.288. 6430.1597 The purpose of this N/A article is to provide an overview on breaking bad news and to review the utility of the SPIKES and PEWTER evidencebased communication models for oncology nurses. . Level IV clinical practice guidelines, quality B SPIKES method, PEWTER protocol By using the evidence-based communication strategies depicted in this article, oncology nurses can support the delivery of bad news and maintain communication with their patients and their patients' families in an effective and productive manner. Bagacean, C., Cousin, I., Ubertini, A.-H., El Yacoubi El Idrissi, M., Bordron, A., Mercadie, L., Garcia, L. C., Ianotto, J.-C., De Vries, P., & Berthou, C. (2020). Simulated patient and role play methodologies for communication skills and empathy training of undergraduate medical students. Bmc Medical Education, 20(1). https://doi.org/10.1186/s12909020-02401-0 Three raters evaluated 20 students playing the doctor role, 10 in the SRP group and 10 in the ASP group. The videos were analyzed with the Calgary-Cambridge Referenced Observation Guide (CCG) and, for a more accurate evaluation of non-verbal communication, we also evaluated signs of empathy, communication. Differences in communication between SRP and ASP groups. From the 6 main tasks of the CCG score, we obtained higher scores in the ASP group for the task Gathering information (p = 0.0008). Concerning the 17 descriptors of the CCG, the ASP group obtained significantly better scores for Exploration of the patients problems to discover the biomedical perspective (p = 0.007), Exploration of the patients problems to discover background information and context (p = 0.0004) and for Closing Ten SRP videos and 10 ASP videos were randomly se lected from our data base. .The videos were then analyzed by 3 raters, who carried out data collection independently. Over the 2 sessions, 20 IMPACT OF FORMAL EDUCATION the session Forward planning (p = 0.02). With respect to non-verbal behavior items, nervousness was significantly higher in the ASP group compared to the SRP group (p < 0.0001). Concerning empathy, no differences were found between the SRP and ASP groups. nervousness, and posture. Empathy was rated with the CARE questionnaire. Independent Mann Whitney U tests and Chi square tests were performed for statistical analysis. Level III, quality B Corey, V. R., & Gwyn, P. G. (2016). Experiences of nurse practitioners in communicating bad news to cancer patients. Journal of the Advanced Practitioner in Oncology, 7(5), 485494. students participated in the study, 9 (45%) male and 11 (55%) female (4 male in the SRP group and 5 in the ASP group, 6 female in the SRP group and 5 in the ASP group). How oncology Five Floridapractitioners licensed NPs with communicate with at least 2 years of patients has a strong oncology impact on quality health experience were care. Methodology educated on the consisted of two steps. use of the First, five FloridaSPIKES protocol. licensed NPs with at least Participants were 2 years of oncology female, with an experience were educated average age of on the use of the SPIKES 33.8 years, and protocol and utilized it in had 2 to 10 years clinical practice for 30 of professional days. Second, experience. All semistructured individual worked in private interviews were practice, with conducted to record their three reporting perceptions of using the associated acute SPIKES protocol. Level care duties III, Quality B 66 First, five Florida-licensed NPs with at least 2 years of oncology experience were educated on the use of the SPIKES protocol and utilized it in clinical practice for 30 days. Second, semistructured individual interviews were conducted to record their perceptions of using the Thematic analysis results support the concept that "the experiences of the nurse practitioner when delivering bad news to cancer patients are shaped by their own communication skills." Educating oncology NPs in using the SPIKES protocol when delivering bad news has the potential to positively impact the experiences of both NPs and patients. IMPACT OF FORMAL EDUCATION Coombs, L. A., Hunt, L., & Cataldo, J. (2016). A scoping review of the nurse practitioner workforce in oncology. Cancer Medicine, 5(8), 19081916. https://doi.org/10.1002/cam4.76 9 Chung, H. O., Oczkowski, S. J., Hanvey, L., Mbuagbaw, L., & You, J. J. (2016). Educational interventions to train healthcare professionals in end-of-life communication: a systematic review and meta-analysis. BMC medical education, 16, 131. An electronic literature search of English language articles was conducted. Using the scoping review criteria, the research question was identified How much care in oncology is provided by nurse practitioners (NPs)? Key search terms were kept broad and included: NP AND oncology AND workforce. The literature was searched between 2005 and 2015, using the inclusion and exclusion criteria, 29 studies were identified, further review resulted in 10 relevant studies that met all criteria Level 5 Practicing healthcare professionals and graduates exiting training programs are often illequipped to facilitate important discussions about end-of-life care with patients and their families. We conducted a 67 The literature was searched between 2005 and 2015, using the inclusion and exclusion criteria, 29 studies were identified, further review resulted in 10 relevant studies that met all criteria. We searched MEDLINE, Embase, CINAHL, ERIC and the Cochrane Central Register of Controlled Trials from the date of inception SPIKES protocol. (1) provider and patient satisfaction assessment, (2) NP function, (3) recommendatio ns for enhancing NP roles, (4) identification of practice and physician characteristics that employ NPs, and (5) assessment of NPs in palliative care interventions. N/A NPs are utilized in both inpatient and outpatient settings, across all malignancy types and in a variety of roles. Academic institutions were strongly represented in all relevant studies, a finding that may reflect the Accreditation Council for Graduate Medical Education (ACGME) duty work hour limitations. There was no pattern associated with state scope of practice and NP representation in this scoping review Very low to low quality evidence suggests that end-of-life communication training may improve healthcare professionals self-efficacy, knowledge, and EoL communication scores compared to usual teaching. Further studies comparing two active educational interventions are recommended with IMPACT OF FORMAL EDUCATION https://doi.org/10.1186/s12909016-0653-x systematic review to evaluate the effectiveness of educational interventions aimed at providing healthcare professionals with training in end-of-life communication skills, compared to usual curriculum. Level 1 meta-analysis. Cvengros, J. A., Behel, J. M., Finley, E., Kravitz, R., Grichanik, M., &Dedhia, R. (2016). Breaking Bad News: A Small-Group Learning Module and Simulated Patient Case for Preclerkship Students. MedEdPORTAL: the journal of teaching and learning resources, 12, 10505. https://doi.org/10.15766/mep_23 74-8265.10505 Breaking bad news is a difficult skill that can elicit significant distress among learners. As such, it is important for learners to practice this skill in a controlled environment, which affords time to address any distress that arises and the opportunity to receive supportive feedback on performance. This breaking bad news module was designed for preclerkship students with previous training in 68 to July 2014 for randomized control trials (RCT) and prospective observational studies of educational training interventions to train healthcare professionals in end-of-life communication skills. The small-group session was delivered to groups of 1012 students and facilitated by a faculty member with expertise in communication skills. The smallgroup session included approximately 60 minutes of didactics and discussion, followed by a 30minute faculty a continued focus on contextually relevant high-level outcomes Learners then had 30 minutes to practice with the SPs and received constructive feedback from the SPs and the faculty facilitator. Approximately 1 week following the small-group module, learners participated in an individual In the 20152016 academic year, 217 medical students participated in this module. Learners demonstrated proficiency in the physical exam skills with 90% of learners asking about 5/8 components of the presenting complaint and 85% performing 5/8 physical exam maneuvers correctly. Similarly learners demonstrated expected levels of competence in interpersonal and communication skills. IMPACT OF FORMAL EDUCATION Dafallah, M.A., Ragab, E.A., Salih, M.H., Osman, W.N., Mohammed, R.O., Osman, M., Taha, M.H., (2020). Breaking bad news: Awareness and practice among Sudanese doctors. AIMS Public Health, 7(4), 758-768. https://doi.org/10.3934/piblichea lth.2020058 69 basic communication skills and served as capstone to the preclerkship portion of the communication skills curriculum. Level III, Quality B. demonstration with simulated patients (SPs). A descriptive crosssectional study recruited 192 doctors, at Wad Medani teaching hospital, Sudan. A questionnaire-based on SPIKES protocol was distributed among 10 departments in our hospital. Data were analyzed using SPSS and Microsoft excel. Level III, quality B 192 doctors were enrolled in this study, stratified by random sampling. we estimated the sample size assuming a small effect size (Cohens d = 0.15), with ten different clusters (representing the specialties of participating doctors), and power of 0.8, significance of 5%. The minimum required sample size is (n = 159) doctors. (Cohen J. 1988. Statistical encounter with an SP and were assessed on physical examination skills and communication skills. SPIKES protocol questions Large number of Sudanese doctors will try to adhere to SPIKES protocol. Training is an important factor in the success of breaking bad news. IMPACT OF FORMAL EDUCATION Elf, M., Nordin, S., Wijk, H., & Mckee, K. J. (2017). A systematic review of the psychometric properties of instruments for assessing the quality of the physical environment in healthcare. Journal of Advanced Nursing, 73(12), 27962816. https://doi.org/10.1111/jan.1328 1 To identify instruments measuring the quality of the physical healthcare environment, describe their psychometric properties. Systematic psychometric review. Level III, quality B 70 power analysis for the behavioral sciences (2nd ed.). A systematic literature search in Medline, CINAHL, Psychinfo, Avery index and reference lists of eligible papers (1990-2016). Twenty-three instruments were included. Most of the instruments are intended for healthcare environments related to the care of older people. Many of the instruments were old, lacked strong, contemporary theoretical foundations, varied in the extent to which they had been used in empirical studies and in the degree to which their validity and reliability had been evaluated. Although we found many instruments for measuring the quality of the physical healthcare environment, none met all of our criteria for robustness. Of the instruments, The Multiphasic environmental assessment procedure, The Professional environment assessment protocol and The therapeutic environment screening have been used and tested most frequently. The Perceived hospital quality indicators are user centered and combine aspects of the physical and social environment. The Sheffield care environment assessment matrix has potential as it is comprehensive developed using a theoretical framework that has the needs of older people at the center. IMPACT OF FORMAL EDUCATION 71 Ergin, E., & inar Ycel, . (2019). The Effect of Music on the Comfort and Anxiety of Older Adults Living in a Nursing Home in Turkey. Journal of Religion & Health, 58(4), 1401 1414. https://smcproxy1.saintmarys.ed u:2166/10.1007/s10943-01900811-z impact of environment on the elderly. The study was designed as a randomized controlled experimental study with a pretest/posttest and a control group. Level I, Quality B. The study sample comprised 56 seniors who resided in a nursing home. Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 1149-1160 N/A Fallowfield, L. (1993). Giving sad and bad news. Lancet, 341(8843). Fennimore, L., Wholihan, D., Breakwell, S., Malloy, P., Virani, R., & Ferrell, B. (2018). A Framework for Integrating Oncology Palliative Care in Doctor of Nursing Practice (DNP) Education. Journal of It was determined that music reduced anxiety experienced by the older adults since it improved their comfort. N/A The study data were collected using the Mini-Mental State Examination, Identification Form, General Comfort Questionnaire, and Beck Anxiety Inventory. N/A N/A N/A N/A N/A The primary aims of the educational project were to: 1. prepare DNP program faculty to integrate evidence-based palliative care content into DNP program applicants were selected based on the completeness of their applications and if their professional/teach These topics are considered the variables consistently being addressed in the DNP curriculum: Program evaluation results include participant demographic information and descriptions of the impact of the program on curriculum reported by course participants at 6, 12, and 18 months following the course. N/A IMPACT OF FORMAL EDUCATION professional nursing: official journal of the American Association of Colleges of Nursing, 34(6), 444448. https://doi.org/10.1016/j.profnur s.2018.09.003 curricula; and 2. Prepare DNP graduates and advanced practice nurses in providing evidenced based palliative care in oncology. Prospective applicants for the project were selected following submission of an application that included: 1. participant demographics followed by information on their institution's DNP curriculum, particularly topics related to oncology and palliative care. 2. Participant goals and expectations including at least three goals to be accomplished following the course. Gonalves, J. A., Almeida, C., To explore the opinion Amorim, J., Baltasar, R., Batista, and difficulties of J., Borrero, Y., Fall, J. Portuguese family P., Faria, I., Henriques, M., doctors on dealing with Maia, H., Fernandes, T., communication with Moreira, M., Moreira, S., Neves, patients with life C., Ribeiro, A., Santos, A., threatening diseases. Silva, F., Soares, S., Sousa, C., Level III, quality B Vicente, J., Xavier, R. (2017). Family physicians' opinions on and difficulties with breaking 72 ing experience contained topics in oncology palliative care, hospice, or endof-life content. system change, health policy, leadership development, interdisciplinary communication, principles of business/financ e, and patient/family communication. A questionnaire was sent to about 10% of family doctors of Northern Portugal. The questionnaire included questions about the disclosure of information, if This article focuses mainly on these personal questions. Most questions were answered using a verbal rating scale (always, often, sometimes, Breaking bad news is still a difficult task. Their attitude to this duty is different from what they would wish if they themselves had a lifethreatening disease. One important conclusion is the need of specific training in communication for family physicians that should begin in the training phase of their specialty. IMPACT OF FORMAL EDUCATION bad news. Porto biomedical journal, 2(6), 277281. https://doi.org/10.1016/j.pbj.201 7.04.004 Ghoshal, A., Salins, N., Damani, A., Chowdhury, J., Chitre, A., Muckaden, M. A., Deodhar, J., &Badwe, R. (2019). To tell or not to tell: Exploring the preferences and attitudes of patients and family caregivers on disclosure of a cancer-related diagnosis and prognosis. Journal of global oncology, 5, 112. https://doi.org/10.1200/JGO.19.0 0132 To understand the preferences and attitudes of patients and family caregivers on disclosure of cancer diagnosis and prognosis in an Indian setting. Overall, 250 adult patients with cancer and 250 family caregivers attending the outpatients of a tertiary cancer hospital for the first time were recruited purposively. The mean ages of patients and caregivers were 49.9 years (range, 23-80 years) and 37.9 years (range, 19-67 years), respectively. Separately, they completed prevalidated, close-ended preference questions and were interviewed for open-ended attitude 73 they feel they need training courses and what they would want if they had a lifethreatening disease. A total of 250 adult patients (response rate, 47.17% overall, 73.2% in men, and 26.8% in women) and 250 family caregivers (response rate, 40.65% overall, 84.0% in men, and 16.0% in women) participated. Significant differences were observed in the preference to full disclosure of the name of illness between patients (81.2%) and caregivers (34.0%) and with the expected length of survival rarely, never; ex. do you feel prepared to break bad news to your patients?). The primary objective was measured using a validated, intervieweradministered questionnaire. The preference questionnaire had seven diagnoses- and four prognosisrelated questions and was adapted from previous similar studies.14,15 The secondary objective was explored by asking five open-ended attitude questions (Data Supplement). Patients with cancer preferred full disclosure of their diagnoses and prognoses, whereas the family caregivers preferred nondisclosure of the same to their patients. This novel information obtained through a large study with varied participants from different parts of the country will help formulate communication strategies for cancer care. IMPACT OF FORMAL EDUCATION questions. Level III, Quality B. Gorniewicz, J., Floyd, M., Krishnan, K., Bishop, T. W., Tudiver, F., & Lang, F. (2017). Breaking bad news to patients with cancer: A randomized control trial of a brief communication skills training module incorporating the stories and preferences of actual patients. Patient education and counseling, 100(4), 655666. https://doi.org/10.1016/j.pec.201 6.11.008 between patients (72.8%) and caregivers (8.8%; P < .001). This study tested the 66 participants. A effectiveness of a brief, volunteer group learner-centered, of health breaking bad news professional (BBN) communication students who skills training module were paid $100 using objective participated in evaluation measures. this study. They This randomized control were enrolled in study (N=66) compared the colleges of intervention and control medicine, groups of students (n=28) pharmacy, or and residents' (n=38) nursing and had objective structured completed the clinical examination Communications (OSCE) performance of Skills for Health communication skills Professionals using Common Ground course. A second Assessment and Breaking group of Bad News measures. participants was Level I because it is a comprised of RCT, quality B because family medicine of small sample size. and internal medicine residents who completed the OSCEs as part of their usual academic 74 The measures comprised within the BBN Skills Form were developed by summing the categorical checklist items within each of the scales. Follow-up performance scores of intervention group students improved significantly regarding BBN (colon cancer (CC), p=.007, r=-.47; breast cancer (BC), p=.003, r=-.53), attention to patient responses after BBN (CC, p < .001, r=-.74; BC, p=.001, r=-.65), and addressing feelings (BC, p=.006, r=.48). At CC follow-up assessment, performance scores of intervention group residents improved significantly regarding BBN (p=.004, r=-.43), communication related to emotions (p=.034, r=-.30), determining patient's readiness to proceed after BBN and communication preferences (p=.041, r=-.28), active listening (p=011, r=.37), addressing feelings (p<.001, r=-.65), and global interview performance (p=.001, r=-.51). IMPACT OF FORMAL EDUCATION Guetterman, T. C., Kron, F. W., Campbell, T. C., Scerbo, M. W., Zelenski, A. B., Cleary, J. F., & Fetters, M. D. (2017). Initial construct validity evidence of a virtual human application for competency assessment in breaking bad news to a cancer patient. Advances in medical education and practice, 8, 505 512. https://doi.org/10.2147/AMEP.S 138380 exercises at the beginning of their first year of training. Despite interest in using Second-year and virtual humans (VHs) for third-year internal assessing health care medicine communication, evidence residents at the of validity is limited. We University of evaluated the validity of Wisconsin in the a VH application, Midwestern MPathic-VR, for United States assessing performanceparticipated in a based competence in seminar, WiTalk, breaking bad news on BBN to (BBN) to a VH patient. patients, who We used a two-group were the target quasi-experimental audience. The design, with residents Group A seminar participating in a 3-hour included 15 seminar on BBN. Group residents. Twelve A (n=15) completed the days later, Group VH simulation before B attended the and after the seminar, seminar, which and Group B (n=12) included 12 completed the VH residents. Seven simulation only after the residents (Group BBN seminar to avoid A, n=4; Group B, the possibility that testing n=3) had previous alone affected exposure to a performance. Pre- and BBN training. postseminar differences The primary data for Group A were collection 75 A primary goal of WiTalk was for individuals to learn the SPIKES protocol for BBN.40 SPIKES provides a structured method for BBN, in which the physician attends to setting up the meeting, assesses the patients perception of what is occurring, obtains an invitation to provide information, provides knowledge information to the patients Improved prepost scores demonstrate acquisition of skills in BBN to a VH patient. Pretest sensitization did not appear to influence posttest assessment. These results provide initial construct validity evidence that the VH program is effective for assessing BBN performance-based communication competence. IMPACT OF FORMAL EDUCATION Hoffmann, R. L., Klein, S., Connolly, M., & Rosenzweig, M. Q. (2018). Oncology nurse practitioner web education resource(onc-power): an evaluation of a web-enhanced education resource for nurse practitioners who are new to cancer care. Journal of the Advanced Practitioner in Oncology, 9(1), 2737. 76 analyzed with a paired ttest, and comparisons between Groups A and B were analyzed with an independent t-test. Quasi experimental, level II, quality B occurred in the period January February 2011. Western physicians tend to favor complete disclosure of a cancer diagnosis to the patient, while non-Western physicians tend to limit disclosure and include families in the process; the latter approach is prevalent in clinical oncology practice in India. Few studies, however, have examined patient preferences with respect to disclosure or the role of family members in the process. Participants ranged in age from 18 to 88, with a mean age of 53.5 years. More than half the participants were male (60%), had some college education (68%), were terms of age, gender, or employment status. Since minimal further information was obtained from participants who did not know their diagnosis. about their condition, uses empathic responses to address emotions, and then summarizes the conversation and the strategy.40 The questionnaires were coded and all data were entered into a database for analysis. We report descriptive statistics of patients that participated in the study and identified differences between those who knew and did not know the diagnosis. Patients ranged in age from 18-88 (M=52) and were mostly male (59%). Most patients (72%) wanted disclosure of the diagnosis cancer, a preference significantly associated with higher education and English proficiency. A majority wanted their families to be involved in the process. Patients who had wanted and not wanted disclosure differed with respect to their preferences regarding the particulars of disclosure (timing, approach, individuals involved, role of family members). Almost all patients wanted more information concerning their condition, about immediate medical issues such as treatments or side effects, IMPACT OF FORMAL EDUCATION Hurst, S. A., Baroffio, A., Ummel, M., & Burn, C. L. (2015). Helping medical students to acquire a deeper understanding of truthtelling. Medical education online, 20, 28133. https://doi.org/10.3402/meo.v20. 28133 Truth-telling is an important component of respect for patients selfdetermination, but in the context of breaking bad news, it is also a distressing and difficult task. We investigated the long-term influence of a simulated patient-based teaching intervention, integrating learning objectives in communication skills and ethics into students attitudes and concerns regarding truth-telling. We followed two cohorts of medical students from the preclinical third year to their clinical rotations (fifth year). Open-ended responses were analyzed to explore medical students reported difficulties in breaking bad news. Level III, quality B 77 At the time of the intervention, preclinical third year students (out of 6 study years) were recruited (120 in 2004 and 105 in 2005), and the two cohorts of medical students were followed through their clinical rotations (fifth year). The teaching intervention was a 90-min, SP-based seminar jointly developed by the ethics and clinical communication teams. It included a 15min ethical discussion on truth-telling and a 60-min practice of communication skills in the context of a breaking bad news case. The learning objectives were (1) to provide students with an opportunity to experience the application of ethical concepts to a realistic situation and (2) rather than long-term or non-medical issues. Responses to open-ended questions were transcribed and imported into QSR NUD*IST, version N6 (QSR International, Victoria, Australia), qualitative software to facilitate data analysis and allow quantification of results. Codes for participants concerns regarding delivering bad news, and their comments, were developed through coding of all content by the authors (SAH, CLB, AB, and MU) as a group, with regular discussions to resolve disagreements, refine, and group the content into first-level categories. All authors then used the resulting coding grid to recode the entire content in parallel, with regular meetings to resolve disagreements. Finally, we conducted a matrix analysis to compare the most salient concerns related by students at different stages of their studies. Quotations presented in this article are illustrative of the identified phenomena and are translated from the original version in French. IMPACT OF FORMAL EDUCATION 78 Institutional Review Sample Consent Form. Institutional Review Board, Saint Mary's College, Notre Dame, IN. (n.d.). Institutional Review Board Sample Consent Form | Saint Mary's College, Notre Dame, IN (saintmarys.edu) N/A N/A to integrate doctorpatient communication skills and ethical skills in balancing what to tell and how to tell. N/A Institutional Review Board Levels of Review. Institutional Review Board, Saint Mary's College, Notre Dame, IN. (n.d.). https://www.saintmarys.edu/port al/institutional-reviewboard/levels-review N/A N/A N/A N/A Johnson, J., &Panagioti, M. (2018). Interventions to improve the breaking of bad or difficult news by physicians, medical students, and interns/residents: a systematic review and metaanalysis. Academic medicine: Assess the effectiveness of news delivery interventions to improve observer-rated skills, physician confidence, and patient-reported depression/anxiety. Seventeen studies were included in the systematic review and metaanalysis, including 19 independent before-after studies of interventions to improve the communication of bad or difficult news Interventions are effective for improving news delivery and physician confidence. Further research is needed to test the impact of interventions on patient outcomes and determine optimal components and length. N/A IMPACT OF FORMAL EDUCATION journal of the Association of American Medical Colleges, 93(9), 14001412. https://doi.org/10.1097/ACM.00 00000000002308 Eligible studies included randomized controlled trials (RCTs), non-RCTs, and controlled beforeafter studies of interventions to improve the communication of bad or difficult news by physicians, medical students, and residents/interns. The EPOC risk of bias tool was used to conduct a risk of bias assessment. Level II because not all studies included were RCT, quality B Kebede, B. G., Abraha, A., Cancer is a growing Andersson, R., Munthe, C., concern in Ethiopia. Linderholm, M., Linderholm, B., Though communication & Berbyuk Lindstrm, N. is essential for the (2020). Communicative treatment process, few challenges among physicians, studies have looked at patients, and family caregivers in communication in cancer care: An exploratory Ethiopian cancer care. qualitative study in Due to the large number Ethiopia. PloS one, 15(3), of patients and scarcity of e0230309. resources, it is vital to https://doi.org/10.1371/journal.p understand how to one.0230309 manage consultations in order to effectively help as many patients as possible in this 79 comparisons on 1,322 participants and 9 independent comparisons on 985 participants for the main and secondary (physician confidence) analyses (mean [SD] age = 35 [7] years; 46% male), respectively. by physicians, medical students, and residents/interns . N/A This explorative qualitative study was conducted at the Oncology Department of the Tikur Anbessa (Black Lion) Specialized Teaching Hospital (TASH) in Addis Ababa, Ethiopia. A triangulation of This study has identified a number of serious challenges for successful and ethically acceptable health communication in Ethiopian cancer care. The study contributes to our understanding of the complexity around the role of family, combined with patients dependency on family members for communication, support, and access to care, which creates particular ethical dilemmas for the medical staff. IMPACT OF FORMAL EDUCATION 80 challenging work environment. Kron, F. W., Fetters, M. D., Scerbo, M. W., White, C. B., Lypson, M. L., Padilla, M. A., Gliva-McConvey, G. A., Belfore, L. A., 2nd, West, T., Wallace, A. M., Guetterman, T. C., Schleicher, L. S., Kennedy, R. A., Mangrulkar, R. S., Cleary, J. F., Marsella, S. C., & Becker, D. M. (2017). Using a computer simulation for teaching communication skills: A blinded multisite mixed-methods randomized controlled trial. Patient education and counseling, 100(4), 748759. https://doi.org/10.1016/j.pec.201 6.10.024 To assess advanced communication skills among second-year medical students exposed either to a computer Simulation (MPathicVR) featuring virtual humans, or to a multimedia computerbased learning module, and to understand each groups experiences and learning preferences. A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Level III, Quality B. second-year medical students exposed either to a computer Simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, Lika, N., Brenda, D., Karla, D., Michael, P.-O., & Neenah, E.-L. (2017). Communicating risks and benefits in informed consent for research: a qualitative study. Global Qualitative Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research Risks and benefits to inform the development of a survey about the perspectives of research nurses data collection methods was used. exposure to either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each groups experiences and learning preferences. A qualitative descriptive study design based on semistructured, open-ended MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each. They achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. MPathic-VRs virtual human simulation offers an effective and engaging means of advanced communication training. From the experts perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and IMPACT OF FORMAL EDUCATION 81 Nursing Research, (2017). https://doi.org/10.1177/2333393 617732017 participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. who are responsible for obtaining informed consent for clinical trials Licqurish, S. M., Cook, O. Y., Pattuwage, L. P., Saunders, C., Jefford, M., Koczwara, B., Johnson, C. E., & Emery, J. D. (2019). Tools to facilitate communication during physician-patient consultations in cancer care: an overview of systematic reviews. Ca: A Cancer Journal for Clinicians, 69(6), 497520. Tools have been N/A developed to facilitate communication and support information exchange between people diagnosed with cancer and their physicians. Patient-reported outcome measures, question prompt lists, patient-held records, tape recordings individual indepth interviews was used to complement literature review findings for the development of a future survey. The qualitative descriptive method is an effective method for obtaining informants direct answers in relation to practical issues and for instrument development Eleven systematic reviews of studies evaluating tools to facilitate patientphysician communication were reviewed and summarized benefits communication. Inconsistencies in experts opinions and critique of certain widely used communication practices require further consideration and additional research. Routine use of patient-reported outcome measures and feedback of results to clinicians can improve pain management, physician-patient communication, and symptom detection and control; increase utilization of supportive care; and increase patient involvement in care. Question prompt lists can increase the number of questions asked by patients without increasing IMPACT OF FORMAL EDUCATION https://doi.org/10.3322/caac.215 73 of consultations, decision aids, and survivorship care plans have all been promoted as potential tools, and there is extensive literature exploring their impact on patient outcomes Level III, Quality B. Making Responses Anonymous. (n.d.). https://help.surveymonkey.com/ articles/en_US/kb/How-do-Imake-surveys anonymous. N/A Manfei Xu, Fralick, D., Zheng, J. Z., Bokai Wang, TU, X. M., & Changyong Feng. (2017). The differences and similarities between two-sample t-test and paired t-test. Shanghai Archives of Psychiatry, 29(3),184188. https://doi.org/10.11919/j.issn.10 02-0829.217070 Markowitz, R. I., & Reid, J. R. (2018). Teaching and learning in the millennial age. Pediatric 82 in this overview of systematic reviews. Across the systematic reviews, 87 publications reported on 84 primary studies involving 15,381 participants N/A consultation length and may encourage them to reflect and plan questions before the consultation. In this paper, we discuss N/A the differences and similarities between these two t-tests. Three examples are used to illustrate the calculation procedures of the twosample t-test and paired t-test. Level 4. N/A N/A Medical education has changed and evolved over the years and has been greatly influenced by advances in N/A What we teach is ultimately more important than how we teach. Because teaching, i.e. the passing along of knowledge, experience and wisdom from one generation to the N/A N/A N/A IMPACT OF FORMAL EDUCATION Radiology, 48(10), 13771380. https://doi.org/10.1007/s00247018-4215-8 McElroy, J. A., Proulx, C. M., Johnson, L. S., Heiden-Rootes, K. M., Albright, E. L., Smith, J., & Brown, M. T. (2019). Breaking bad news of a breast cancer diagnosis over the telephone: an emerging trend. Supportive Care in Cancer, 27(3), 943950. https://doi.org/10.1007/s00520018-4383-y technology. While the learners have also changed and the information and skills to be learned and acquired have exponentially increased, the ultimate purpose of medical education has not changed. Our focus is and has always been to improve patient care. Level 7 expert opinion This study evaluated how breast cancer diagnoses were shared with patients. Level III, quality B 83 next, is predicated on our overarching and universal primary goal of helping the patient. Patient care, teaching and research are really not separate at all they are just different facets of the same gemstone; we try to do our best to provide the most effective and compassionate care to all our patients and to the future patients of our trainees and students. And we are truly privileged to be able to call this our profession. Current members phone call with Receiving a telephone call about of the Dr. Susan breast cancer breast cancer diagnosis may be the Love Research diagnosis versus norm rather than the exception in Foundation's in person health care today. Trends in practice, Army of Women diagnosis. as well as current best practices cohort were sent based primarily on expert opinion, one email with a may not provide optimal care for link to a survey women diagnosed with breast assessing how cancer. Patient outcome research to their breast cancer guide future practice, such as the diagnosis was impact of modes of delivery of bad communicated, a news, is urgently needed to description of determine appropriate patienttheir support centered approaches for notification system during of breast cancer diagnoses. treatment, basic demographic information, and breast cancer diagnosis details IMPACT OF FORMAL EDUCATION 84 Melnyk, B.M., & FineoutOverholt, E. (2014). EvidencedBased Practice in Nursing & Healthcare (3rd ed.). Lippincott Williams & Wilkins. N/A N/A N/A N/A Mishelmovich, N., Arber, A., & Odelius, A. (2016). Breaking significant news: the experience of clinical nurse specialists in cancer and palliative care. European Journal of Oncology Nursing, 21, 153159. https://doi.org/10.1016/j.ejon.20 15.09.006 The aim of the research was to explore specialist cancer and palliative care nurses experience of delivering significant news to patients with advanced cancer. Qualitative study, level III, quality B 10 clinical nurse specialists working in one acute NHS trust. Clinical nurse specialists were recruited from the following specialties: lung cancer, breast cancer, gynecological cancer, upper and lower gastrointestinal cancer and palliative care. importance of relationships; perspective taking; ways to break significant news; feeling prepared and putting yourself forward. Monden, K. R., Gentry, L., & Cox, T. R. (2016). Delivering bad news to When physicians lack proper training, breaking bad news can Physician respondents. A questionnaire was used to determine Four themes emerged from the data: importance of relationships; perspective taking; ways to break significant news; feeling prepared and putting yourself forward. The findings revealed that highly experienced clinical nurse specialists (CNSs) felt confident in their skills in delivering significant news and they report using patient centered communication to build a trusting relationship so significant news was easier to share with patients. CNSs were aware of guidelines and protocols for breaking significant and bad news but reported that they used guidelines flexibly and it was their years of clinical experience that enabled them to be effective in disclosing significant news. Some areas of disclosure were found to be challenging in particular news of a terminal prognosis to patients who were of a younger age. Results revealed that 91% of respondents perceived delivering bad news as a IMPACT OF FORMAL EDUCATION patients. Proceedings (Baylor University. Medical Center), 29(1), 1012. Moran, K. J., Burson, R., & Conrad, D. (2020). The doctor of nursing practice project: A framework for success. Burlington, MA: Jones & Bartlett Learning Moura Villela, E. F., Bastos, L. K., de Almeida, W. S., Pereira, A. O., de Paula Rocha, M. S., de Oliveira, F. M., & Bollela, V. R. (2020). Effects on medical students of longitudinal smallgroup learning about breaking bad news. The Permanente journal, 24, 19.157. https://doi.org/10.7812/TPP/19.1 57 85 lead to negative consequences for patients, families, and physicians. A questionnaire was used to determine whether a didactic program on delivering bad news w as needed at our institution. Level III, Quality B. This was an N/A informational textbook and guideline about the doctor of nursing practice project. whether a didactic program on delivering ba d news was needed at our institution. very important skill, but only 40% felt they had the training to effectively deliver such news N/A N/A To examine training in breaking bad news, to improve medical students competence and confidence in dealing with this important aspect of clinical practice. level 3, quality B Students participated in activities (4 h/wk) that included discussion about different perspectives on breaking bad news for health professionals, patients, and families; practice with the SPIKES Results of the preintervention focus group demonstrated that only 30% of the students were aware of the importance of breaking bad news and of the existence of specific protocols to guide physicians in these situations. Findings from the postintervention focus group indicated that 90% of students understood the importance and began to apply protocols in their practice. Participants included 30 thirdyear medical students at a Midwestern Brazilian public medical school in the 2018 academic year (second semester). The intervention consisted of a 6month elective IMPACT OF FORMAL EDUCATION 86 course that was created in 2016. Mostafavian, Z., & Shaye, Z. A. (2018). Evaluation of physicians' skills in breaking bad news to cancer patients. Journal of family medicine and primary care, 7(3), 601605. https://doi.org/10.4103/jfmpc.jf mpc_25_18 Delivering bad news to patients is one of the most difficult tasks of physicians that play a big role in the process of treatment and cooperation of patients. The objective of this study is to evaluate the ability and skills of physicians in delivery bad news to cancer patients. Level II, Quality B. Seventy eligible physicians were entered to our study by convenience sampling method. Sample size was calculated based on Ghaffarinejad et al. study[16] using the estimating ratio formula in which P of 54.5% was the frequency of always and often answers to the protocol9; the ABCDE mnemonic by VandeKieft10; general guidelines; roleplaying strategy and simulations to train how to deal with many bad-news situations; and students personal skills and personal limitations The first part consisted of eight personal questions (age, sex, marital status, specialty, length of time since graduation, disease experience in doctor or his favorite person, the person receiving the news, and the average time to The results of this study show that the ability of physicians in giving bad news is not enough in some aspects. Therefore, holding educational courses during physicians education and after graduation are recommended to increase patients trust and decreasing worries and inconvenience of physicians in difficult situations of delivering bad news. IMPACT OF FORMAL EDUCATION 87 question of keeping phone conversations when presenting bad news, = 0.05 and d = P/4 Ngatse-Ipangui, R., &Dassah, M. O. (2019). Impact of social entrepreneurs on community development in the cape town metropolitan municipality area, South Africa. Journal for Transdisciplinary Research in Southern Africa, 15(1). This article focuses on social entrepreneurs impact on community development and provides an understanding of their impact. Level 4, Quality B. deliver bad news). The second part consisted of 16 questions on bad news in two main areas including the psychological and environmental domains. Each question was based on the SPIKES protocol. This questionnaire has been internationally validated in Iran The sample It was found consisted of 73 that social respondents entrepreneurs representing positively social impact organizations, communities social development in entrepreneurs and several ways: individual improvements township through residents, selected training, by using the educating and facilitating To enhance their impact, social entrepreneurs should involve beneficiaries trapped within socioeconomic problems in the process of community development. IMPACT OF FORMAL EDUCATION 88 margin of error formula. I Nightingale, F. (1969). Notes on nursing: what it is and what it is not. New York: Dover Publications. Nursing framework on Florence Nightingale's environmental theory N/A Ong, L. M. L., de Haes, J. C. J. M., Hoos, A. M., & Lammes, F. B. (1995). Doctor-patient communication: a review of the literature. Social Science & Medicine, 40(7), 903918. https://doi.org/10.1016/02779536(94)00155-M Communication can be seen as the main ingredient in medical care. In reviewing doctor-patient communication, the following topics are addressed: (1) different purposes of medical communication; (2) analysis of doctor-patient communication; (3) specific communicative behaviors; (4) the influence of N/A communities engagement in different activities such as home-based care and developing childrens mentality and creating space for people to develop their needs. N/A Communication during medical encounters can be analyzed by using different interaction analysis systems (IAS). These systems differ with regard to their clinical relevance, observational strategy, N/A Consequences of specific physician behaviors on certain patient outcomes, namely: satisfaction, compliance/adherence to treatment, recall and understanding of information, and health status/psychiatric morbidity are described. Finally, a framework relating background, process and outcome variables is presented. IMPACT OF FORMAL EDUCATION communicative behaviors on patient outcomes; and (5) concluding remarks. Level III, Quality B. Papadakos, C. T., Stringer, T., self-regulated learning, Papadakos, J., Croke, J., motivational beliefs, Embleton, A., Gillan, C., Miller, communication training. K., Weiss, A., Wendtlandt, K., Giuliani, M. (2020). Effectiveness of a multiprofessional, online and simulation-based difficult conversations training program on self-perceived competence of oncology healthcare provider trainees. Journal of Cancer Education: The Official Journal of the American Association for Cancer Education, 2020 Mar 05. https://doi.org/10.1007/s13187020-01729-x 89 reliability/validi ty and channels of communicative behavior. Several communicative behaviors that occur in consultations are discussed. Phase 1 involved 1. a needs communication assessment of skills HCP trainees who 2. speaking in encounter plain language difficult conversa 3. tips for tions in their breaking bad practice. During news phase 2, 4. incident evaluations were disclosure con ducted of a 5. resilience and pilot of a training coping program called Difficult Conversations in Cancer designed based on the results of phase 1 to build competency among multiprofessional, online, and simulation-based communication skills training for HCP trainees can lead to significant changes in motivational beliefs, which are essential to promoting self-regulated learning. A blended approach with theoretical learning completed online ahead of an in person session is feasible for HCP trainees. To provide optimal training, these programs should be evaluated and improved regularly, and evaluation outcomes should include pre- and post-course surveys with a blinded self perceived competency measure to avoid bias in addition to achievement-based outcomes to support findings. IMPACT OF FORMAL EDUCATION Pouyesh, V., Amaniyan, S., Haji Mohammad Hoseini, M., Bashiri, Y., Sieloff, C., Griffiths, P., & Vaismoradi, M. (2018). The effects of environmental factors in waiting rooms on anxiety among patients undergoing coronary angiography: A randomized controlled trial. International journal of nursing practice, 24(6), e12682. https://doi.org/10.1111/ijn.12682 According to Florence Nightingale's hypothesis, the environment can play a central role in the healing of the patient's body and mind. The nurse should, therefore, strive to provide a healing and stressreducing environment for patients about to undergo invasive procedures. This study aimed to 90 multiprofessional teams in difficult conversations. Phase 3 determined the effectiveness of the program on participants motivational be liefs around having difficult conversations by examining self efficacy, task value, and goal orientation before and after com pletion of the program. In this randomized controlled trial, 200 patients undergoing coronary angiography in an urban area of Iran were assigned randomly to the following intervention groups (1) nature sounds; (2) nature sounds and daylight; (3) nature sounds, daylight, and color enhancements; and (4) control. Portable monitors were used to measure Patients who experienced environmental affecting interventions had significantly lower physiological indices of anxiety than the control group (P < 0.001). Some significance was demonstrated between the three interventions groups, with patients in the intervention group that experienced maximum environmental interventions demonstrating the most overall reduction in anxiety indices. Environmental factors were IMPACT OF FORMAL EDUCATION Powell, P. A., & Roberts, J. (2017). Situational determinants of cognitive, affective, and compassionate empathy in naturalistic digital interactions. Computers in Human Behavior, 68, 137148. investigate the effects of environmental factors on anxiety as experienced by patients in waiting rooms prior to coronary angiography. Level 3, Quality B. Empathy is apparent in computer-mediated communication (CMC), yet little is known about the situational predictors of empathic responses when interacting digitally. We used a diary methodology to explore: (1) the degree three types of empathy (cognitive, affective, and compassionate) are experienced in students' everyday (text- and image-based) dyadic digital interactions; (2) which factors are important for (different types of) empathy in CMC; and (3) how empathy reported in everyday CMC affects participants' perceptions of their empathy in CMC 91 the patients' physiological indices upon admission and 30 and 60 minutes thereafter. One hundred Several student volunteers situational (50 variables (e.g., women, Mage = 22 number of .57 years) communication completed a s, recipient) digital were related to interaction diary empathy for three overall, while consecutive days, others (e.g., yielding 1939 subject, mood) observations. contributed to Participants discrete reported contextual significantly more profiles for the cognitive than empathy affective subtypes. empathy, and significantly greater affective than compassionate empathy. shown to have a positive effect on the indices of anxiety experienced by patients waiting for the procedure of coronary angiography; this is therefore an area of study and practice worthy of further development. Empathy reported in the diaries predicted a more favorable ratio of perceived CMC to FtF empathy, particularly for those lower in baseline trait empathy. These findings help elucidate the multidimensional experience of empathy in CMC interactions. IMPACT OF FORMAL EDUCATION and face-to-face (FtF) contexts. Ramirez, A. J., Graham, J., Three hundred and Richards, M. A., Cull, A., ninety-three out of 476 Gregory, W. M., Leaning, M. S., (83%) consultants Snashall,D. C., & Timothy, A. returned their R. (1995). Burnout and questionnaires. The psychiatric disorder among estimated prevalence of cancer clinicians. British Journal psychiatric disorder in of Cancer, 71(6), 12639. cancer clinicians was 28%, and this is similar to the rate among British junior house officers. 92 . The three components of 'burnout'-emotional exhaustion, depersonalisation and low personal accomplishment-were assessed using the Maslach Burnout Inventory. Psychiatric disorder was independently associated with the stress of feeling overloaded (P < 0.0001), dealing with treatment toxicity/errors (P < 0.004) and deriving little satisfaction from professional status/esteem (P = 0.002). 'Burnout' was also related to these factors, and in addition was associated with high stress and low satisfaction from dealing with patients, and with low satisfaction from having adequate Among cancer clinicians, 'burnout' was more prevalent among clinical oncologists than among medical oncologists and palliative care specialists. clinicians who felt insufficiently trained in communication and management skills had significantly higher levels of distress than those who felt sufficiently trained. If 'burnout' and psychiatric disorder among cancer clinicians are to be reduced, increased resources will be required to lessen overload and to improve training in communication and management skills. IMPACT OF FORMAL EDUCATION 93 Rao, A., Ekstrand, M., Heylen, E., Raju, G., & Shet, A. (2016). Breaking bad news: Patient preferences and the role of family members when delivering a cancer diagnosis. Asian Pacific journal of cancer prevention: APJCP, 17(4), 17791784. https://doi.org/10.7314/apjcp.20 16.17.4.1779 Western physicians tend to favor complete disclosure of a cancer diagnosis to the patient, while non-Western physicians tend to limit disclosure and include families in the process; the latter approach is prevalent in clinical oncology practice in India. Few studies, however, have examined patient preferences with respect to disclosure or the role of family members in the process. Participants ranged in age from 18 to 88, with a mean age of 53.5 years. More than half the participants were male (60%), had some college education (68%), were terms of age, gender, or employment status. Rat, A.C., Ricci, L., Guillmin, F., Ricatte, C., Ppngy, M., Vieux, R., Spitz, E., Muller, L. (2018). Development of a webbased formative self-assessment tool for physicians to practice web based formative self assessment tool; SPIKES. BReaking bAD NEws Tool (BRADNET) items were developed by We used a referral sampling strategy in which clinicians from the research team recruited other resources (each at a level of P < or = 0.002). r patients who knew their diagnosis, did not know their diagnosis, and the accompanying family member. N/A Patients ranged in age from 18-88 (M=52) and were mostly male (59%). Most patients (72%) wanted disclosure of the diagnosis cancer, a preference significantly associated with higher education and English proficiency. A majority wanted their families to be involved in the process. Patients who had wanted and not wanted disclosure differed with respect to their preferences regarding the particulars of disclosure (timing, approach, individuals involved, role of family members). Almost all patients wanted more information concerning their condition, about immediate medical issues such as treatments or side effects, rather than long-term or non-medical issues. The good practices communication framework list comprised 70 specific issues related to breaking bad news pooled into 8 main domains: opening, preparing for the delivery of bad news, IMPACT OF FORMAL EDUCATION 94 breaking bad news (bradnet). Jmir Medical Education, 4(2), 17.https://doi.org/10.2196/mede du.9551. reviewing existing protocols and recommendations for delivering bad news. We also examined instruments for assessing patient-physician communications and conducted semistructured interviews with patients and physicians. From this step, we selected specific themes and then pooled these themes before consensus was achieved on a good practices communication framework list. Level 5 physicians in private practice or hospitals. The sampling strategy was based on the maximum variation strategy to achieve maximum diversity on relevant aspects of breaking bad news Reed, D., & Sharma, J. (2016). Delivering Difficult News and Improving Family Communication: Simulation for Neonatal-Perinatal Fellows. MedEdPORTAL: the journal of teaching and learning resources, 12, 10467. https://doi.org/10.15766/mep_23 74-8265.10467 Breaking bad news (BBN) in the emergency department (ED) represents a challenging and stressful situation for physicians. Many medical students and residents feel stressed and uncomfortable with such situations because of insufficient training. Our randomized Medical students and residents were randomized into a 160-hour ED clinical rotation without a formal BBN curriculum (control group [CG], n = 31) or a 156-hour ED clinical rotation A generalized linear mixed model47 (GLMM) measured changes before and after the BBNSBT in self-efficacy, the SPIKES competence form and the communication techniques, consultation content, attention, physician emotional management, shared decision making, and the relationship between the physician and the medical team. After constructing the items from this list, the items were extensively refined to make them more useful to the target audience, and one item was added. BRADNET contains 71 items, each including a question, response options, and a corresponding message, which were divided into 8 domains and assessed with 12 selfassessment sessions. The BRADNET Web-based platform was developed according to the cognitive load theory and the cognitive theory of multimedia learning. Group-by-time effects adjusted by study year revealed a significant improvement in TG as compared with CG on self-efficacy (P < 0.001), the BBN process (P < 0.001), and communication skills (P < 0.001). TG showed a significant gain regarding the BBN process (+33.3%, P < 0.001). After the training, students with limited clinical experience prior to the rotation showed BBN performance IMPACT OF FORMAL EDUCATION Rosenzweig, M. Q. (2012). Breaking bad news: a guide for effective and empathetic communication. The Nurse Practitioner, 37(2), 14. https://doi.org/10.1097/01.NPR. 0000408626.24599.9e 95 controlled study aimed to assess the efficacy of a four-hour BBN simulation-based training on perceived selfefficacy, the BBN process, and communication skills. Level II, quality B. and a four-hour BBN simulationbased training (training group [TG], n = 37). Both groups were assessed twice: once at the beginning of the rotation (pre-test) and again four weeks later. Breaking negative news to patients is a common occurrence for nurse practitioners. This difficult task requires patience and refined communication skills, and must be approached with empathy for all parties involved. There are several ways to deliver bad news to patients successfully using patient-centered communication techniques and methods (Rosenzweig, 2012). Level 7 expert opinion. N/A mBAS. We adjusted the effects of time, group, and group-by-time by the study year as a confounding factor. GLMMs were performed with a covariance matrix of the compound symmetry type. N/A skills equal to that of students in the CG who had greater clinical experience. Breaking bad news is an important clinical skill that can be frequently utilized in the context of routine practice. Following an established protocol while integrating empathetic communication makes the difficult task of breaking bad news more comfortable for the NP and helps improve the communication between the patient and family. These skills can be learned in continuing education programs or easily integrated into NP curriculum (Rosenzweig, 2012). IMPACT OF FORMAL EDUCATION Rosveh, A. K., Amjad, R. N., Rozveh, J. K., & Rasouli, D. (2017). Attitudes toward telling the truth to cancer patients in Iran: a review article. International Journal of Hematology- Oncology and Stem Cell Research, 11(3), 178 184. level 7- expert opinion (narrative review). This study is a narrative review that included articles published in Iran on attitudes toward telling the truth to cancer patients. The present study extracted data from articles published in PubMed, Science Direct, Scientific Information Database (SID), Magiran, Iran Medex, Google Scholar, Iranian Research Institute for Information Science and Technology with key terms such as truth disclosure, breaking bad news, death awareness and disclosure of diagnosis without any time restriction. level 7expert opinion (narrative review). 96 The present study extracted data from articles published in PubMed,Science Direct, Scientific Information Database (SID), Magiran, Iran Medex, Google Scholar, Iranian Research Institute for Information Science and Technology with key terms such as truth disclosure, breaking bad news, death awareness and disclosure of diagnosis without any time restriction. Rouge Bugat ME, Omnes, C., resiliency framework, joy N/A Delpierre, C., Escourrou, E., initiative. Level 7 expert Boussier, N., Oustric, S., Delord, opinion J.P., Bauvin, E., & Grosclaude, P. (2016). Primary care N/A Totally, 21 articles including 14 in English and 7 in Persian were selected and reviewed. The results of the study have shown that although treatment team and caregivers are unwilling to disclose the truth to patients, they have a tendency to obtain more information about their disease. N/A Oncology clinicians are at increased risk for burnout; however, building resilience in the face of adversity to positively adapt to the changing health care system is key IMPACT OF FORMAL EDUCATION 97 physicians and oncologists are partners in cancer announcement. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 24(6), 24739. https://doi.org/10.1007/s00520015-3049-2 Sykes N. (1989). Medical students' fears about breaking bad news. Lancet (London, England), 2(8662), 564. https://doi.org/10.1016/s01406736(89)90688-0 Stanley, D., Blanchard, D., Hohol, A., Hutton, M., McDonald, A., & Lee, A. (2017). Health professionals' perceptions of clinical leadership. a pilot study. Cogent Medicine, 4(1). https://doi.org/10.1080/2331205 X.2017.1321193 Study showing that medical students felt stressed about breaking bad news to patient because there was no proper training in breaking bad news. Level III, Quality B. To identify how clinical leadership was perceived by Health Professionals (HPs) (excluding nurses and doctors) and to understand how effective clinical leadership relates to initiating and establishing a culture of change and progression in the health services (Stanley et al., 2017). Level III, Quality B. N/A N/A Study shows that when medical students had training in breaking bad news, it was a less uncomfortable experience for them. A total of 307 complete surveys were returned. Participants represented 6.1% of the total WA HP workforce and a wide range of HP disciplines. The majority of respondents were female (86.5%), the median age was 38.9 years and the majority This pilot study used a mixed methods approach, although quantitative methodological principles dominated. An on-line (SurveyMonkey ) questionnaire was distributed via email links to HPs Improvements in clinical care and changes in practice can be initiated by clinical leaders (Stanley et al., 2017). IMPACT OF FORMAL EDUCATION Servotte, J. C., Bragard, I., Szyld, D., Van Ngoc, P., Scholtes, B., Van Cauwenberge, I., Donneau, A. F., Dardenne, N., Goosse, M., Pilote, B.,Guillaume, M., & Ghuysen, A. (2019). Efficacy of a short role-play Training on breaking bad news in the emergency department. The western journal of emergency medicine, 20(6), 893902. https://doi.org/10.5811/westjem. 2019.8.43441 Breaking bad news (BBN) in the emergency department (ED) represents a challenging and stressful situation for physicians. Many medical students and residents feel stressed and uncomfortable with such situations because of insufficient training. Our randomized controlled study aimed to assess the efficacy of a four-hour BBN simulation-based training on perceived self- 98 of respondents worked in acute hospital environments (59.9%) and in a metropolitan location (73.7%). Most participants (79.2%) saw themselves or were reportedly seen by others (76.2%) as clinical leaders (Stanley et al., 2017). Medical students and first-year residents specializing in emergency medicine (EM). A convenience sample was invited to participate in the study. It included medical students (n = 64) following a onemonth ED internship and first-year EM throughout the Western Australian Department of Health. Qualitative data was analyzed by Statistical Product and Service Solutions (Version 21) (Stanley et al., 2017). Medical students and residents were randomized into a 160-hour ED clinical rotation without a formal BBN curriculum (control group [CG], n = 31) or a 156-hour ED clinical rotation and a four-hour BBN simulationbased training Group-by-time effects adjusted by study year revealed a significant improvement in TG as compared with CG on self-efficacy (P < 0.001), the BBN process (P < 0.001), and communication skills (P < 0.001). TG showed a significant gain regarding the BBN process (+33.3%, P < 0.001). After the training, students with limited clinical experience prior to the rotation showed BBN performance skills equal to that of students in the CG who had greater clinical experience. IMPACT OF FORMAL EDUCATION efficacy, the BBN process, and communication skills. Level II, quality B. Setubal, M., Gonalves, A. V., Rocha, S. R., & Amaral, E. M. (2017). Breaking bad news training program based on video reviews and SPIKES strategy: What do perinatology residents think about It? Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia, 39(10), 552559. Resident doctors usually face the task to communicate bad news in perinatology without any formal training. The impact on parents can be disastrous. The objective of this paper is to analyze the perception of residents regarding a training program in 99 residents (n = 9) beginning their first month of internship. Each participant gave his or her signed informed consent on a voluntary basis. Five students did not complete the rotation and were excluded from the study; therefore, a total of 68 participants were included. The TG and the CG had, respectively, 37 and 31 members (Stanley et al., 2017). The participants were a group of volunteer residents from the 1st to the 4th year from the obstetrics and pediatrics programs at a medical school in So Paulo, Brazil. (training group [TG], n = 37). Both groups were assessed twice: once at the beginning of the rotation (pre-test) and again four weeks later. The SPIKES training sessions were conducted by the PI, a trained psychologist with vast experience in perinatology. A session could be individual, in Residents evaluated training as a good support to systematize and to encourage reflections on the process of communicating bad news in perinatology. Residents suggest formal training must be included in their program's curricula. IMPACT OF FORMAL EDUCATION https://doi.org/10.1055/s-00371604490 communicating bad news in perinatology based on video reviews and setting, perception, invitation, knowledge, emotion, and summary (SPIKES) strategy. RCT level I, B Good quality Tan, J. Y. S., Lam, K. F. Y., Lim, H. A., Chua, S. M., Kua, E. H., Griva, K., & Mahendran, R. (2018). Post-intervention sustainability of a brief psychoeducational support group intervention for family caregivers of cancer patients. Asia-Pacific Psychiatry: Official Journal of the Pacific Rim College of Family caregivers of cancer patients experience many negative effects due to the heavy responsibility involved. Although various psychosocial interventions have been found to improve caregivers' quality of life (QOL), the sustainability 100 Caregivers of patients attending an outpatient clinic at a cancer center in Singapore were recruited (Tan et al., 2018). pairs or in groups and lasted between 1h and 2h30m depending of the number of participants. After completion, the residents filled out a Likert scale questionnaire of eight items, rating them from 1 to 5, with 1 meaning not at all and 5 a lot, evaluating the SPIKES training. Participants completed the Caregiver QOLCancer scale at baseline, immediately postintervention, and at 4 and 8 weeks after Understanding the sustainability of the effects of the intervention is important in determining the need to initiate periodic booster sessions to provide consistent support for caregivers. Further research could investigate the sustainability over an even longer period, as well as intraindividual change trajectories using growth modeling among a larger sample. IMPACT OF FORMAL EDUCATION Psychiatrists, 10(3), 12305. https://doi.org/10.1111/appy.123 05 U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2020). Health Communication: Decrease the proportion of adults who report poor communication with their health care provider HC/HIT-02. In Healthy People 2030. https://health.gov/healthypeople/ objectives-and-data/browseobjectives/healthcommunication/decreaseproportion-adults-who-reportpoor-communication-theirhealth-care-provider-hchit-02 Villarruel, A. M. (2018). Building innovation and sustainability in programs of research: innovation and 101 of the benefits of these interventions over time has been less consistently investigated and hence less clearly established. This study aims to examine the trajectories of change in caregivers QOL over an 8-week follow-up period (Tan et al., 2018). This is a healthy people N/A 2030 guideline the end of the intervention. Data from 56 participants were analyzed (Tan et al, 2018). N/A N/A Innovation and sustainability are two important concepts of impactful programs of N/A Innovation is an important component of sustainable programs of research. Understanding the social and political context and N/A IMPACT OF FORMAL EDUCATION sustainability. Journal of Nursing Scholarship, 50(1), 5 10. https://doi.org/10.1111/jnu.1235 7 Vakada, S., Bachmann, G. A., & Lu, C.W. (2018). Breaking bad news to patients with breast cancerthe benefits of hope and optimism [9l]. Obstetrics & Gynecology, 131(1), 131. https://doi.org/10.1097/01.AOG. 0000533548.61068.25 research. While at first glance these concepts and approaches may seem at odds, they are synergistic. We examine the social, political, and policy context as it relates to innovation and sustainability. We present an exemplar of a program of research and discuss factors to consider in developing innovative and sustainable programs of research. Level V, Good quality Receiving a diagnosis of N/A breast cancer can be devastating. In the interest of avoiding false hope, health care professionals may break the news without imparting a sense of optimism. Studies reflect that optimistic patients may have a greater sense of well-being and employ useful coping skills. Incorporating strategies for optimism could be an important psychological 102 addressing relevant policy issues are factors to be considered in both innovation and sustainability. A literature review using standard search engines was utilized which involved a total of 7 scholarly articles, journals and websites devoted to breast cancer, hope and optimism (Vakada et al., 2018). Optimism can be acquired through behavioral modifications. Hospitals and clinics should consider developing optimism intervention strategies and begin teaching them to patients at the point of diagnosis. This could help empower women to immediately begin employing positive coping skills (Vakada et al., 2018). IMPACT OF FORMAL EDUCATION VandeKieft G. K. (2001). Breaking bad news. American family physician, 64(12), 1975 1978. Warnock, C., Buchanan, J., & Tod, A. M. (2017). The difficulties experienced by nurses and healthcare staff involved in the process of breaking bad news. Journal of advanced nursing, 73(7), 16321645. https://doi.org/10.1111/jan.1325 2 intervention (Vakeda et al., 2018).. This is a guideline. This study is a narrative review that included articles published in Iran on attitudes toward telling the truth to cancer patients. The present study extracted data from articles published in PubMed, Science Direct, Scientific Information Database (SID), Magiran, Iran Medex, Google Scholar, Iranian Research Institute for Information Science and Technology with key terms such as truth disclosure, breaking bad news, death awareness and disclosure of diagnosis without any time restriction. Level 7expert opinion (narrative review). 103 N/A N/A N/A The present study extracted data from articles published in PubMed,Science Direct, Scientific Information Database (SID), Magiran, Iran Medex, Google Scholar, Iranian Research Institute for Information Science and Technology with key terms such as truth disclosure, breaking bad news, death awareness and disclosure of diagnosis without any N/A Totally, 21 articles including 14 in English and 7 in Persian were selected and reviewed. The results of the study have shown that although treatment team and caregivers are unwilling to disclose the truth to patients, they have a tendency to obtain more information about their disease. IMPACT OF FORMAL EDUCATION Wolfe, A. D., Denniston, S. F., Baker, J., Catrine, K., & HooverRegan, M. (2016). Bad news deserves better communication: A customizable curriculum for teaching learners to share lifealtering information in pediatrics. MedEdPORTAL : the journal of teaching nd learning resources, 12, 10438. https://doi.org/10.15766/mep_23 74-8265.10438 Learners have repeatedly expressed a desire for more structured training in communicating with families, especially when sharing life-altering information and breaking bad news. Concurrently, parents have indicated that pediatricians could conduct difficult conversations with greater skill. Based on local needs assessments and available pediatric literature, this guide presents didactic materials and a workshop-style, casebased, longitudinal approach for teaching communication skills to learners in pediatrics. Level IV guideline quality B 104 time restriction. In total, 50 related articles were found; of which 19 were on psychological aspects of cancer. This is a The modified guideline SPIKES approach and didactic portion of this resource were validated as an initial training tool, yielding significant improvements in self-efficacy of pediatric providers and learners. Evaluations of the role-playing components provided by pediatric residents and fellows have been positive for the format and value of the Findings: Multiple inter-related factors presented challenges to staff engaging in activities associated with breaking bad news. Traditional subjects such as diagnostic and treatment information were described but additional topics were identified such as the impact of illness and care at the end of life. A descriptive framework was developed that summarizes the factors that contribute to creating difficult experiences for staff when breaking bad news IMPACT OF FORMAL EDUCATION Yip, S. M., Meyers, D. E., Sisler, J., Wycliffe-Jones, K., Kucharski, E., Elser, C., Temple- Oberle, C., Spadafora, S., Ingledew, P. A., Giuliani, M., Kuruvilla, S., Sumar, N., & Tam, V. C. (2020). Oncology education for family medicine residents: a national needs assessment survey. BMC medical education, 20(1), 283. https://doi.org/10.1186/s12909020-02207-0 This study aimed to determine the current state of oncology education in Canadian family medicine postgraduate medical education programs. survey was designed to evaluate ideal and current oncology teaching, educational topics, objectives, and competencies in FM PGMEs. The survey was sent to Canadian family medicine (FM) residents and program directors (PDs (FM PGME) and examine opinions regarding optimal oncology education in these programs. Level III, quality B 105 In total, 150 residents and 17 PDs affiliated with 16 of 17 Canadian medical schools completed the survey. learning experience. Participants reported a particular benefit from the inclusion of parent perspectives. clinical rotation for residents in oncology Current FM PGME oncology education is suboptimal, although the degree differs in the opinion of residents and PDs. This study identified topics and methods of education which could be focused upon to improve FM oncology education. IMPACT OF FORMAL EDUCATION Zielinska, P., Jarosz, M., Kwiecinska, A., & BetkowskaKorpala, B. (2017). Main Communication barriers in the process of delivering bad news to oncological patients- medical perspective. Folia medica Cracoviensia, 57(3), 101-112. The purpose of this paper is to examine competencies (knowledge, skills and experience) in delivering bad news by medical specialists in the areas related to the causal and symptomatic treatment of oncological patients; identification of major communication problems and obstacles in this specific situation and evaluation of teaching needs for delivering bad news. 106 The largest group among the study participants consisted of people between 36 and 50 years old 54%, Nearly 60% of the respondents were medical specialists, while others were in the middle medical specialist training. The study was performed on a group of 61 medical specialists in the areas related to the causal and symptomatic treatment of oncological patients. It used the snowball sampling technique. The questionnaire was sent via e-mail. characteristics of the surveyed doctors (gender, age, professional experience, practiced specialization), characteristics of patients with whom the responding doctors work (whether they remain in causal or palliative treatment, age group), and knowledge on how to deliver bad news (participation in training on communication with the patient, knowledge of communication techniques and tools dedicated to the process of delivering bad news. Delivering bad news is doctors everyday life. Conducting difficult conversations with patients and their close ones is a stressful situation for the doctor, therefore, training of interpersonal skills, particularly in the area of emotion management and the use of adequate communication techniques should be a routine. This will help to reduce anxiety, increase selfconfidence, which in the longer term, can reduce the risk of burnout syndrome in the medical profession and the increase of job satisfaction. IMPACT OF FORMAL EDUCATION 107 Zylner, I. A., Lomborg, K., Christiansen, P. M., & Kirkegaard, P. (2019). Surgical breast cancer patient pathway: experiences of patients and relatives and their unmet needs. Health Expectations: An International Journal of Public Participation in Health Care and Health Policy, 22(2), 262272. https://doi.org/10.1111/hex.1286 9 The aim of this study was to explore patients and relatives experiences with the surgical breast CPP and to identify any unmet needs. Level III, quality B This study was based on focus groups with patients who had surgery for breast cancer, and their relatives. The settings were two Danish surgical breast cancer clinics. surgical breast cancer patient pathways Zwingmann, J., Baile, W. F., Schmier, J. W., Bernhard, J., & Keller, M. (2017). Effects of patient-centered communication on anxiety, negative affect, and trust in the physician in delivering a cancer diagnosis: A randomized, experimental study. Cancer, 123(16), 3167 3175. https://doi.org/10.1002/cncr.306 94 When bad news about a cancer diagnosis is being delivered, patientcentered communication (PCC) has been considered important for patients' adjustment and well-being. However, few studies have explored how interpersonal skills might help cancer patients cope with anxiety and distress during bad-news encounters. Level III, Quality B. Ninety-eight cancer patients and 92 unaffected subjects of both sexes were randomly assigned to view a video of a clinician delivering a first cancer diagnosis with either an enhanced patientcentered communication (E-PCC) style or video exposure Overall, patients and relatives found the structure of the surgical breast CPP satisfactory. The time in the surgical department was short, and most patients found it difficult to cope with the situation. Empathy and a supportive relationship between patients, relatives and healthcare professionals were of great importance. Five key points were identified in which some of the participants had unmet needs. Suggestions for change were related to information, communication, choice of treatment, flexibility in the pathway and easy access to the clinic after surger Under a threatening, anxietyprovoking disclosure of bad news, a short sequence of empathic PCC influences subjects' psychological state, insofar that they report feeling less anxious and more trustful of the oncologist. Video exposure appears to be a valuable method for investigating the impact of a physician's communication style during critical encounters. IMPACT OF FORMAL EDUCATION 108 a low patientcentered communication (L-PCC) style. IMPACT OF FORMAL EDUCATION 109 Appendix D Informed Consent Document ("Institutional Review Board", n.d.) Informed Consent Form You are invited to participate in a project designed to determine whether healthcare providers who receive formal education in breaking bad news to patients have a more positive experience delivering the bad news during the office visit than bad news delivered by healthcare providers not formally educated. You have been chosen to participate in this project because you are a person who will likely be breaking bad news as a healthcare provider in the future. The purpose of this investigation is to improve the healthcare provider's self-efficacy of breaking bad news to a patient through an educational module, ultimately improving the experience with the healthcare provider. Your participation may help us learn the impact formal education about breaking bad news to the patient has on the healthcare providers. You will be asked to fill out an assessment about communication skills. After filling out the assessment, you will be asked to watch an educational presentation about breaking bad news to patients and the necessary communication skills to improve these difficult conversations. After watching the educational presentation, you will be asked to retake the assessment to see if you feel more confident in breaking bad news to patients compared to how you felt before watching the educational presentation. We ask you to answer honestly because we are very interested in your honest opinion. Because we want to learn from what is said by each person in the survey, the surveys will be completed using the SurveyMonkey platform. The anonymity feature is activated on IMPACT OF FORMAL EDUCATION 110 SurveyMonkey, and you will be able to see this before you start filling out the assessment. The data will be reviewed by myself and a Saint Mary's faculty member. No information about you that would reveal your identity will be disclosed. Discussing the process of breaking bad news may be uncomfortable or upsetting, as it may bring forward memories of difficult conversations you or someone you know were involved in. Furthermore, you are free to stop participating in this project at any time. The whole procedure should take approximately one hour. If you have questions about this project, please ask Kathryn Vera at 269-470-6770. You are making a decision about whether or not to participate. Your initials on the SurveyMonkey consent indicate that you have read this information and have decided to participate in the project. You may withdraw at any time should you choose to do so, and if you withdraw, your comments will not be included in the report. Withdrawing will not in any way affect your health or treatment. You will be given a copy of this form to keep within the SurveyMonkey platform. I agree to participate in this project. I am at least 18 years of age. The purpose of the project has been explained to me. I understand that the information obtained about me will be confidential. I have been told the benefits and drawbacks of participating. I know whom to contact for further information. I understand the procedure may take up to two hours. I know that my participation is voluntary, that refusal to participate will involve no penalty, and that I may withdraw at any time. Initials of Participant Date IMPACT OF FORMAL EDUCATION Initials of Group Facilitator ("Institutional Review Board", n.d.) 111 Date IMPACT OF FORMAL EDUCATION 112 Appendix E Survey Instrument IMPACT OF FORMAL EDUCATION 113 IMPACT OF FORMAL EDUCATION 114 IMPACT OF FORMAL EDUCATION 115 IMPACT OF FORMAL EDUCATION Axboe et al., (2016). 116 IMPACT OF FORMAL EDUCATION 117 Appendix F IRB Approval Letter IMPACT OF FORMAL EDUCATION 118 Appendix G Poster Presentation The physical space in which the bad news is exchanged. Assess the patient's knowledge and thoughts of their medical situation. Obtain the patient's consent to give the results and information. hile giving the information, speak with words that are understandable to the patient. se empathetic responses to address the patient's emotions. Discussion of main points of the conversation, with the goal of constructing a plan of care. IMPACT OF FORMAL EDUCATION 119 Appendix H SPIKES Protocol Educational Module earning Objectives DNP Practice Innovation Project Breaking Bad News athryn M. Vera Department of Nursing Science, Saint Mary s College Dr. Sue Anderson March 18 th, 2022 hat Comes to Mind? Personal experience on the receiving side? Personal experience delivering the bad news? hat do you remember about this experience? The setting (room, level of physical comfort). The emotions felt by all parties involved. The face of the person giving the bad news, the face of the person receiving the bad news. SPI ES Protocol A six step protocol for breaking bad news6 Four important objectives Obtaining information from the patient Sharing medical information with the patient Giving support to the patient Promotion of collaboration between patient and healthcare provider in developing a plan of care6. 1. nderstand the importance of formal education for healthcare providers regarding the phenomenon of breaking bad news to patients in a clinical setting. 2. earn how to effectively break bad news to patients utilizing the SPI ES protocol. 3. Increase self efficacy in breaking bad news to patients. Background The phenomenon of breaking bad news in a clinical setting can lead to a negative experience for the healthcare provider when delivered inappropriately.1 Bad news is defined as any news that drastically and negatively alters the patient s view of her or his future (Buckman, 1984, p. 1597). Poor healthcare provider outcomes resulting from breaking bad news include an increase in stress 3 anxiety 4, emotional exhaustion, and lower sense of personal accomplishment. 5 Self Efficacy Definition One s belief in the ability to perform a certain skill through the skill set that one possesses under varying circumstances 7 The ability for successful functioning must incorporate both skill competency and the confidence to use the skill 7 Improved self efficacy leads to an increase in goal attainment 8 IMPACT OF FORMAL EDUCATION 120 Self Efficacy Evidence shows formal training to improve the process of breaking bad news to patients leads to increased confidence of the healthcare provider, as well as an overall more satisfying and less uncomfortable experience for the healthcare provider, the patient, and the patient s family members 9,6 Setting Assessing the patient s PERCEPTION Before talking about bad news, ask the patient about their understanding of the situation. Open ended questions are preferable. Assess if the patient is in denial or having unrealistic expectations6. This is helpful in clarifying what the patient already knows. IMPACT OF FORMAL EDUCATION Obtaining the patient s INVITATION Ask the patient if it is ok to go overall of the information with them, or if there are certain parts that they do not want to know6 Don t assume that they want to know all of the details. If this is the case, offer to answer any questions they might have 6. Giving NO EDGE and Information to the Patient se a preamble to decrease the shock of the bad news6 Avoid medical jargon6 Give information in small increments 6 Avoid being blunt6 Identify issues that the patient would like addressed. hat questions do you have? hat part of this seems the hardest right now? Addressing the Patient s EMOTIONS with EMPATHETIC Responses Observe for emotions 6 Identify the emotions and ask open ended questions 6 Identify the reason for the emotions 6 Please share with me what you are most worried about. hat are your thoughts about the news I just shared? Acknowledge a connection between the patient s emotions and reason for the emotions 6 Is the patient family member angry? Are there many different emotions being shown? Identify, ask, make a connection. 121 IMPACT OF FORMAL EDUCATION 122 STRATEGY and S MMARY Ask the patient s permission to present treatment options6 Explore the patient s treatment goals6 ork to establish hope along with realistic expectations6 Ensure all of the patient s questions have been answered6 hat questions do you have? Is there anything I can answer or clarify? Helpful Hints Empathic Statements Prepare ahead of time utilizing the SPI ES protocol. eep a few of the aforementioned phrases in mind to guide the conversation. Silence is ok 10 Nonverbal cues are powerful, such as making eye contact, nodding. Try not to fidget, rub your face, touch your hair11 As a healthcare provider, seek help for stress and mental health wellness when needed. Exploring Statements How do you mean? Tell me more about it (Baile et al., 2000, p.307). (Baile et al., I know this isn t the news you were hoping for (Baile et al., 2000, p.307). I m sorry to have to tell you this (Baile et al., 2000, p. 307). Baile et al., 2000, p. 307). Yes, your understanding of the reason for the tests is very good (Baile et al., 2000, p. 307). It appears that you have thought things through very well (Baile et al., 2000, p. 307 (Baile et al., 2000, p.307). Could you tell me what you are worried about? p.307). I can tell you weren t expecting to hear this 2000, p. 307) I can understand how you felt that way (Baile et al., 2000, p .307). You said it frightened you? (Baile et al., 2000, p. 307). Validating Statements (Baile et al., 2000, p.307). Could you explain what you mean? I can see how upsetting this is to you (Baile et al., 2000, Now, you said you were concerned about your children. Tell me more. (Baile et al., 2000 p.307). IMPACT OF FORMAL EDUCATION Application to the DNP APRN Increases the healthcare provider s self efficacy and confidence in breaking bad news, with the goal of improving the experience of healthcare providers.1,12,13 Improves the experience for the healthcare provider in breaking bad news, which will ultimately improve health outcomes for the patient. 1 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. References Gorniewicz , ., Floyd, M., rishnan, ., Bishop, T. Tudiver, ., F., & ang, F. (2017). Breaking bad news to patients with cancer A randomized control trial of a brief communication skills training module incorporating the stories and preferences of actual patients . , (4), 655 666. https doi.org 10.1016 j.pec.2016.11.008 Buckman R. (1984). Breaking bad news why is it still so difficult?. , (6430), 1597 1599. Fallowfield, . (1993). Giving sad and bad news. , (8843). Sykes N. (1989). Medical students' fears about breaking bad news. , (8662), 564. https doi.org 10.1016 s01406736(89)90688 0 Ramirez, A. ., Graham, ., Richards, M. A., Cull, A., Gregory, . M., eaning, M.Snashall, S., D. C., & Timothy, R. (1995). Burnout and psychiatric disorder among cancer clinicians. , (6), 1263 9. Baile, . F.,Buckman, R., enzi , R., Glober, G., Beale, E. A., & udelka, A. P. (2000). SPI ES A six step protocol for delivering bad news application to the patient with cancer. , (4), 302 311. https doi.org 10.1634 theoncologist.5 4 302 Bandura, A. (1997). H Freeman Times Books Henry Holt & Co. https doi.org 10.1136 bmj.288.6430.1597 Bandura, A. (1990). Perceived self efficacy in the exercise of personal agency. , (2), 128 163. https doi.org 10.1080 10413209008406426 Moura Villela, E. F., Bastos, . ., de Almeida, . S., Pereira, A. O., de Paula Rocha, M. S., de Oliveira, F. M., &Bollela, V. R. (2020). Effects on medical students of longitudinal small group learning about breaking bad news. , , 19.157. https doi.org 10.7812 TPP 19.157 nol, A. S. ., oole, T., Desmet, M.,Vanheule, S., & Huiskes, M. (2020). How speakers orient to the notable absence of talk a conversation analytic perspective on silence in psychodynamic therapy. , , 584927 584927. https doi.org 10.3389 fpsyg.2020.584927 Fan, ., Chen, ., Meng, ., iang, H., hao, Q., hang, ., & Fang, C. . (2019). Preference of cancer patients and family members regarding delivery of bad news and differences in clinical practice among medical staff. , (2), 583 589. https doi.org 10.1007 s00520 0184348 1 Chung, H. O.,Oczkowski , S. ., Hanvey, ., Mbuagbaw, ., & You, . . (2016). Educational interventions to train healthcare professionals in end of life communication a systematic review and meta analysis. , , 131. https doi.org 10.1186 s12909016 0653 x ohnson, ., &Panagioti, M. (2018). Interventions to improve the breaking of bad or difficult news by physicians, medical students, and interns residents a systematic review and meta analysis. , (9), 1400 1412. https doi.org 10.1097 ACM.0000000000002308 123 Questions?  ...

... Running Head: SURVIVAL GUIDE FOR HEMODIALYSIS Renal Diet and Fluid Restriction Survival Guide for Hemodialysis Carly Thompson, RN, DNP Student Saint Marys College Faculty team leader: Sue Anderson PhD, RN, FNP-BC Faculty reader: Patricia Keresztes PhD, RN, CCRN Date of Submission: June 20, 2020 1 SURVIVAL GUIDE FOR HEMODIALYSIS 2 Abstract Problem Statement There is a lack of appropriate diet and fluid restriction education for End Stage Renal Disease (ESRD) patients which places these patients at a higher risk for morbidity and mortality. The current educational resources are not adequate to serve this population of patients. Literature Review Fifty percent of hemodialysis patients have been nonadherent in some form during their treatments, and nonadherence to renal diet and fluid restriction is a common issue (Ibrahim, Hossam, & Belal, 2015). The education required to understand hemodialysis and the interventions necessary to maintain the body between treatments is extensive. For the ESRD population with limited health literacy levels, educational material is often too advanced for the patients to understand (Escobedo & Weismuller, 2013; Levine et al., 2018; Taylor et al., 2016; Taylor et al. 2017). Nonadherence to the renal diet and fluid restrictions, often an outcome of poor medical education, affects hospital readmission and mortality and is associated with a poor quality of life, and depression. (Ibrahim, Hossam, & Belal, 2015). PICOT In End Stage Renal Disease patients newly starting hemodialysis, how does a survival education guide for diet and fluid restriction education affect patients knowledge of diet and fluid restriction within their first year of hemodialysis? Results Ten patients were enrolled and participated in the project. Paired t-test was performed to compare the pre-test and post-test scores of the End Stage Renal Disease Adherence Questionnaire. The results were found to be significant with a p-value of <0.001. Qualitative results assessing the patients insight on renal diet and fluid restriction provided three themes: family involvement, fluid restriction struggle and significant life changes. The Renal Diet and Fluid Restriction Survival Guide Brochure significantly improved the patients knowledge of the renal diet and fluid restrictions in patients that have been on hemodialysis for one year or less. SURVIVAL GUIDE FOR HEMODIALYSIS Table of Contents Abstract.. 2 Introduction... 4 Background 4 Problem Statement 6 PICOT and Objectives.. 7 Literature Review.. 7 Theoretical and Implementation Models... 15 Social Entrepreneurship.. 18 Sustainability 21 Ethical Considerations 21 Methods.23 Implementation.26 Data Analysis....29 Timeline.29 Budget30 Results31 Discussion..32 Conclusion.34 Appendices....35 References.46 3 SURVIVAL GUIDE FOR HEMODIALYSIS 4 Renal Diet and Fluid Restriction Survival Guide for Hemodialysis According to the National Kidney Foundation, as of December 31, 2017 there were 746,557 Americans with end stage renal disease (ESRD). Of those ESRD patients, 468,000 of them require hemodialysis on a regular basis to survive. Arif et al. (2017) identified that among their specified population of ESRD patients, 46.3% of the patients initiated hemodialysis while inpatient in the hospital. In addition, that population was found to have a lack of nephrology care prior to initiating hemodialysis. There is a lack of education on the renal diet and fluid restrictions due to no prior nephrology care before initiating hemodialysis (Arif et al., 2017). The purpose of this research project was to create and evaluate a renal diet and fluid restriction survival guide for ESRD patients who had started hemodialysis in the last one year. Improvement in nutritional care is an approach that has been shown to improve clinical outcomes, morbidity, mortality, and healthcare expenses (Van Duong et al., 2019). Background ESRD patients who require hemodialysis must follow a renal diet and fluid restriction due to their kidneys no longer functioning. Without functioning kidneys, the waste products and additional fluid is not being removed from a patients body. This patient population in general receives hemodialysis three times a week. In between those sessions, they must be careful about what they put into their bodies to prevent becoming fluid overloaded and having electrolyte imbalances (National Kidney Foundation, 2019). The United States Renal Data Systems (USRDS) reported that in 2015, 36% of ESRD patients received little or no pre-ESRD nephrology care. In addition, 110,306 patients did not receive any diet or fluid restriction education prior to initiating hemodialysis versus the 9,274 patients that did (US Renal Data Systems, 2017). When patients were receiving the diet and SURVIVAL GUIDE FOR HEMODIALYSIS 5 fluid restriction education prior to initiation, adequate time was not spent establishing and monitoring diet adherence with the patient to ensure success (Martinez, 2014). The lack of dietary care prior to hemodialysis initiation has led to an increase in noncompliance, hospital readmissions, and increased morbidity and mortality (Denhaerynck et al., 2007). In 2019, the total Medicare spending on patients with chronic kidney disease and ESRD was over $120 billion, which accounts for 33.8% of Medicare spending (USRDS, 2019). In the setting where a multidisciplinary team participated in an ESRD hemodialysis patients diet and fluid restriction education, there was a reduction in hospitalizations, an improvement in quality of life and decreased medical expenses. (Yu et al., 2014) The educational tools for renal diet and fluid restriction were lacking in the adult nephrology unit for this DNP Practice Innovation Project. The hemodialysis booklet that was provided to patients covered the medical aspect of ESRD and the process of hemodialysis but lacked a section dedicated to diet and fluid restriction. Five additional handouts to address diet and fluid restriction were provided to patients to fulfill the lack of information within the current booklet. Patients beginning dialysis were overwhelmed with not only the physical demand of hemodialysis but also the mental demands of reviewing a booklet and five additional handouts. For a patient to seek information themselves, the online renal diet information is copious but at too high of a literacy level when compared to the 5th grade reading level that is recommended by the Joint Commission (Stossel, Segar, Gliatto, Fallar, & Karani, 2012). Online tools were found to be 73% accurate and difficult to use and interpret to be put into action by a patient (Lambert, Mullan, Mansfield, Koukomous, & Mesiti, 2017). SURVIVAL GUIDE FOR HEMODIALYSIS 6 Problem Statement The lack of prior nephrology care, including diet education in ESRD patients who initiate hemodialysis while inpatient, puts this population of ESRD patients at a higher risk for increased morbidity and mortality. As identified above, the current educational resources were not adequate to serve this population. Without adequate education, ESRD patients initiating hemodialysis had not been provided with the tools for success. This project provided a tool to fulfill the need of a renal diet and fluid education at the adult nephrology unit. The Survival Guide for Renal Diet and Fluid Restriction provided the basic knowledge required for an ESRD patient on hemodialysis to know how to make appropriate food choices, as well as gave information on how to manage the fluid restriction requirement. The goal was to provide a quick guide to increase the knowledge base of the ESRD patient who initiated treatment within the last one year without causing the patient to feel overwhelmed. The goal for this educational tool was for it to not only be applicable in the inpatient setting but also for this education to continue in the primary care setting. By creating an educational tool that could be used by collaborating providers it gave the patient a team that worked together to empower them to improve their health by making diet and fluid restriction changes. The goal was not only to educate the patient but increase collaboration by making the tool something primary care could use to reinforce the diet and fluid restriction education. The ESRD on hemodialysis population needs health promotion and education. This innovative project filled that gap in the current practice. SURVIVAL GUIDE FOR HEMODIALYSIS 7 PICOT and Objectives In End Stage Renal Disease (ESRD) patients newly starting hemodialysis, how does a survival education guide for diet and fluid restriction education affect patients knowledge of diet and fluid restriction within their first year of hemodialysis? 1. The APRN examined and integrated up to date research to show evidence and support reasoning behind why the Renal Diet and Fluid Restriction Survival Guide Brochure filled a void in current education to hemodialysis patients. 2. The APRN evaluated and defended the Renal Diet and Fluid Restriction Survival Guide Brochure intervention to obtain IRB approval. 3. The APRN examined and appraised the patients knowledge who chose to be a part of this project to evaluate if the Renal Diet and Fluid Restriction Brochure provided effective education. 4. The APRN categorized and analyzed data received from participants using the ESRD-AQ tool and determined effectiveness of the Renal Diet and Fluid Restriction Brochure. Literature review This literature review was performed using Pubmed, MeSH and EBSCOhost searching key terms: ESRD, Renal Diet, education, literacy, hemodialysis, fluid overload, fluid restriction, hyperkalemia, readmission, CKD, patient education, health literacy, diet education, theory of goal attainment. Initial search resulted in 502 articles. After excluding articles focusing on acute kidney injury due to the possibility of recovery affecting results, limited to adult age of 18 years SURVIVAL GUIDE FOR HEMODIALYSIS 8 and older to correlate with this projects location, and limited articles to being published in the last five years, the final number of articles was 37. ESRD Pathophysiology End stage renal disease (ESRD) is defined as the loss of kidney function. The kidneys are responsible for maintaining a stable environment for cell and tissue metabolism by balancing water and electrolytes, excreting waste, conserving nutrients and acid base regulation (McCance & Huether, 2014). The primary causes of ESRD are poorly managed diabetes mellitus and hypertension. These two conditions are responsible for 70% of cases. Other causes of ESRD include glomerulonephritis, cystic diseases, renal artery stenosis, analgesic overuse, cirrhosis and multiple myeloma (Dunphy, Winland-Brown, Porter & Thomas, 2015). Patients may not experience symptoms of ESRD until the kidneys are failing with a glomerular filtration rate (GFR) of 10-15% of the normal rate. To diagnose ESRD, objective symptoms include skin with uremic frost, potential altered mental status, peripheral edema, lungs with crackles heard by auscultation, and increased blood pressure. The subjective symptoms of ESRD may include anorexia, fatigue, weakness, uremia, pruritus and dry skin, nausea and vomiting (Dunphy, Winland-Brown, Porter & Thomas, 2015). To confirm that a patient is in ESRD, diagnostic testing must be performed. Blood tests to confirm ESRD are elevated serum blood urea nitrogen (BUN), elevated creatinine, and a decreased GFR. Supportive blood tests are a complete blood count (CBC) and comprehensive metabolic panel (CMP). These would indicate imbalances caused by the ESRD including anemia, hyperkalemia and hyperphosphatemia. Urinalysis can be used to confirm the presence of proteinuria, although a blood test is primary indicator. Renal ultrasounds are indicated for chronic kidney disease SURVIVAL GUIDE FOR HEMODIALYSIS 9 (CKD) to obtain a baseline of kidney size and characteristics. As the disease progresses ultrasounds can identify decreased kidney size, polycystic kidney disease or any obstructive disease process that could be a differential diagnosis to ESRD. Renal biopsy is used in acute kidney injury but not CKD or ESRD. This is due to expected progression of the disease, and it is only used if other diagnostic methods are unable to identify etiology (Dunphy, Winland-Brown, Porter & Thomas, 2015). When a patient progresses to ESRD, the management options are peritoneal dialysis, hemodialysis or kidney transplant. In this project, the focus was on patients undergoing hemodialysis. Hemodialysis patients commonly receive treatments three times a week for approximately four hours each time. Diet and fluid management is essential between those treatments due to the kidneys inability to excrete fluids and electrolytes such as potassium that build up in the patients system. Nonadherence to renal diet and fluid restrictions can cause hospitalizations due to hypertension, pulmonary edema, and hyperkalemia leading to arrhythmias (Dunphy, Winland-Brown, Porter & Thomas, 2015). Renal Diet and Fluid Restriction Nonadherence to renal diet and fluid restriction is a common problem in ESRD patients receiving hemodialysis. Fifty percent of hemodialysis patients have been nonadherent in some form during their treatments (Ibrahim, Hossam, & Belal, 2015). Parker (2019) believes that nonadherence is influenced by the patients current knowledge, and their current and past experiences with their ESRD including previous education and treatments. This nonadherence can lead to hospital readmissions and increased mortality rates. ESRD patients on hemodialysis are readmitted to the hospital for a variety of reasons that put them at a higher risk of mortality. SURVIVAL GUIDE FOR HEMODIALYSIS 10 Usvyat et al., (2013) reported on the relationship of frequent hospitalizations and mortality in hemodialysis patients and found that approximately 33% of the patients in the study did not survive. The patients who died during the study had an increased hospitalization rate (from 0.32 to 1.85 admissions per patient) leading up to the month of their death. Although all the deaths were not solely due to nonadherence to diet and fluid restriction, it was noted that these issues contributed to the deaths (Usvyat et al., 2013). Nonadherence affects hospital readmissions and mortality and is associated with a poor quality of life, depression and poor understanding of their disease process due to lack of appropriate education about their disease process and diet and fluid restrictions. (Ibrahim et al., 2015). For hemodialysis to be a successful treatment plan, it requires four things: fluid restrictions, dietary restrictions, medication prescriptions taken as prescribed, and routine attendance of hemodialysis sessions. One area of improvement in this population is to ensure there are proper educational resources to empower the patients to adhere to their renal diet and fluid restrictions. ESRD patients were given a small chapter book about starting hemodialysis on the unit where this project took place. Although it provided an overview of the medical aspect of ESRD and a description of the process of hemodialysis, there were only two pages dedicated to diet. Those few pages described the laboratory tests that could be high, but it did not provide any further dietary education or meal suggestions. In discussion with the Unit manager, she stated the current book is the best resource she could find but acknowledges that the dietary education is poor and led to staff providing patients with additional handouts. (M. Larson, personal communication, 10/16/2018). The additional handouts had diet and fluid restriction information, but it required five additional handouts to ensure patients receive all the educational information SURVIVAL GUIDE FOR HEMODIALYSIS 11 they need. Patients had received an overwhelming amount of information with a book and five handouts to read. Appropriate amount of education Three themes emerged from the review of literature about effective renal diet education aimed at ESRD patients. The first theme was about the appropriate amount of education to provide a patient with ESRD to reduce the feeling of being overwhelmed and consequently nonadherent. Pisani et al., (2016) reported beneficial effects when educating ESRD patients using diet education that consists of six points. The six points Pisani et al., (2016) utilized were: 1. do not add salt to the table or when cooking 2. avoid salami, sausages, dairy products and canned food 3. replace noodles and bread with hypoproteic food 4. only eat meat, fish and eggs once a day 5. have 45 servings a day of fruits or vegetables 6. once or twice a week you may have noodles with legumes instead of the meat, fish or eggs, with fruit and vegetables. The patients found the information provided in six points about the renal diet simple and easy to remember. With keeping education simple, 70% of patients adhered to the renal diet compared to 44% of patients who did not receive similar education. Lambert, Mansfield and Mullan (2019) reported similar results when doing an assessment with dieticians that provide renal diet education. The dieticians found that ESRD patients required help to understand the diet. They SURVIVAL GUIDE FOR HEMODIALYSIS 12 had to clarify conflicting information and simplify complex educational resources into instructions that were understandable to the patient. Multidisciplinary Education The second theme was the importance of multidisciplinary education. When ESRD patients are supported not only by nephrology, but also primary care providers and dieticians they have better outcomes (Lin, Chertow, Yan, Malcolm & Goldhaber-Fiebert, 2018). Patients who are cared for by a multidisciplinary approach experience decreased inpatients stays, shorter length of stay, and lower medical costs (Yu et al., 2014). Chan, Cheah, and Padzil (2019) investigated using a multidisciplinary approach to improve phosphate control in hemodialysis patients and found that the adherence in phosphate binders increased from 17.2 to 41.4% when a multidisciplinary approach was taken. When a patient had providers from multiple disciplines monitoring and educating them, reports show patients have a prolonged life expectancy. Having a multidisciplinary team in stages 3 and 4 of kidney disease prior to advancing to ESRD may reduce the need for hemodialysis due to the close monitoring of disease progression and early interventions with blood pressure, diet, fluid and electrolyte balance (Lin, Chertow, Yan, Malcolm & Goldhaber-Fiebert, 2018). Both nephrologists and primary care providers need to be prepared to care for ESRD patients. If a primary care provider does not feel confident in providing education about the renal diet, the patient should be referred to a dietary specialist member of the multidisciplinary team (Anderson & Nguyen, 2018). When considering a multi-disciplinary team, the social support system should be included. It is beneficial to focus not only on the health professionals and patient, but also family and support people to improve the diet and fluid adherence in hemodialysis patients SURVIVAL GUIDE FOR HEMODIALYSIS 13 (Sousa et al., 2019). Having a support system outside of the medical team provides encouragement to patients to meet their goals and results in improved adherence. When outpatient hemodialysis facility staff were asked their perception on what disparities they see in hemodialysis patients, 7.1% identified a lack of social support as a problem because there was no one to assist with care at home (Lipford et al., 2018). Literacy level of education The third educational theme is the consideration about educational tools being presented at the correct health literacy level for the patient. There are many interpretations on the definition of health literacy. According to the CDC (2016), The Patient Protection and Affordable Care Act of 2010, Title V, defines health literacy as the degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make appropriate health decisions. Limited health literacy has been identified in ESRD patients on hemodialysis. Taylor et al., (2016) utilized the Single-item Literacy Screener to define the literacy level of the 6,842 ESRD patients, 2,621 of whom were on hemodialysis. The hemodialysis population in the study had a 20% prevalence of limited health literacy. Escobedo and Weismuller (2013) reported a higher limited health literacy level of 41% of hemodialysis patients utilizing the Newest Vital Sign screening tool. Both studies indicated that limited health literacy negatively impacts the ESRD patients ability to understand and manage the disease process. The education required to understand hemodialysis and what interventions are required to maintain the body between treatments is extensive. Unfortunately, in medicine, often the educational resources do not appear to match the finding of limited health literacy. Williams, Muir and Rosdahl (2016) SURVIVAL GUIDE FOR HEMODIALYSIS 14 reported on the readability of patient education materials in ophthalmology using the FleschKincaid Grade Level (FKGL) and the Suitability Assessment of Materials (SAM) instruments. After evaluating 950 educational resources, the average readability level was 11th grade. Similarly, Hadden et al., (2016) evaluated 77 patient education materials for hand surgery and found an average of ninth to tenth grade reading levels. Applying those results to the ESRD population with limited health literacy levels, the materials would be too advanced for the patients to understand and apply (Escobedo & Weismuller, 2013; Levine et al., 2018; Taylor et al., 2016; Taylor et al. 2017). Although limited health literacy has been identified as a problem for ESRD patients in many studies, few solutions have been proposed. The problem goes even deeper, in that providers have a lack of awareness regarding how important health literacy is when educating their patients (De et al., 2015). The solution is in the provider and the providers approach. Rudd (2017) reported the need to evaluate and adjust all health providers communication skills regarding educating based on health literacy levels. The first task is to identify what level of literacy an educational tool needs to be at to be appropriate for the patient. The Joint Commission recommends patient education material be presented at a fifth-grade reading level. (Stossel, Segar, Gliatto, Fallar, & Karani, 2012). To achieve the fifth-grade reading level, an assessment tool can evaluate the readability grade level. Grabeel, Russomanno, Oelschlegel, Tester and Heidel (2018) compared using hand scored versus computerized health literacy evaluation tools on 148 educational materials. The two tools assessed were the Flesch-Kincaid (F-K) and the Simple Measure of Gobbledygook (SMOG). The authors reported that SMOG provided a precise measurement and graded the same tools at a higher reading level than the S-K tool with 147 of the 148 educational materials rated above a sixth-grade reading level. SURVIVAL GUIDE FOR HEMODIALYSIS 15 Jain and Green (2016) agreed with the Joint Commission on the appropriate health literacy grade level. They identified ways providers can help patients with limited health literacy understand medical information, including using plain, simple language without medical jargon, explaining test results so the patient understands what they mean, slowly presenting education, focusing on no more than three key points and repeat them, using teach-back, encouraging questions, and writing things down that are important to remember (Jain & Green, 2016). This project incorporated results from the literature review to make a Renal Diet and Fluid Restriction Survival Guide to empower patients to care for themselves and have improved outcomes. Theoretical Framework and Implementation Model Kings Theory of Goal Attainment focuses on effective nurse and patient communication (King, 1996). The nurse and patient need effective communication to set goals for the diet and fluid restriction education and make plans for resolution of their goal including lifestyle changes. The interaction between the nurse and patient can impact and influence how the goals are achieved. King stated in her work that not just individuals, but the family and community are a part of the framework that helps to make an interaction successful with health as the goal (Frey et al, 2002). King wrote in 1981 that nursing is the care of human beings. She expanded that statement in 1995 to say that with each individual a nurse interacts with, they also are reacting to a behavior. King said that nursing care is based on perceiving, thinking, relating, judging and acting based on that behavior. According to King, the goal of nursing is being able to help an individual to attain health and then to maintain and restore it when needed. When an individual is unable to attain, maintain and restore health, then the nurses role is to help an individual die with dignity (King, 1996). SURVIVAL GUIDE FOR HEMODIALYSIS 16 Gonzalo (2011) describes individuals as social, rational and reacting beings that are controlling, purposeful, action oriented, and time oriented in their behavior. An individuals behavior plays a role in interactions due to the perception of that behavior. In the theory of goal attainment, the perceptions of both the nurse and patient influence their interactions. The goals, needs, and values of each individual in the interaction will influence the process. If the goals of the health professional and the goals of the patient are not in line with one another, the patient may deny the interaction. Gonzalo (2011) stated that every individual has a right to knowledge and to participate in their medical care. The interactions that occurs between a healthcare provider and a patient can influence both an individuals life, health and community either negatively or positively depending on the effectiveness of that interaction (Gonzalo, 2011). Caceres (2015) implemented Kings Theory of Goal Attainment in determining a patients functional status. Caceres found that the aspect of the theory that talks about mutual decision making provided insight into how a patient saw and understood their functional status. Relating that to this project, in providing education to hemodialysis patients, the investigator and patient had to have a mutual decision making and investment into their education to have a successful interaction. King (1997) breaks down her Theory of Goal Attainment model into three interacting systems: personal, interpersonal, and social: The personal system is based on the way an individual will respond to objects and events in their life. Influences throughout a persons life shape them into who they are and how they make decisions. By evaluating the personal system SURVIVAL GUIDE FOR HEMODIALYSIS 17 including perception of self, growth and development, body image, space and time, the healthcare provider can individualize the health goals. The interpersonal system is based on interactions between two or more people and is where collaboration occurs. The interpersonal system is key in this project due to the intervention requiring an interaction between two people. The nurse providing the education and the patient receiving the intervention needs to have a successful transaction of information for the project to be successful. When an interaction takes place the key concepts that can impact the interpersonal system are: effective communication with the patient, transaction of information between provider and patient, roles of provider and patient as perceived by the patient, and stress both outside of education and stress of lifestyle changes. The social system is based on the interactions within a group of people with defined roles. In this project the social system would come into play when interprofessional collaboration occurs. The different roles that may interact in the project are primary care, nephrology, dietary, family and friends. All must share the goals of care in order for the patient to be able to achieve them. Defining the roles and the importance of each person in the role will be what connects each person to work towards the goal of the patient. To define the roles, nurses must consider the organization, authority, power, status and decision making of each member. Wang, Liu, Zhang, Ye and Zhang (2019) validated Kings Theory of Goal Attainment in a pharmacist and patient interaction. They found that the theory not only improves the patients SURVIVAL GUIDE FOR HEMODIALYSIS 18 health outcomes, but also improves the provider and patient relationship, which then has a positive impact on future interactions. The transaction process of the theory had statistically significant (p value < 0.001) results on both health goals and patient satisfaction indicating how important the interaction between provider and patient is in improving health outcomes. The Theory of Goal Attainment describes a dynamic relationship of interactions between the nurse and patient, where the patient gains information through education to attain specific goals. The relationship includes the personal, interpersonal, and social interactions that affect any progress towards the patients goal. A study investigating nurse practitioner practice using Kings theory of goal attainment found the theory applicable using mutual goal setting and positive transactions and interaction (de Leon-Demare, MacDonald, Gregory, Katz, & Halas, 2015). In this project, the interaction occurred when educating ESRD patients about the renal diet and fluid restrictions. To achieve the educational goal, according to this theory, the nurse and patient had to make a joint transaction based on a shared goal. If an interaction is successful between a provider and patient, it will provide growth and development with the education provided and the relationship will be enhanced. The interactions when providing education are important for the success of the shared goal. An interaction needs to occur with the patient as well as including the personal and interpersonal system to ensure success. This framework guided interactions to support the personal, interpersonal and social system of the patients that were educated in this project. Social Entrepreneurship and Innovation Martin and Osberg (2007) stated that social entrepreneurship is imperative to drive social change and benefit society. The people who share the authors beliefs of driving change are the SURVIVAL GUIDE FOR HEMODIALYSIS 19 ones that set the practitioners apart. A social entrepreneur has the ability to see an opportunity to add value to an underserved or disadvantaged population, as well as be willing to take on the risks to pursue it to improve a populations quality of life (Martin & Osberg, 2007). Another interpretation of social entrepreneurship in medical providers was by Fuchs and Cullen (2015), where they stated: innovation has both a qualitative and quantitative component. It refers to doing something new, or something old in a new way, that creates user-defined value that is a significant multiple of the competitive offering. Sick care sorely needs innovation that is not incremental or sustaining, but rather significantly adds at least 10 times the present value to have an impact (Fuchs and Cullen, 2015). In addition to addressing personal and interpersonal needs, Kings Theory of Goal Attainment also addressed the social aspects of health needs. A social entrepreneur needs to address all three areas to create change. Werber, Mendel and Derose (2014) evaluated social entrepreneurship in a religious congregation and reported that the congregation had a distinctive ability to identify unmet needs in their participants that providers were not identifying. They also had a significant impact on the participants seeking medical help. A social entrepreneur is able to identify an unmet need and then find the best way to address it as this congregation has by meeting personal, interpersonal and social aspects of the patient. To do that, this project found an unmet need, which is renal diet and fluid restriction education and put an educational intervention in place to meet that need. The educational intervention took into account the personal, interpersonal and social aspects in the nurse and patient interaction during the educational process. SURVIVAL GUIDE FOR HEMODIALYSIS 20 There are many interpretations as to what innovation of a project means. Baregheh, Rowley & Sambrook (2009) work towards a multidisciplinary definition of innovation which includes the generation, acceptance and implementation of a new idea, process or product. Thompson (1965) identified that innovation is not only important for an organization and market competition, but also acknowledged the need for innovation for social development (Thompson, 1965). In this project a new idea of how to educate patients receiving hemodialysis about the renal diet and fluid restriction was created and implemented to solve a problem. Using that definition of innovation encourages new paths of discovery and implementation as a mode for the social entrepreneur to advance their idea. If social entrepreneurship is done the right way, it will enhance the medical profession and improve patient care due to enhances patient education. This project focused on a population that wasnt receiving effective education about an appropriate renal diet and fluid restriction. As a social entrepreneur, there was the ability to provide a valuable service to this population by providing streamlined educational material to empower the patient with knowledge to better manage their renal failure. Social entrepreneurship isn't meant to be temporary; it is a social initiative to make a change in healthcare to improve the lives of others. Part of social entrepreneurship is constantly learning new skills and changing to improve the world. This project aimed to improve the lives of those with ESRD on hemodialysis by educating them about their diet and fluid restrictions. The patients receiving hemodialysis may be able to achieve electrolyte balance temporarily with hemodialysis. However, by empowering them to improve their own life through a change in diet and fluid restriction, these patients can obtain long-term quality of life and health improvement. SURVIVAL GUIDE FOR HEMODIALYSIS 21 Sustainability Sustainability in this project would be for the educational tool to be maintained and kept up to date with evidence-based material to provide continuing education on the renal diet and fluid restriction. For this educational tool to have sustainability post project, the DNP student identified and trained a change champion on the adult nephrology unit to continue education with new hemodialysis patients. The change champion was a nephrology nurse certified by the American Nephrology Nurse Association (ANNA) that took the initiative to continue the project by providing education to the patients. The change champion will need to continue assessing evidence-based practice recommendations to keep the tool up to date. The key stakeholder, who also is the unit manager, stated she would be interested in keeping the brochure on file for future educational use with patients. The cost of sustainability consisted of the time it took to train the current staff and ensuring the brochure would be available to them. Another consideration for sustainability would be for this educational material to be distributed to primary care providers to incorporate multidisciplinary care in assisting hemodialysis patients with their diet and fluid restriction. In that case this DNP student would take on the approach of handing out the brochure to primary care offices for their use while leaving contact information for any questions or concerns. Ethical Considerations Institutional Review Board (IRB) Approval was requested from Spectrum Health prior to implementing this project. Spectrum Health sent a letter on February 10, 2020 that determined that this project was a quality improvement project and does not need IRB approval and gave SURVIVAL GUIDE FOR HEMODIALYSIS 22 permission to start the project in their hospital. The letter was then submitted to Saint Marys College IRB and received approval on February 11, 2020. Informed consent was obtained from each participant. The participants were 18 years and older. The risk of this study was assuming patients had no prior knowledge of the renal diet and fluid restrictions. If a patient found it insulting that their knowledge was being tested it could have been an ethical risk. Although there was no pressure on the results, the testing of knowledge may have induced emotional stress on the patient. The benefit of this study was providing an educational tool that is a quick cheat-sheet style guide that a patient can reference quickly when making a diet or fluid choice without having to read copious amounts of information. It is a physical piece of paper that when patients were taught about the renal diet and fluid restrictions, they were able to follow along. It can be a tool for providers who need help explaining the renal diet and fluid restriction in a simple way. The pretest/posttest provided an added benefit to understand what areas of knowledge were lacking to improve education going forward. By understanding the areas that are lacking, contribution to increased nursing knowledge and practice change for this group of patients can occur. To determine how effective the renal diet and fluid restriction survival guide was, the pre-test and post-test results were analyzed for statistical significance. The results were logged by the investigator and compiled into an excel report. Each participant was assigned a number and no personal identifying information was kept. No information about the individual patients was disclosed. The paper records will be stored in a folder in a locked drawer, in a locked office on the Adult Nephrology Unit per the hospitals IRB requirement. The electronic documents are SURVIVAL GUIDE FOR HEMODIALYSIS 23 in a locked excel file in a password protected computer. In accordance with the Department of Health and Human Services (HHS) part 46 Protection of Human Subjects all records from this project will be retained for at least three years after completion. After that time, the records will be properly disposed of within Health Insurance Portability and Accountability Act (HIPPA) regulations by shredding any paper materials ensuring unreadability and clearing electronic media that is deidentified and stored on a password protected computer. Methods The intervention in this project was a Renal Diet and Fluid Restriction Survival Guide. The location of this project was Spectrum Health Butterworth Hospital in Grand Rapids, MI. It is a 1,120-bed hospital with a specialized heart center. The adult nephrology unit is located in the hospital where patients who are on hemodialysis and need to continue those treatments while admitted can go to receive their hemodialysis. This unit also does hemodialysis on patients with acute kidney injury (AKI) and patients with advanced chronic kidney disease (CKD) that are initiated on hemodialysis while inpatient. For inclusion in the DNP Innovation Project, patients were initiated on hemodialysis within the last one year. This was due to studies indicating that the longer a patient has been on hemodialysis, the less likely they are to be able to change food and fluid habits for compliance (Lee & Molassiotis, 2002; Morduchowicz et al., 1993). The projects goal was to recruit 13 patients based on the G power analysis indicating that to achieve 0.9 power the minimum sample size would have needed to be 13 patients. (Faul, Franz 2019) (Appendix F). G Power analysis was performed with assistance from Professor Kristen Kuter, Saint Marys College. SURVIVAL GUIDE FOR HEMODIALYSIS 24 That goal aligned with the approximate number of patients seen for hemodialysis and initiated on hemodialysis in Spectrums Nephrology unit. Patients with AKI were not included due to the possibility of recovery and the short-term need for hemodialysis and the renal diet. The patients with newly initiated hemodialysis either came to the adult nephrology unit for their treatment or if they were in the ICU, a nephrology nurse took the equipment to their room to do the treatment there. The patients who initiated hemodialysis or had been on it within the last a year were identified by this nephrology nurse and investigator. If the patient was cognitively able to participate and sign a consent, they were approached by this investigator to discuss participation in the project including benefits and risks. The Renal Diet and Fluid Restriction Survival Guide was created to fill a gap in appropriate education materials available at the identified inpatient hemodialysis unit. The survival guide utilized information about the renal diet and fluid restriction provided by the National Kidney Foundation (2019). In the survival guide, different electrolytes that are filtered by the kidneys are described in simple language, as well as identifying what will happen if they build up in the body when a person is diagnosed with renal failure. The areas the brochure focused on were potassium, phosphorus, sodium and fluid restriction. It also gave ideas on what foods to eat and what foods to avoid in proteins, fruits, vegetables, dairy and desserts. The final page of the brochure provided tips on what to do when a patient is on a fluid restriction but is thirsty. See Appendix A for the renal diet and fluid restriction survival guide. Prior to implementation of the project, on the hemodialysis unit ESRD patients were given a small chapter book about starting dialysis. Although it provided an overview of the medical aspect of ESRD and a description of the process of hemodialysis, there were only two SURVIVAL GUIDE FOR HEMODIALYSIS 25 pages dedicated to diet. Those two pages described the laboratory tests that could be high such as potassium and phosphorus, but it did not provide any further dietary education or meal suggestions. In a discussion with the Unit manager, she stated the current book was a great resource about hemodialysis, but she acknowledged that the dietary education was poor and leads to staff needing to provide patients with additional handouts. (M. Larson, personal communication, 10/16/2018). The additional handouts had diet and fluid restriction information, but it took five handouts about different subjects to ensure patients received all the educational information they needed. Patients who were very ill received a book and five handouts to read, which was an overwhelming amount of information to receive at one time. I am a Registered Nurse who works with hemodialysis patients. When asked, the patients indicated that a short guide with a simple list of what foods to avoid and foods to eat would be helpful. They said they want something small that they can bring along when leaving the house to make good food choices. The Renal Diet and Fluid Restriction Survival Guide is a short, simple guide with a literacy level of 5th grade as recommended by the Joint Commission (Stossel, Segar, Gliatto, Fallar, & Karani, 2012). To ensure the educational material was at the 5th grade reading level, it was tested using the Flesch-Kincaid Grade Level Index. The FleschKincaid Grade Level Index determines readability by determining the average number of syllables per word and the average number of words per sentence. The Renal Diet and Fluid Restriction Survival Guide Brochure scored a 5.4 in Flesch-Kincaid Grade level index. That Flesch-Kincaid Grade Level index would correlate with the grade level of reading comprehension the patient had to understand the document. SURVIVAL GUIDE FOR HEMODIALYSIS 26 Implementation Plan This project was implemented in three phases. In the pre-implementation phase the project was discussed with the identified patients, and if they were willing to participate, they were asked to sign the informed consent form. Also, in the pre-implementation phase, if the patient chose to participate, knowledge was assessed using the End Stage Renal Disease Adherence Questionnaire (ESRD-AQ). Permission was received from the author of the ESRDAQ, Youngmee Kim, and the American Nephrology Nurses Association (ANNA) to utilize the ESRD-AQ in the project. See Appendix B for ESRD-AQ. The ESRD-AQ served as a pretest and posttest in this project to assess the patients knowledge of the renal diet and fluid restriction. The implementation phase occurred immediately after the pretest is completed. The implementation phase included the intervention of providing the patient with the Renal Diet and Fluid Restriction Survival Guide and then discussing the material included in the guide. Following Kings Theory of Goal Attainment, a positive relationship with the patient was created during each phase by sitting and listening to the patient to ensure common goals are present. The post-implementation phase occurred 2 to 14 days after the implementation as recommended by the ESRD-AQ author (Kim, Evangelista, Phillips, Pavlish, & Kopple, 2010). The average amount of days in between the pre and posttest was 3.5 days in the patients that participated in the project with a range of two to eight days. The amount of days in between the pre and posttest was related to being able to collect posttest data prior to the patients projected discharge date. The post-implementation phase included the posttest to determine knowledge gained with the educational material. After the posttest was administered, the remaining post SURVIVAL GUIDE FOR HEMODIALYSIS 27 implementation period included documenting all results in a chart format and then analyzed the information to determine if the intervention was statistically significant. To determine the knowledge of the patient both prior to administering the Renal Diet and Fluid Restriction Survival Guide and after, the ESRD Adherence Questionnaire (ESRD-AQ) tool was be utilized as a pretest and posttest. The ESRD-AQ was developed by Youngmee Kim and published in the ANNA journal with her colleagues Evangelista, Phillips, Pavlish and Kopple (2010). It has 46 questions that measure attendance at hemodialysis sessions, medication use, fluid restriction and renal diet adherence. This project utilized questions 1-5 for demographic information and 29 through 46 which focused on the renal diet and fluid intake. Questions 5 through 28 are not without merit in general but were not applicable to this project. The ESRDAQ has been used in many studies investigating adherence in hemodialysis including the relationship between illness perceptions, adherence and outcomes on hemodialysis patients (Kim & Evangelista, 2010) and an evaluation about cultural adaptations and adherence (Lins et al., 2017). The limitations of using this tool were that the readability was only tested with a sample group and did not use a reliable and valid measure. The tool was not at the appropriate literacy level, which led to increased time in administration to ensure that the patient understood the questions being asked. The authors of the ESRD-AQ determined the appropriate time to retest using the tool is 2 to 14 days after the intervention is administered. The patients in this project were inpatient in the hospital for different amounts of time so the post-test administration was done in person on average 3.5 days after the pretest during their next hemodialysis session prior to the patients discharge date. SURVIVAL GUIDE FOR HEMODIALYSIS 28 The reliability of the ESRD-AQ indicated a strong test-retest stability with the ICC results ranging from 0.83-1.00. The self-reported adherence appeared to be consistent between the pretest and posttest as indicated by the phi correlations. To determine validity, the authors had seven experts including two nephrologists, one nurse practitioner, two hemodialysis nurses and two renal dieticians assess the content and make changes prior to giving the tool to five patients identified in a target group for feedback. To then test for validity, Kim et al., (2010) stated that the item-level content validities in the 46 questions ranged between 0.86 and 1.00. That range gives the average of I-CVI of 0.99 which implies that the content is adequately represented by the questions. The authors then used the Mann-Whitney U test to evaluate the mean scores from the two groups of patients. The two groups are identified as patients that adhere to treatments and patients that do not adhere to treatments. That comparison indicated that the ESRD-AQ was able to differentiate from the adhering group versus the non-adherers. The plan was to administer the ESRD-AQ during one of the patients first hemodialysis treatments or for the patients who are already on hemodialysis, it was administered during their next treatment session while inpatient. For patients who were initiating hemodialysis while inpatient, the general process is to have three hemodialysis treatments three days in a row before being ready for discharge and started at an outpatient center. If the pre-test and intervention were both given on the first day, the third day was the targeted date for the post-test. All three phases largely depended on the patients status and discharge, so close monitoring and follow up was important to complete the pretest, intervention and posttest. SURVIVAL GUIDE FOR HEMODIALYSIS 29 Data analysis As pre-test and post-tests were being done, the scores were documented in a table format for analysis. Once all the participants results were in, data analysis was performed using StatCrunch software. The Paired t-test was utilized to analyze the data and G*Power analysis for power of the project. The analysis was completed by the investigator. Timeline The initial timeline for this project once pre-implementation began was 8 months until completion. The pre-implementation and implementation phases were somewhat simultaneous. The final month was used for data analysis. See Gantt chart below. Project Timeline 8/1/2019 9/20/2019 11/9/2019 12/29/2019 2/17/2020 4/7/2020 5/27/2020 Preparatory phase: IRB approval and tool preparation Pre-implementation Implementation Post-implementation Data Analysis After some initial delays in IRB approval the project timeline had to be re-evaluated and updated. The Coronavirus Pandemic impacted the ability to do the project on time at the hospital site because all non-emergent services and research were placed on hold for a short time. The nephrology unit census was significantly decreased during the pandemic as well. This also impacted the number of patients that data were able to be collected on within the timeline. The updated Gantt chart with timeline below. 7/16/2020 SURVIVAL GUIDE FOR HEMODIALYSIS 30 Budget The budget for this project consisted of the cost to print materials. The investigator donated time to perform the tasks identified above. Due to a positive working relationship with the adult nephrology unit there was no cost involved for performing the project at that location. The materials needed included a consent for each patient, two copies of the ESRD-AQ tool for pretest and posttest and the brochure intervention. The average cost of printing is $0.09 per page for black and white copies of the ESRD-AQ tool and $0.37 for color copies. Since 10 patients participated, that amounted to $14.50 that was paid for by the DNP student performing this project. Minimal additional costs were required for data analysis due to this investigator was able to perform the data analysis independently using Statcrunch software that added an additional $14.99 increasing the total spent to $29.49. This project had significance, as evidence by the pvalue of <0.001, in improving knowledge of the renal diet and fluid restriction. Additional copies of the tool were printed to continue providing education to the ESRD on hemodialysis patients. SURVIVAL GUIDE FOR HEMODIALYSIS 31 Results Quantitative Ten patients participated in the project. The number is less than the goal of 13 patients due to delays in project initiation and low patient census related to the Coronavirus Pandemic impact. The time since initiation of hemodialysis in the 10 patients when performing the pretest ranged from 1-210 days on hemodialysis with an average of 66.2 days. As pre-test and post-tests were being done, the scores were documented in a table format for analysis. The range of days from pretest to posttest was two to eight days between with an average of 3.5 days. Once all the participants results were in, data analysis began. The Paired t-test was used to analyze the data. The analysis was completed by the investigator utilizing StatCrunch software. In the ESRD-AQ assessment tool, numbers were assigned to each answer. The lower the score the more adhering the patient was to the diet, so the goal score a patient could achieve would be 18 points. The poorest diet adherence score would be 108 points. The patients pretest score mean was 51.8 and posttest score mean was 32.6. The patients on average showed almost a 20 point improvement on their scores. When using the paired t-test, the p value was <0.0001, indicating significance in the results. (Appendix G). Qualitative The first five questions in the ESRD-AQ were general information and demographics that asked when they started, have they ever used a different mode for dialysis such as peritoneal or transplant and what their transportation and support system entails. Of the 10 patients, seven of them had family or spouse support that took them to and from hemodialysis. The three patients SURVIVAL GUIDE FOR HEMODIALYSIS 32 that did not have a support system had the bottom three scores suggesting that support system has an impact on a hemodialysis patients diet and fluid restriction compliance. After performing the posttest with each participant, the investigator asked what the biggest struggles and easiest aspect for the patients were on the renal diet and fluid restriction. There were three main themes that arose from those questions: family, fluid restriction and life changes. The most common of those themes was family. The participants varied on expressing how much easier it will be because of family or how the family does not take an active participation so it will be harder for them to be compliant. I wish my family understood more, my wife needs this education too because she does all the cooking, my family changed their diets too so that helps me (participant feedback, 2020). The next theme was fluid restriction, three of the patients still make some urine so they were less concerned about the fluid restriction and others identified it would be their biggest struggle. I still urinate some so the fluid restriction hasnt been my issue but good to learn now before it becomes one, fluid restriction will be hard on the hot days this summer, hardest part is figuring out the fluid stuff because I get cramps in my legs, the hardest part for me are not having fast food, desserts, and following a fluid restriction on a hot day (participant feedback, 2020). The last theme was life changes. For the patients who had just started hemodialysis there was a lot of changes coming into their life at once. Beginning hemodialysis three times a week is a big adjustment and the diet and fluid restrictions put an additional strain on the patient. had to change my whole life around.lost a lot of friends when I had to change my lifestyle, this is all so new, I have a lot of changes to make (participant feedback, 2020). SURVIVAL GUIDE FOR HEMODIALYSIS 33 Discussion The strength in this study was the educational tool. Feedback from participants stated it was accessible and small enough to take with them, I like the information on this and how it is small enough that I can put this in my purse to use at restaurants (participant feedback, 2020). The Renal Diet and Fluid Restriction Survival guide brochure was easily understood by all of the participants, so the literacy level was appropriate. Although unable to achieve the goal number of participants, each participant that qualified by being ESRD and starting within the last one year agreed to participate simply in knowing they were able to keep the educational tool. Limitations in the project were the number of participants and the pre-test/post-test. Although the goal patient number was 13 people, but only 10 people were able to be recruited. The G*Power analysis was redone with the mean and standard deviation and resulted in a power of 1.0 showing that the significant results as evidence by the p-value are supported by the power analysis (Appendix H). The other limitation was the pre-test and post-test questionnaire. The ESRD-AQ focuses on adherence, but not knowledge. There is a lack of a current validated tool to measure actual knowledge on the renal diet and fluid restriction rather than adherence alone. The investigator asked a few questions post ESRD-AQ on what the most difficult and easy aspects of the diet and fluid restrictions were for them and that provided useful information on where to go forward with future study. Participants identified the need for family involvement to be successful in a diet change. APRNs can take this information and use it when providing education both inpatient and outpatient to ensure that the support system participates in the education. As providers we are not able to change how difficult the fluid restriction is other than SURVIVAL GUIDE FOR HEMODIALYSIS 34 giving tips on how to get through it, but we can involve the people who the patients are eating and drinking those meals with. A few of the participants also stated they did not always know the reasons behind restrictions in the diet until they were given the renal diet and fluid restriction survival guide brochure. This is something the multidisciplinary team can change by not only teaching the diet but give the patient a better understanding of why those changes need to be made in an appropriate literacy level. One of the participants stated that now that he knows why he must do all the changes; he feels more involved instead of just being talked at about what he needs to do. Patients who understand the changes may be more likely to make the changes. Providers need to take from this project the need to incorporate support system education, correct literacy level for patients, smaller amounts of information at a time and change the way the information is provided by giving the why in addition to the what to do. Conclusion As the literature identified, hemodialysis patients are at a high risk for readmissions into the hospital and an increase in mortality without proper education. Hemodialysis is often started inpatient and without care from a nephrologist prior to initiation. This project aimed to educate patients who have started hemodialysis within one year and patients initiated while inpatient during this project. With so many life changes occurring for this population, the education about the renal diet and fluid restrictions must be informative but not overwhelming. This project took into consideration the appropriate literacy level of the population and created an educational project at that level. This educational tool was evaluated in the inpatient setting and found to be statistically significant in improving diet and fluid education to hemodialysis patients. Knowing it is statistically significant, it may be utilized by primary care providers as well in an outpatient SURVIVAL GUIDE FOR HEMODIALYSIS 35 setting. By creating an educational tool that can be used by collaborating providers it gives the patient a multidisciplinary team that works together to empower the patient to improve his or her health by adhering to the diet and fluid restriction. The identified population in this project benefited from health promotion and education. This innovative project will fill a gap in the current practice of patient education on renal diet and fluid restrictions. SURVIVAL GUIDE FOR HEMODIALYSIS 36 References Anderson, C. A., & Nguyen, H. A. (2018, March). Nutrition education in the care of patients with chronic kidney disease and endstage renal disease. In Seminars in dialysis (Vol. 31, No. 2, pp. 115-121). Arif, F. M., Sumida, K., Molnar, M. Z., Potukuchi, P. K., Lu, J. L., Hassan, F., ... & Kovesdy, C. P. (2017). Early mortality associated with inpatient versus outpatient hemodialysis initiation in a large cohort of US veterans with incident end-stage renal disease. Nephron, 137(1), 15-22. 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A., de Ferris, M. D. G., Cohen, S., ... & Rak, E. (2018). Disparities in health literacy and healthcare utilization among adolescents and young adults with chronic or end-stage kidney disease. Journal of pediatric nursing, 38, 57-61. SURVIVAL GUIDE FOR HEMODIALYSIS 40 Lin, E., Chertow, G. M., Yan, B., Malcolm, E., & Goldhaber-Fiebert, J. D. (2018). Cost -effectiveness of multidisciplinary care in mild to moderate chronic kidney disease in the United States: A modeling study. PLoS medicine, 15(3), e1002532. Lins, S. M. D. S. B., Leite, J. L., Godoy, S. D., Fuly, P. D. S. C., Arajo, S. T. C. D., & Silva, . R. (2017). Cultural adaptation of the end-stage renal disease adherence questionnaire for hemodialysis patients. Revista brasileira de enfermagem, 70(6), 1169-1175. Lipford, K. J., McPherson, L., Hamoda, R., Browne, T., Gander, J. C., Pastan, S. O., & Patzer, R. E. (2018). Dialysis facility staff perceptions of racial, gender, and age disparities in access to renal transplantation. BMC nephrology, 19(1), 5. Martin, R. L., & Osberg, S. (2007). Social entrepreneurship: The case for definition. Martnez, C. R. (2014). Nutritional knowledge and perception on dialysis: influence on adhesion and transgression; initial study. Nutricion hospitalaria, 31(3), 1366-1375. McCance, K. & Huether, S. (2014). Pathophysiology: The biologic basics for disease in adults and children. (7th ed.). St. Louis, MO: Mosby, Elsevier Inc Morduchowicz, G., Sulkes, J., Aizic, S., Gabbay, U., Winkler, J., & Boner, G. (1993). Compliance in hemodialysis patients: a multivariate regression analysis. Nephron, 64(3), 365-368. National Kidney Foundation. (2019). Dialysis. Retrieved from: https://www.kidney.org/atoz/content/dialysisinfo National Kidney Foundation. (2016). End Stage Renal Disease in the United States. Retrieved SURVIVAL GUIDE FOR HEMODIALYSIS 41 from: https://www.kidney.org/news/newsroom/factsheets/End-Stage-Renal-Disease-inthe-US National Kidney Foundation. (2019). How your kidneys work. Retrieved from: https://www.kidney.org/kidneydisease/howkidneyswrk National Kidney Foundation. (2019). Nutrition and Dialysis. Retrieved from: https://www.kidney.org/nutrition/Dialysis Parker, J.R. (2019). Use of an educational intervention to improve fluid restriction adherence in patients on hemodialysis. Nephrology Nursing Journal, 46(1), 43-47. Pisani, A., Riccio, E., Bellizzi, V., Caputo, D. L., Mozzillo, G., Amato, M., ... & Sabbatini, M. (2016). 6-tips diet: a simplified dietary approach in patients with chronic renal disease. A clinical randomized trial. Clinical and experimental nephrology, 20(3), 433-442. Rudd, Rima. (2017). Health Literacy: Insights and Issues. Studies in Health Technology and Informatics, 240, 60-78. doi: 10.3233/978-1-61499-790-0-60 Sousa, H., Ribeiro, O., Pal, C., Costa, E., Miranda, V., Ribeiro, F., & Figueiredo, D. (2019). Social support and treatment adherence in patients with endstage renal disease: A systematic review. In Seminars in dialysis (Vol. 32, No. 6, pp. 562-574). Stossel, L., Segar, N., Gliatto, P., Fallar, R., & Karani, R. (2012). Readability of Patient Education Materials Available at the Point of Care. Journal of General Internal Medicine, 27(9), 1165-1170. doi: 10.1007/s11606-012-2046-0 Taylor, D. M., Bradley, J. A., Bradley, C., Draper, H., Johnson, R., Metcalfe, W., ... & Ravanan, SURVIVAL GUIDE FOR HEMODIALYSIS 42 R. (2016). Limited health literacy in advanced kidney disease. Kidney international, 90(3), 685-695. Taylor, D. M., Fraser, S. D., Bradley, J. A., Bradley, C., Draper, H., Metcalfe, W., ... & Roderick, P. J. (2017). A systematic review of the prevalence and associations of limited health literacy in CKD. Clinical Journal of the American Society of Nephrology, 12(7), 1070-1084. Thompson, V. A. (1965). Bureaucracy and innovation. Administrative science quarterly, 1-20. U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. (2014). National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD. U.S. Renal Data System, USRDS 2017 Annual Data Report: Chapter 1: Incidence, Prevalence, Patient Characteristics, and Treatment Modalities. (2017). National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD. Usvyat, L. A., Kooman, J. P., van der Sande, F. M., Wang, Y., Maddux, F. W., Levin, N. W., & Kotanko, P. (2013). Dynamics of hospitalizations in hemodialysis patients: results from a large US provider. Nephrology Dialysis Transplantation, 29(2), 442-448. Van Duong, T., Tseng, I., Wong, T. C., Chen, H. H., Chen, T. H., Hsu, Y. H., ... & Feng, Y. W. (2019). Adaptation and Validation of Alternative Healthy Eating Index in Hemodialysis Patients (AHEI-HD) and Its Association with all-Cause Mortality: A Multi-Center Follow-Up Study. Nutrients, 11(6), 1407. Wang, D., Liu, C., Zhang, Z., Ye, L., & Zhang, X. (2019). Validation of the King's transaction SURVIVAL GUIDE FOR HEMODIALYSIS 43 process for healthcare provider-patient context in the pharmaceutical context. Research in Social and Administrative Pharmacy, 15(1), 93-99. Werber, L., Mendel, P. J., & Derose, K. P. (2014). Social entrepreneurship in religious congregations' efforts to address health needs. American Journal of Health Promotion, 28(4), 231-238. Williams, A. M., Muir, K. W., & Rosdahl, J. A. (2016). Readability of patient education materials in ophthalmology: a single-institution study and systematic review. BMC ophthalmology, 16(1), 133. Yu, Y. J., Wu, I. W., Huang, C. Y., Hsu, K. H., Lee, C. C., Sun, C. Y., ... & Wu, M. S. (2014). Multidisciplinary predialysis education reduced the inpatient and total medical costs of the first 6 months of dialysis in incident hemodialysis patients. PloS one, 9(11), e112820. SURVIVAL GUIDE FOR HEMODIALYSIS 44 Appendix A: Diet and Fluid restriction Survival Guide Brochure What is a fluid restriction and why do I have one? People on dialysis must limit fluid. That means your doctor will tell you how much fluid you can have a day. Diet and fluid restriction advice was obtained from the following references: National Kidney Foundation When you drink too much fluid between your dialysis sessions, it can make you uncomfortable. Fluid buildup can cause swelling, make it hard to breathe and may increase your blood pressure. Fluid is not only what you drink. Fluid can be hidden in foods you eat, such as jello, ice, sherbet, sauces, and gravies. Every persons dietary needs are different. This brochure is to serve as a guide, but please see your kidney doctor, family doctor or dietician for a meal plan. What do I do when I am thirsty? Limit salt and spicy foods. Stay cool. You are thirstier when you feel hot. Sip instead of gulp and use a small cup for your drink. Try ice instead of fluid, but dont forget to count the ice you eat as fluid intake. If you take medicines with meals, try to swallow them with food instead. Use mouth wash or brush your teeth when your mouth feels dry. Suck on hard candy or a wedge of lemon or lime. Contact Us Carly Thompson RN, DNP Student Saint Marys College Notre Dame, IN Email: cthompson01 @saintmarys.edu RENAL DIET AND FLUID RESTRICTION SURVIVAL GUIDE SURVIVAL GUIDE FOR HEMODIALYSIS Why a Renal Diet and fluid restriction? When your kidneys fail, your body cannot keep a healthy balance of fluid, electrolytes, or get rid of waste. Potassium If the potassium in your blood gets too high, it can affect your heart and how well your heart works. Foods high in potassium are: Fruit: bananas, oranges, mangos, apricots, melons, kiwi, prunes, nectarines, and dried fruits such as raisins. Vegetables: avocados, broccoli, tomatoes, sweet potatoes, baked potatoes, French fries and chips, pumpkin, beets, cooked spinach, cooked asparagus, lima beans, carrot juice, brussels sprouts, and winter squash. Other foods high in potassium: sunflower and pumpkin seeds, nuts and nut butters, yogurt, cottage cheese, tuna, soy and white beans. You need to eat more protein. Eat less salt, potassium and phosphorus. You also need to learn how to control fluid intake to feel your best. What foods do I avoid and why? Salt Too much salt in your diet can cause your body to keep too much water. That extra water makes you gain weight between dialysis sessions and may causing swelling and trouble breathing. Avoid putting extra salt on your food. Use other herbs and spices in place of salt to flavor your food. When your kidneys arent working, your body cannot balance the amount of potassium. Eating the right amount of protein, salt, potassium and phosphorus can help you to control the buildup of waste and fluid in your body. 45 What should I eat? Protein Fruits and Vegetables and Dairy Phosphorus If your kidneys dont work, they cannot get rid of extra phosphorus. If it builds up in your body, it can make your bones weak. Your doctor may have you take a medication with your meals to help lower your phosphorus level. Foods high in Phosphorus are beans, peas, seeds, dairy, and whole grain and high fiber bread People on dialysis need more protein Protein helps build and repair skin, muscles and organs You need 8-10 ounces of protein every day Examples of proteins: 3 ounces is about the size of a deck of cards: pound beef, half chicken breast, fish filet or pork chop 1 ounce is one egg or cup egg substitute Fruit: apple, berries, cherries, grapes, peach, tangerine, plum, pear Juice: apple cider, cranberry juice cocktail, grape juice and lemonade Vegetables: cabbage, carrots, cauliflower, celery, cucumber, eggplant, garlic, lettuce, onion, peppers, zucchini and yellow squash Dairy: butter, cream cheese, heavy cream, ricotta cheese, brie cheese, non-dairy whip cream, and sherbet Desserts Pies, cake, sherbet, and cookies Avoid: dairy, chocolate, nuts and bananas SURVIVAL GUIDE FOR HEMODIALYSIS Appendix B: End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) 46 SURVIVAL GUIDE FOR HEMODIALYSIS 47 Reprinted from the Nephrology Nursing Journal, 2010, Volume 37, Number 4, pp. 377-393. Reprinted with permission of the American Nephrology Nurses Association, East Holly Avenue, Box 56, Pitman, NJ 08071-0056; Phone: 856-256-2300; Fax: 856-589-7463; Email: nephrologynursing@ajj.com; Website: https://www.annanurse.org/ SURVIVAL GUIDE FOR HEMODIALYSIS Appendix C: CITI 48 SURVIVAL GUIDE FOR HEMODIALYSIS 49 SURVIVAL GUIDE FOR HEMODIALYSIS 50 SURVIVAL GUIDE FOR HEMODIALYSIS Appendix D: Consent Informed Consent Form Renal Diet and Fluid Restriction Survival Guide Study Saint Marys College You are invited to participate in a study designed to find out if a survival guide on the renal diet and fluid restriction given to patients who started hemodialysis in the last one year increases patient knowledge on the subject. You have been chosen to participate in this study because you are a person who has started hemodialysis in the last one year. The purpose of this investigation is to attempt to find out the current renal diet and fluid restriction knowledge and if a survival guide brochure on the renal diet and fluid restriction increases that knowledge. Your participation may help us learn what education information and type of tool will help patients newly on hemodialysis learn about renal diet and fluid restrictions, and this information may help us to provide adequate education to hemodialysis patients. You will be asked to participate in a pretest provided by Carly Thompson, a Doctorate of Nurse Practitioner student from Saint Mary's College. This pretest will ask questions about your current knowledge of the renal diet and fluid restrictions. You will then receive education via a survival guide brochure on the renal diet and fluid restriction. Two to Four days after you receive the education depending on your discharge date you will take a posttest provided by Carly to determine if the education provided was adequate in teaching you about the renal diet and fluid restriction. Because we want to learn how effective the renal diet and fluid restriction survival guide is, we will use your pretest and posttest results. The results will be put into a report. In the report, each person will be assigned a number, and the identity of those who took the pretest and posttest will not be revealed. Only Carly will know your identity. The report will be presented as group data so no information about you that would reveal your identity will be disclosed. During the process of the pretest, education and posttest, you are free to stop participating in this study at any time if you feel uncomfortable. The risks of this study would be assuming patients have no knowledge can be an ethical risk because the patient may find it insulting that we are testing their knowledge, and taking a test can be a stressful thing for anyone even if no pressure is on the results so testing knowledge may induce emotional stress on the patient. Benefits of this study is providing an educational tool that is a quick cheat sheet style guide. It can be something a patient can reference quickly when making a diet or fluid choice without having to read copious amounts of information. It is physical piece of paper that when performing education, they can have it in front of them to read. It can be a tool for providers who need help explaining the renal diet and fluid restriction in a simple way. The pretest/posttest will be a benefit to understand what areas the knowledge is lacking to improve education going forward. The pretest and education on the first visit should take approximately thirty minutes to one hour and will occur during your hemodialysis treatment. The posttest two to four days later should take approximately fifteen to thirty minutes. If you have questions about this study, please ask Carly. She will be happy to answer them. She is available by email at cthompson01@saintmarys.edu. You will be given a copy of this form to keep. You 51 SURVIVAL GUIDE FOR HEMODIALYSIS 52 are making a decision about whether or not to participate. Your signature indicates that you are at least 18 years of age, have read the information provided above, and have decided to participate in the study. You may withdraw at any time without penalty after signing this form should you choose to discontinue participation in this study and your testing results will not be included in the report. Withdrawing will not in any way affect your health or treatment. I agree to participate in this study. I am at least 18 years of age. The purpose of the study has been explained to me. I understand that the information obtained about me will be confidential. I have been told the benefits and drawbacks of participating. I know whom to contact for further information. I understand the procedure may take up to two hours total. I know that my participation is voluntary, that refusal to participate will involve no penalty, and that I may withdraw at any time. __________________________________ _________________ Signature of Participant Date __________________________________ _________________ Signature of Investigator Date SURVIVAL GUIDE FOR HEMODIALYSIS Appendix E: Concept Map Appendix F: G*POWER analysis 53 SURVIVAL GUIDE FOR HEMODIALYSIS Appendix G: Statcrunch analysis Appendix H: Power Analysis post project 54  ...

... 1 Sleep Hygiene Education for Parents of School-Age Children Katherine Sollmann, RN-BSN Family Nurse Practitioner Track Department of Nursing, Saint Marys College Faculty Team Leader: Dr. Jennifer Bauer 2 Abstract The problem of insufficient sleep during childhood is contributing to short-term and long-term physical, mental, emotional, and behavioral problems for children (slund et al., 2018). Many health-based interventions have been focused on improving nutrition or increasing physical activity during childhood. While these are important topics to be addressed, improving sleep hygiene will affect overall health throughout the lifespan. This practice innovation project, based on current evidence, introduces a parent educational program pertaining to sleep hygiene for school aged children in South Bend, Indiana. The goal of this project was to establish a way of promoting sleep hygiene for school aged children that can be translated into primary care and other settings such as schools and child welfare agencies. 3 Contents Introduction..5 Background..5 Problem Statement...6 PICOT and Objectives.....6 Definition of Terms..7 Literature Review.8 Concept Map..12 Strengths and Weaknesses of the Current Literature.13 Foundational Theory..13 Implementation Model...17 Social Entrepreneurship & Innovation...18 Sustainability..18 Ethical Considerations...19 Methods..23 Data Collection and Analysis.26 Results....28 4 Discussion......39 Conclusion.40 References..41 Appendix A. CITI Certification.49 Appendix B. Gantt Chart...50 Appendix C. Informed Consent.51 Appendix D. Measurement Tools..56 Appendix E. Literature Synthesis Table58 5 Introduction What if there was an intervention for lowering childhood obesity, decreasing risk for mental illness, increasing quality of life, improving learning and behavior, and preventing future chronic diseases for children? What if this intervention came at no financial cost to the patient, their family, or the provider? Evidence suggests that sleep is the intervention children need to reap many of these benefits. Unfortunately, nearly two thirds of children do not get enough sleep (Office of Disease Prevention and Health Promotion [ODPHP], n.d.). This takes a considerable toll on children, their families, schools, and the health care system. While many studies and subsequent recommendations have correlated childhood obesity with nutrition and physical activity, insufficient sleep can play an important role in metabolism, food choices, and activity levels (Agaronov et al., 2018). Lack of sleep disproportionately affects ---people of color (Carnethon, 2016). When looking for ways to improve health disparities, optimizing sleep can be an important step in the right direction. Background One of the objectives included in Healthy People 2030 is to increase the proportion of children who get sufficient sleep. According to Healthy People 2030, nearly one third of children between the ages of 4 months and 14 years did not receive sufficient sleep based on parent survey in 2016-2017. Healthy People 2030 draws the link between insufficient sleep and health complications such as cardiac problems, obesity, and endocrine disorders such as diabetes as well as learning, mood, and behavioral issues. In order to meet the objective set forth by Healthy People 2030, a variety of interventions are suggested such adjusting the start time for schools, educating parents, and promoting behavioral interventions (ODPHP, n.d.). 6 Problem Statement This practice innovation project focused on the phenomenon involving the negative effects of inadequate childhood sleep. Approximately one-third of children do not get the recommended amount of sleep (ODPHP, n.d.). Lack of sleep during childhood plays a detrimental role in long-term health outcomes as well as cognitive and affective functioning. Children who do not receive adequate sleep may have behavior difficulties, irritability, decreased motivation, and inability to focus (slund et al., 2018). While many factors influence the amount and quality of sleep during childhood, this project was designed to help parents prioritize sleep and optimize their childrens sleep hygiene. PICOT and Objectives After reviewing literature and examining the specific problem of inadequate childhood sleep, the following PICOT question was asked: Are parents of school age children (P) who participate in a sleep promotion program (I) more likely to prioritize sleep hygiene for their child (O) than prior to participation in the program (C) over a 30 day period (T)? The DNP student sought to impact the parents of school age children, providing them with education and tools to prioritize sleep and optimize their childrens sleep hygiene. This type of project recognizes the unmet need of a group, develops a program to help meet that need, and evaluates the effectiveness and outcomes of the program (Moran et al., 2020). The unmet need this project sought to address is the need for sufficient sleep among school-age children. The program aimed to help parents understand and address their childrens need for proper sleep hygiene in order to increase their childrens sleep quality and duration. Evaluation of this projects effectiveness and outcomes involved the use of the Child and Adolescent Sleep 7 Checklist (CASC) and parent survey designed to evaluate knowledge, attitudes, self-efficacy and beliefs. Definition of Terms Parenting The term parenting is described in the literature as complex, dynamic, and multifaceted (Lindhiem & Shaffer, 2017). Parenting involves aspects of the environment in which parenting takes place, such as culture or socioeconomic status; attributes of the parent themselves, such as levels of education and stress; and characteristics of the child, such as developmental stage and temperament. When examining specific dimensions of parenting, one study found only weak to moderate associations between certain parenting behaviors and child wellbeing. The conclusion was that it is important to consider a wide variety of influences on child wellbeing (Crandell et al., 2018). By reading and synthesizing the information obtained for this project, the concept of parenting is defined as the dynamic combination of factors originating in the environment, the parent, and the child which influences the behavior, health, and development of the child and, in turn, affects the parent and environment. Behavior Change When looking at parenting through the lens of health promotion and behavior change, it is essential to recognize the complexity of parenting and examine the various factors determining observed behaviors, the parent-child relationship, and willingness to receive intervention. Successful parenting interventions that lead to behavior change will increase engagement and empower parents, particularly those who are at risk or who have had negative past experiences with institutional intervention (Dawson-McClure et al., 2017). Behavior change requires education, understanding, encouragement, and consistency. 8 Sleep Hygiene Sleep hygiene can be defined as the consistently followed routines that foster adequate and appropriate sleep at night which promote wakefulness during the day (Orji et al., 2017). There are a variety of valid and reliable measurement tools used to assess sleep hygiene. Many of these scales examine items such as caffeine intake, activities prior to bedtime, sleep location, availability of electronics at bedtime, fears and worries, parasomnias, insomnia, and snoring (Meltzer et al., 2013). Literature Review The original literature search for this paper involved the use of the following three databases: Psych Info, CINAHL-FT, and Social Work Abstracts. The search headings parenting, behavior, behavior change, and health were utilized, as well as the filter NOT for the terms infant, baby, and/or neonate. Articles from the years 2015-2020 in the English language were included in each search. Psych Info provided 161 articles, CINAHLFT resulted in 51 articles, and Social Work Abstracts brought forth 56 articles. These results were examined and applicable articles were selected for this exploration of central concepts relating to parenting, behavior change, and health. The articles varied from Level II through Level V with the majority providing A or B quality using the Johns Hopkins Nursing EvidenceBased Practice Appendix C (Dang & Dearholt, 2017). Another literature search was conducted using the University of Notre Dames Hesburgh Library One Search. The terms sleep hygiene and parent education in any field were used for inclusion and the term infant in any field was used for exclusion. Thousands of results were 9 narrowed down using the following filters: 2016-present, peer-reviewed journals, and English language. Approximately 2,000 articles remained, and these were sorted by date and relevance. Theme One: Inadequate Sleep Causes a Range of Problems One of the themes of the literature is the need for adequate sleep for optimal functioning. The negative effects of inadequate childhood sleep are wide-ranging. Approximately two thirds of children are not getting the recommended amount of sleep (Office of Disease Prevention and Health Promotion [ODPHP], n.d.). Children, their families, schools, and the healthcare system pay the price for this in a myriad of ways. Poor sleep has been linked to diabetes and cardiovascular mortality, as well as depression and suicide (slund et al., 2018). Lack of sleep in childhood plays a detrimental role in cognitive and affective functioning. Children who do not receive adequate sleep may have behavioral difficulties, irritability, decreased motivation, and inability to focus (slund et al., 2018). Many studies have correlated childhood obesity with nutrition and physical activity. Insufficient sleep can play an important role in metabolism, food choices, and activity levels (Agaronov et al., 2018). Researchers studying excessive daytime sleepiness in children determined that factors contributing to the problem of insufficient sleep include inadequate sleep hygiene, sleep-onset issues, limit-setting issues, nighttime fears, and nightmares (Thomas & Burgers, 2018). As health care systems and other organizations look to address health disparities, it is important to examine the way inadequate sleep can lead to poor health outcomes. People of color are disproportionally affected by lack of sleep (Carnethon, 2016). One recent study examined the link between adverse childhood experiences (ACEs) and delinquent behavior of preadolescent children in foster care (Hambrick et al., 2018). Sleep appeared to be a mediating factor in the association between ACEs and delinquent behavior, leading to recommendations of assessing for 10 sleep problems in foster youth, assisting foster parents in establishing proper sleep habits, and including sleep in treatment plans (Hambrick et al., 2018). Theme Two: Parent Sleep Hygiene Education Improves Childrens Sleep Another theme in the literature is the value of parent education on the topic of sleep hygiene in order to improve childrens sleep. There are many examples of program development and evaluation aimed at helping parents and families adopt health-promoting behaviors. A group of researchers in Australia used a randomized control trial to study the effectiveness of a program involving brief consultations between parents of primary school children and a school nurse trained in teach sleep management techniques (Quach et al., 2016). Using Sleep Disorders Questionnaire (SDQ), Pediatric Quality of Life Inventory (PedsQL), and the Depression, Anxiety, and Stress Scale (DASS-21), they found improvement in child psychosocial health, sleep, and parent mental health (Quach et al., 2016). This study also highlighted the effectiveness of involving school nurses in health-promoting interventions among school-age children (Quach et al., 2016). Another study utilized trained psychologists and pediatricians to offer sleep hygiene practices and behavior management strategies for parents of children with attention deficit hyperactivity disorder in two sessions over the course of two weeks and a follow-up phone call (Hiscock et al., 2015). This study was also designed as a randomized control trial that found improvement in childrens sleep, behavior, quality of life, and functioning at both the threemonth and six-month follow-up (Hiscock et al., 2015). Recently, Liu et al. (2019) began studying the implementation of a family-based program designed to address overweight and obesity among eight- to twelve-year-old children and their families. They are utilizing a randomized wait list design for their study (Liu et al., 2019). Their 11 program involves weekly 90-minute sessions over the course of 10 weeks and will include sleep hygiene practices as well as nutrition, physical activity, mental health, and parenting practices (Liu et al., 2019). Marsh et al. (2020) designed and implemented a healthy lifestyle program for parents of pre-school age children. Using a two-arm, randomized control study design, the researchers were able to study the effectiveness of the program involving six weeks of access to a study website as well as a half-day workshop (Marsh et al., 2020). Their program addressed sleep as well as other healthy lifestyle behaviors such as limited screen time and family meals (Marsh et al., 2020). One of their key findings was improved sleep among participants (Marsh et al., 2020). Another study by Ball et al. (2020) developed and evaluated a program designed to support parents of infants. The sleep portion of their program involved adapting the previously developed Possums Sleep Program for use in their population (Ball et al., 2020). The program was implemented through parent visits with antenatal and postnatal practitioners who presented parents with a 14-page illustrated booklet, and feedback was obtained from both parents and providers (Ball et al., 2020). This study was implemented as an initial field-testing of the program and feedback will incorporated prior to use of the program in randomized control trials (Ball et al., 2020). 12 Concept Map Society Sleep Hygiene Education Parent Child School Health care Child/Family Services Routines Boundaries Relationship Physical health Mental health Behavior Figure 1. Concept Map The concept map (Figure 1.) created to guide this project provides a visual representation of the many factors determining and influencing a childs sleep. The concept map shows the way society encompasses both the child and the family. The parent plays a central role in the childs sleep and acts as a mediator between the child and society. It is also possible to use this concept map to identify which factors are modifiable and where interventions can be targeted. The current practice innovation project seeks to provide parent sleep hygiene education so that parents may improve their routines and set appropriate boundaries in ways that promote sleep, as well as providing parents with tools for helping children overcome fears, decrease screen use, and take part in activities that promote sleep onset. The ultimate goal of this project was to promote a culture that normalizes healthy sleep behaviors and enacts policies that allow children and families to prioritize sleep and establish lifelong healthy sleep habits. Engaging school 13 nurses and parents in this project was another way of creating an environment that supports adequate and healthy sleep for all children. Strengths of Current Literature There are many strengths to the current literature surrounding sleep hygiene for schoolage children and parent education related to sleep hygiene. There is also a great deal of literature related to other health-related educational programs for parents of school-age children addressing a variety of health promotion behaviors such as nutrition or exercise. These types of studies translate well to the current project and inform the effectiveness of parent education programs. The research also provides insights about utilizing a school setting for implementing parent education programs and addressing health-related concerns such as sleep or obesity. Weaknesses of Current Literature Two areas of weakness in the literature surrounding parenting involve theoretical foundations and measurement tools. At this time, there appears to a shortage of research grounded in theory as it pertains to parenting, sleep health, and behavior change (Blunden et al., 2016). Building on existing frameworks allows a variety of research and researchers to benefit from one anothers work. There is also an inherent difficulty in measuring parenting, which is a complex and dynamic construct (Lindhiem & Shaffer, 2017). Identifying valid and reliable tools that can measure the construct of parenting and constructs related to parenting will allow continued research and improvements across many fields including nursing, medicine, prevention science, social work, psychology, public policy, and more (Eddy, 2017). Foundational Theory The foundational theory used to guide this practice innovation project is Urie Bronfenbrenners ecological systems theory and Process-Person-Context-Time (PPCT) model 14 for bioecological research. Bronfenbrenner is known for examining the interdependent and dynamic relationship between individuals and their environment. While the commonly referenced social ecological theory, or ecological systems theory, is widely attributed to Bronfenbrenner, it is important to understand the way he developed, critiqued, and refined his own theory on human development starting in the 1970s and then finally landing in the 1990s with a bioecological theory of human development based on the factors of process, person, context, and time (Rosa et al., 2013). For a number of reasons, Bronfenbrenners theory laid the groundwork for this practice innovation project which aimed to address the problem of insufficient sleep among school age children. Overview of Ecological Systems Theory Bronfenbrenners work examined the role of the environment, or context, on human development while also noting the characteristics of the individual that affected the environment. He saw this as bidirectional and ever-changing. Because of this, he often used the term ecological system to describe this phenomenon. Originally, Bronfenbrenner described four separate systems which he named microsystem, mesosystem, exosystem, and macrosystem. The microsystem refers to the environment where an individual spent the most time and had face-toface interactions such as at home or school. The mesosystem describes the interaction between different microsystems. The exosystem has an indirect effect on the individual, often through a set policy. The macrosystem is an all-encompassing culture or belief system that effects the functioning of lower systems. In the 1980s, Bronfenbrenner added the chronosystem which references the time in which interactions between the systems are taking place, making it important to consider historical events or other factors (Rosa et al., 2013). 15 In the 1990s, Bronfenbrenner identified the importance of what he referred to as proximal processes. This term was used to describe the interaction between a person and their immediate environment. Bronfenbrenner wanted to stress that the proximal processes were the most significant factor in human development. Bronfenbrenner believed the Process-PersonContext-Time (PPCT) model most adequately identified the bioecological system determining an individuals development. The PPCT model includes proximal processes (Process), individual characteristics (Person), the various ecological systems such as microsystem, mesosystem, exosystem, and macrosystem (Context), and accounts for the chronosystem (Time) as well (Eriksson et al., 2018). Central Assumptions The central assumptions of Bronfenbrenners ecological systems theory include the necessity of a multifaceted approach to the health and development of an individual and an understanding that many dynamic factors affect outcomes. Another assumption is that the interaction between a set of environmental factors and characteristics of an individual will uniquely determine a persons health and development. Finally, it is assumed that proximal processes, the interactions occurring most closely to the individual, will have the strongest influence on outcomes (Eriksson et al., 2018). Key Concepts Bronfenbrenner described key concepts to his theory as they developed over time. First, the concept of ecological systems were described as the microsystem, mesosystem, exosystem, and macrosystem. Next, Bronfenbrenner described the concept of chronosystems and the importance of using time as a way to place an individual contextually in history or within the 16 lifespan. Finally, the concept of proximal processes was introduced and found to be an essential component of Bronfenbrenners PPCT model (Eriksson et al., 2018). Defining the Role of the Nurse According to Bronfenbrenners ecological systems theory and PPCT model, the role of the nurse is to see the patient as an individual and to understand the significant impact of the patients immediate surroundings. It is also essential for the nurse to consider the context in which the patient lives and carries out the activities of daily life. Identifying the factors influencing a patients health stemming from the microsystem, mesosystem, exosystem, and macrosystem will allow the nurse to help the patient overcome barriers and maximize the assets available to them in order to promote the health and well-being of the patient. Finally, the nurse must try to understand the implication of time and recognize the patient as an individual moving through the lifespan and existing within a unique historical context that impacts the patients health and development. With this understanding, the nurse is able to individualize care for a patient while also advocating for improvements at each level of the ecological system. Foundation for Practice Innovation Project The ecological systems theory and PPCT model served as the foundation for the practice innovation project which sought to address the problem of inadequate sleep among school age children. As with many health behaviors during childhood, sleep is influenced by a multitude of factors. In order to adequately address this problem, the project needed to acknowledge the factors contributing to the problem. Bronfenbrenners theory guided the interventions and focus on proximal processes while also considering factors related to the parent who is responsible for prioritizing sleep and optimizing the habits that promote sleep. Understanding contextual factors for sleep also guided the project. Particularly because this project was implemented in a school 17 setting, it was helpful to consider aspects of the school environment such as start time, amount of homework, exposure to sunlight during the day, and other aspects of the environment. Finally, the project occurred during the aftermath of the COVID-19 global pandemic which places it a time of historical significance. Using Bronfenbrenners PPCT model will account for the many variables impacting the implementation and applicability of the practice innovation project. Implementation Model Knowledge To Action Framework The implementation model used to for the practice innovation project is a form of planned action theory first described by Graham et al. in 2006. The Knowledge To Action (KTA) framework involves knowledge creation and knowledge application. There are seven phases beginning with the identification of a problem and examination of evidence pertaining to the problem. The next phase is the adaptation of knowledge to the context of the problem at hand. The third phase is identification of barriers; this is followed by implementation of interventions. The next two phases require monitoring and evaluating the use of the newfound knowledge with the final phase being sustainable knowledge use (Graham et al., 2006). This framework provides an implementation model that fit well with the practice innovation project because parent education on sleep hygiene is not enough to improve the health of children. Parents must apply what they have learned and be moved to action. Barriers to their ability to adopt new habits and routines that promote optimal sleep needed to be addressed for this project to be effective. Proper monitoring and evaluation allowed the researcher to contribute to the evidence on improving childhood sleep and lay a foundation for sustainable, lifelong, healthy sleep. 18 Social Entrepreneurship and Innovation Two necessary qualities of an innovative project are that it is implementable and achievable (Kaya et al., 2016). Excellent ideas can be a beginning point, but for innovation to truly make a difference and lead to lasting benefits, it must be created into something that can be implemented in the population that it hopes to affect. There needs to be goal in mind that can be attained. By narrowing the focus of a project and simplifying the design, the likelihood of achieving the intended goal will increase. Principles of social entrepreneurship revolve around the concept of systemic change (Bornstein, 2007). Social entrepreneurship, in addition to innovation, allows for effective interventions that not only help parents to prioritize sleep and optimize childhood sleep habits, but also establish lifelong habits that contribute to all aspects of health and well-being. When parents, health care providers, school administrators, teachers, and others in our community begin to understand and value the factors that contribute to childhood sleep, systemic change can take place, and the trend of inadequate childhood sleep can be stopped. Sustainability For this project to be sustainable, it was essential to examine the systems at work in influencing the many factors that affect children and the amount and quality of their sleep. By offering a program that focuses on parent education, a lasting impact can be made on the lives of children and their families. A sustainable practice innovation project is one in which the intended consequences continue to develop over time, long after the research has concluded. Involving the school community in this project can bring about lasting change. School policies in the past have incorporated nutrition and physical activity into the curriculum and parent education. These initiatives have been a successful part of the school curriculum and have influenced the types of 19 school lunches families send and the amount of time teachers incorporate into the school day for physical activity. Shedding light on the importance of sleep helps families to build a culture at home and school where sleep is a priority. Ethical Considerations Practice Innovation Project Application, Risks, & Benefits Through the application process, risks for participants was examined and ensured to be reasonable as compared to the benefits. The project was designed to make certain risks are minimized. The process for selecting participants was equitable and informed consent was obtained in a transparent and appropriate manner. Parents were reassured that their participation was voluntary and there were no repercussions for not participating. The privacy and confidentiality of all participants was protected, and the data obtained was monitored and kept secure. The risks were reevaluated during the study. Foreseeable risks to this study involved the psychological well-being of the parents who participate in the study. As parents are educated on the correlation between inadequate childhood sleep and physical and mental health consequences, parents could potentially experience feelings of guilt or doubt in their ability to parent. For those who experienced negative consequences of participation, resources were provided to help them gain confidence and to connect with a community of parents who may have similar feelings. It was important to reassure parents, find strengths, and build upon those so they had confidence to attempt new methods for prioritizing and optimizing sleep for their children. The benefits of this study include establishing new routines for school age children that instill lifelong sleep hygiene behaviors. Benefits may also include the short-term effects of better sleep for all family members such as improved mood, focus, and energy levels. It was essential to evaluate the effectiveness of using an online platform 20 to not only share information and gather data, but also to obtain informed consent. Moore et al. systematically reviewed informed consent obtained through app based programming and found strengths such as the ability to test for comprehension to ensure that participants fully understood the research to which they were consenting (2017). Benefits of the Practice Innovation Project The participants of this study may have experienced benefits from participation. They learned about how to help their children establish a bedtime routine. They also learned about the amount of sleep their children need and ways to improve sleep habits. Others may benefit from the knowledge gained by this study such as school nurses, childcare providers, and primary care providers. Participants received a childrens book and a toothbrush for their participation in the study. The value of these items is estimated around $10. If a participant dropped out of the study, they were permitted to keep the items. No payment was provided for participation. Risks of the Practice Innovation Project Possible risks of participating in this study included psychological distress or feelings of guilt related to routines or habits that negatively affect sleep for the children of participants. Participating may have led to an increase in worry about sleep problems or disorders in the children of participants. The researchers tried to minimize these risks by providing contact information for local health care providers and counseling resources. Participants were informed that they do not have to answer any questions they do not want to answer. Because this study collects information about participants, one of the risks of this research was a loss of confidentiality. Sample and Selection Process for the Practice Innovation Project 21 The participants must be over age 18 and the parent or primary caregiver of a student at Good Shepherd Montessori School in South Bend, Indiana. The parent or caregiver must be responsible for a child between the ages of three years and 10 years in order to participate. If two parents or multiple caregivers wanted to participate, they could both take part in the informational session, but only one person could submit the CASC questionnaire and KASB survey. If a family has multiple children at Good Shepherd Montessori School, the answers provided on the questionnaire and the KASB survey should pertain to the youngest child who is a student at Good Shepherd Montessori School. This study aimed to have 60 or more participants. Role of Participants in the Practice Innovation Process The first part of this study involved filling out a brief questionnaire (24 items) about the participants childs sleep-related behaviors using a 6-point scale. The participant were also asked to complete a short survey related to knowledge, attitudes, self-efficacy, and beliefs related to sleep habits and routines in their household. The questionnaire and survey questions were filled out online and submitted confidentially or participants were able to request a paper format. Participants then attended an informational session where the Sweet Dreamzzz Sleep Health Education program was presented to them either in-person at Good Shepherd Montessori School or through a live, virtual format (Pajama Program, n.d.). The researcher was granted permission by the Pajama Program to utilize the Sweet Dreamzzz slideshow presentation. The researcher had a variety of times available so participants could choose the time that works best for their schedule. Four to six weeks after the informational session, they were asked to complete the same questionnaire and survey questions. These were completed online or they could request a paper format. 22 Participation in this study involved filling out a questionnaire and survey which took approximately 30 minutes at the beginning and end of the study. Participants were asked to attend a one-hour informational session. Total time to participate is approximately two hours. Participation in this study ended after completing the follow-up questionnaire and survey. Informed Consent The informed consent process began in January of 2022. Parents of three10-year-old students at Good Shepherd Montessori School were emailed the informed consent document (see Appendix C). Paper copies of the informed consent document were sent home in the students folders as well. Parents were asked to direct their questions to the researcher and school nurse, Katherine Sollmann. A reminder to return the informed consent document was included in the weekly school newsletter in September so that all participants could be identified by midFebruary. See Appendix C for Informed Consent documentation. Confidentiality The information collected from the participants was encrypted and stored using 256-bit SSL/TLS encryption (Johnson, 2021). Paper materials with identifiers were kept in a locked file cabinet. Participant identifiers were removed as soon as possible. Each participants identity, personal information, responses, etc. will not be disclosed to anyone outside of the research team unless otherwise agreed upon. The research team kept the information collected about participants during the research for future research projects and for study recordkeeping. Participant names and other information that can directly identify participants were stored securely and separately from the research information collected. The research team will not keep participant names or other information that can identify participants directly. The results of this 23 study could be published in an article or presentation, but will not include any information that would let others know who the participants are. Methods Population The intended population for the practice innovation project was parents and caregivers of students at Good Shepherd Montessori School in South Bend, Indiana. This private school provides education to a diverse group of students from three years old to 14 years old. Because the use of the survey instrument was validated for caregivers of children from three years old to 18 years old, this study sought participation of parents of students age three years to age 10 years. This was a convenience sample due to the proximity of this population to the DNP student conducting the research. As the school nurse at Good Shepherd Montessori School, the DNP student had access via email and other methods of communication, as well as in-person contact prior to the COVID-19 pandemic, with caregivers of all students at the school. Caregivers were familiar with receiving information from the school nurse on a variety of topics and were likely to be receptive of the intervention provided in this practice innovation project. Because the aim of this project involved sleep hygiene and does not seek to address sleep disorders, there was no reason to exclude caregivers of children with existing physical or psychological conditions. Anyone who did not consent to participation in the study was not included. The DNP student excluded her own family members from participation in the study. Recruitment Protocol Caregivers of students at Good Shepherd Montessori School were contacted via email by the school nurse who is also the DNP student conducting the research. The email presented an overview of the practice innovation project and provided a link to the electronic informed 24 consent documentation. Incentives for participation included a childrens book and toothbrush; valued at $10. It was made clear to all caregivers that participation was voluntary, and they were not required to participate in the study. Key Stakeholder The key stakeholder for this project was Dan Driscoll, the founder and Head of School at Good Shepherd Montessori School. Dan Driscoll oversees the day-to-day operations of the school as well as long-term strategic planning. He was supportive of this project and verbalized his enthusiasm for parent education on prioritizing and optimizing sleep for their children. Dan Driscoll understands the essential role that overall health and well-being play in a students ability to learn and thrive in the school environment. Part of the Good Shepherd Montessori School Mission Statement includes, We believe that education of the whole person is an ongoing process that occurs most successfully when activities at home and school are consistent, (Good Shepherd Montessori School, n.d.). In the past, Good Shepherd Montessori School has placed a great deal of importance on nutrition and physical activity when it comes to providing health education to children and their parents. Dan Driscoll understands that sleep is now known to be a vital component in the health and well-being of all people, especially children. He allowed the researcher to contact parents of Good Shepherd Montessori School students and utilize school space for any in-person educational sessions. The positive feedback from Dan Driscoll was an indication that the Good Shepherd Montessori School community is focused on the health and well-being of students and their families and were open to participating in this practice innovation project. Practice Innovation Project Implementation Schedule 25 Prior to implementation, the summer of 2021 was spent on preparing the project proposal for Institutional Review Board approval through Saint Marys College. Once the IRB approval was obtained during the Fall of 2021, identification of the participants began with a goal of completing the informed consent process with all participants by January 2022. The participants, parents of school-age children attending Good Shepherd Montessori School, were asked to complete the Child and Adolescent Sleep Checklist (CASC) and answer a few survey questions about knowledge, attitudes, self-efficacy, and beliefs (KASB). By February 1st, 2021 parent educational sessions were scheduled throughout the month of February. Four to six weeks after completing the educational sessions, participants completed the CASC and answered the KASB survey questions. The goal was to complete the post-intervention data collection by April 10th, 2022. April and May 2022 were focused on data analysis. During the month March of 2022, the researcher worked on presenting the project in both poster and paper format for submission to a peer-reviewed journal and/or a conference. See Appendix B for Gantt Chart. Budget The budget for this project involved minimal expenses. The cost of training and materials to become a trainer for the Sweet Dreamzzz sleep education program was $249. The researcher covered this expense and is now in a position to train other care providers on how to implement this program across a variety of settings. Following this initial expense, no major expenses were expected. Some parent education materials were provided free of charge from the Sweet Dreamzzz organization. Other materials were printed out at Good Shepherd Montessori School using their printer and paper. The Sweet Dreamzzz program recently partnered with another organization, The Pajama Program. The board overseeing these organizations is called the Good Night Counsel (Pajama Program, n.d.). The organization may have received grant funding that 26 could be applied for use in this project if needed. Participants in this research project were given a childrens book and toothbrush as an incentive for participation. As a member of Sigma Theta Tau, the researcher may apply for grant funding if needed for the expansion and sustainability of the practice innovation project. Data Collection and Analysis This practice innovation project sought to address the detrimental effects of inadequate childhood sleep by offering parent education and targeted interventions to improve sleep hygiene. When designing this project, it was essential to determine the correct tools for gathering information so that data can be collected and analyzed appropriately. A wide variety of tools exist with the purpose of assessing sleep in children. While polysomnography is capable of evaluating brain activity, oxygen level, heart and respiratory rate, as well as eye and leg movements, this method for gathering data has not proved to be feasible on a larger scale (Gregory et al., 2011). However, actigraphy, which involves monitoring of heart rate and movement through a small wearable device, has been used in many studies successfully (Gregory et al., 2011). Parental sleep logs and a variety of questionnaires are widely utilized in the literature on pediatric sleep, sometimes alongside actigraphy in order to validate information provided by parents (Gregory et al., 2011). There is also a vast array of parent surveys available for research on childhood sleep (Van Meter & Anderson, 2020). Quantitative Data Sleep measures can be applied in research to collect data on many aspects of pediatric sleep. A helpful article by Van Meter and Anderson (2020) provided updates on current evidence for the use of many different tools used to assess youth sleep. They examined sleep measures based on four domains including insomnia, sleep hygiene, sleepiness, and sleep quality (Van 27 Meter & Anderson, 2020). In light of their findings, it is evident that the tool used should be determined by goals of the practice innovation project. Upon reflection, the purpose of the practice innovation project is to provide education to parents in order to help them prioritize and optimize their childs sleep. For this reason, it seems that the domain of sleep hygiene, and possibly sleep quality, apply best to this project. Survey Instruments The survey instrument chosen for this practice innovation project is the Child and Adolescent Sleep Checklist (CASC). This instrument is the best fit to answer the research question for the population receiving the intervention with a goal of improving sleep hygiene for families who participate in the project. The Child and Adolescent Sleep Checklist consists of 24 items and has been validated for caregivers of children from three years old to 18 years old (Oka et al., 2009). The CASC has shown to be valid in diverse populations as well and has been used across a variety of clinical settings (Horiuchi et al., 2020). The inclusion of 24 items provided valuable information without being too cumbersome for caregivers to complete. Because this measure has been validated for a wide range of ages, it was useful for the identified population. It is not necessary for the survey instrument to be tailored to meet the needs of the project, and the use of this instrument was free. The researcher received permission to utilize an additional questionnaire pertaining to caregiver knowledge, attitudes, self-efficacy, and beliefs. Previous research using the Sweet Dreamzzz program included this questionnaire, and permission was granted by the original researchers to utilize it for the purpose of this project (Wilson et al., 2014). See Appendix D. for both measurement tools. 28 Results Effect of Intervention on School Night Bedtime Investigating the effect of the intervention on the school night bedtimes of students uses a pre/post design with no external control group (i.e. students served as their own control). Due to sample size limitations, no covariates were included in the model. A one-sided t-test was conducted to evaluate if the bedtime was earlier post-intervention than pre-intervention. The resulting test was significant t(28) = -2.0344, p-value = 0.02574. However, the size of the effect is quite small, with bedtimes occurring, on average, about 10 minutes earlier in the post-test group. Inspecting a plot of pre/post intervention school night bedtimes provides more information. In the figure, a line with a slope of 1 and intercept of 0 is provided for reference. Thus, the points below the line had earlier bedtimes post intervention, those on the line stayed the same, and those above the line had later bedtimes. From this, it is noted that those that had later bedtimes in the pre-intervention assessment tended to decrease their bedtimes postintervention. Arguably, this is a desirable trait of the intervention, however it is not empirically testable with this design and sample size. 29 Effect of Intervention on Weekend Bedtime Similar to school night bedtimes, the same methods were used to evaluate the effectiveness of the intervention on weekend bedtimes. A one-sided t-test was conducted to evaluate if the weekend bedtime was earlier post-intervention than pre-intervention. The resulting test was significant t(28) = -2.544, p-value = 0.008382. The size of the effect is somewhat larger for weekend bedtimes than it was for school night bedtimes; on average bedtimes were around 15 minutes earlier. However, visual inspection of the analogous scatterplot shows a similar trend, those with later bedtimes pre-intervention tended to have earlier bedtimes post-intervention. 30 Effect of Intervention on Difference Between Weekend and School Night Bedtimes A t-test was conducted to evaluate the difference between bedtimes on school nights and weekends pre/post intervention. Pre-intervention, school night bedtimes averages 43 minutes earlier on school nights than on weekends. Post-intervention that difference decreased to 37 minutes earlier on school nights. The above analysis suggest this is due to weekend bedtimes being reported as earlier post-intervention. However, the paired samples t-test used to evaluate this difference suggests the difference is not statistically significant t(28) = -1.2562, p-value = 0.1097. The figure below shows the distribution of differences in weekend and school night bedtimes for the sample, pre and post intervention. The differences were calculated school night 31 bed time weekend bed time, so a negative number of, for example, -60 minutes implies the school night bedtime is an hour before the weekend night bedtime. Effect of Intervention on Difference Between Weekend and School Day Wake Times Similar to above, this section analyzes the difference between school day and weekend get out of bed times. The plot below is analogous to the one in the section above. A negative number implies the student gets out of bed earlier on the school day. A paired samples t-test testing if the differences in wake times decreased post-intervention was non-significant, t(28) = 1.0678, p-value = 0.1474. 32 33 Effect of Intervention on Caffeine Use Before Bedtime Evaluating the effect of the intervention of caffeine use before bed, we first look at a bar plot of the responses to the caffeine use item on the survey. In the pre-test, the overwhelming majority of students did not consume caffeine before bed, and Never was selected on the survey. Thus, there is very little room for improvement. Responses were encoded such that "Always" 0, "Sometimes" 1, "Occasionally" 2, and "Never" 3. Because the data are not continuous and has fewer than 5 categories, instead of a paired samples t-test, a one-sided paired samples permutation test with was used to statistically test the change. The result was non-significant, with p = 0.250246. This is not surprising; from examining the data, 25 of 29 responses were the same pre/post, 3 scores indicating decreased caffeine use and 1 score indicated increased caffeine use. 34 Effect of Intervention on TV, Plays Video Games, Surfs the Internet Testing the effect of the intervention on screen use before bed, and using the same permutation test as above, the resulting test was insignificant, with p = 0.084765. 35 Effect of Intervention on Sleeps Varying Lengths Testing the effect of the intervention on sleep length consistency, as measured by the item asking if the children sleep varying lengths of time each night, the same paired-samples permutation test was used, along with the same encoding of labels to ordinal scores. The resulting test was insignificant, p = 0.878951. 36 Effect of Intervention on Feels Groggy For the feels groggy question, the same paired-samples permutation test was used, along with the same encoding of labels to ordinal scores. The permutation test was on the changes of the ordinal scores significant, p = 0.031491. The interpretation of this significant test is that parents tended to rate their students as less groggy after receiving the intervention. 37 Effect on Time to Fall Asleep Using the coding "20 minutes or less" 3, "40 minutes or less" 2, "1 hour or less" 1, and "1 hour or more" 0, a permutation test was used to evaluate if the time to fall asleep decreases from pre to post intervention. The permutation test was not significant, p = 0.141006. 38 Pre- and Post-Test Scores on the KASB Survey The scores on the last survey scale were lower post-intervention that pre-intervention, and the difference was statistically significant t(28) = 4.9346, p-value = 1.658e-05. 39 Discussion While examining the results of this study, it is notable that the population consists of parents and caregivers who have chosen to send their children to a Montessori school. These caregivers have chosen a non-traditional method of education for a variety of reasons, but it is possible to presume that many parents have considered a variety of educational options and chosen one that is in line with their values and goals for their children. The parents may also be educating themselves on other matters related to their childs well-being such as sleep. Perhaps there were many of items where no significant improvement was found after the intervention because parents had already instituted healthy sleep habits and made sleep a priority in their 40 homes. Another reason why significant improvement may not have been seen is because sleep hygiene is an ingrained habit that depends on many factors. In order to bring about change, repeated educational sessions and input from a variety of sources such as teachers, medical providers, and others may lead to greater improvement. Allowing for more time between the intervention and the follow-up may be a better representation of whether families were able to adjust their routines and establish better sleep hygiene. Finally, more significant outcomes may have been found by involving the children themselves and helping them understand the importance of sleep and the actions they can take to prioritize their sleep. Conclusion This practice innovation project sought to address the problem of inadequate sleep during childhood. Building a foundation for optimal sleep has the potential to make a significant impact on both the physical and mental health of children in the short-term and well into the future. Using Bronfenbrenners ecological systems theory, implementation of this practice innovation project occurred in a school setting. The goal was to address many of the factors influencing childhood sleep. This project will translate well into primary care and allow providers to educate parents with an evidence-based program on sleep-hygiene. Through principles of innovation and social entrepreneurship, this practice innovation project sought to bring about sustainable change that benefits children and their families. 41 References Agaronov, A., Ash, T., Sepulveda, M., Taveras, E. M., & Davison, K. K. (2018). Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. Childhood Obesity, 14(8), 485500. https://doi.org/10.1089/chi.2017.0235 Albuquerque, U. P., de Medeiros, P. M., Ferreira Jnior, W. S., da Silva, T. C., da Silva, R. R. V., & Gonalves-Souza, T. (2019). Social-Ecological Theory of Maximization: Basic Concepts and Two Initial Models. Biological Theory, 14(2), 7385. https://doi.org/10.1007/s13752-019-00316-8 slund, L., Arnberg, F., Kanstrup, M., & Lekander, M. (2018). 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Family-based, healthy living intervention for children with overweight and obesity and their families: a real world trial protocol using a randomised wait list control design. BMJ Open, 9(10), e027183. https://doi.org/10.1136/bmjopen-2018027183 Marsh, S., Taylor, R., Galland, B., Gerritsen, S., Parag, V., & Maddison, R. (2020). Results of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial. PLoS ONE 15(9), e0238977. https://doi.org/10.1371/journal. pone.0238977 McCormack, L., Thomas, V., Lewis, M. A., & Rudd, R. (2017). Improving low health literacy and patient engagement: A social ecological approach. Patient Education and Counseling, 100(1), 813. https://doi.org/10.1016/j.pec.2016.07.007 Meltzer, L. J., Avis, K. T., Biggs, S., Reynolds, A. C., Crabtree, V. M., & Bevans, K. B. (2013). The Children's Report of Sleep Patterns (CRSP): A self-report measure of sleep for school-aged children. Journal of Clinical Sleep Medicine, 9(3), 235245. https://doi.org/10.5664/jcsm.2486 46 Moore, S. Tasse, A.M., Thorogood, A., Winship, I., Zawati, M., & Doerr, M. (2017). Consent processes for mobile app mediated research: Systematic review. Journal of Medical Internet Research, Mhealth Uhealth, 5(8), e126. https://doi.org/10.2196/mhealth.7014 Moran, K., Burson, R., & Conrad, D. (2020). The Doctor of Nursing Practice Project. Jones & Bartlett Learning. Office of Disease Prevention and Health Promotion. (n.d.) Sleep. Healthy People 2030. U.S. Department of Health and Human Services. https://health.gov/healthypeople/objectivesand-data/browse-objectives/children/increase-proportion-children-who-get-sufficientsleep-emc-03 Office of Head Start: An Office of the Administration for Children and Families. (2019, June 4). History of head start. https://www.acf.hhs.gov/ohs/about/history-of-head-start Oka, Y., Horiuchi, F., Tanigawa, T., et al. (2009). Development of a new sleep screening questionnaire: Child and adolescent sleep checklist (CASC). Japanese Journal of Sleep Medicine, 3(2), 404-408. Orji, M. L., Anyanwu, O., Ibekwe, R., & Onyire, N. (2017). Sleep hygiene of children in Abakaliki, Ebonyi State, Southeast Nigeria. Sahel Medical Journal, 20(3), 98-101. https://doi.org/10.4103/1118-8561.223168 Pajama Program. (n.d.). Pajama Program National Initiatives. Retrieved from https://pajamaprogram.org/national-programs/ Quach, J., Wake, M., Gold, L., Arnup, S., & Hiscock, H. (2016). A brief school-entry sleep intervention improves child and parent outcomes: A randomized controlled trial. Journal of Sleep Research, 25(s2), 2828. Rosa, E.M. & Trudge, J.R.H. (2013). Urie Bronfenbrenners Theory of Human Development: Its 47 Evolution From Ecology to Bioecology. 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University of Michigan Office of Research. Retrieved May 7, 2021, from https://research-compliance.umich.edu/informed-consent-guidelines van der Heijden, K.B., Smits, M.G., & Gunning, W.B. (2006). Sleep hygiene and actigraphy evaluated sleep characteristics in children with ADHD and chronic sleep onset insomnia. Journal of Sleep Research, 15(1), 55-62. https://doi.org/10.1111/j.13652869.2006.00491.x Van Meter, A.R. & Anderson, E.A. (2020). Evidence base update on assessing sleep in youth. Journal of Clinical Child & Adolescent Psychology, 49(6), 701-736. https://doi.org/10.1080/15374416.2020.1802735 48 Wilson, K.E., Miller, A.L., Bonuck, K., Lumeng, J.C., & Chervin, R.D. (2014). Evaluation of a sleep education program for low-income preschool children and their families. Sleep, 37(6), 1117-1125. https://doi.org/10.5665/sleep.3774 49 Appendix A. CITI Certification 50 Appendix B. Gantt Chart pproval tain In ormed Consent Gantt Chart Pro ect Proposal and I Identi y Participants and Pre Intervention ata Collection Intervention: Parent Education Post Intervention ata Collection ata nalysis Presentation o indings 51 Appendix C. Informed Consent CONSENT TO BE PART OF A RESEARCH STUDY 1. KEY INFORMATION ABOUT THE RESEARCHERS AND THIS STUDY Study title: Sleep Improvement Study for Parents of School-Age Children Principal Investigator: Katherine Sollmann, RN-BSN, DNP Student, Saint Marys College, Notre Dame, Indiana Faculty Advisor: Jenna Bauer, DNP, Saint Marys College, Notre Dame, Indiana You are invited to take part in a research study. This form contains information that will help you decide whether to join the study. Taking part in this research project is voluntary. You do not have to participate and you can stop at any time. Please take time to read this entire form and ask questions before deciding whether to take part in this research project. 2. PURPOSE OF THIS STUDY Many school-age children do not get enough sleep. Lack of sleep can affect a childs health and behavior. This research study is designed to look at the effectiveness of an educational sleep health program for parents and caregivers called Sweet Dreamzzz. The Sweet Dreamzzz program has been used throughout the country in a variety of settings including Head Starts and foster care. Through the data collected from parents of school-age children at Good Shepherd Montessori School, this study will examine the ways the program influences sleep habits and routines when implemented by a school nurse in a private school setting. 3. WHO CAN PARTICIPATE IN THE STUDY 3.1 Who can take part in this study? Participants must be over age 18 and the parent or primary caregiver of a student at Good Shepherd Montessori School in South Bend, Indiana. The parent or caregiver must be responsible for a child between the ages of 3 and 12 in order to participate. If two parents or multiple caregivers want to participate, they may both take part in the informational session, but only one person may submit the questionnaire, short-answer survey, and sleep log. If a family has multiple children at Good Shepherd Montessori School, the answers provided on the questionnaire, the short-answer survey, and the sleep log should pertain to the youngest child who is a student at Good Shepherd Montessori School. 3.2 How many people are expected to take part in this study? This study aims to have 60 or more participants. 4. INFORMATION ABOUT STUDY PARTICIPATION 4.1 What will happen to me in this study? The first part of this study will involve filling out a brief questionnaire (24 items) about your childs sleep-related behaviors using a 6-point scale. You will also be asked to answer 5 short answer style questions related to sleep habits and routines in your household. The questionnaire and survey questions can be filled out online and submitted confidentially or you can request a paper format. You will then attend an informational session where the Sweet Dreamzzz Sleep Health Education program will be presented to you either in-person at Good Shepherd Montessori School or through a live, virtual format. The researcher will have a variety 52 of times available so you can choose the time that works best for you. Four to six weeks after the informational session, you will be asked to complete the same questionnaire and five short answer survey questions. These can be completed online or you may request a paper format. 4.2 How much of my time will be needed to take part in this study? Participation in this study will involve filling out a questionnaire and survey which will take approximately 30 minutes at the beginning and end of this study. You will also be asked to record your childs bedtime and wake-up time for 7 days at the beginning of this study and for 7 days at the end of this study which should take no more than 5 minutes per day. It is estimated that a total of 70 minutes will be spent on recording information in a sleep log. You will be asked to participate in a 1-hour informational session. Total time to participate is approximately 3 hours. 4.2.1 When will my participation in the study be over? Participation in this study will end after completing the questionnaire, survey, and sleep log in November. 5. INFORMATION ABOUT STUDY RISKS AND BENEFITS 5.1 What risks will I face by taking part in the study? What will the researchers do to protect me against these risks? Possible risks of participating in this study include psychological distress or feelings of guilt related to routines or habits that negatively affect your childs sleep. Participating may lead to worry about sleep problems or disorders in your child. The researchers will try to minimize these risks by providing you with contact information for local health care providers and counseling resources. You do not have to answer any questions you do not want to answer. Because this study collects information about you, one of the risks of this research is a loss of confidentiality. See Section 8 of this document for more information on how the study team will protect your confidentiality and privacy. 5.2 How could I benefit if I take part in this study? How could others benefit? You might benefit from being in the study. You will learn about how to help your child establish a bedtime routine. You will also learn about the amount of sleep your child needs and ways to improve sleep habits. Others may benefit from the knowledge gained from this study. 6. ENDING THE STUDY 6.1 If I want to stop participating in the study, what should I do? You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you. If you decide to leave the study before it is finished, please tell one of the persons listed in Section 9. Contact Information. If you choose to tell the researchers why you are leaving the study, your reasons may be kept as part of the study record. The researchers will keep the information collected about you for the research unless you ask us to delete it from our records. If the researchers have already used your information in a research analysis it will not be possible to remove your information. 7. FINANCIAL INFORMATION 7.1 Will I be paid or given anything for taking part in this study? You will receive a childrens book, a pair of pajamas for your child, a toothbrush, and an alarm clock for your 53 participation in the study. The total value of these items is $40. If you withdraw before the end of the study, you may keep the items. 7.2 Who could profit or financially benefit from the study results? This research is being supported by Katherine Sollmann, RN-BSN, DNP Student, Good Shepherd Montessori School, and Saint Marys College. This study was initiated and designed by the investigator, Katherine Sollmann. No individuals nor institutions will receive compensation for outcomes related to this study. The individual, Katherine Sollmann, and the institutions, Good Shepherd Montessori School and Saint Marys College do not have any proprietary interests in the outcome of this study. No significant payments will be received for this study. The company whose product is being studied: This study utilizes the Sweet Dreamzzz sleep health education program which is part of the Pajama Program, a 501(c)(3) nonprofit organization. The Pajama Program is not financing this project. No individuals or organizations will receive any compensation affected by the outcome of this study. No incentive payments or payments per participant will be received. 8. PROTECTING AND SHARING RESEARCH INFORMATION 8.1 How will the researchers protect my information? The information collected from the participant will be encrypted and stored using 256-bit SSL/TLS encryption. Paper materials with identifiers will be kept in a locked file cabinet. Participant identifiers will be removed as soon as possible. The participants identity, personal information, responses, etc. will not be disclosed to anyone outside of the research team unless otherwise agreed upon. 8.2 Who will have access to my research records? There are reasons why information about you may be used or seen by the researchers or others during or after this study. Examples include: University, government officials, study sponsors or funders, auditors, and/or the Institutional Review Board (IRB) may need the information to make sure that the study is done in a safe and proper manner. 8.3 What will happen to the information collected in this study? We will keep the information we collect about you during the research for future research projects and for study recordkeeping. Your name and other information that can directly identify you will be stored securely and separately from the research information we collected from you. We will not keep your name or other information that can identify you directly. The results of this study could be published in an article or presentation, but will not include any information that would let others know who you are. 8.4 Will my information be used for future research or shared with others? We may use or share your research information for future research studies. If we share your information with other researchers it will be de-identified, which means that it will not contain your name or other information that can directly identify you. This research may be similar to this study or completely different. We will not ask for your additional informed consent for these studies. 9. CONTACT INFORMATION Who can I contact about this study? Please contact the researchers listed below to: 54 Obtain more information about the study Ask a question about the study procedures Report an illness, injury, or other problem (you may also need to tell your regular doctors) Leave the study before it is finished Express a concern about the study Principal Investigator: Katherine Sollmann, RN-BSN, DNP Student Email: ksollmann01@saintmarys.edu Phone: 847-208-1915 Faculty Advisor: Jenna Bauer, DNP Email: jbauer@saintmarys.edu Phone: 574-276-8941 If you have questions about your rights as a research participant, or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact the following: Saint Marys College IRB Chair Catherine Pittman cpittman@saintmarys.edu 10. YOUR CONSENT Consent/Assent to Participate in the Research Study By signing this document, you are agreeing to be in this study. Make sure you understand what the study is about before you sign. I/We will give you a copy of this document for your records and I/we will keep a copy with the study records. If you have any questions about the study after you sign this document, you can contact the study team using the information in Section 9 provided above. I understand what the study is about and my questions so far have been answered. I agree to take part in this study. Print Legal Name: _____________________________________________________ Signature: ___________________________________________________________ Date of Signature (mm/dd/yy): ___________________________________________ You will be given a copy of this form after completing all of the required information. 11. OPTIONAL CONSENT Consent to be Contacted for Participation in Future Research 55 Researchers may wish to keep your contact information to invite you to be in future research projects that may be similar to or completely different from this research project. _____ Yes, I agree for the researchers to contact me for future research projects. _____ No, I do not agree for the researchers to contact me for future research projects. 56 Appendix D. Measurement Tools 57 1 Appendix E. Literature Synthesis Table 2 Citation (APA format) Conceptual Framework Study design/ method Sample/ Setting Data Analysis Study Findings Appraisal of Worth to Practice 119 studies Major variables studied and definitions Sleep promotion, childhood obesity, family-based interventions Agaron ov, A., Ash, T., Sepulveda, M., Taveras, E. M., & Davison, K. K. (2018). Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. Childhood Obesity, 14(8), 485 500. https://doi.org/10.1 089/chi.2017.0235 Morriss ey, B., Taveras, E., Allender, S., & Strugnell, C. (2020, April). Sleep and obesity among children: A systematic review of multiple sleep dimensions. Pediatric Obesity. https://doi.org/10.1 111/ijpo.12619 No conceptual framework identified. System atic review Analysis of frequency of findings, interventio ns, etc. Sleep promotion strategy most utilized were education on sleep hygiene Valuable for the current project and connects sleep promotion as an intervention for childhood obesity. No conceptual framework identified. System atic review 112 studies sleep and obesity Dimension s of sleep, such as quality, efficiency and bed/wake times, and relationship with weight status Lack of valid and reliable tools to measure sleep characteristics Valuable when designing study and identifying tools for meaurement of variables 3 Becker, S. P., & Gregory, A. M. (2020). Editorial Perspective: Perils and promise for child and adolescent sleep and associated psychopathology d i h C VI 9 pandemic. Journal of Child Psychology and Psychiatry, and Allied Disciplines. https://doi.org/10.1 111/jcpp.13278 Brnhor st, C., Wijnhoven, T. ., K , ., Yngve, A., Rito, A. I., Lissner, L., Duleva, V., Petrauskiene, A., & Breda, J. (2015). WHO European Childhood Obesity Surveillance Initiative: associations between sleep duration, screen time and food consumption frequencies. BMC Public Health, 15(1), 442. https://doi.org/10.1 186/s12889-0151793-3 No conceptual framework identified. Editoria l NA child and adolescent sleep, COVID pandemic NA Sleep problems likely to emerge or worsen during and following pandemic Valuable for placing the project in the time of COVID No conceptual framework identified. Correlat ional study with existing data 10453 children ages 6-9 from five Europea n countrie s age, sex, outdoor play time, educational level of parents, sleep duration, screen time logistic multilevel models to assess association s relation between high screen time exposure and consumption of high fat foods, long sleep duration related to positive food choices Valuable for supporting the idea that sleep correlates to overall health promotion 4 Carneth on, M. R., De Chavez, P. J., Zee, P. C., Kim, K.-Y. A., Liu, K., Goldberger, J. J., Ng, J., & Knutson, K. L. (2016). Disparities in sleep characteristics by race/ethnicity in a population-based sample: Chicago Area Sleep Study. Sleep Medicine, 18, 5055. https://doi.org/10.1 016/j.sleep.2015.07. 005 Center for Disease Control and Prevention. (2020, August 19). About Social Determinants of Health (SDOH). https://www.cdc.go v/socialdeterminant s/about.html Daniel, L. C., Childress, J. L., Flannery, J. L., Weaver-Rogers, S., Garcia, W. I., Bonilla-Santiago, G., & Williamson, A. A. (2020). Identifying Modifiable Factors No conceptual framework identified. Crosssection al populat ion based epidemi ologic study 495 adults ages 3564 sleep characteristics, race Analysis of variance, effect modificatio n Shorter sleep duration in non-Whites possibly contributing to disparities in the onset of cardiovascular and metabolic disease Valuable for connecting the potential role of race and health disparities to sleep NA NA NA NA NA NA Valuable for addressing health disparities and connecting the project to important interventions. No conceptual framework identified. Quantit ative analysis 119 parents race, sleep health, household chaos, caregiver sleep knowledge mediation models conducted using ordinary least squares path analysis Interventions targeting sleep may be enhanced by targeting parenting skills and household routines to reduce chaos. Valuable for planning project intervention. 5 Linking Parenting and Sleep in Racial/Ethnic Minority Children. Journal of Pediatric Psychology, 45(8), 867876. https://doi.org/10.1 093/jpepsy/jsaa034 Fatima, Y., Doi, S. a. R., & Mamun, A. A. (2015). Longitudinal impact of sleep on overweight and obesity in children and adolescents: a systematic review and bias-adjusted meta-analysis. Obesity Reviews: An Official Journal of the International Association for the Study of Obesity, 16(2), 137149. https://doi.org/10.1 111/obr.12245 Gohil, A., & Hannon, T. S. (2018). Poor Sleep and Obesity: Concurrent Epidemics in Adolescent Youth. Frontiers in Endocrinology, 9. No conceptual framework identified. Metaanalysis 22 longitudi nal studies short sleep and overweight/ob esity No conceptual framework identified. System atic review Not Optimal sleep, specified sleep duration, quality, sleep chronotype, obesity, glucose metabolism, cardiometaboli Metaanalysis of 24821 participants , association between variables Evidence that short sleep duration in young subjects is significantly associated with future overweight/obesity Valuable for identifying the problem with poor childhood sleep. NA Extensive evidence linking sleep to obesity Valuable for identifying the problem with poor childhood sleep. 6 https://doi.org/10.3 389/fendo.2018.003 64 Hale, L., Kirschen, G.W., LeBourgeois, M.K., Gradisar, M., Garrison, M.M., MontgomeryDowns, H., Kirschen, H., McHale, S.M., Chang, A.M., & Buxton, O.M. (2018). Youth screen media habits and sleep: Sleepfriendly screen behavior recommendations for clinicians, educators, and parents. Child and Adolescent Psychiatry Clinicians of North America, 27(2), 229-245. https://doi.org/10.1 016/j.chc.2017.11.0 14 Honake r, S. M., & Meltzer, L. J. (2016). Sleep in pediatric primary care: A review of the literature. Sleep Medicine Reviews, 25, 3139. c risk, OSA, interventions No conceptual framework identified. Literatu re review Not Sleep specified requirements, consequences of insufficient sleep, screen habits, interventions, policies, and strategies NA Clinicians can help Valuable for identifying families improve sleep the role of screen time as health and screen it affects sleep media habits No conceptual framework identified. Literatu re review 424 articles NA Need for improvement in sleep service among pediatric PC providers Sleep in pediatric primary care Valuable for identifying the problem and translating to PC 7 https://doi.org/10.1 016/j.smrv.2015.01. 004 Office of Disease Prevention and Health Promotion. (2020). Increase the proportion of children who get sufficient sleep EMC-03. Healthy People 2030. U.S. Department of Health and Human Services. https://health.gov/h ealthypeople/object ives-anddata/browseobjectives/children/ increaseproportion-childrenwho-get-sufficientsleep-emc-03 Paruthi Shalini, Brooks Lee ., m si Carolyn, Hall Wendy A., Kotagal Suresh, Lloyd Robin M., Malow Beth A., Maski Kiran, Nichols Cynthia, Quan Stuart F., Rosen Carol L., Troester Matthew M., & NA NA NA NA NA NA Valuable for relating the project to Healthy People 2030 No conceptual framework identified. Recom mendat ion by the Americ an Academ y of Sleep Medicin e NA Recommended amount of sleep for healthy children NA Sleep recommendations and links to general health, CV health, metabolic health, mental health, immunologic health, developmental health, longevity, and human performance Valuable for guiding intervention for project 8 Wise Merrill S. (2016). Consensus Statement of the American Academy of Sleep Medicine on the Recommended Amount of Sleep for Healthy Children: Methodology and Discussion. Journal of Clinical Sleep Medicine, 12(11), 15491561. https://doi.org/10.5 664/jcsm.6288 Sevecke , J. R., & Meadows, T. J. (2018). It Takes a Village: Multidisciplinary Approach to Screening and Prevention of Pediatric Sleep Issues. Medical Sciences, 6(3), 77. https://doi.org/10.3 390/medsci6030077 William son, A. A., Milaniak, I., Watson, B., Cicalese, O., Fiks, A. G., Power, T. J., Barg, F. K., Beidas, R. S., Mindell, J. A., & Rendle, K. A. No conceptual framework identified. Proposa l of multidis ciplinar y approac h to pediatri c sleep Not Sleep issues, specified screening, monitoring, barriers NA Multidisciplinary approach recommended Valuable for guiding intervention for project No conceptual framework identified. Qualitat ive assessm ent 23 caregive rs, 22 primary care provider s analysis of semistructured interviews Adaptations to EB sleep intervention for effective implementation in urban primary care Valuable for addressing health disparities and improving effectiveness of interventions. multilevel factors related to sleep and interventions 9 (2020). Early Childhood Sleep Intervention in Urban Primary Care: Caregiver and Clinician Perspectives. Journal of Pediatric Psychology, 45(8), 933945. https://doi.org/10.1 093/jpepsy/jsaa024 Baker, S., Morawska, A., & Mitchell, A. (2019). Promoting hi d s h hy habits through selfregulation via parenting. Clinical Child and Family Psychology Review, 22(1), 5262. https://doi.org/10.1 007/s10567-01900280-6 Beets, M. W., Brazendale, K., & Weaver, R. G. (2019). The need for synergy between biological and behavioral approaches to address accelerated weight gain during the summer in No conceptual framework identified. Literatu re review Not Examined selfspecified regulation principles, parenting interventions, and health NA Current interventions only provide information and guidelines and do not train parents on how to impement healthprotective practices Valuable for planning parenting intervention CCRM model Proposa l for applicat ion of the CCRM model NA NA The CCRM model is useful in addressing this problem Possibly valuable in addressing circadian and circannual rhythm Biological and behavioral approaches to address childhood weight gain 10 children. The International Journal of Behavioral Nutrition and Physical Activity, 16. https://doi.org/10.1 186/s12966-0190800-y Blunden , S., Benveniste, T., & Thompson, K. (2016). Putting hi d s s problems to bed: Using Behavior Change Theory to increase the success f hi d s s education programs and contribute to healthy development. Children, 3(3). https://doi.org/10.3 390/children303001 1 Crandell , J. L., Sandelowski, M., Leeman, J., Havill, N. L., & Knafl, K. (2018). Parenting behaviors and the well-being of children with a chronic physical condition. Families, Bronfenbren ner's ecological systems theory Proposa l for applicat ion of ESM to sleep educati on NA Sleep impact, sleep solutions, ecological systems Skinner's core dimensions of parenting Metaanalysis 47 studies Skinner's core dimensions such as parent warms, parent rejection, etc. child depression, quality of life, physical functioning, NA Correlation al analysis Bronfenbrenner's theory is useful when examining sleep education and sleep solutions Valuable for tying theory and sleep education/solutions together Supports the use of core dimensions in parenting research as an organizing framework Not valuable to the current project. 11 Systems, & Health, 36(1), 4561. https://doi.org/10.1 037/fsh0000305 Dang, D., & Dearholt, S. (2017). Johns Hopkins nursing evidence-based practice: model and guidelines. 3rd ed. Indianapolis, IN: Sigma Theta Tau International. Dawson -McClure, S., Calzada, E., Brotman, L., Calzada, E. J., & Brotman, L. M. (2017). Engaging parents in preventive interventions for young children: Working with cultural diversity within low-income, urban neighborhoods. Prevention Science, 18(6), 660670. https://doi.org/10.1 007/s11121-0170763-7 externalizing/i nternalizing behaviors NA NA NA NA NA NA Useful for appraising the literature and designing intervention based on EBP Stage-based framework for implementa tion of early childhood programs and systems Proposa l of implem enting evidenc e-based parenti ng interve ntions in schools NA NA NA Challenges to engaging families, especially low-income families of color Valuable in designing an EBP that addresses engagement factors, particularly for varying racial and ethnic groups 12 Eddy, J. M. (2017). Facing a fundamental problem in prevention science: The measurement of a key construct. Prevention Science, 18(3), 322325. https://doi.org/10.1 007/s11121-0170747-7 Hoefer, R., & Bryant, D. (2017). A quantitative evaluation of the multi-disciplinary approach to prevention services (maps) program to protect children and strengthen families. Journal of Social Service Research, 43(4), 459469. https://doi.org/10.1 080/01488376.2017 .1295009 Larsen, J. K., Hermans, R. C. J., Sleddens, E. F. C., Vink, J. M., Kremers, S. P. J., Ruiter, E. L. M., & Fisher, J. O. (2018). How to bridge the No conceptual framework identified. Explora tion of a proble m NA NA NA Lack of valid and reliable tools to measure parenting Possibly valuable when determining measurement of parenting behaviors Weiner's attribution theory Quantit ative analysis , pretest/po st-test 64 families parenting skills, parenting satisfactions, use of nonfamily resources mean comparison s Statistically significant improvement in family engagement, parenting behaviors and perceptions, involvement with CPS Valuable for the current project and possible example to follow with study design Proposing a conceptual framework Position paper NA food parenting as related to habits, volitional regulation behaviors NA Dual process view toward food parenting Possibly valuable in addressing intentionbehavior discordance in general health behaviors 13 intention-behavior gap in food parenting: Automatic constructs and underlying techniques. Appetite, 123, 191 200. https://doi.org/10.1 016/j.appet.2017.12 .016 Lindhie m, O., & Shaffer, A. (2017). Introduction to the special series: Current directions for measuring parenting constructs to inform prevention science. Prevention Science, 18(3), 253256. https://doi.org/10.1 007/s11121-0160724-6 Mazzuc chelli, T. G., & Ralph, A. (2019). Selfregulation approach to training child and family practitioners. Clinical Child and Family Psychology Review, 22(1), 129 145. https://doi.org/10.1 No conceptual framework identified. Examini ng measur ement of parenti ng constru cts NA NA NA Challenges of measuring complex constructs such as parenting Possibly valuable if considering parenting as a variable Social cognitive theory Examini ng strategi es for selfregulati on in practiti oners NA Strategies to encourage and assess selfregulation skills in practitioners NA Self-regulation is associated with efective goal directed action, practitioners with higher selfregulation deliver EBPs in clinical practice Somewhat valuable for translating to primary care 14 007/s10567-01900284-2 Riley, A. R., Walker, B. L., & Hall, T. A. (2020). Development and initial validation of a m s f s preferences for behavioral counseling in primary care. Families, Systems, & Health, 38(2), 139 150. https://doi.org/10.1 037/fsh0000481 Sawyer, M. r., Crosland, K. a., Miltenberger, R. g., & Rone, A. b. (2015). Using behavioral skills training to promote the generalization of parenting skills to problematic routines. Child & Family Behavior Therapy, 37(4), 261 284. https://doi.org/10.1 080/07317107.2015 .1071971 Schalkw ijk, A. a. H., Bot, S. D. M., de Vries, L., No conceptual framerwork identified Quantit ative analysis of propose d measur ement tool 396 parents of young children No conceptual framework identified. Multiple baseline across particpants design No conceptual Qualitat ive study 18 children, BIPS, conduct, emotions, healthy habits, behavior change, psychoeducati on, usual care, auxilary care, media resources, problem behavior, selfefficacy component analyses and correlations BIPS holds potential for informing the design and disseminiation of primary care parenting interventions Valuable- possible measurement scale Caregiver accuracy with impelemntation, effects on parenting skills, BST was generalized to naturally occuring routines and improved chid behavior Valuable method for parenting intervention Extended family support, social context Conclude that parents and children need parenting support and Possibly valuable for including extended family Analyzed transcripts for themes 15 Westerman, M. J., Nijpels, G., & Elders, P. J. M. (2015). Perspectives of obese children and their parents on lifestyle behavior change: A qualitative study. The International Journal of Behavioral Nutrition and Physical Activity, 12. https://doi.org/10.1 186/s12966-0150263-8 Shah, R., Kennedy, S., Clark, M. D., Bauer, S. C., & Schwartz, A. (2016). Primary carebased interventions to promote positive parenting behaviors: A metaanalysis. Pediatrics, 137(5). https://doi.org/10.1 542/peds.20153393 Tang, C. m., & Sinanan, A. n. (2015). Change in parenting behaviors from infancy to framework identified. 24 parents No conceptual framework identified. Review of Literatu re 13 studies No conceptual framework identified. Second 1364 ary data mothers analysis help from extended family and social context when attempting to make lifestyle behavior changes. Practitioner should play a more supportive role. and social context in intervention primary care interventions on parenting practices, early childhood development quantitativ e metaanalysis PC based interventions modestly affect positive parenting behaviors Possibly valuable for translating project to PC family income, parenting behaviors, poverty status, ethnicity hierarchical linear modeling, two level Ethnicity and income status were significantly related, as income increased, Not valuable to the current project. 16 early childhood: Does change in family income matter? Journal of Family Social Work, 18(5), 327348. https://doi.org/10.1 080/10522158.2015 .1080777 Vance, A. J., & Brandon, D. H. (2017). Delineating among Parenting Confidence, Parenting SelfEfficacy and Competence. ANS. Advances in Nursing Science, 40(4), E18 E37. https://doi.org/10.1 097/ANS.000000000 0000179 Watson Caring Science Institute. (n.d.) Caring science & human caring theory. https://www.watso ncaringscience.org/j ean-bio/caringsciencetheory/#theory Bornstei n, D. (2007). How to negative parenting behaviors decreased, No conceptual framework identified. Review of Literatu re 35 studies Parenting selfefficacy, confidence, and competence NA The three concepts have the same consequence- all contribute to positive growth, development, quality of life, and psychological wellbeing Valuable to the project when designing intervention and minimizing risks Watson's Caring Theory NA NA NA NA NA Possibly valuable as a nursing theory to guide intervention and planning NA NA NA NA NA NA Useful for ideas surrounding 17 Change the World: Social Entrepreneurs and the Power of New Ideas. Oxford University Press. Corralej o, S. M., & Domenech Rodrguez, M. M. (2018). Technology in parenting programs: A systematic review of existing interventions. Journal of Child and Family Studies, 27(9), 27172731. https://doi.org/10.1 007/s10826-0181117-1 Elias, B. L., Polancich, S., Jones, C., & Convoy, S. (2015). Evolving the PICOT method for the digital age: The PICOT-D. Journal of Nursing Education, 54(10), 594599. https://doi.org/10.3 928/0148483420150916-09 Florean, I. S., Dobrean, A., Ps , C. R., sustaintability and social entrepreneurship No conceptual framework identified. System atic review 31 articles technologybased parenting interventions, demographic information, treatment outcomes, feasibility NA Improved parent knowledge, behavior, and self-efficacy, but vast majority validated with white American famlies, Valuable for designing a technology-based intervention No conceptual framework identified. Proposa l for evolvin g PICOT method NA Use of digital data compenents in order to identify data measures NA Need to evolve the PICOT to the PICOT-D method Valuable for determining how to incorporate digital data into PICOT question and study design No conceptual Metaanalysis 2160 studies, 15 RCTs effectiveness of online parenting Data analysis showed Findings suggest effectiveness for Helpful insights for planning online parenting intervention 18 Georgescu, R. D., & Milea, I. (2020). The Efficacy of internetbased parenting programs for children and adolescents with behavior problems: A meta-analysis of randomized clinical trials. Clinical Child and Family Psychology Review. https://doi.org/10.1 007/s10567-02000326-0 Harris, M., Andrews, K., Gonzalez, A., Prime, H., & Atkinson, L. (2020). Technologyassisted parenting interventions for families experiencing social disadvantage: A meta-analysis. Prevention Science, 21(5), 714727. https://doi.org/10.1 007/s11121-02001128-0 Kaya, N., & Turan, N. (2016). Innovation in nursing: A concept analysis. framework identified. interventions in reducing child/adolesce nt behavior problems effectivene ss but small effect size and no sig difference to classical parenting interventio ns parents and child behavior parenting intervention for famlies with demographic challenges, parental psychological well-being, parenting, child behavior Data analysis- Qstatistics, metaregression, effect size and moderators Findings support the use of technologyassited parenting interventions for populations experiencing social disadvantage Helpful insights for planning online parenting intervention NA Term innovation is widely used, but not clearly defined and can refer to a number of concepts Valuable for understanding what constitutes nursing innovation No conceptual framework identified. Metaanalysis 9 studies, 864 participa nts Wilson, Walker, and Avant framework with 8 Literatu re review Not Concept specified analysis of innovation in nursing 19 Journal of iterative Community & Public procedural Health Nursing, steps 2(1). https://doi.org/10.4 172/24719846.1000108 MacDo No nell, K. W., & Prinz, conceptual R. J. (2017). A framework review of identified. technology-based youth and familyfocused interventions. Clinical Child and Family Psychology Review, 20(2), 185 200. https://doi.org/10.1 007/s10567-0160218-x Moran, Multiple K., Burson, R., & coneptual Conrad, D. (2020). frameworks The Doctor of presented Nursing Practice Project. Jones & Bartlett Learning. Riegler, L.J., Raj, S.P., Moscato, E.L., Narad, M.E., Kincaid, A., & Wade, S.L. (2020). Pilot trial of a telepsychotherapy parenting skills intervention for veteran families: Implications for managing parenting stress during COVID-19. Journal of Psychotherapy, 30(2), Literatu re review 30 studies (RCT designs) Technologybased interventions in mental/behavi oral health of children/famili es NA Studies show promise in reducing youth behavioral problems, depressive/anxious symptoms, and teaching parents Useful for planning interventions for an online parenting project NA NA NA NA NA Valuable resource for planning of project Significant and clinically meaningful outcomes in terms of parent, family, and child factors Valuable for planning on online parenting intervention Quasi41 experim started, ental 22 complet ed Veteran and paired t family tests outcomes, child outcomes 20 290-303. https://dx.doi.org/10.1037/int0000 220 Sanders Social , M. R., & learning Mazzucchelli, T. G. theory (2017). The Power of Positive Parenting: Transforming the Lives of Children, Parents, and Communities Using the Triple P System. Oxford University Press. Sanders Social , M. R., Turner, K. M. learning T., & Metzler, C. W. theory (2019). Applying self-regulation principles in the delivery of parenting interventions. Clinical Child and Family Psychology Review, 22(1), 24 42. https://doi.org/10.1 007/s10567-01900287-z Shorey, No S., & Ng, E. D. conceptual (2019). Evaluation framework of moth s identified. perceptions of a NA NA NA NA Triple P parenting program backed by 30 years of ongoing research Valuable to understand because this has been an effective parenting intervention and is wellstudied Proposa l of applicat ion of selfregulati on principl es in parenti ng interve ntions NA NA NA When parents increase selfregulation, parenting behaviors improve Possibly valuable to guide intervention Qualitat ive semistructur ed 16 mothers Phone based parenting intervention and access to app, emotional NA Positive effects on variables measured Possbily valuable to guide intervention 21 technology-based supportive educational parenting program (Part 2): Qualitative study. Journal of Medical Internet Research, 21(2), e11065. https://doi.org/10.2 196/11065 Shorey, S., Ng, Y. P. M., Ng, E. D., Siew, A. L., Morelius, E., Yoong, J., & Gandhi, M. (2019). Effectiveness of a technology-based supportive educational parenting program on parental outcomes (Part 1): Randomized controlled trial. Journal of Medical Internet Research, 21(2), e10816. https://doi.org/10.2 196/10816 Smith, J. D., Cruden, G. H., Rojas, L. M., Ryzin, M. V., Fu, E., Davis, M. M., Landsverk, J., & Brown, C. H. intervie ws well-being, parent involvement B d s self-efficacy theory and B w ys theory of attachment RCT 236 parents Phone based parenting intervention and access to app, emotional well-being, parent involvement Linear mixed models were used to compare groups Significant positive effects on variables measured Possibly valuable to guide intervention No conceptual framework identified. Metaanalysis 6532 articles, narrowe d down to 40 Behavioral interventions delivered in primary care, mental, emotional, and NA Pediatric primary care can implement effect parenting interventions resulting in positive and equitable Valuable for translating the project to primary care 22 (2020). Parenting interventions in pediatric primary care: A systematic review. Pediatrics, 146(1). https://doi.org/10.1 542/peds.20193548 Taylor, C. B., i zsimm s Craft, E. E., & Graham, A. K. (2020). Digital technology can revolutionize mental health services delivery: The COVID-19 crisis as a catalyst for change. International Journal of Eating Disorders, 53(7), 11551157. https://doi.org/10.1 002/eat.23300 Weberg , D., & Davidson, S. (2019). Leadership for Evidence-Based Innovation in Nursing and Health Professions. Jones & Bartlett Learning. behavioral outcomes outcomes for parents and children No conceptual framework identified. Proposa l of need for digital mental health interve ntions NA Training, licensing, safety, privacy, payment, evaluation NA Barriers must be addressed so digital mental health interventions can be delivered effectively Valuable for incorporating current COVID-19 pandemic needs into project No conceptual framework identified. NA NA NA NA Innovation in nursing Valuable for incorporating leadership and EBP into the project 23 Wijngaa rden, J. D. H. van, Scholten, G. R. M., & Wijk, K. P. van. (2012). Strategic analysis for health care organizations: The suitability of the SWOT-analysis. The International Journal of Health Planning and Management, 27(1), 3449. https://doi.org/10.1 002/hpm.1032 Yap, M. B. H., CardamoneBreen, M. C., Rapee, R. M., Lawrence, K. A., Mackinnon, A. J., Mahtani, S., & Jorm, A. F. (2019). Medium-term effects of a tailored web-based parenting intervention to reduce adolescent risk of depression and anxiety: 12Month findings from a randomized controlled trial. Journal of Medical Internet Research, 21(8), e13628. No conceptual framework identified. Explora tative study 26 respond ants Use of SWOT analysis, methods for internal and external analysis, involvement, responses, effects NA Differences between strengths and weaknesses, opportunities and threats remain arbitrary in the health care sector due to complexities Not valuable to the current project. No conceptual framework identified. RCT 359 parents 332 adolesce nts Partners in parenting program, depression and anxiety symptoms Correlation al, mediation analysis Improvement in parenting risk and protective factors and adolescent risk for anxiety and depression lasting up to 9 months Valuable as an example of utilizing a web-based parenting intervention 24 https://doi.org/10.2 196/13628 Albuqu erque, U. P., de Medeiros, P. M., Ferreira Jnior, W. S., da Silva, T. C., da Silva, R. R. V., & Gonalves-Souza, T. (2019). Socialecological theory of maximization: Basic concepts and two initial models. Biological Theory, 14(2), 7385. https://doi.org/10.1 007/s13752-01900316-8 Brother s, S., Lin, J., Schonberg, J., Drew, C., & Auerswald, C. (2020). Food insecurity among formerly homeless youth in supportive housing: A socialecological analysis of a structural intervention. Social Science & Medicine, 245, 112724. https://doi.org/10.1 016/j.socscimed.201 9.112724 Social ecological theory Proposa l for use of theory NA NA Social ecological theory Observ ational + intervie ws 39 youth food (age 18- insecurity, 24) stigma, neighborhood food resources, monthly hunger cycles, housing policies, kitchen use and food storage, social networks, cooking skills, coping strategies NA Ethnobiological investigations could benefit from the propsed theory to describe interactions between human groups and the environment Not valuable to the current project. Correlation al Supportive housing provides shelter but does not guarantee access to nutritious food 25 Ceci, S.J. (2006). Urie Bronfenbrenner, 1917-2005. American Psychologist, 61(2), 173-174. https://doi.org/10.1 037/0003066X.61.2.173 Cross, W. E. (2017). Ecological factors in human development. Child Development, 88(3), 767769. https://doi.org/10.1 111/cdev.12784 Eriksson , M., Ghazinour, M., & Hammarstrm, A. (2018). Different uses of B f s ecological theory in public mental health research: What is their value for guiding public mental health policy and practice? Social Theory & Health, 16(4), 414433. https://doi.org/10.1 057/s41285-0180065-6 NA NA NA NA NA NA Valuable in understanding Bronfenbrenner and his theory Bronfenbren ner's ecological theory Review of Literatu re 4 studies Systems evaluated, processes evaluated, niche NA Helpful insights about the levels of ecological theory explored in various articles, identifying gaps, and suggestions for future research Valuable in that it addresses the use of this theory as related to minority populations Bronfenbren ner's ecological theory System atic review 16 studies Applying ecological theory to mental health research NA Studies using ecological theory that take into account interactions between and within various systems are most valuable Valuable to the current project as an example of correctly utilizing Bronfenbrenner's theory 26 Gool, F. W. R. van, Theunissen, N. C. M., Bierbooms, J. J. P. A., & Bongers, I. M. B. (2017). Literature study from a social ecological perspective on how to create flexibility in healthcare organisations. International Journal of Healthcare Management, 10(3), 184195. https://doi.org/10.1 080/20479700.2016 .1230581 Hertler, S. C., Figueredo, A. J., PeaherreraAguirre, M., Fernandes, H. B. F., & Woodley of Menie, M. A. (2018). Urie Bronfenbrenner: Toward an evolutionary ecological systems theory. In S. C. Hertler, A. J. Figueredo, M. Peaherrera- Bronfenbren ner's social ecological theory System atic review 19 studies Flexibility in healthcare organizations NA Lack of evidence on creating flexibility within health care organizations Not valuable to the current project. Bronfenbren ner's ecological systems theory Chapter from a book NA Many variables studied as related to natural ecological systems NA Bronfenbrenner's theory is useful when examining natural ecological systems Not valuable to the current project. 27 Aguirre, H. B. F. Fernandes, & M. A. Woodley of Menie (Eds.), Life History Evolution: A Biological MetaTheory for the Social Sciences (pp. 323 339). Springer International Publishing. https://doi.org/10.1 007/978-3-31990125-1_19 Kilanow ski, J.F. (2017). Breadth of the Socio-Ecological Model. Journal of Agromedicine, 22(4), 295-297. https://doi.org/10.1 080/1059924X.2017 .1358971 Lichten berger, D. (2012, August 2). Shaping influences: Human development. Drew Lichtenberger. http://drewlichtenb erger.com/6shaping-influenceshumandevelopment/ Office of Head Start: An Bronfenbren ner's ecological systems theory Review of Literatu re Not clearly stated Analysis of many articles related to agricultural safety practices from a SEM perspective NA An adapted version of the SEM helps increase agricultural safety Not valuable to the current project. Bronfenbren ner's ecological systems theory NA NA NA NA NA Valuable visual image of Bronfenbrenner's theory NA NA NA NA NA NA NA 28 Office of the Administration for Children and Families. (2019, June 4). History of head start. https://www.acf.hh s.gov/ohs/about/his tory-of-head-start McCor mack, L., Thomas, V., Lewis, M. A., & Rudd, R. (2017). Improving low health literacy and patient engagement: A social ecological approach. Patient Education and Counseling, 100(1), 813. https://doi.org/10.1 016/j.pec.2016.07.0 07 Rosa, E.M. & Trudge, J.R.H. (2013). Urie B f s theory of human development: Its evolution from ecology to bioecology. Journal of Family Theory & Review, 5(4), 243258. Socioecological theory NA NA NA NA Proposal of utilizing social ecological perspetive in regards to health literacy Valuable to planning multilevel intervention No conceptual framework identified. Examin ation of Bronfen brenner 's theory NA NA NA Identification of Bronfenbrenner's three stages of theory development Valuable for understanding the application of Bronfenbrenner's theory and PPCT model 29 https://doi.org/10.1 111/jftr.12022 Trach, J., Lee, M., & Hymel, S. (2018). A socialecological approach to addressing emotional and behavioral problems in schools: Focusing on group processes and social dynamics. Journal of Emotional and Behavioral Disorders, 26(1), 11 20. https://doi.org/10.1 177/106342661774 2346 Trudge, J.R.H., Payir, A., Mercon-Vargas, E., Cao, H., Liang, Y., Li, ., & B i , L. (2016). Still misused after all these years? A reevaluation of the uses of B f s Bioecological Theory of Human Development. Journal of Family Theory & Review, 8(4), 427-445. Bronfenbren ner's ecological systems theory Review of Literatu re Not clearly stated Examined literature on SEL and group dynamics NA Addressing emotional and behavioral problems with groupbased interventions and SEL strategies Not valuable to the current project. No conceptual framework identified. Review of Literatu re Review of 20 articles Examined the use of Bronfenbrenne rs theory Data analysis looked at frequency and use of variables Few studies applied Bronfenbrenner's theory and PPCT model as intended by Bronfenbrenner Valuable for understanding how to apply Bronfenbrenner as the theoretical foundation for the project 30 https://doi.org/10.1 111/jftr.12165 Baily, L.R. (2018). History and ethical principles. CITI Program: Social & Behavioral Research. Harmon , A. (2010, April 21). Indian tribe wins fight to limit research of its DNA. The New York Times. https://www.nytime s.com/2010/04/22/ us/22dna.html?pag ewanted=all&mcubz =3 Moore, S. Tasse, A.M., Thorogood, A., Winship, I., Zawati, M., & Doerr, M. (2017). Consent processes for mobile app mediated research: Systematic review. Journal of Medical Internet Research, Mhealth Uhealth, 5(8), e126. NA NA NA NA NA NA NA NA NA NA No conceptual framework identified. Review of Literatu re Review of 26 articles Analysis of many variables including privacy, confidentiality, data security, and more Data analysis looked at frequency and use of variables Training module for understanding Belmont Report, informed consent, and ethical use of human subjects in social and behavioral research Overview of controversy about use of genetic material without explicit informed consent for studies Valuable for designing the project to meet IRB approval Use of app for informed consent has advantages and can contribute to participant understanding and transparency Valuable for designing on online or app based intervention, particularly for informed consent Not valuable to the current project. 31 https://doi.org/10.2 196/mhealth.7014 Peberdy , L., Young, J., Massey, D. et al. ( 8). P s knowledge, awareness, and attitudes of cord blood donation and banking options: An integrative review. BMC Pregnancy Childbrith, 18(395). https://doi.org/10.1 186/s12884-0182024-6 Saint ys C . (n.d.). Institutional review board (IRB) for research involving human participants. https://www.saintm arys.edu/portal/insti tutional-reviewboard Sterling, R.L. (2011). Genetic research among the Havasupai: A cautionary tale. American Medical Association Journal of Ethics, 13(2), 113117. No conceptual framework identified. Review of Literatu re Review of 25 articles NA NA Determined a number of barriers to parent's understanding and willingness to utilize cord blood banking Not valuable to the current project. NA NA NA NA NA NA Important resource for planning and designing project in order to gain IRB approval NA NA NA NA NA Examining the use of genetic information, vulnerable populations, and informed consent Valuable from an ethical perspective when designing research with human subjects 32 Mollard , E., Hatton-Bowers, H., & Tippens, J. (2020). Finding strength in vulnerability: Ethical approaches when conducting research with vulnerable populations. Journal of Midwifery and Womens Health, 0, 1-6. https://doi.org/10.1 111/jmwh.13151 Beeber, A. S., Palmer, C., Waldrop, J., Lynn, M. R., & Jones, C. B. (2019). The role of doctor of nursing practice-prepared nurses in practice settings. Nursing Outlook, 67(4), 354 364. https://doi.org/10.1 016/j.outlook.2019. 02.006 Christen sen, M., & Craft, J. (2017). The nursing professorial unit: Translating acute and critical care nursing research. International No conceptual framework identified. Analysis of strengt hsbased researc h NA No conceptual framework identified. Descrip tive explora tory study 6 Cs of collaborativ e research Descrip tive explora tory study Examined studies using strengthsbased research When working with vulnerable populations, researchers can avoid deficit discourse by focusing on strengths and other methods identified in this article. Valuable for planning an intervention that builds upon particpants' strengths 130 DNP Examined roles Identificati Program of DNP on of directors graduates and themes how they compare to others Low numbers of DNP graduates makes it difficult to study outcomes Valuable for role of DNP in non-academic settings Examine d1 nursing professi onal unit Effective collaboration Valuable for evidence led to translation based research. Examined the NPU translation of EBP NA NA 33 Practice Development Journal, 7(2), 110. https://doi.org/10.1 9043/ipdj.72.009 Cowan, L., Hartjes, T., & Munro, S. (2019). A model of successful DNP and PhD collaboration. Journal of the American Association of Nurse Practitioners, 31(2), 116123. https://doi.org/10.1 097/jxx.0000000000 000105 Cohn, E.G., McCloskey, D.J., Kovner, C.T., Schiffman, R., & Mitchell, P.H. (2018). Connecting translational nurse scientists across the nation- The nurse scientisttranslational research interest group. The Online Journal of Issues in Nursing, 23,(2). https://doi.org/10.3 912/OJIN.Vol23No0 2Man03 No conceptual framework identified. Creatio n of a clinical pathwa y NA NA NA Need for collaboration Valuable for role of the DNP No conceptual framework identified. Descrip tive study NA Examined the Nurse Scientist Translational Interest Research Group NA Multidisciplinary approach recommended Not valuable to the current project. 34 McCaul ey, L., Broome, M., Frazier, L., Hayes, R., Kurth, A., Musil, C., Vi , . (2020). Doctor of Nursing Practice (DNP) degree in the United states: Reflecting, readjusting, and getting back on track. Nursing Outlook, 68(4), 494 503. https://doi.org/10.1 016/j.outlook.2020. 03.008 Nationa l Organization of Nurse Practitioner Faculties. (2016). White Paper: The Doctor of Nursing Practice Nurse Practitioner Clinical Scholar. https://cdn.ymaws.c om/www.nonpf.org /resource/resmgr/d ocs/ClinicalScholarFI NAL2016.pdf. Robert, R.R. & Pape, T.M. (2011). Scholarship in nursing: Not an isolated concept. No conceptual framework identified. Descrip tive Deans from topranked nursing schools Examined the DNP vs APRN role, education NA There is confusion about the value and role of the DNP Not valuable to the current project. No conceptual framework identified. Summa ry and recom mendat ions NA NA NA Clinical scholarship and the DNP Not valuable to the current project. No conceptual framework identified. Position paper NA NA NA Clinical scholarship and nursing Not valuable to the current project. 35 MedSurg Nursing, 20(1), 41-44. Sabatell i, R. M. (2017). Training translational scholars within family science programs. Family Relations, 66(4), 766772. https://doi.org/10.1 111/fare.12262 Singleto n, J. K. (2017). Evidence-based practice beliefs and implementation in Doctor of Nursing Practice students. Worldviews on Evidence-Based Nursing, 14(5), 412 418. https://doi.org/10.1 111/wvn.12228 Trautm an, D.E., Idzik, S., Hammersia, M., & Rosseter, R. (2018). Advancing scholarship through translational research: The role of the PhD and DNP prepared nurses. The Online Journal No conceptual framework identified. Position paper NA NA NA Incorporating translational scholarship into training programs Not valuable to the current project. Advancing Research through Close Collaboration (ARCC) model 54 students EBP beliefs and implementatio n Pretest/Posttest DNP students made gains in EBP beliefs and implementation Not valuable to the current project. No conceptual framework identified. NA NA NA Collaboration between DNP and PhD Not valuable to the current project. Explora tory analysis 36 of Issues in Nursing, 23(2). https://doi.org/10.3 912/OJIN.Vol23No0 2Man02 slund, L., Arnberg, F., Kanstrup, M., & Lekander, M. (2018). Cognitive and behavioral interventions to improve sleep in school-age children and adolescents: A systematic review and meta-analysis. Clinical Sleep Medicine, 14(11), 1937-1947. http://dx.doi.org/10.5664/jcsm.749 8 System atic review 6 RCTs Cognitive and behavioral interventions to improve sleep effect size, sensitivity Cognitive and behavioral sessions can improve sleep  ...