Adapting a community pharmacy intervention to improve medication safety.

BACKGROUND: Community pharmacies are an ideal location to address challenges of over-the-counter medication safety, yet many successful interventions are only tested in a few pharmacies without expansion, creating unrealized opportunities to improve patient care on a larger scale. Scaling up to numerous pharmacies can be challenging because each community pharmacy has unique needs and layouts and requires individualized adaptation. OBJECTIVES: This paper reports techniques for (a) adapting a community pharmacy intervention to fit the unique physical layout and patient needs of health system pharmacy sites without increasing staff workload, (b) identifying strategies to gather feedback on adaptations from stakeholders, and (c) developing materials to share with pharmacy champions for them to independently implement and sustain the intervention in their organization. PRACTICE DESCRIPTION: The study team collaborated with Aurora Pharmacy, Inc to develop an intervention designed to increase awareness of safe over-the-counter medication use for older adults. PRACTICE INNOVATION: Senior Safe, a community pharmacy-based intervention, was designed, implemented, and tested using the Exploration, Preparation, Implementation, and Sustainment implementation framework. EVALUATION METHODS: Senior Safe was adapted through pilot testing and a randomized control trial. Feedback was collected from key stakeholders, including pharmacy staff, older adults, and a research advisory group. RESULTS: A finalized version of Senior Safe, as well as an implementation package, was provided to Aurora Pharmacy to integrate into all 63 sites. CONCLUSION: This multiphase study illustrated that refining an intervention is possible and welcomed by pharmacy staff, but it requires time, resources, and funds to create an impactful, sustainable community pharmacy intervention.

Using the integrated theory of health behavior change to assess factors affecting diabetes medication adherence among black adults during COVID-19: an explanatory sequential mixed methods design.

OBJECTIVES: (1) Evaluate changes in medication adherence and the role of psychosocial and interpersonal factors on adherence. (2) Explain the changes in medication adherence based on patient perceptions of adherence behaviors. DESIGN: We used an explanatory sequential mixed methods design for surveys at baseline and 1-year follow-up, followed by interviews. The Integrated Theory of Health Behavior Change guided the design of a questionnaire including self-reported measures of medication adherence, psychosocial factors such as illness and medication beliefs, self-efficacy, and depressive symptoms, interpersonal factors including social support and patient-provider communication, and socio-demographic and clinical factors. A convenience sample (n = 228) of adult patients with type 2 diabetes who self-identified as Black/African American completed the mail/telephone surveys. Nine semi-structured interviews were conducted with respondents of both surveys who had changes in medication adherence. Descriptive, mean differential, bivariate correlational analyses, and content analysis was conducted. Data integration merged quantitative and qualitative results as a joint display. RESULTS: Response rates for the baseline and follow-up survey were 28% and 47% respectively. Medication adherence scores were significantly correlated with illness perceptions (r = .30) and depression (r = .25) at baseline, and self-efficacy (r = -.51) and depression (r = .37) at follow-up. Qualitative themes included patient perceptions of adherence behaviors, impact of the COVID-19 pandemic, health literacy and self-efficacy. Mixed methods integration showed contrasting perceptions of the same themes including adherence behaviors, medication beliefs, social support, and patient-provider communication among participants whose medication adherence increased and decreased overtime. CONCLUSION: Self-efficacy, diabetes beliefs, and depressive symptoms were key psychosocial factors that affected medication adherence among Blacks/African Americans. Contrasting perceptions of beliefs in medicines, social support, provider relationships and communication among increased and decreased adherence participant groups explained the changes in adherence, which can be used to adapt existing interventions.

Psychometric evaluation of a culturally adapted illness perception questionnaire for African Americans with type 2 diabetes.

BACKGROUND: Diabetes is burdensome to African Americans, who are twice as likely to be diagnosed, more likely to develop complications and are at a greater risk for death and disability than non-Hispanic whites. Medication adherence interventions are sometimes ineffective for African Americans because their unique illness perceptions are not adequately addressed. The Illness Perception Questionnaire-Revised (IPQ-R) that assesses illness perceptions has shown reliability and validity problems when used with African Americans. Thus, the study objective was to adapt the IPQ-R for African Americans and assess the validity and reliability of the culturally adapted questionnaire. METHODS: The parent study used an exploratory sequential mixed methods design, to explore African Americans' illness perceptions qualitatively, used the results to adapt the IPQ-R, and tested the culturally adapted IPQ-R items quantitatively. In this paper, a preliminary culturally adapted IPQ-R refined based on the qualitative study, was administered to 170 middle-aged United States-based African Americans with type 2 diabetes in a face-to-face survey. Content, construct, convergent, and predictive validity, including reliability was examined. Pearson and item-total correlations, item analysis, exploratory factor analysis, multiple linear regression analysis, and test-retest were conducted. RESULTS: A revised culturally adapted IPQ-R was identified with a 9-factor structure and was distinct from the old factor structure of the original IPQ-R. The 'consequences' domain from the IPQ-R occurred as two factors (external and internal consequences) while the 'emotional representations' domain in the IPQ-R emerged as separate 'present' and 'future' emotional representation factors. Illness coherence' was differently conceptualized as 'illness interpretations' to capture additional culturally adapted items within this domain. Most items had factor loadings greater than 0.4, with moderate factor score correlations. Necessity and concern beliefs in medicines significantly correlated with domains of the culturally adapted IPQ-R. Pearson's correlation values were not greater than 0.7, indicating good convergent validity. The culturally adapted IPQ-R significantly predicted medication adherence. None of the correlation values were higher than 0.7 for the test-retest, indicating moderate reliability. Most domains of the culturally adapted IPQ-R had Cronbach's alpha values higher than 0.7, indicating good internal consistency. CONCLUSIONS: The results provide preliminary support for the validity of the culturally adapted IPQ-R in African Americans with diabetes, showing good construct, convergent and predictive validity, as well as reliability.

"Why Am I Not Taking Medications?" Barriers and Facilitators of Diabetes Medication Adherence Across Different Health Literacy Levels.

Medication adherence is important for diabetes management. Better knowledge of how patient factors relate to medication adherence allows us to develop more tailored interventions. We explore patients' perceptions of the barriers to and facilitators of medication adherence across different levels of health literacy. Semi-structured interviews with 23 participants with type 2 diabetes (T2D) were completed, and direct content analysis identified the facilitators of and the barriers to medication adherence through the lens of the Health Literacy Pathway model. Linking medication-taking to daily routine and focusing on the internal locus of control are imperative approaches to fostering self-efficacy of medication use. Understanding patients' life experiences and clarifying medication misinformation help patients address their concerns with medications. Lowering the cost of medications and simplifying therapy regimens can alleviate participants' perceived barriers to medication-taking. In this study, we explore medication adherence from the experience of people with T2D and can inform tailored interventions to improve medication adherence.

Sociocultural Influences on African Americans' Representations of Type 2 Diabetes: A Qualitative Study.

Objective: Illness representations, known as patients' beliefs and expectations about an illness, may be influenced by cultural beliefs and personal experiences. This study explored African Americans' perceptions of the sociocultural factors that influence their representations of diabetes. Design: Six semi-structured focus groups. Setting: Private space at a convenient site. Participants: Forty African Americans, aged 45-60 years with type 2 diabetes for at least one year prior. Results: Participants perceived that there was a race-mediated effect of how they developed diabetes because of poverty due to past slavery, racial discrimination by health care providers, and the stigma associated with diabetes within the African American community. Participants perceived that poverty influenced African Americans' unhealthy eating habits, which led to diabetes diagnosis among their ancestors and their development of the disease since it was hereditary. Participants also perceived that there was provider ill intention, ie, providers were purposefully making people sick, and their lack of education on diabetes from providers was done on purpose, as information on diabetes was withheld and not shared due to racial discrimination. Perceived stigma by the community led to African Americans' avoidance and denial of the disease, and subsequently the development of diabetes. Conclusions: To enhance disease management for African Americans with diabetes, it is important to focus on the sociocultural context of how African Americans view their world that may be influenced by their knowledge of negative historical circumstances and their current provider relationship, which, in turn, may be reflected in their perceptions of diabetes.

Improving prescription auxiliary labels to increase patient understanding.

OBJECTIVES: To develop new, easy-to-understand prescription auxiliary labels, assess patient understanding of both new and existing labels, and compare the effectiveness of existing labels with the newly developed ones. DESIGN: Cross-sectional study. SETTING: Semistructured interviews. PARTICIPANTS: Convenience sample of adults from minority populations who were currently taking or had previously taken a prescription medication and could understand English. INTERVENTION: Easy-to-understand prescription auxiliary labels were developed. Both these newly created labels and existing labels were shown to participants. Participants' health literacy levels and understanding of the information provided on the labels were determined. The reading difficulty of the auxiliary labels was determined using a Lexile Score. MAIN OUTCOME MEASURES: Interpretation and understanding of prescription auxiliary labels. RESULTS: The study included 120 participants with a mean age of 40 years (SD = 14). All existing prescription auxiliary labels yielded less than 50% "excellent" interpretations except for those indicating "Take with food" and "Do not chew or crush." The newly designed labels were better understood compared with existing labels. Some existing labels yielded Lexile scores above the sixth-grade reading level. There was an association between higher levels of education (χ2 = 20.86, P = 0.02) or higher REALM-R (Rapid Estimate of Adult Literacy in Medicine, Revised) scores (χ2 = 26.79, P = 0.02) and better interpretation of auxiliary labels. CONCLUSION: Simpler auxiliary labels with improved patient comprehension can be developed. Auxiliary label understanding and interpretation is low for commonly used labels. Pharmacies should consider using existing manufacturer auxiliary labels that meet the criteria for patients with low literacy.

Patient and pharmacist perspectives on opioid misuse screening and brief interventions in community pharmacies.

BACKGROUND: Pharmacy-based screening and brief interventions (SBI) offer opportunities to identify opioid misuse and opioid safety risks and provide brief interventions that do not overly burden pharmacists. Currently, such interventions are being developed without patient input and in-depth contextual data and insufficient translation into practice. The purpose of this study is to qualitatively explore and compare patient and pharmacist perceptions and needs regarding a pharmacy-based opioid misuse SBI and to identify relevant SBI features and future implementation strategies. METHODS: Using the Consolidated Framework for Implementation Research, we conducted semi-structured interviews with 8 patients and 11 pharmacists, to explore needs and barriers to participating in a pharmacy-based SBI. We recruited a purposive sample of English-speaking patients prescribed opioids for chronic or acute pain and pharmacists practicing in varied pharmacies (small independent, large-chain, specialty retail) settings. We used an inductive content analysis approach to analyze patient interview data. Then through a template analysis approach involving comparison of pharmacist and patient themes, we developed strategies for SBI implementation. RESULTS: Most patient participants were white, older, described living in suburban areas, and were long-term opioid users. We identified template themes related to individual, interpersonal, intervention, and implementation factors and inferred applications for SBI design or potential SBI implementation strategies. We found that patients needed education on opioid safety and general opioid use, regardless of opioid use behaviors. Pharmacists described needing patient-centered training, protocols, and scripts to provide SBI. A short-self-reported screening and brief interventions including counseling, naloxone, and involving prescribers were discussed by both groups. CONCLUSIONS: Through this implementation-focused qualitative study, we identified patient needs such as opioid safety education delivered in a private and convenient format and pharmacist needs including training, workflow integration, protocols, and a time-efficient intervention for effective pharmacy-based SBI. Alternate formats of SBI using digital health technologies may be needed for effective implementation. Our findings can be used to develop patient-centered pharmacy-based SBI that can be implemented within actual pharmacy practice.

An Implementation-Focused Qualitative Exploration of Pharmacist Needs Regarding an Opioid Use Disorder Screening and Brief Intervention.

BACKGROUND: Screening and brief interventions (SBI) can help identify opioid safety risks and healthcare professionals can accordingly intervene without a significant increase in workload. Pharmacists, one of the most accessible healthcare professionals, are uniquely positioned to offer SBI. To design an effective intervention with high potential for implementation, we explored pharmacist needs and barriers regarding SBI for opioid use disorders. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted 11 semi-structured 60-minute interviews with community pharmacists. We used a purposeful sample of English-speaking pharmacists practicing in varied pharmacies (small independent, large-chain, specialty-retail) and positions (managers, owners, full-time/part-time pharmacists). Transcriptions were analyzed using deductive content analysis based on CFIR constructs, followed by inductive open coding. Utilizing a theoretical framework for data collection and analysis, a diverse sample of pharmacist roles, peer debriefing, and 2 independent coders for each transcript, altogether increased the credibility and transferability of our research. Data collection and analysis continued until data saturation was achieved. RESULTS: Pharmacists described good working relationships with colleagues, organization cultures that were open to new initiatives, and believed the SBI to be compatible with their organization goals and pharmacy structure, which are facilitators for future SBI implementation. Pharmacists were motivated by improved patient outcomes, more patient interaction and clinical roles, representing facilitators at the individual level. They also described stigma toward patients, mixed need for change, and lack of knowledge regarding SBI, which are potential barriers to be addressed. Pharmacists believed that the SBI model was adaptable, not complicated, and benefits outweighed implementation costs. CONCLUSIONS: We addressed current SBI literature gaps-mainly lack of focus on implementation and contextual data, through rigorous implementation-focused qualitative research. Our exploratory findings have direct implications on future pharmacy-based SBI implementation.

Peer Ambassador Perspectives in a Culturally Tailored Self-Management Intervention for African Americans with Type 2 Diabetes: A Qualitative Study.

OBJECTIVE: Diabetes disproportionately affects African Americans, leading to higher morbidity and mortality. This study explores the experiences of African American adults who successfully self-manage their type 2 diabetes (called Peer Ambassadors) and provided phone-based peer support in a 6-month culturally tailored diabetes self-management program for African Americans guided by the information-motivation-behavioral skills model. DESIGN: A group discussion using a semi-structured discussion guide was conducted. Qualitative content analysis was used to identify the facilitators and barriers to completing the role of a Peer Ambassador and to develop strategies for overcoming possible challenges in the future. SETTING: Key informant discussions were conducted in a community location to gain insights into Ambassadors' motivations and challenges in delivering peer support. PARTICIPANTS: Three Peer Ambassadors completed ethics training and peer mentor training and received a phone call guide before providing support to their peers. RESULTS: There were four core themes related to Peer Ambassador experiences: (1) Motivation to be a Peer Ambassador, (2) program elements that supported Peer Ambassador role, (3) key elements of achieving engagement, and (4) challenges related to being a Peer Ambassador. CONCLUSIONS: This study showed Peer Ambassadors in a culturally tailored peer supported self-management program found fulfillment in sharing experiences and supporting peers. They highly valued educational group sessions for knowledge updates and sustaining their health-related goals, suggesting the potential benefits of recognizing milestones or providing advanced training for future program sustainability. Findings suggest the importance of recruiting motivated patients and providing effective facilitation for peer support roles, including addressing barriers such as time commitment and lack of socialization opportunities.

Advancing the use of community pharmacy quality measures: a qualitative study.

OBJECTIVES: To describe consumers' ability to interpret pharmacy quality measures data presented in a report card, to examine the tools that consumers require to interpret the information available in a pharmacy quality report card, and to determine whether pharmacy quality measures influence consumers' choice of a pharmacy. DESIGN: Qualitative study. SETTING: Three semistructured focus groups conducted in a private meeting space at a public library in Sioux Falls, SD, from April 2011 to May 2011. PARTICIPANTS: 29 laypeople. INTERVENTION: Participants' skills interpreting and using pharmacy quality information were examined based on mock report cards containing the Pharmacy Quality Alliance (PQA) quality measures. MAIN OUTCOME MEASURES: Consumer perceptions of pharmacy quality data. RESULTS: Participants reported difficulty understanding quality measures because of knowledge deficits. They wanted supportive resources on drug class of their medications to help them understand the measures. Participants had different opinions on whether their pharmacies should be compared with other pharmacies based on specific quality measures. For example, they favored the use of drug-drug interactions as a quality measure for comparing pharmacies, while medication adherence was deemed of limited use for comparison. Participants stated that pharmacy report cards would be useful information but would not prompt a change in pharmacy. However, participants perceived that this information would be useful in selecting a new pharmacy. CONCLUSION: The results suggest that consumers require simplification of PQA quality measures and supportive resources to interpret the measures. Consumers may favor certain quality measures based on their perception of the role of the pharmacist. Education is required before full use of this quality-of-care information can be realized.

A qualitative inquiry into the patient-related barriers to linkage and retention in HIV care within the community setting.

Background: People with the Human Immunodeficiency Virus (PWH) experience barriers to care within the community that impedes their progress from when they discover that they are HIV positive to becoming virally suppressed. For individuals with HIV to achieve sustained viral suppression, they must be linked to care to start receiving anti-retroviral therapy and remain retained in care for continuous treatment. However, HIV surveillance data shows that many PWH are not linked to care and become lost to continuous follow-up care. Although pharmacists, PWH, and social workers interact with one another and are aware of their roles in HIV care, their perspectives on barriers to linkage and retention in care have not been investigated collectively. Objectives: Explore the perspectives of PWH, pharmacists, and social workers on barriers to linkage and retention of HIV care within the community setting. Methods: Convenience sampling was used to recruit 15 stakeholders (five PWH, five community pharmacists, and five social workers) who participated in 1-h, semi-structured interviews based on three domains of the Patient-centered Medical Home Model including (1) experiences (individual and system-level barriers to care experienced by PWH), (2) activities (social workers and pharmacists initiatives that impact adherence to care)and (3) interventions (critical issues pharmacists can address in the community to engage PWH in their HIV care). We conducted a directed content analysis based on deductive coding. To establish rigor, we focused on Lincoln and Guba's criteria of rigorous qualitative methodology: credibility, dependability, confirmability, and transferability. Similarities and divergences of themes were discussed during data analysis and agreement was reached before interpretation. Results: Emergent themes uncovered barriers to linkage and retention in HIV care as HIV-related stigma, having mental health illnesses including a history of substance abuse and social determinants of health such as homelessness, food insecurity, and insurance issues. Conclusion: The perspectives of pharmacists, social workers, and PWH can provide insight into barriers that should be identified and addressed in people living with HIV to enhance their linkage and retention in care.

A scoping literature review of pharmacy-based opioid misuse screening and brief interventions.

BACKGROUND: Although prescription opioid dispensing rates have continued to decrease, overdose deaths involving prescription opioids have increased during the COVID-19 pandemic. Screening and brief interventions (SBI) are an effective prevention strategy to identify and address opioid misuse and safety risks. Emerging literature on pharmacy-based SBI needs to be systematically appraised to develop robust interventions. OBJECTIVE: Our objective was to conduct a scoping review of the literature regarding pharmacy-based opioid misuse SBI to identify relevant literature that explore the topic, evaluate the patient-centeredness of included studies, and explore the use of dissemination and implementation science in the literature. METHODS: The review was conducted according to Preferred Reporting of Systematic Reviews and Meta-analyses -Scoping reviews (PRISMA-Sc) guidelines. We searched PubMed, CINHAL, PsychInfo, and Scopus for studies regarding pharmacy-based SBI, published in the last 20 years. We also conducted a separate grey literature search. Two of three total reviewers screened each abstract individually and identified eligible full-texts for inclusion. We critically appraised quality of included studies and qualitatively synthesized the relevant information. RESULTS: The search resulted in 21 studies (categorized as intervention, descriptive, and observational research) and 3 grey literature reports. Of the recently published 21 studies, 11 were observational research, with six interventions in the pilot stages. Screening tools varied but naloxone was the brief intervention in 15 of the 24 results. Only eight studies had high validity, reliability, and applicability and only five were patient-centered. Implementation science principles were addressed in eight studies (mainly interventions). Overall, the findings suggest high potential for evidence-based SBI to be successful. CONCLUSIONS: Overall, the review suggested a strong lack of a patient-centered and implementation science-focused approach to designing pharmacy-based opioid misuse SBI. Findings suggest that a patient-centered, implementation focused approach is needed for effective and sustained pharmacy-based opioid misuse SBI.

Evaluation of a student-led interprofessional innovative health promotion model for an underserved population with diabetes: a pilot project.

Interprofessional education seeks to encourage different health professions to interact and learn together during their training process which will eventually lead to collaborative healthcare practices and improved care for patients. This study determined whether student understanding of diabetes management and the role of health professionals in diabetes care improved after the implementation of an interprofessional health promotion program. Sixty-three students from five health professions led six educational sessions concentrating on critical components of diabetes management. The longitudinal program covered topics within the Alphabet Strategy (A-G). Students were surveyed to determine their understanding of diabetes management. Data were gathered at the beginning of the study and its conclusion. Forty-seven students completed the program and the pre- and post-survey. There were significant improvements in students' knowledge of diabetes care, understanding of the roles of healthcare professionals and ability to work with other healthcare professionals. Nineteen patients completed the study. There were no significant differences in patients' diabetes knowledge, understanding of diabetes care and clinical outcomes. This study acknowledged the potential value of an interprofessional team approach to care. This innovative model could be applied to other practice settings and used for the management of other chronic diseases.

Best practices for conducting and writing mixed methods research in social pharmacy.

Mixed method approaches are increasingly being used in social pharmacy research due to its potential to uncover insights that are not possible with separate quantitative and qualitative studies. Despite their increasing use, there are some limitations in these publications. Typically, specific mixed method designs are not chosen, quantitative and qualitative data are not systematically integrated, and the credibility or validity of the approach is not addressed. In this paper, we discuss mixed method designs and their applications in social pharmacy. Different integration techniques and legitimation types are detailed. We describe new methodological developments and provide examples from recent mixed method studies in social pharmacy. Finally, we also provide recommendations for planning, conducting, reporting, and evaluating mixed method studies. We suggest that researchers interested in conducting mixed method studies follow recommended guidelines and obtain training in mixed methods to ensure that rigorous mixed method studies are conducted in social and administrative pharmacy.

Erratum to "Perceptions of psychosocial and interpersonal factors affecting self-management behaviors among African Americans with diabetes" [Exploratory Research in Clinical and Social Pharmacy 3C (2021) 100057].

[This corrects the article DOI: 10.1016/j.rcsop.2021.100057.].

Protocol for a Pilot Randomized Controlled Mixed Methods Feasibility Trial of a Culturally Adapted Peer Support and Self-Management Intervention for African Americans.

BACKGROUND: Due to diabetes disparities commonly seen among African Americans, it is important to address psychosocial and sociocultural barriers to medication adherence among African Americans with diabetes. Building on our prior work testing a culturally adapted peer supported diabetes self-management intervention for African Americans, this study will conduct a pilot randomized controlled feasibility trial that compares the culturally adapted intervention with a standard diabetes self-management program. METHODS: Using an intervention mixed-methods design, the six-month trial will be conducted at two sites. Twenty-four African Americans with uncontrolled type 2 diabetes will be randomized to the intervention or control arm. Feasibility and acceptability outcomes in four domains (recruitment, intervention acceptability, intervention adherence, retention) will be collected. Primary clinical outcome (A1C), secondary outcome (medication adherence) and patient-specific psychosocial measures will be collected at baseline, 2 months, and 6 months. Document review, interview and focus groups will be used to gather qualitative data on feasibility and acceptability. RESULTS: Expected results are that the trial protocol will be feasible to implement and acceptable for participants, and there will be a signal of clinically meaningful reduction in A1C and improvements in medication adherence. CONCLUSIONS: The results of this trial will inform a future powered large-scale randomized controlled trial testing the effectiveness of the culturally tailored intervention.

Engaging Patient Advisory Boards of African American Community Members with Type 2 Diabetes in Implementing and Refining a Peer-Led Medication Adherence Intervention.

African Americans are more likely than non-Hispanic whites to be diagnosed with and die from diabetes. A contributing factor to these health disparities is African Americans' poor diabetes medication adherence that is due in part to sociocultural barriers (e.g., medicine and illness misperceptions), which negatively affect diabetes management. In our prior work, we engaged with community stakeholders to develop and test a brief version of a culturally adapted intervention to address these barriers to medication adherence. The objective of this study was to elicit feedback to inform the refinement of the full 8-week intervention. We utilized a community-engaged study design to conduct a series of meetings with two cohorts of patient advisory boards of African Americans with type 2 diabetes who were adherent to their diabetes medicines (i.e., peer ambassadors). In total, 15 peer ambassadors were paired with 21 African American participants (i.e., peer buddies) to provide specific intervention support as peers and serve in an advisory role as a board member. Data were collected during nine board meetings with the patient stakeholders. A qualitative thematic analysis of the data was conducted to synthesize the findings. Feedback from the patient advisory board contributed to refining the intervention in the immediate-term, short-term, and long-term. The inclusion of African American community members living with type 2 diabetes on the advisory board contributed to further tailoring the intervention to the specific needs of African Americans with type 2 diabetes in the community.

A feasibility pilot trial of a peer-support educational behavioral intervention to improve diabetes medication adherence in African Americans.

BACKGROUND: African Americans are twice as likely to die from diabetes, compared to other racial and ethnic groups in the USA. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. A pilot study was conducted to determine the feasibility and acceptability of a peer-supported intervention targeting diabetes and medication beliefs, communication, and self-efficacy skills to enhance medication adherence among African Americans with type 2 diabetes. METHODS: Based on the extended self-regulatory model and information-motivation-behavioral skills model, this intervention was piloted using a single group pre/post-intervention study design at two sites. Seventeen African Americans who self-reported as adherent to diabetes medicines (ambassadors) were paired with 22 African Americans with self-reported poor medication adherence (buddies). Feasibility outcomes evaluated recruitment, retention, and intervention adherence. Measures assessed at baseline and 1-month post-intervention included glycemic control (hemoglobin A1c), self-reported medication adherence, diabetes beliefs, concerns about diabetes medicines, and diabetes self-efficacy. Wilcoxon signed-rank tests assessed for differences in mean scores of outcome variables at baseline compared with a 3-month follow-up. Semi-structured 60-min interviews were conducted with each buddy to explore their acceptability of the intervention. To ensure the rigor of the qualitative data, we focused on analytic criteria such as credibility, confirmability, and transferability. RESULTS: Most buddies and ambassadors were female and about 56 years old. Feasibility outcomes included recruitment success rates of 73% for buddies and 85% for ambassadors relative to our goals. Retention rate for hemoglobin A1c and medication adherence outcome assessment was 95% for buddies. Both buddies and ambassadors had excellent intervention adherence, with buddies having a mean attendance of 7.76 out of 8 sessions/phone calls and ambassadors completing > 99% of the 105 intervention calls with Buddies. Results showed a signal of change in hemoglobin A1c (effect size = 0.14) and medication adherence (effect size = 0.35) among buddies, reduction in buddies' negative beliefs about diabetes and an increase in necessity beliefs of diabetes medicines. Summative interviews with buddies showed they valued ambassador's encouragement of self-management behaviors. CONCLUSIONS: Results support conduct of an efficacy trial to address medication adherence for African Americans with type 2 diabetes using a peer-supported tailored intervention. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04028076 .

Perspectives on a Novel Culturally Tailored Diabetes Self-Management Program for African Americans: A Qualitative Study of Healthcare Professionals and Organizational Leaders.

BACKGROUND: There is an urgent need for culturally tailored diabetes self-management education to improve health outcomes in African Americans, especially given the disproportionate prevalence of diabetes and medication non-adherence. Stakeholder engagement can guide and enrich the development of these interventions by integrating content directly addressing barriers to African Americans' adherence with existing community-based diabetes self-management education programs. The aim of this study is to explore stakeholder perspectives on a novel culturally tailored diabetes self-management program for African Americans. METHODS: Thirteen semi-structured individual interviews were conducted in a large Midwestern U.S. city with healthcare professionals and organizational leaders serving African American communities and/or providing diabetes education. Transcripts were analyzed using directed content analysis with the Consolidated Framework for Implementation Research and inductive content analysis. RESULTS: Five overarching themes were identified: (1) fulfill needs among stakeholders, (2) creating a supportive and trusting environment to address distrust, (3) building relationships and empowering peers, (4) logistical organization barriers to program implementation and (5) challenges to program acceptance by participants. CONCLUSION: Stakeholders delineated how the new culturally tailored diabetes self-management program aligned with the needs of African American patients. Perceived challenges and corresponding strategies to address barriers to participation were identified to inform program implementation and sustainability.

Feasibility of a Randomized Controlled Mixed Methods Trial to Address Health Literacy, Beliefs, Medication Adherence, and Self-Efficacy (ADHERE) in a Clinical Pharmacist-Led Clinic.

Purpose: To assess the feasibility and acceptability of a health literacy-psychosocial support intervention - ADHERE and explore changes in glycemic values and medication adherence. Patients and Methods: Thirty-one participants with hemoglobin A1c (HbA1c) ≥ 8% were randomly allocated to control (usual care) or intervention groups (receiving usual care plus a 6-session pharmacist-led intervention focusing on the modifiable psychosocial factors that may influence medication adherence). Feasibility metrics evaluated recruitment, retention, and intervention adherence. Questionnaires were administered to collect psychosocial factors and self-reported medication adherence at baseline, the end of the intervention, 3 months, and 6 months post intervention. HbA1c values were extracted from electronic medical records. Repeated measures analysis of variance was used to compare differences in mean outcomes between the control and intervention groups. To assess intervention acceptability, eleven individuals participated in semi-structured interviews about their intervention experiences. Qualitative content analysis was used for analyzing the interviews. Results: Thirty participants completed the study. Overall, the findings support the feasibility of the intervention. There were significant differences in HbA1c values. Participants in the intervention group had lower A1C (8.3 ± 1.4) than in the control group (9.2 ± 1.3) at the time of 6-month follow-up (p = 0.003). In addition, the participants in the intervention group showed improved HbA1c at 6-month follow-up (8.3 ± 1.4), compared to baseline (9.4 ± 1.5, p = 0.011) and after 6-session intervention (8.9 ± 1.6, p = 0.046). However, there were no significant differences in medication adherence between groups over time. Qualitative themes suggest participants liked the intervention and perceived the additional support from the pharmacist as beneficial. Conclusion: A pharmacist-led intervention to provide additional health literacy-psychosocial support may contribute to long-term improvements in HbA1c. Equipping pharmacists with patient-specific diabetes medication adherence information and building in additional follow-up support for patients may improve patient health outcomes.