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.

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.

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.

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.

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 Culturally Tailored Diabetes Self-Management Intervention Incorporating Race-Congruent Peer Support to Address Beliefs, Medication Adherence and Diabetes Control in African Americans: A Pilot Feasibility Study.

Introduction: Current diabetes self-management programs are often insufficient to improve outcomes for African Americans because of a limited focus on medication adherence and addressing culturally influenced beliefs about diabetes and medicines. This study evaluated the feasibility and acceptability of a novel culturally tailored diabetes self-management intervention that addressed key psychosocial and sociocultural barriers to medication adherence for African Americans. Methods: The intervention consisted of group education and race-congruent peer-based phone support. Three African Americans who were engaged in taking their diabetes medicines (ambassadors), were matched with 8 African Americans who were not engaged in taking medicines (buddies). We conducted a single group, pre/post study design with African Americans with type 2 diabetes. Wilcoxon signed rank tests assessed mean score differences in outcomes at baseline compared with 6-months follow-up. Semi-structured interviews explored buddies' acceptability of the intervention. Results: Buddies and ambassadors were similar in age and mostly female. Recruitment rates were 80% for buddies and 100% for ambassadors. Retention rate for primary outcomes was 75%. Buddies had a mean completion of 13.4/17 of sessions and phone calls. Ambassadors completed 84% of intervention calls with buddies. Although there were no statistically significant differences in mean A1C and medication adherence, we found a clinically meaningful decrease (-0.7) in mean A1C at the 6-month follow up compared to baseline. Secondary outcomes showed signal of changes. Themes showed buddies perceived an improvement in provider communication, learned goal setting strategies, and developed motivation, and confidence for self-management. Buddies perceived the program as acceptable and culturally appropriate. Conclusion: This culturally tailored diabetes self-management intervention that addresses diabetes self-management, psychosocial and behavioral barriers to medication adherence, and incorporates race-congruent peer support from African Americans engaged in taking medicines seemed feasible and acceptable. The results provide support for a fully powered randomized trial to test the intervention's efficacy. Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04857411. Date of Registration: April 23, 2021.

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.

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.].

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.

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.

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.

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.

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.

Investigation of Barriers and Facilitators to Medication Adherence in Patients With Type 2 Diabetes Across Different Health Literacy Levels: An Explanatory Sequential Mixed Methods Study.

Type 2 diabetes (T2D) incurs tremendous healthcare costs associated with various complications due to poor blood sugar control. Medication adherence, which is correlated with patients' health literacy, should be consistently practiced to achieve optimal control of blood sugar. A comprehensive understanding of specific communication and psychosocial factors related to medication-taking behaviors across different levels of health literacy among people with T2D will guide the development of effective interventions and strategies to enhance medication adherence. To understand barriers and facilitators to medication adherence in people with T2D across different health literacy levels, the Health Literacy Pathway Model was used to identify the psychosocial and communication factors that may influence medication adherence. This mixed methods study used an explanatory sequential design, including a quantitative survey followed by qualitative semi-structured interviews. Two hundred and five participants completed the survey questionnaire, and 23 participants completed semi-structured interviews. Confirmed by quantitative and qualitative data, having stronger self-efficacy and fewer concerns about medications, as well as experiencing fewer perceived barriers to medication-taking, are necessary for better medication adherence among those with low adherence. Our findings will be useful to tailor interventions for diabetes care through addressing concerns among low-adherent patients with low health literacy and emphasizing self-efficacy and perceived barriers to medication adherence among all low-adherent patients with T2D.

Using an exploratory sequential mixed methods design to adapt an Illness Perception Questionnaire for African Americans with diabetes: the mixed data integration process.

BACKGROUND: Although qualitative methods have been used to develop quantitative behavioral health measurements, studies rarely report on the exact development process of these questionnaires. In this methodological paper, we highlight the procedure of a mixed data integration process in using qualitative data to create quantitative questionnaire items. METHODS: We used an exploratory sequential mixed methods study design to culturally adapt the Illness Perception Questionnaire-Revised (IPQ-R) and address the sociocultural contexts of African Americans with type 2 diabetes. Forty African Americans with type 2 diabetes taking oral diabetes medication completed the qualitative focus groups and 170 participants completed the quantitative phase (surveys). Using the 'building approach' to integration, qualitative themes from the focus groups were matched to survey domains based on the self-regulatory model. Qualitative themes assessing perceptions of diabetes among African Americans were used to develop new survey items for a culturally adapted IPQ-R, as well as adapt original survey items. RESULTS: Important themes included the effect on friend/family relationships, lifestyle changes, food experiences (consequences domain), importance of medications (treatment control), comparisons with family members (illness coherence), fear, future worries, and anger (emotional representations). A new domain, 'sociocultural influences' was added to the adapted questionnaire based on qualitative themes of race and racism on provider roles, personal control, and community influences. Merging and integration of the qualitative and quantitative phases, (reported via a joint display) showed evidence of congruence between the illness perceptions from the qualitative focus groups and scores on the survey items. CONCLUSION: The use of mixed methods allowed for the development of a robust and patient-centered questionnaire. Future research should consider psychometric testing of the adapted IPQ-R, so that it may be used in addressing illness perceptions among African Americans.

Ideal instruments used to measure health literacy related to medication use: A systematic review.

BACKGROUND: Prior studies showed the association between inadequate health literacy (HL) and poor medication-related skills, while none of the published studies have reviewed and compared the existing instruments used to measure medication-related HL. This systematic review comprehensively summarizes the existing instruments that assess medication-related HL. OBJECTIVES: To identify appropriate HL instruments related to medication use as screening tools for enhancing patients' ability to use medications correctly. METHODS: This review retrieved medication-related HL instruments that were published between 2000 and 2019 from three databases (i.e., PubMed, Scopus, EMBASE) and by hand-searching. The PRISMA procedure was followed as well as the SURGE guideline to assess the quality of studies. Psychometric properties, HL dimensions, and types of medication information gleaned from the items in three types of HL instruments (i.e., general, disease-specific, medication-specific) were compared to identify appropriate medication-related HL instruments. RESULT: Forty-eight instruments were identified from 44 studies, whereas 70.8% instruments were either disease- or medication-specific HL instruments. Most instruments with different sample sizes showed certain an extent of reliability and validity. The distributions of HL dimensions and types of medication information among the relevant items were varied across different types of instruments. The five instruments (named as the 16SQ, AKQ-CQ, DHLKI, AKT, and ChMLM) were identified as the most appropriate instruments for three types of medication-related HL, respectively. These appropriate instruments consistently covered items related to HL dimensions of literacy and comprehension and medication-related information regarding dosing, treatment indication, and side effects/precautions. CONCLUSION: Of 48 identified instruments mainly derived from disease- or medication-specific studies, the five most appropriate medication-related HL instruments were identified to support clinicians in facilitating patients' correct medication use. Further confirmation to explore the usefulness among these instruments are needed.

Preliminary engagement of a patient advisory board of African American community members with type 2 diabetes in a peer-led medication adherence intervention.

BACKGROUND: The Peers Supporting Health Literacy, Self-efficacy, Self-Advocacy, and Adherence (Peers LEAD) program is a culturally tailored educational-behavioral 8-week intervention that addressed psychosocial and sociocultural barriers to diabetes medication adherence in African Americans. A brief 3-week version of the Peers LEAD intervention used a community engagement approach to examine the feasibility and acceptability of the intervention amongst patient stakeholders. MAIN BODY: African Americans who were adherent to their diabetes medicines were paired with those who were non-adherent to their medicines. Together, they participated in the group and phone-based medication adherence intervention. Input from this brief intervention was important for the design of the remainder weeks of the 8-week program. The intervention targeted negative beliefs about diabetes, use of diabetes medicines, and offering culturally tailored peer support to improve medication adherence in African Americans. To receive input in the development and implementation of the program, we worked with community advisors and a peer ambassador board of African Americans who were adherent to their diabetes medicines. The peer ambassador board and community advisors reviewed intervention materials to ensure they were understandable and appropriate for the community. As well, they provided feedback on the process for intervention delivery. CONCLUSION: The active engagement of the peer ambassador board and community advisors led to a revised intervention process and materials for a medication adherence program for African Americans with type 2 diabetes.

Perceptions of psychosocial and interpersonal factors affecting self-management behaviors among African Americans with diabetes.

Background: African Americans are more likely to be diagnosed with diabetes and have diabetes complications as compared to non-Hispanic Whites, but have lesser medication adherence and poorer self-management behaviors. Interventions to improve self-management behaviors may not be successful if psychosocial and interpersonal factors of African Americans are not addressed. Objective: The study objective was to qualitatively explore perceptions of African Americans with type 2 diabetes (T2DM) regarding self-management behaviors and understand the effect of psychosocial and interpersonal factors on behavior change. Methods: Adults with T2DM who self-identified as African American/Black were selected from a cohort participating in a mixed-methods study in a midwestern state. The data collection and analysis were guided by the Integrated Theory of Behavior Change. Ten semi-structured, 60-min, theory-based interviews were conducted and content analysis was utilized to identify themes. Themes were then categorized based on theoretical domains. Results: The sample was mostly female, an average of 52 years old, and had a high school education or more. Four themes were identified. Two themes were categorized as psychosocial factors: 1) attitude and beliefs regarding diabetes and 2) sociocultural influences on self-management, while two were interpersonal factors: 3) role of family and social support and 4) relationships with healthcare professionals. Themes connected back to the theory and directly affected self-management behaviors. Conclusion: Future research should focus on incorporating these themes when designing interventions that improve T2DM self-management behaviors and outcomes in African Americans. Health care professionals should emphasize individualized and culturally appropriate T2DM education and counseling.