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.