Evaluation of a community pharmacy-based medication therapy management programme: A study protocol of a pilot randomized controlled trial with an embedded qualitative study

OBJECTIVES: The main objectives are: to evaluate the feasibility and effectiveness of a community-pharmacy based medication therapy management programme; to explore patients’ experiences and views towards medication therapy management service delivered by community pharmacists. RESEARCH DESIGN AND METHODS: A mixed-methods research design consisting of a pilot randomized controlled trial embedded with qualitative study will be used in this study. The study consists of two phases: a 6-month follow-up pilot randomized control trial (quantitative approach) to assess the feasibility and effectiveness of a community pharmacy-based medication therapy management programme. The primary outcome is HbA1C and secondary outcomes include: clinical and health services utilization and process measures, medication adherence, diabetes distress as well as satisfaction with care. Phase two consists of an embedded qualitative study using semi-structured interviews to explore patients’ experiences and views with the medication therapy management programme. Study data collection will be collected between April 2021 and December 2021. ETHICS CONSIDERATION: The study has been approved by institutional review boards from Princess Nourah bent Abdulrahman University (Approval # 20–0240), King Fahad Medical City (Approval # 20-388E) and Birmingham University (Approval # ERN_20-0768).