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

ObjectivesThe 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 methodsA 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 considerationThe 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).