Effect of a structured pharmacist-led medication therapy management intervention on glycemic control and medication adherence in adults with type 2 diabetes mellitus: a randomized controlled trial protocol

Abstract

Background: 537 million adults are suffering from Type 2 diabetes mellitus (T2DM) globally. Poor medication adherence is one of the largest factors that can be modified in achieving glycemic control. Although randomized evidence-based studies of structured pharmacist-led medication therapy management (MTM) are limited, community pharmacists are well suited to deliver structured MTM.

Objective: The goal was to assess the effect of a structured MTM intervention provided by a pharmacist on glycated hemoglobin (HbA1c) and medication adherence at 6 months compared with usual pharmacist care in adults with T2DM.

Methods: This parallel group, two-arm randomized controlled trial (RCT) will include adults age ≥18 years with type 2 diabetes (T2DM) confirmed, HbA1c ≥7.5%, and at least one oral antihyperglycemic and/or one injectable non-insulin agent as prescribed. Participants will be assigned to either a six-month, 5 contact pharmacist-led MTM group or a group receiving usual pharmacy care at random. Participants will be randomized between pharmacist-led MTM (5 contacts / 6 months) and usual pharmacy care. The key outcome is change in HbA1c between the groups at six months. Secondary outcomes are MMAS-8 score, blood pressure, LDL cholesterol, medication possession ratio and acute care utilization for diabetes. Sustainability will be evaluated in a 12 month follow-up. There are 20% attrition, so 80% of 270 participants will be present to provide 80% power. Data will be analysed based on intention to treat principle, with mixed effects models.

Results: As this is a protocol, no outcome data are currently available. Planned analyses will include assessment of intervention effects and sustainability.

Conclusion: This study is sufficiently powered to evaluate the effectiveness of structured pharmacist-led MTM on glycemic control and adherence to drugs in adults with T2DM.