Evaluation of a Medication Therapy Management Program in Medicare Beneficiaries at High Risk of Adverse Drug Events: Study Methods

Little is known about the effectiveness or optimal design of medication therapy management (MTM) programs as mechanisms for improving patient safety, motivating this multicenter trial sponsored by the Agency for Healthcare Research and Quality. Six hundred subjects at high risk of adverse drug events (ADEs) will be enrolled across three study sites. The study is designed as a randomized controlled trial with three arms. The control group (Arm 1) will receive usual care and have no MTM visits. Intervention groups (Arms 2 and 3) will undergo two MTM visits with a pharmacist over 6 months. The main safety outcomes are the number of ADEs, hospital admissions, and emergency room visits at 90 and 180 days, which will be compared among all three study arms. Additional safety outcomes include measures of MTM process and delivery. This paper details the methods of this study evaluating the impact of community-based MTM on enhancing patient safety.