An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial

BACKGROUND: Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users. METHODS/DESIGN: This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruited from community pharmacies in the greater Montreal area will be studied with informed consent. A participating pharmacy with recruited participants represents a cluster, the unit of randomization. For every four pharmacies recruited, a simple 2:2 randomization is used to allocate clusters into intervention and control arms. Participants will be followed for 1 year. Within the intervention clusters, participants will receive a novel educational intervention detailing risks and safe alternatives to their current potentially inappropriate medication, while the control group will be wait-listed for the intervention for 6 months and receive usual care during that time period. The primary outcome is the rate of change in benzodiazepine use at 6 months. Secondary outcomes are changes in risk perception, self-efficacy for discontinuing benzodiazepines, and activation of patients initiating discussions with their physician or pharmacist about safer prescribing practices. An intention-to-treat analysis will be followed. The rate of change of benzodiazepine use will be compared between intervention and control groups at the individual level at the 6-month follow-up. Risk differences between the control and experimental groups will be calculated, and the robust variance estimator will be used to estimate the associated 95% confidence interval (CI). As a sensitivity analysis (and/or if any confounders are unbalanced between the groups), we will estimate the risk difference for the intervention via a marginal model estimated via generalized estimating equations with an exchangeable correlation structure. DISCUSSION: Targeting consumers directly as catalysts for engaging physicians and pharmacists in collaborative discontinuation of benzodiazepine drugs is a novel approach to reduce inappropriate prescriptions. By directly empowering chronic users with knowledge about risks, we hope to imitate the success of individually targeted anti-smoking campaigns. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01148186