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Open Access Study protocol

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

Philippe Martin1, Robyn Tamblyn2, Sara Ahmed3 and Cara Tannenbaum1*

Author Affiliations

1 InstitutUniversitaire de Gériatrie de Montréal, Faculté de Pharmacie, Université de Montréal, Montréal, QC, Canada

2 Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, QC, Canada

3 Faculty of Medicine, School of Physical & Occupational Therapy, McGill University, Montréal, QC, Canada

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Trials 2013, 14:80  doi:10.1186/1745-6215-14-80

Published: 20 March 2013

Abstract

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

Keywords:
Patient education; Benzodiazepine use; Inappropriate prescription; Older adult health; Cognition disorders; Drug therapy; Polypharmacy