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

Trials. 2013 Mar 20:14:80. doi: 10.1186/1745-6215-14-80.


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: identifier: NCT01148186.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Benzodiazepines / adverse effects
  • Benzodiazepines / therapeutic use*
  • Community Pharmacy Services
  • Drug Interactions
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Inappropriate Prescribing / prevention & control*
  • Intention to Treat Analysis
  • Interdisciplinary Communication
  • Patient Care Team
  • Patient Education as Topic*
  • Patient Safety
  • Physician-Patient Relations
  • Polypharmacy
  • Quebec
  • Research Design*
  • Risk Assessment
  • Risk Factors
  • Self Efficacy
  • Time Factors


  • Benzodiazepines

Associated data