title: An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01148186.
authors.affiliation: Faculté de Pharmacie, InstitutUniversitaire de Gériatrie de Montréal, Université de Montréal, Montréal, QC, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Martin
authors.forename: Robyn
authors.initials: R
authors.lastname: Tamblyn
authors.forename: Sara
authors.initials: S
authors.lastname: Ahmed
authors.forename: Cara
authors.initials: C
authors.lastname: Tannenbaum
mesh_terms: D000367:Age Factors; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D003157:Community Pharmacy Services; D004347:Drug Interactions; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control*; D057194:Intention to Treat Analysis; D033183:Interdisciplinary Communication; D010348:Patient Care Team; D010353:Patient Education as Topic; D061214:Patient Safety; D010817:Physician-Patient Relations; D019338:Polypharmacy; D011792:Quebec; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D020377:Self Efficacy; D013997:Time Factors
chemical_list: D001569:Benzodiazepines