title: A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study.
abstract: BACKGROUND
  Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when evaluating real-world applicability of an intervention. Although adherence interventions by community pharmacists have been tested, problems with internal and external validity have limited the usefulness of these studies, and further well-designed and well-conducted research is needed. We aimed to determine the real-world effectiveness of a community pharmacy adherence intervention using a robust study design. This novel design integrates cluster randomization and an outcome evaluation of medication adherence using a population-based administrative data source in the province of Saskatchewan, Canada.
  
  
  METHODS
  Community pharmacies from across the province of Saskatchewan, Canada were randomized to deliver an adherence intervention to their patients or usual care. Intervention pharmacies were trained to employ a practical adherence strategy targeted at new users of statin medications. While randomization and implementation of the intervention occurred at the community pharmacy level, the outcome analysis will occur at the level of the individual subjects. The primary outcome is the mean statin adherence among all eligible new users of statin medications. Secondary outcomes include the proportion of new statin users who exhibit adherence>or=80%, and persistence with statin use.
  
  
  CONCLUSIONS
  This novel study design was developed to combine the rigor of a randomized trial with a pragmatic approach to implementing and capturing the results in a real-world fashion. We believe this approach can serve as an example for future study designs evaluating practice-based adherence interventions.
  
  
  BACKGROUND
  ClinicalTrials.gov no. NCT00971412.
authors.affiliation: College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.
authors.forename: Charity D
authors.initials: CD
authors.lastname: Evans
authors.forename: Dean T
authors.initials: DT
authors.lastname: Eurich
authors.forename: Jeff G
authors.initials: JG
authors.lastname: Taylor
authors.forename: Alfred J
authors.initials: AJ
authors.lastname: Remillard
authors.forename: Yvonne M
authors.initials: YM
authors.lastname: Shevchuk
authors.forename: David F
authors.initials: DF
authors.lastname: Blackburn
mesh_terms: D002318:Cardiovascular Diseases / Q000188:drug therapy*; D003157:Community Pharmacy Services / Q000592:standards*; D005500:Follow-Up Studies; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D055118:Medication Adherence; D017063:Outcome Assessment, Health Care / Q000592:standards; D012042:Registries; D015203:Reproducibility of Results; D012525:Saskatchewan
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors