title: Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation.
abstract: BACKGROUND
  Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation.
  
  
  OBJECTIVE
  Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials.
  
  
  METHODS
  Actors portrayed clients and "walked through" study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials.
  
  
  RESULTS
  Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns.
  
  
  CONCLUSIONS
  Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.
authors.affiliation: Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland, 97239-3098, USA. fussellh@ohsu.edu
authors.forename: Holly E
authors.initials: HE
authors.lastname: Fussell
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Kunkel
authors.forename: Dennis
authors.initials: D
authors.lastname: McCarty
authors.forename: Colleen S
authors.initials: CS
authors.lastname: Lewy
mesh_terms: D003153:Community Health Services / Q000379:methods; D003625:Data Collection; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods; D054577:National Institute on Drug Abuse (U.S.); D016544:Patient Simulation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D019966:Substance-Related Disorders / Q000534:rehabilitation*; D014481:United States