Using a standardized patient walk-through to improve implementation of clinical trials.
This report describes a standardized patient (SP) walk-through to facilitate implementation of a clinical trial within the National Drug Abuse Treatment Clinical Trials Network (CTN). SPs are actors trained to portray a set of symptoms consistently across interactions with multiple clinicians. The Oregon/Hawaii Node of the CTN employed one SP to pilot participant screening processes in a study testing a combined pharmacological and behavioral therapy for women and men dependent on prescription opioid analgesics. The SP mimicked an individual seeking treatment and "walked" through study intake processes. Findings such as study staff members' inadequacy in describing issues of patient confidentiality and problems explaining the Health Insurance Portability and Accountability Act led to modifications to the clinical implementation of the study. Research coordinators and the staff found the use of an SP to be highly effective. The node is now making routine use of SPs in the implementation of CTN protocols.
Fussell
Holly E
HE
Department of Public Health and Preventive Medicine, Oregon Health and Science University, Portland, OR 97239, USA. fussellh@ohsu.edu
Kunkel
Lynn E
LE
Lewy
Colleen S
CS
McFarland
Bentson H
BH
McCarty
Dennis
D
D001521:Behavior Therapy / Q000379:methods; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003219:Confidentiality; D005260:Female; D006254:Hawaii; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D008297:Male; D009293:Opioid-Related Disorders / Q000534:rehabilitation; D009922:Oregon; D016544:Patient Simulation; D010865:Pilot Projects; D012107:Research Design / Q000592:standards*; D012108:Research Personnel / Q000592:standards; D019966:Substance-Related Disorders / Q000534:rehabilitation*; D014481:United States