Issues in conducting randomized controlled trials of health services research interventions in nonacademic practice settings: the case of retail pharmacies.

OBJECTIVE To describe unexpected challenges and strategies to overcome them when conducting randomized controlled trials (RCT) of health services research interventions in retail pharmacies. STUDY SETTING Thirty-six retail drug stores in Indianapolis. STUDY DESIGN We conducted an RCT to evaluate the effectiveness of an intervention to increase pharmacists' involvement in caring for customers. We describe: (1) our RCT as originally designed, (2) unexpected challenges we faced; and (3) how we resolved those challenges. DATA COLLECTION/EXTRACTION METHODS Randomized controlled trial. PRINCIPAL FINDINGS Major modifications in research design were necessitated by factors such as corporate restructuring, heightened sensitivity to patient confidentiality, and difficulties altering employees' behavior. We overcame these barriers by conducting research that is consistent with corporate goals, involving appropriate corporate administrators and technical personnel early in the process, and being flexible. CONCLUSIONS Health services researchers should conduct RCTs in a variety of non-academic practice settings to increase generalizability and better reflect the true impact of interventions. Pragmatic problems, although significant, can be successfully overcome.