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Issues in Conducting Randomized Controlled Trials of Health Services Research Interventions in Nonacademic Practice Settings: The Case of Retail Pharmacies

Authors

  • Morris Weinberger,

  • Michael D. Murray,

  • David G. Marrero,

  • Nancy Brewer,

  • Michael Lykens,

  • Lisa E. Harris,

  • A. Jeffrey Newell,

  • Joyce Collins,

  • William M. Tierney


This study was funded by a grant from the Agency for Healthcare Research in Quality (5 R01 HS09083). Dr. Weinberger was supported by the Health Services Research and Development Service, Department of Veterans Affairs, through a Research Career Scientist Award.

Morris Weinberger, Ph.D., Vergil N. Slee Distinguished Professor of Health Care Quality Management, Department of Health Policy and Administration, University of North Carolina at Chapel Hill, 1105c McGavran–Greenberg Hall, CB #7411, Chapel Hill, NC 27599-7411.

Morris Weinberger, Ph.D., was Director of Health Services Research, Roudebush VAMC; Senior Scientist, Regenstrief Institute for Health Care; and Professor of Medicine, Indiana University School of Medicine. Michael D. Murray, Pharm.D., is Professor of Pharmacy, Purdue University; and Senior Scientist, Regenstrief Institute for Health Care. David G. Marrero, Ph.D., is Professor of Medicine, Indiana University School of Medicine. Nancy Brewer is a Project Coordinator, Regenstrief Institute for Health Care. Michael Lykens, M.D., is Associate Professor of Medicine and Clinical Director of Pulmonary, Critical Care and Occupational Medicine, Indiana University School of Medicine. Lisa E. Harris, M.D., is Chief of Medicine, Wishard Memorial Hospital; Associate Professor of Medicine, Indiana University School of Medicine; and Investigator, Regenstrief Institute for Health Care. A. Jeffrey Newell, R.Ph., is Manager of Community Care, CVS/Pharmacy. Joyce Collins, R.Ph., is Area Pharmacy Human Research Manager, CVS/Pharmacy, William M. Tierney, M.D., is Chief of General Medicine and Geriatrics and Professor of Medicine, Indiana University School of Medicine; Senior Scientist, Regenstrief Institute for Health Care; and Senior Investigator, Roudebush VAMC.

Abstract

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 nonacademic practice settings to increase generalizability and better reflect the true impact of interventions. Pragmatic problems, although significant, can be successfully overcome.

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