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A Randomized Controlled Trial

Morris Weinberger, PhD; Michael D. Murray, PharmD; David G. Marrero, PhD; Nancy Brewer; Michael Lykens, MD; Lisa E. Harris, MD; Roopa Seshadri, PhD; Helena Caffrey, MS; J. Franklin Roesner, MD; Faye Smith, MS; A. Jeffrey Newell, RPh; Joyce C. Collins, RPh; Clement J. McDonald, MD; William M. Tierney, MD

JAMA. 2002;288:1594-1602.

Context  It is not known whether patient outcomes are enhanced by effective pharmacist-patient interactions.

Objective  To assess the effectiveness of a pharmaceutical care program for patients with asthma or chronic obstructive pulmonary disease (COPD).

Design, Setting, and Participants  Randomized controlled trial conducted at 36 community drugstores in Indianapolis, Ind. We enrolled 1113 participants with active COPD or asthma from July 1998 to December 1999. Outcomes were assessed in 947 (85.1%) participants at 6 months and 898 (80.7%) at 12 months.

Interventions  The pharmaceutical care program (n = 447) provided pharmacists with recent patient-specific clinical data (peak expiratory flow rates [PEFRs], emergency department [ED] visits, hospitalizations, and medication compliance), training, customized patient educational materials, and resources to facilitate program implementation. The PEFR monitoring control group (n = 363) received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group (n = 303) received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention.

Main Outcome Measures  Peak expiratory flow rates, breathing-related ED or hospital visits, health-related quality of life (HRQOL), medication compliance, and patient satisfaction.

Results  At 12 months, patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group (P = .02) but not than PEFR monitoring controls (P = .28). There were no significant between-group differences in medication compliance or HRQOL. Asthma patients receiving pharmaceutical care had significantly more breathing-related ED or hospital visits than the usual care group (odds ratio, 2.16; 95% confidence interval, 1.76-2.63; P<.001). Patients receiving pharmaceutical care were more satisfied with their pharmacist than the usual care group (P = .03) and the PEFR monitoring group (P = .001) and were more satisfied with their health care than the usual care group at 6 months only (P = .01). Despite ample opportunities to implement the program, pharmacists accessed patient-specific data only about half of the time and documented actions about half of the time that records were accessed.

Conclusions  This pharmaceutical care program increased patients' PEFRs compared with usual care but provided little benefit compared with peak flow monitoring alone. Pharmaceutical care increased patient satisfaction but also increased the amount of breathing-related medical care sought.

Author Affiliations: Regenstrief Institute for Health Care (Drs Weinberger, Murray, Harris, McDonald, and Tierney, and Mss Brewer and Smith), Roudebush Veterans Affairs Medical Center (Drs Weinberger and Tierney), Department of Medicine, Indiana University School of Medicine (Drs Weinberger, Murray, Marrero, Lykens, Harris, Seshadri, Roesner, McDonald, and Tierney, and Ms Caffrey), Indianapolis; and Purdue University School of Pharmacy, West Lafayette, Ind (Dr Murray); CVS Pharmacy, Woodsocket, RI (Mr Newell and Ms Collins). Dr Weinberger is now the Vergil N. Slee Distinguished Professor of Healthcare Quality Management of Health Policy, University of North Carolina at Chapel Hill.

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