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A Randomized Controlled Trial

Jeannie K. Lee, PharmD; Karen A. Grace, PharmD; Allen J. Taylor, MD

JAMA. 2006;296:(doi:10.1001/jama.296.21.joc60162).

Context  Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence.

Objective  To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C).

Design, Setting, and Patients  A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006.

Intervention  After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months.

Main Outcome Measures  Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence.

Results  A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (–6.9 mm Hg; 95% CI, –10.7 to –3.1 mm Hg) vs the usual care group (–1.0 mm Hg; 95% CI, –5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions.

Conclusions  A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.

Trial Registration  clinicaltrials.gov Identifier: NCT00393419

Published online November 13, 2006 (doi:10.1001/jama.296.21.joc60162).

Author Affiliations: Departments of Pharmacy (Drs Lee and Grace) and Cardiology (Dr Taylor), Walter Reed Army Medical Center, Washington, DC.

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