Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices

Abstract

Background: The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.

Methods and results: This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects. There was no improvement in the Guideline Advantage score from baseline to 12 months in the control group (64.7% versus 63.1%, respectively; P=0.21). There was a statistically significant improvement in the intervention group from 63.3% at baseline to 67.8% at 12 months (P=0.02). The estimated benefit of the intervention was 5.0%±2.4% (95% confidence interval=-0.5% to 10.4%; P=0.07). Several criteria were significantly better for intervention subjects, including appropriate statin therapy (P<0.001), body mass index, screening (P<0.001), and alcohol screening (P<0.001). Only 13.7% of subjects with diabetes mellitus had hemoglobin A1c at goal at baseline, and this increased to 30.8% and 21.0% in the intervention and control group, respectively, at 12 months (P=0.10).

Conclusions: The centralized, remote pharmacist intervention was successfully implemented. The improvements in outcomes were modest, in part because of higher than expected baseline guideline adherence. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT 01983813.

Trial registration: ClinicalTrials.gov NCT01983813.

Keywords: cardiovascular diseases; diabetes mellitus; guideline adherence; risk factors.

© 2018 American Heart Association, Inc.

Figures

Figure 1

ICARE Study Consort Flow Diagram