Adherence and Outcomes with Urate-Lowering Therapy: A Site-Randomized Trial

Abstract

Purpose: The purpose of this study was to test a pharmacist-led intervention to improve gout treatment adherence and outcomes.

Methods: We conducted a site-randomized trial (n=1463 patients) comparing a 1-year, pharmacist-led intervention to usual care in patients with gout initiating allopurinol. The intervention was delivered primarily through automated telephone technology. Co-primary outcomes were the proportion of patients adherent (proportion of days covered ≥0.8) and achieving a serum urate <6.0 mg/dl at 1 year. Outcomes were reassessed at year 2.

Results: Patients who underwent intervention were more likely than patients of usual care to be adherent (50% vs 37%; odds ratio [OR] 1.68; 95% confidence interval [CI] 1.30, 2.17) and reach serum urate goal (30% vs 15%; OR 2.37; 95% CI 1.83, 3.05). In the second year (1 year after the intervention ended), differences were attenuated, remaining significant for urate goal but not for adherence. The intervention was associated with a 6%-16% lower gout flare rate during year 2, but the differences did not reach statistical significance.

Conclusions: A pharmacist-led intervention incorporating automated telephone technology improved adherence and serum urate goal in patients with gout initiating allopurinol. Although this light-touch, low-tech intervention was efficacious, additional efforts are needed to enhance patient engagement in gout management and ultimately to improve outcomes.

Trial registration: ClinicalTrials.gov NCT02790463.

Keywords: Adherence; Allopurinol; Gout; Pharmacist; Pragmatic trial; Randomized trial; Serum urate.

Conflict of interest statement

CONFLICT OF INTEREST: The authors have no conflict of interest to declare.

Copyright © 2018 Elsevier Inc. All rights reserved.

Figures

Figure 1:. Flow diagram summarizing design of the RAmP-UP study.

The study included 1,463 gout patients initiating allopurinol from 116 participating clinic sites from the Kaiser Permanente Southern California Health System.

Figure 2:. Gout flare rate during the intervention period (year one) and follow-up post-intervention (year two).

Gout flare rates (per 100 pt yrs) and 95% confidence intervals were calculated for each 6-month interval over a two-year follow-up period. Flare rates shown for gout patients receiving the intervention (solid line) and usual care (dotted line).