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

https://doi.org/10.1016/j.amjmed.2018.11.011Get rights and content

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.

Section snippets

Study Design, Setting, Randomization, and Participants

RAmP-UP was a large pragmatic site-randomized study that enrolled patients from May 2014 to July 2015. The study involved 116 clinics within Kaiser Permanente Southern California,20 an integrated healthcare system with approximately 4 million members.21 The study was approved by institutional review boards at Kaiser Permanente Southern California and at the University of Alabama at Birmingham. A waiver of informed consent was granted. To minimize contamination, 24 close-proximity clinics were

Results

There were 1551 eligible patients initiating allopurinol with ICD-9 codes for gout (Figure 1): 782 (50.4%) received usual care at 50 clinics, and 769 (49.6%) received care at 51 intervention sites. There were 88 patients not offered an automated call following the second level of randomization, leaving 681 patients in the intervention for analysis (372 [55%] completers, responding to at least 1 automated survey). There were no significant differences in characteristics between the remaining 681

Discussion

Described as potentially “curative,”25, 26 lowering urate is a key tenet of effective gout management. Despite the availability of efficacious and well-tolerated agents, gout management and related outcomes remain suboptimal. This deficiency has been attributed not only to poor patient adherence but also to inadequate prescribing practices.27 Although subspecialty management guidelines support gradual dose titration of urate-lowering agents to achieve a target urate goal,14, 28 this approach is

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    Funding: This work is funded by the National Institutes of Health (NIH) / National Institute of Arthritis and Musculoskeletal and Skin Diseases (P50AR060772). TRM receives research support from NIH/National Institute of General Medical Sciences (U54GM115458) and the National Institute on Alcohol Abuse and Alcoholism (R25AA020818).

    Conflicts of Interest: The authors have no conflicts of interest to declare.

    Authorship: All authors confirm equal access to data and a role in writing the manuscript.

    Trial Registration: NCT 02790463 https://www.ClinicalTrials.gov

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