Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study

Abstract

Background Despite the availability of effective therapies, most gout patients achieve suboptimal treatment outcomes. Current best practices suggest gradual dose-escalation of urate lowering therapy and serial serum urate (sUA) measurement to achieve sUA < 6.0 mg/dl. However, this strategy is not routinely used. Here we present the study design rationale and development for a pharmacist-led intervention to promote sUA goal attainment. Methods To overcome barriers in achieving optimal outcomes, we planned and implemented the Randomized Evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) study. This is a large pragmatic cluster-randomized trial designed to assess a highly automated, pharmacist-led intervention to optimize allopurinol treatment in gout. Ambulatory clinics (n=101) from a large health system were randomized to deliver either the pharmacist-led intervention or usual care to gout patients over the age of 18 years newly initiating allopurinol. All participants received educational materials and could opt-out of the study. For intervention sites, pharmacists conducted outreach primarily via an automated telephone interactive voice recognition system. The outreach, guided by a gout care algorithm developed for this study, systematically promoted adherence assessment, facilitated sUA testing, provided education, and adjusted allopurinol dosing. The primary study outcomes are achievement of sUA < 6.0 mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently. Conclusion Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients.

Monitoring of Urate-Lowering Therapy Among US Veterans Following the 2012 American College of Rheumatology Guidelines for Management of Gout

“…Of interest, a randomized clinical trial assessing the impact of ambulatory care clinical pharmacists on achieving SUA goals is currently under way. 20 Additionally, the lab reference ranges must be modified and comments added to guide providers on goal SUA rather than citing a reference range for a "normal" adult population without gout. Finally, population management methods such as medication use evaluations should be performed with provider feedback to target patients not being appropriately monitored or titrated.…”

Improving adherence to gout therapy: an expert review

“… 55 The benefits of pharmacist-led care are being further investigated in the Randomized Evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways study, wherein gout patients newly initiating allopurinol are being randomized to either pharmacist-led intervention or usual care. 56 …”

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

“…RAmP-UP was a large pragmatic site-randomized study that enrolled patients from May of 2014 to July of 2015. The study involved 116 clinics within Kaiser Permanente Southern California 20 , an integrated healthcare system with approximately 4 million members 21 . To minimize contamination, 24 close-proximity clinics were combined into nine units, resulting in 101 unique randomized study locations allocated to deliver either the intervention (n=51 sites) or usual care (n=50 sites).…”

“…Following first allopurinol receipt, prescribed and initially dosed at the discretion of the primary gout provider, pharmacist management was provided to patients at intervention sites. We developed an intervention protocol to supplement usual care, which was modeled after an algorithm developed through expert consensus 20 . The algorithm incorporated a treat-to-target approach (including urate monitoring and allopurinol dose escalation).…”