Coburn Brian W, Cheetham T Craig, Rashid Nazia, Chang John M, Levy Gerald D, Kerimian Artak, Low Kimberly J, Redden David T, Bridges S Louis, Saag Kenneth G, Curtis Jeffrey R, Mikuls Ted R
Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, United States.
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Contemp Clin Trials. 2016 Sep;50:106-15. doi: 10.1016/j.cct.2016.07.019. Epub 2016 Jul 20.
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<6.0mg/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.
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 18years 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<6.0mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently.
Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients.
尽管有有效的治疗方法，但大多数痛风患者的治疗效果仍未达到最佳。目前的最佳实践建议逐步增加降尿酸治疗的剂量，并进行系列血清尿酸（sUA）测量，以实现sUA<6.0mg/dl。然而，这一策略并未得到常规应用。在此，我们介绍一项由药剂师主导的干预措施的研究设计原理及开展情况，以促进sUA目标的实现。
为克服实现最佳治疗效果的障碍，我们计划并实施了一项由门诊护理药剂师主导的优化降尿酸途径干预措施的随机评估（RAmP-UP）研究。这是一项大型实用整群随机试验，旨在评估一种高度自动化的、由药剂师主导的干预措施，以优化痛风患者的别嘌醇治疗。来自一个大型医疗系统的101家门诊诊所被随机分配，为新开始使用别嘌醇的18岁以上痛风患者提供药剂师主导的干预措施或常规护理。所有参与者都收到了教育材料，并可选择退出研究。对于干预组，药剂师主要通过自动电话交互式语音识别系统进行随访。随访由为本研究开发的痛风护理算法指导，系统地促进依从性评估、便利sUA检测、提供教育并调整别嘌醇剂量。主要研究结局为一年后sUA<6.0mg/dl的实现情况及治疗依从性。随着随访的持续进行，研究结果将随后报告。
门诊护理药剂师和自动呼叫技术是改善痛风患者健康结局的潜在重要但未充分利用的资源。
