Pain Research Informatics Multimorbidities and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
Pain Research Informatics Multimorbidities and Education (PRIME) Center, VA Connecticut Healthcare System, West Haven, CT, United States of America; Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States of America.
Contemp Clin Trials. 2022 Aug;119:106857. doi: 10.1016/j.cct.2022.106857. Epub 2022 Jul 18.
Given limited efficacy and potential harms of long-term opioid therapy, it is patient-centered and guideline-concordant to offer patients the opportunity to engage in a supportive, patient-centered tapering program. The goal of this study was to develop and pilot an interactive web-based program designed to support patients willing to consider an opioid taper; this manuscript describes the development and the protocol for a pilot randomized trial of Summit.
We used intervention mapping to develop the Summit program; during the development period we engaged multiple stakeholder groups and conducted usability testing to refine the interactive, theory-informed, multi-component mobile website program which includes education, video testimonials, self-management skills, and access to a peer specialist. We will evaluate the Summit program in a two-arm, 9 month randomized-controlled trial where 64 individuals will be assigned either to the Summit program or to a control group (pain tracking app). As a pilot trial, the primary outcomes are feasibility and acceptability; we will also measure patient-reported outcomes related to pain, quality of life, and opioid use.
We developed an interactive program; results of the pilot trial are pending. If shown to be effective, Summit would be useful both in augmenting care for patients who are engaged in a taper with primary care.
鉴于长期阿片类药物治疗的疗效有限且存在潜在危害，为愿意接受阿片类药物减量的患者提供参与支持性、以患者为中心的减量计划的机会，这是以患者为中心且符合指南的做法。本研究的目的是开发并试行一个基于网络的互动程序，以支持愿意考虑阿片类药物减量的患者；本文描述了 Summit 的开发和试行随机试验方案。
我们使用干预映射来开发 Summit 计划；在开发过程中，我们让多个利益相关者群体参与，并进行可用性测试，以完善互动式、基于理论、多组件的移动网站程序，其中包括教育、视频见证、自我管理技能以及获得同行专家的支持。我们将在一项为期 9 个月的双臂随机对照试验中评估 Summit 计划，其中 64 名参与者将被分配到 Summit 计划组或对照组（疼痛跟踪应用程序）。作为一项试行试验，主要结果是可行性和可接受性；我们还将测量与疼痛、生活质量和阿片类药物使用相关的患者报告结果。
我们开发了一个互动程序；试行试验的结果仍在等待中。如果证明有效，那么 Summit 将对正在接受初级保健人员指导进行减量的患者的护理具有重要意义。
