Opioid tapering support using a web-based app: Development and protocol for a pilot randomized controlled trial

Abstract

BackgroundGiven 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. MethodsWe 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. ImplicationsWe 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.