NCT07140926

A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder

Digital Innovation in Medication-Assisted Treatment for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,524 (actual)
• Sponsor: Bright Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a mobile health app called Recovery Connect can help people stay in treatment for opioid use disorder. The study is being done with adults receiving medication-assisted treatment in outpatient opioid treatment programs. The main questions it aims to answer are: Does Recovery Connect increase the number of people who remain in treatment after 30 days? Does Recovery Connect improve continuity of care during the first month of treatment? Researchers are using a stepped-wedge design, which means that all participating clinics will eventually use the app, but they will begin at different time points in a randomized order. This allows researchers to compare outcomes before and after each clinic starts using Recovery Connect. Participants will: Use the Recovery Connect app for daily check-ins, coping strategies, and reminders to support their recovery Share progress and risk information through the app so counselors can provide timely, personalized support Work with treatment teams trained to use the app to guide care and reinforce accountability

Detailed description

This study is a stepped-wedge cluster randomized clinical trial evaluating the implementation and effectiveness of Recovery Connect, a mobile health application designed to support individuals receiving medication-assisted treatment (MAT) for opioid use disorder (OUD). Recovery Connect is intended to enhance treatment delivery by: Providing clinicians with real-time, self-monitored patient progress data to support measurement-based and data-informed care. Delivering personalized care plans, reminders, and evidence-based coping strategies directly to patients. Facilitating continuous communication and accountability between patients and counselors between sessions. Study Design The trial is conducted across nine outpatient opioid treatment program (OTP) clinics, grouped into eight clusters. Using a stepped-wedge design, each cluster will transition from usual care to the Recovery Connect intervention at randomized, sequential time points, such that all clinics will eventually receive the intervention. All clinicians at each cluster will receive standardized training on Recovery Connect at rollout, with follow-up reinforcement training provided two weeks later. Auxiliary staff (e.g., front desk, peer support, navigators) will also be trained to support patient onboarding. Participants All clinicians at participating clinics will be included. Patient-level data will be analyzed for all new admissions and readmissions during the study period. Data Collection App Usage and Engagement: Patient and clinician usage data, including daily check-ins, logins, and secure messages, will be captured directly through the app. Patient Treatment Outcomes: Treatment retention and continuity data will be obtained via the Methasoft medical record system, following standard clinic protocols. Operational Definitions Exposure: Patients are considered "exposed" if their admission occurred after clinicians at their clinic had completed Recovery Connect training. Linkage: Patients are considered "linked" if they downloaded the app and were connected with a trained clinician during admission. Engagement: Defined by app activity within the first week after linkage, including logins, daily check-ins, and secure messaging. Analyses The primary analyses will use an intent-to-treat framework, including all eligible patients whose clinic underwent Recovery Connect training. Outcomes will be assessed using multilevel logistic regression and cluster-controlled discrete-time survival analyses, accounting for the stepped-wedge design.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	Recovery Connect	Recovery Connect is a white-labeled version of the Recovery Path platform, rebranded to maintain partner organizations' brand identity while leveraging its established digital infrastructure. Recovery Path is a HIPAA-compliant remote patient monitoring system that supports a blended model of care for medication for opioid use disorder (MOUD), integrating in-person treatment with continuous digital engagement. The app provides patients with daily check-ins, access to evidence-based resources and coping strategies, and secure messaging with their care teams. Clinicians receive real-time data on patient progress, risks, and setbacks. Between visits, clinicians can recommend tailored coping tools and psychoeducational content, reinforcing accountability and enhancing continuity of care. RC is also integrated into the clinic's electronic medical record system to streamline workflows, reduce administrative burden, and improve documentation accuracy through auto-generated case notes.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-11-01
• Completion: 2024-12-31
• First posted: 2025-08-26
• Last updated: 2025-08-26

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study