Digital Innovation in Medication-Assisted Treatment for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,524
- 试验地点
- 9
- 主要终点
- Treatment retention
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newly admitted patients to participating clinics
排除标准
- •Dosing suggesting a transfer from a non-participating clinic, or if they had previously used the app prior to their most recent admission during the study period.
研究组 & 干预措施
Implementation of digital app at the clinic (Recovery Connect)
Implementation consists of two components:
Clinician training: Addiction treatment professionals complete live virtual training with step-by-step guides, video tutorials, and ongoing technical support. Training covers app features, patient linkage, and app-based communication strategies.
Patient onboarding: Following training, clinicians introduce the app to newly admitted patients, assist with downloading and linking via QR code, and demonstrate core features such as daily check-ins, homework activities, and secure messaging.
干预措施: Recovery Connect (Device)
Usual Care
Clinics in the control condition continue providing standard medication-assisted treatment (MAT) for opioid use disorder (OUD) without the Recovery Connect app. Usual care includes in-person counseling sessions, medication management, and access to peer support and ancillary services, following each clinic's existing protocols and best practices. Patients do not receive access to the Recovery Connect platform during this phase, and clinicians do not use app-based tools or data to inform care.
结局指标
主要结局
Treatment retention
时间窗: From admission to 60 days post admission (in order to determine whether a 30 day gap began in the first 30 days and thus determine 30-day retention)
Retention is defined according to federal guidelines, which allow patients to be readmitted within 30 days without restarting the intake process. A patient is considered not retained if a treatment gap of 30 consecutive days begins within the first 30 days after intake. The first day of that gap is recorded as the dropout date.
Treatment retention
时间窗: From admission to 60 days post admission (in order to determine whether a 30 day gap began in the first 30 days and thus determine 30-day retention)
Retention is defined according to federal guidelines, which allow patients to be readmitted within 30 days without restarting the intake process. A patient is considered not retained if a treatment gap of 30 consecutive days begins within the first 30 days after intake. The first day of that gap is recorded as the dropout date.
次要结局
- Treatment continuance(From admission to 30 days post-admission)
- 3, 7, and 30 day doses(3, 7 and 30 days post admission)
- 3, 7, and 30 day doses(3, 7 and 30 days post admission)
- Treatment continuance(From admission to 30 days post-admission)