Developing and Testing an Intervention to Enhance Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial of Linkage to Recovery Support Services
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Overall intervention acceptability
研究概览
简要总结
The aims of the current study are to: Aim 1. Develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; Aim 3. Explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.
详细描述
This 5-year project seek to advance our understanding of the clinical and public health utility of recovery community centers and help bridge the gap between clinical treatment and community-based recovery support services. As a first step in this work, the investigators will develop and test a new intervention for peer-facilitated assertive linkage of patients receiving opioid use disorder pharmacotherapy to recovery community centers (RCCL), relative to a matched control condition (CC). This study aims to: Aim 1. Develop, manualize, and refine RCCL and CC protocols via stakeholder feedback. RCCL and CC protocols will be developed and manualized by adapting published community-based mutual-help linkage protocols. Upon preliminary manual development, feedback cycles will be conducted with relevant stakeholders (recovery coaches, recovery community center members, pharmacotherapy prescribers) to inform protocol revision, and promote its feasibility, acceptability, and adoptability. Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of RCCL versus CC, via a pilot randomized controlled trial. More specifically, the feasibility of study procedures and RCCL/CC interventions, acceptability of interventions, and preliminary efficacy of RCCL relative to CC will be assessed. Aim 3. Explain quantitative findings by gaining an in-depth understanding of RCCL feasibility, acceptability, and efficacy via qualitative interviews in a subset of RCCL participants, peer facilitators, and linkage managers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •age ≥ 18 years
- •past-year opioid use disorder diagnosis per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- •currently undergoing outpatient buprenorphine treatment through a provider or program at Massachusetts General Hospital
- •current residence in Massachusetts
排除标准
- •non-English fluency
- •active suicidality
- •neurodevelopmental disorders or neural trauma preventing informed consent
- •active psychosis
- •past-year attendance at a recovery community center or recovery support center
结局指标
主要结局
Overall intervention acceptability
时间窗: Month 1
Assessed via 1 single-item statement addressing the the acceptability of the intervention. The item is measured on a 6-point Likert scale (Strongly Disagree - Strongly Agree). Higher scores indicate greater acceptability.
Overall intervention satisfaction
时间窗: Month 1
Assessed via the Client Satisfaction Questionnaire-8 (CSQ8) total score. This is an 8 item measure of client satisfaction with services. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Recovery community center attendance
时间窗: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Percent of participants who attended a recovery community center 1+ time post linkage manager meeting, as assessed via the Timeline Follow Back
Overall intervention feasibility
时间窗: From the date of intervention manual finalization until the date of study completion, assessed up to 48 months
Assessed via the Feasibility: Intervention Implementation \& Training scale average total score. This is a 2-item instrument to assess perceived intervention feasibility. Items are measured on a 6-point Likert scale (Strongly Disagree-Strongly Agree). Score is the calculated mean. Higher scores indicate greater feasibility.
Fidelity: Linkage manager adherence
时间窗: From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months
Percent adherence of linkage managers to intervention protocols, as evaluated by the percentage of sessions that are scored with adequate adherence and assessed by recordings of intervention delivery and adherence evaluation materials developed as part of Aim 1 (e.g., adherence rating scales of critical topics). This is a 14-item instrument evaluating the extensiveness of linkage managers' delivery of critical intervention topics. Items are measured on a 5-point Likert scale (Not at all - Extensively). Score is the calculated mean. Total scores range from 1 to 5, with scores \> 3 indicating adequate adherence.
Use of recovery support services
时间窗: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Percent days use of any recovery support services post linkage manager meeting, as assessed via the Timeline Follow Back
Overall recruitment feasibility
时间窗: Through study completion, ~3 years from recruitment initiation
Number of participants successfully recruited within allotted recruitment time frame (\~3 years)
次要结局
- Intervention appropriateness(Month 1)
- Change in recovery capital from baseline to Month 3(Baseline; Month 1; Month 3)
- Participant retention(From the date of first participant enrollment in the trial to the date of study completion, up to 42 months)
- Feasibility of peer facilitator meet-ups(Month 1; Month 3)
- Intervention helpfulness(Month 1; Month 3)
研究者
Lauren Hoffman
Principal Investigator
Massachusetts General Hospital