R34 Study 2 - Pilot RCT Testing the Effectiveness of RCCs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this pilot randomized clinical trial is to prepare for a larger randomized clinical trial (RCT) and collect some early data to learn if the intervention can help people who use medications for opioid use disorder (MOUD). The main questions it aims to answer are:
- Is it feasible to recruit and randomize people to both treatment groups?
- Does linking people to recovery community centers lead to better recovery outcomes?
Researchers will compare linking people to recovery community centers (RCC) to enhanced treatment as usual to see if recovery outcomes are different.
In one group, participants will learn about their local RCC and will be asked to visit their local RCC on at least two days and write about their experiences. In the other group, participants will learn about different recovery activities, pick any two, and do the activities of their choice on at least two days. They will also be asked to write about their experiences.
People in both groups will answer online survey questions about their recovery outcomes and well-being in five surveys over one year.
详细描述
The goal of this study is to prepare for a large-scale RCT. The current study is a pilot randomized clinical trial (RCT) comparing RCC linkage vs. enhanced treatment as usual (ETAU). Persons engaged in MOUD clinical care (n=128) at MOUD-providing clinics near RCCs serving Black communities will be recruited nationwide. The aims of this study are:
Aim 1: Determine the number of study participants enrolled per month. This information will be used for planning a subsequent R01, in line with the goals of the R34 mechanism used to fund this study.
Aim 2: Determine the feasibility of the chosen randomization procedures and groups in terms of (a) study enrollment, (b) completion of recovery activity assignments, and (c) completion of follow-up assessments.
Exploratory Aim 3: Estimate the size of treatment group differences on recovery outcomes over time, including on (a) the Substance Use Recovery Evaluator (SURE); (b) the Brief Measure of Recovery (BMR-4; derived from the Substance Abuse and Mental Health Services Administration's (SAMHSA) definition of recovery); (c) Experience Of Support (derived from SAMHSA goals of peer recovery support services); (d) Brief Assessment of Recovery Capital (BARC-10); and (e) self-report of participation in recovery support services.
Of note, this is a community-engaged research project, involving three community partners (i.e., the Detroit Recovery Project (DRP), Northern Ohio Recovery Association (NORA), and Let's Talk Safety (PILLARS)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •18+ years of age
- •Uses MOUD (at enrollment; participants may stop using MOUD subsequently) to treat OUD
- •Receives MOUD from a clinic/pharmacy located within 15 miles of an RCC vetted by our study team, which serves a Black community (i.e., defined as being located in a ZIP code where ≥27% of the residents are Black, as per US Census)
- •Is willing and able to engage in study procedures (i.e., online surveys, timeline follow back interview)
- •Is willing to be randomized
排除标准
- •- Has visited a vetted RCC during the past 3 months
结局指标
主要结局
Recruitment Rate
时间窗: Baseline
The recruitment rate will be estimated from the number of study participants enrolled per month; this information will be used for planning a subsequent R01, in line with the goals of the R34 mechanism used to fund this study. The recruitment rate will be reported as mean with standard deviation (based on monthly observations) and will be reported descriptively.
次要结局
- Study Withdrawals(1 month)
- Completion of Recovery Activities(1 month)
- Completion of Follow-up Surveys(Baseline, 1, 3, 6, and 12 month)
- Completion of Timeline Follow-Back (TLFB) Interviews(Baseline, 1, 3, 6, and 12 months)
研究者
Bettina B. Hoeppner
Principle Investigator
Massachusetts General Hospital