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: 1. Is it feasible to recruit and randomize people to both treatment groups? 2. 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.
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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
128
Recovery community centers are brick and mortar buildings that house recovery-oriented organizations, located in the heart of their communities. They act as recovery hubs, offering a variety of recovery support services in house as well as connecting participants to resources in their area. They are peer-led organizations that are open to anyone in early or long-term recovery from substance use and that recognize that there are multiple pathways to recovery. Study participants will be provided with information about their local RCC (including a video link, contact information, a monthly calendar of events, a list of services and activities offered by the RCC, transportation options, etc.) and will be asked to visit the RCC on two different occasions within one month of enrollment.
In this study, the enhanced treatment as usual intervention will encompass providing participants with information about diverse recovery activities (e.g., mutual help group meetings, exercise, job search, recovery coach meetings, etc.) and then to assign participants to complete a recovery activity of their choosing one two different days within one month after enrollment. Participants can do the same activity twice, or different activities on each of the two days assigned.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGRecruitment Rate
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.
Time frame: Baseline
Study Withdrawals
Study withdrawals (i.e., participant-initiated withdrawals from the study after they learn about their randomized treatment assignment) will be reported as the number and percent of participants withdrawing.
Time frame: 1 month
Completion of Recovery Activities
To assess the completion rate of assigned recovery activities, we will ask participants to report whether they completed (=1) or did not complete (=0) each of the two recovery activities they will schedule with study staff after enrollment. Completion rates will be presented as the number and percent of participants completing the first or second recovery activity, respectively.
Time frame: 1 month
Completion of Follow-up Surveys
To assess completion of study assessments, we will check whether participants completed (including partial completions) (=1) or did not complete (=0) follow-up surveys at each assessment time point. Completion rates will be reported as the number and percent of participants completing them.
Time frame: Baseline, 1, 3, 6, and 12 month
Completion of Timeline Follow-Back (TLFB) Interviews
As part of assessing completion of study assessments, we will assess whether study participants completed the Timeline Follow-Back (TLFB) interview (=1) or not (=0) at each assessment time point. In the TLFB interviews, we will ask participants to go back through the last 30 days and report on specific recovery or substance use behaviors. For recovery supports, we will ask participants to tell us on which days they used medications for opioid use disorder or visited their local recovery community center. For substance use, we will ask participants about any non-prescribed opioid use, such as heroin or fentanyl, prescription opioids use without having a prescription for them, and any alcohol use. Completion of TLFB interviews will be reported as number and percent of participants completing them at each assessment point.
Time frame: Baseline, 1, 3, 6, and 12 months
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