Peer Recovery Support in the Homeless Health Care Setting (SUPPORT)
Studying the Use of Peers to Promote Opioid Recovery Treatment: A Pilot Trial
The goal of this clinical trial is to learn whether a peer recovery support program designed for people experiencing homelessness can be successfully delivered as part of opioid use disorder treatment. Peer recovery support specialists are individuals who use their personal experience with substance use and recovery to support others. The main questions this pilot study aims to answer are:
- Is it feasible to conduct the study and deliver the peer recovery support program?
- Is the program acceptable to participants?
- Can the program be delivered as intended?
- Does the program show promise for helping participants stay engaged in opioid use disorder treatment?
Researchers will compare participants who receive peer recovery support in addition to usual opioid use disorder treatment with participants who receive usual treatment alone.
Participants will:
- Be randomly assigned to one of the two study groups.
- Complete a survey when they enroll and another survey approximately 3 months later.
- If assigned to the peer recovery support group, be offered individualized support from a peer recovery support specialist for 3 months, with meetings approximately weekly.
- If assigned to the peer recovery support group, complete an interview at the end of the study about their experiences with the program.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
### Study Rationale
Developing effective strategies to improve opioid use disorder (OUD) treatment retention among people experiencing homelessness (PEH) is important to reducing mortality in this high-risk population. Evidence from general OUD treatment settings suggests that peer recovery support services may improve treatment engagement and outcomes. Peer recovery support may be particularly beneficial for PEH, who often experience adverse social determinants of health, have limited social support, and face challenges navigating health care and social service systems.
The investigators developed a peer recovery support intervention tailored to the homeless health care setting, informed by patient focus groups, interviews with key informants from Health Care for the Homeless programs, and a community-engaged modified Delphi process.
### Study Objectives
The objective of this randomized pilot trial is to evaluate a 90-day peer recovery support intervention designed to improve OUD treatment retention among PEH. The primary objectives are to assess the feasibility of study procedures, intervention feasibility and acceptability, and intervention fidelity. Secondary objectives include exploring preliminary differences in OUD treatment retention and other clinical and psychosocial outcomes between study arms. Findings will inform intervention refinement and the design of a future, larger randomized controlled trial.
### Study Design and Setting
This study is a two-arm randomized pilot trial involving 40 adults with OUD initiating a new treatment episode at the Boston Health Care for the Homeless Program (BHCHP) office-based addiction treatment (OBAT) program at Jean Yawkey Place in Boston, Massachusetts.
Potential participants will be identified through collaboration with OBAT clinicians and staff and through electronic health record reports identifying patients initiating a new OBAT treatment episode. Interested individuals will undergo eligibility screening and informed consent within 7 days of their initial OBAT visit.
Following informed consent, participants will be randomized in a 1:1 ratio to receive either usual OBAT care (n=20) or peer recovery support in addition to usual OBAT care (n=20). Randomization will be conducted using REDCap. Study assignment will be concealed from participants until completion of the baseline survey.
### Study Procedures
Participants in both study arms will complete a baseline survey and a 90-day follow-up survey. Surveys will assess substance use, mental health, social support, and other factors potentially associated with OUD treatment engagement.
Following completion of the baseline survey, participants will be informed of their study assignment. Participants randomized to the intervention arm will be introduced to the peer recovery support specialist through a warm handoff whenever feasible. When an in-person introduction is not possible, the peer recovery support specialist will initiate outreach following enrollment.
Participants randomized to the usual care arm will continue to receive standard OBAT care without the addition of study-provided peer recovery support services.
### Peer Recovery Support Intervention
Participants randomized to the intervention arm will be offered 90 days of individualized support from a peer recovery support specialist in addition to usual OBAT care. The intervention is grounded in principles of harm reduction and patient-centered care, with an emphasis on developing trusting relationships and addressing barriers to OUD treatment engagement.
During the intervention period, the peer recovery support specialist will aim to meet with participants approximately weekly. The frequency, timing, duration, and content of sessions will be tailored to participants' needs, preferences, and availability. Additional contacts or meetings may occur as needed. Sessions may take place in person, by telephone, or by videoconference, with in-person meetings encouraged when feasible. Text messaging may also be used for communication and coordination with participants who provide consent.
Intervention activities may include emotional and recovery support, assistance navigating health care and social service systems, development of recovery-related skills and goals, and connections to treatment and community resources. The specific support provided will be individualized based on each participant's needs and goals.
Participants without access to a mobile phone will be provided with a phone and prepaid service to facilitate communication with the peer recovery support specialist.
Throughout the intervention period, the peer recovery support specialist will meet approximately weekly with an experienced supervisor to review intervention delivery, participant engagement, peer support boundaries, and challenging situations. Additional supervision will be available as needed.
The peer recovery support specialist will document all participant contacts and outreach attempts using standardized forms in REDCap. Documentation will include the frequency, duration, and mode of contact, as well as intervention components delivered. These data will be used to assess intervention delivery and fidelity.
At the conclusion of the 90-day intervention period, the peer recovery support specialist will work with participants, as appropriate, to identify ongoing sources of peer, clinical, or community support.
### Follow-up and Data Collection
Participants in both study arms will be invited to complete a follow-up survey between 90 and 105 days after randomization. Follow-up assessments may be completed in person or by telephone.
Participants randomized to the intervention arm will also be invited to complete a qualitative exit interview lasting approximately 45-60 minutes. Interviews will explore participants' experiences with the intervention, including its acceptability, perceived benefits, fit with participants' needs, and implementation. Interviews will be audio-recorded for qualitative analysis.
Electronic health record data will also be collected to assess OUD treatment engagement and retention during the study period. These data, together with participant surveys, intervention documentation, and qualitative interviews, will be used to evaluate the pilot trial objectives.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Aged at least 18 years
- Proficient in English
- Diagnosis of opioid use disorder, assessed by the clinical provider and documented within the patient's EHR
- New OBAT treatment episode, defined as having had no clinical encounters in the OBAT program during the prior 60 days
Exclusion Criteria:
- Inability to demonstrate adequate understanding of the informed consent information
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Usual OBAT Care
Participants in this arm will receive usual OBAT care |
|
|
Experimentell: Peer support
Participants in this arm will receive usual OBAT care and additional support from a peer recovery support specialist |
Participants assigned to the intervention arm will be offered 90 days of individualized peer recovery support in addition to usual office-based addiction treatment (OBAT) care. The peer recovery support specialist will aim to meet with participants approximately weekly over the intervention period. The frequency, duration, timing, and content of meetings will be tailored to participants' needs and preferences, with additional contacts available as needed. Meetings may take place in person, by telephone, or by videoconference. Intervention activities may include emotional and recovery support, assistance navigating health care and social service systems, development of recovery-related skills and goals, and linkage to treatment and community resources. Participants without access to a mobile phone will be provided with a phone and prepaid service to facilitate communication with the peer recovery support specialist. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment rate
Tidsram: During recruitment period
|
Proportion of eligible individuals who enroll in the study, calculated as the number of enrolled participants divided by the number of eligible individuals screened. |
During recruitment period
|
|
Randomization rate
Tidsram: At enrollment
|
Proportion of enrolled participants who are successfully randomized to a study arm, calculated as the number of randomized participants divided by the total number enrolled. |
At enrollment
|
|
Study retention rate
Tidsram: 90-day follow-up (days 90-105 after randomization).
|
Proportion of randomized participants who complete the 90-day follow-up survey, calculated as the number completing the follow-up survey divided by the total number randomized. |
90-day follow-up (days 90-105 after randomization).
|
|
Client Satisfaction Questionnaire Score
Tidsram: 90-day follow-up (days 90-105 after randomization)
|
Intervention acceptability will be assessed among participants randomized to the peer recovery support intervention using the 8-item Client Satisfaction Questionnaire (CSQ-8). Scores range from 8 to 32, with higher scores indicating greater satisfaction with services received. |
90-day follow-up (days 90-105 after randomization)
|
|
Number of Completed Peer Support Sessions
Tidsram: Randomization through day 90
|
Total number of completed peer support sessions per intervention participant during the 90-day period. |
Randomization through day 90
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Retention in Office-Based Addiction Treatment (OBAT) at 90 Days
Tidsram: Days 75-105 following enrollment
|
Proportion of participants with at least one completed in-person or virtual OBAT clinical encounter between days 75 and 105 following the baseline visit, assessed using electronic health record data. |
Days 75-105 following enrollment
|
|
Self-Reported Buprenorphine Adherence
Tidsram: Past 30 days at the 90-day follow-up
|
Number of days covered by buprenorphine during the 30 days preceding the 90-day follow-up, assessed using the Timeline Followback (TLFB) method. Possible values range from 0 to 30 days, with higher values indicating greater medication coverage. |
Past 30 days at the 90-day follow-up
|
|
Buprenorphine Percent of Days Covered
Tidsram: Enrollment through day 90
|
Percentage of days covered by buprenorphine during the 90-day study period, calculated using electronic health record medication data. Values range from 0% to 100%, with higher values indicating greater medication coverage. |
Enrollment through day 90
|
|
Past 30-Day Non-Prescribed Opioid Use
Tidsram: Past 30 days at the 90-day follow-up.
|
Number of days of non-prescribed opioid use during the 30 days preceding the 90-day follow-up, assessed using the Timeline Followback (TLFB) method. Possible values range from 0 to 30 days, with higher values indicating more frequent opioid use. |
Past 30 days at the 90-day follow-up.
|
|
Change in Opioid Use Severity
Tidsram: Baseline and 90-day follow-up
|
Change in opioid use severity from baseline to the 90-day follow-up, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-based opioid use severity score. Higher scores indicate greater opioid use severity. |
Baseline and 90-day follow-up
|
|
Change in Recovery
Tidsram: Baseline and 90-day follow-up
|
Change in recovery from baseline to the 90-day follow-up, assessed using the Substance Use Recovery Evaluator (SURE) total score. Higher scores indicate greater recovery. |
Baseline and 90-day follow-up
|
|
Change in Emotional Support
Tidsram: Baseline and 90-day follow-up
|
Change in perceived emotional support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Emotional Support Short Form. Higher scores indicate greater perceived emotional support. |
Baseline and 90-day follow-up
|
|
Change in Instrumental Support
Tidsram: Baseline and 90-day follow-up
|
Change in perceived instrumental support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Instrumental Support Short Form. Higher scores indicate greater perceived instrumental support. |
Baseline and 90-day follow-up
|
|
Change in Informational Support
Tidsram: Baseline and 90-day follow-up
|
hange in perceived informational support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Informational Support Short Form. Higher scores indicate greater perceived informational support. |
Baseline and 90-day follow-up
|
|
Change in Companionship
Tidsram: Baseline and 90-day follow-up
|
Change in perceived companionship from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Companionship Short Form. Higher scores indicate greater perceived companionship. |
Baseline and 90-day follow-up
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of Peer Support Sessions
Tidsram: Randomization through day 90
|
Duration in minutes of completed peer support sessions, summarized across intervention participants. |
Randomization through day 90
|
|
Delivery of Intervention Components
Tidsram: Randomization through day 90
|
Frequency with which prespecified peer support intervention components are documented as delivered, based on the Peer Support Contact and Fidelity Log. |
Randomization through day 90
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026P003043
- K23DA058200 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .