The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Duke University
- Study ID
- NCT07216963
- Status
- Not Yet Recruiting
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Conditions
- Opioid Use Disorder
- Overdose
- Overdose, Drug
- Substance Use (Drugs, Alcohol)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Community Paramedic Standard of Care (CP SOC) — BEHAVIORALParticipants randomized to CP SOC will receive 1) community paramedic standard of care after initial response to overdose; 2) Medications for Opioid Use Disorder (MOUD), harm reduction referrals, and linkages to health and social programs as needed; 3) long-term follow-up care with community paramedics in the field after initial contact.
- CROSSROADS — BEHAVIORALThe community paramedic (CP)standard of care (SOC) has three basic components across the sites. The core components of the CP SOC are that CPs: 1) are deployed via 911 as an opioid and/or stimulant overdose response; 2) provide Medications for Opioid Use Disorder (MOUD), harm reduction service referrals, and link patients to health and social programs as needed; and 3) provide long-term follow-up care in the field after initial contact. The CROSSROADS intervention will utilize these SOC aspects and build in technology-supported medical-legal partnerships (MLP) via Docs for Health (D4H) that identifies and addresses health-harming legal needs (HHLN). While CP SOC may refer to services that address some HHLN, the key component of the CROSSROADS intervention is the direct identification and addressing of HHLN via D4H.
Study Details
The goal of this clinical trial is to develop and test the CROSSROADS intervention. CROSSROADS is designed for people who have recently survived an opioid and/or stimulant-related non-fatal overdose and had contact with staff from a Community Paramedic (CP) program. Participants will be randomly placed into one of two groups: 1\) Standard of care from the CP program, or 2) CROSSROADS, which includes CP care plus a Medical-Legal Partnership (MLP). The MLP helps people with legal problems that can affect their health-- like issues with housing or public benefits. Researchers will test if the CROSSROADS intervention reduces drug use and involvement with the criminal legal system. People in the study will be followed for one year and asked to complete surveys at the beginning, and again at 1 month, 6 months, and 12 months.
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Sep 1, 2029
- Completion
- Aug 1, 2030
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Community Paramedic Standard of Care (CP SOC)The community paramedic (CP) standard of care (SOC) has three basic components across all study sites. The core components of the CP SOC are that CPs: 1) are deployed via 911 as an opioid and/or stimulant overdose response; 2) provide Medications for Opioid Use Disorder (MOUD), harm reduction service referrals, and link patients to health and social programs as needed; and 3) provide long-term follow-up care in the field after initial contact.
- Experimental: CROSSROADSThe community paramedic (CP) standard of care (SOC) has three basic components across the sites. The core components of the CP SOC are that CPs: 1) are deployed via 911 as an opioid and/or stimulant overdose response; 2) provide Medications for Opioid Use Disorder (MOUD), harm reduction service referrals, and link patients to health and social programs as needed; and 3) provide long-term follow-up care in the field after initial contact. The CROSSROADS intervention will utilize these SOC aspects and build in technology-supported medical-legal partnerships (MLP) via Docs for Health (D4H) that identifies and addresses health-harming legal needs (HHLN). While CP SOC may refer to services that address some HHLN, the key component of the CROSSROADS intervention is the direct identification and addressing of HHLN via D4H.
Primary Outcome Measure
Frequency of opioid and/or stimulant use [ Time Frame: 12 months ]
Central Contacts
- Margaret Roach, MPH919-660-3008
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33146 | Kathryn Nowotny, PhD (PRINCIPAL_INVESTIGATOR) |
| Boston Medical Center | Boston | Massachusetts | 02118 | Alysse Wurcel, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27701 | Lauren Brinkley-Rubinstein, PhD (PRINCIPAL_INVESTIGATOR) Catherine Paquette, PhD (SUB_INVESTIGATOR) |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | Emily Dauria, PhD (PRINCIPAL_INVESTIGATOR) |
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