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) — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    The 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: CROSSROADS
    The 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

Locations (4)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33146
Kathryn Nowotny, PhD (PRINCIPAL_INVESTIGATOR)
Boston Medical CenterBostonMassachusetts02118
Alysse Wurcel, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27701
Margaret Roach, MPH
919-660-3008
Lauren Brinkley-Rubinstein, PhD (PRINCIPAL_INVESTIGATOR)
Catherine Paquette, PhD (SUB_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15260
Emily Dauria, PhD (PRINCIPAL_INVESTIGATOR)

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