The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study

NCT07216963 | Not Yet Recruiting DMC

• 2 other identifiers: Pro00118502RM1DA064518
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Opioid Use Disorder; Overdose, Drug; Overdose; Substance Use (Drugs, Alcohol)

Keywords

Overdose; Community Paramedic; Medical-Legal Services; Criminal Legal System; Consolidated Framework for Implementation Research; Paramedical Personnel; Human Centered Design; Criminal Legal

Outcome Measures

Primary Outcomes (3)

• Frequency of opioid and/or stimulant use

  As measured by the number of days of use per month per participant.

  12 months

• Number of participants with opioid and/or stimulant use

  As measured by Urine Drug Screen (UDS).

  12 months

• Number of participants with Criminal Legal System Involvement

  Measured by the number of participants with criminal legal system involvement. Criminal legal system involvement includes all intercepts of the Sequential Intercept Model: police/arrest, jail, court, prison, and community supervision.

  12 months

Secondary Outcomes (8)

• Presence of Health Harming Legal Needs (HHLN)

  12 months

• Number of participants with risky substance use behaviors

  12 months

• Risk of overdose as measured by the Opioid Overdose Risk Behavior Scale, version 2 (ORBS-2)

  12 months

• Number of participants who experienced a non-fatal overdose as measured by health record

  12 months

• Number of participants who experienced a fatal overdose

  12 months

Study Arms (2)

Community Paramedic Standard of Care (CP SOC)

ACTIVE COMPARATOR

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.

Behavioral: Community Paramedic Standard of Care (CP SOC)

CROSSROADS

EXPERIMENTAL

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.

Behavioral: CROSSROADS

Interventions

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.

CROSSROADS

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.

Community Paramedic Standard of Care (CP SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older;
• Has interacted with a CP team (and, thus, experienced a non-fatal opioid and/or stimulant overdose) in the last 30 days;
• Has independent legal agency
• Able to independently provide informed consent; and
• Able to speak and understand English.

You may not qualify if:

• \- Active, severe, and untreated mental illness that would make providing consent impossible

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

University of Miami

Miami, Florida, 33146, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Drug Overdose; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse

Study Officials

• Lauren Brinkley-Rubinstein, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Roach, MPH

CONTACT

919-660-3008; margaret.roach@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 15, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)