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

NCT ID: NCT07216963

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2030-08-31

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.

Detailed Description

CROSSROADS is a Hybrid Type I Implementation Effectiveness Trial. The primary objective of the study is to examine how the CROSSROADS intervention, which incorporates a Medical-Legal Partnership (MLP) into community paramedic (CP) standard of care, addresses health-harming legal needs (HHLN) influencing adverse substance use outcomes and risk of CLS (Criminal Legal System) engagement.

The key component of the CROSSROADS intervention is that it directly identifies and addresses HHLN. The MLP utilized in this study is Docs for Health (D4H), a technology-supported mobile application MLP that utilizes a 'screen and intervene' approach.

The primary aim is to compare the CROSSROADS intervention versus standard of care (SOC) CP programs across four sites (Durham, NC; Miami, FL; Pittsburgh, PA; Portland, ME) on 1) frequency of opioid and stimulant use, and 2) CLS (police, incarceration, and probation/parole) involvement. Researchers will randomly assign 400 adults to the SOC CP program (n=200) or CROSSROADS (n=200). Follow-up will occur at 1, 6, and 12 months.

The focus of the study is to examine how Community paramedic programs addressing socio-structural-legal factors influence adverse substance use outcomes and risk of criminal legal engagement. The long-term goal is to assess how innovative non-carceral interventions can be best implemented to address adverse substance use outcomes and prevent CLS exposure.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Community Paramedic Standard of Care (CP SOC)

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

CROSSROADS

Intervention Type: 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.

Interventions

Community Paramedic Standard of Care (CP SOC)

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Brinkley-Rubinstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

University of Miami

Miami, Florida, United States

Boston Medical Center

Boston, Massachusetts, United States

Duke University

Durham, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Margaret Roach, MPH

Role: CONTACT

margaret.roach@duke.edu

919-660-3008

Facility Contacts

Margaret Roach, MPH

Role: primary

margaret.roach@duke.edu

919-660-3008

Other Identifiers

RM1DA064518

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00118502

Identifier Type: -

Identifier Source: org_study_id