Health TrialsbyHealthPanel

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

ConditionsOpioid Use DisorderOverdose, DrugOverdoseSubstance Use (Drugs, Alcohol)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Community Paramedic Standard of Care (CP SOC)Active comparator 1 intervention
Group B: CROSSROADSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of opioid and/or stimulant use

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

Time frame
12 months
2

Number of participants with opioid and/or stimulant use

As measured by Urine Drug Screen (UDS).

Time frame
12 months
3

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.

Time frame
12 months

Secondary outcomes

1

Presence of Health Harming Legal Needs (HHLN)

Measured by the National Center for MLP HHLN Scale, which measures HHLN including income, education \& employment, legal status, and personal stability. The scale "score" is the number of positive responses, indicating the number of identified legal needs a patient has on the screening tool.

Time frame
12 months
2

Number of participants with risky substance use behaviors

Measured by the HIV Risk-taking Behavior Scale (HRBS). The HRBS provides three scores: a total score indicating level of HIV risk-taking behavior; a Drug Use Sub-total indicating level of risk due to drug taking practices; and a Sexual Behavior Sub-total indicating level of risk associated with unsafe sex. The higher the total score, the greater the risk the subject has of contracting and passing on HIV.

Time frame
12 months
3

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

The total score on the ORBS-2 indicates the level of risk, with a higher score signifying a greater risk of overdose.

Time frame
12 months
4

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

Non-fatal overdoses measured by administrative/health records.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: