NCT Number: NCT07216963
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
University of Miami, Miami, Florida, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 months
As measured by the number of days of use per month per participant.
Time frame: 12 months
As measured by Urine Drug Screen (UDS).
Time frame: 12 months
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
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
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
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
Non-fatal overdoses measured by administrative/health records.
Time frame: 12 months
Fatal overdoses are measured by administrative/health records.
Time frame: 12 months
Number of participants who utilized treatment services
Time frame: 12 months
Number of participants who utilized overdose prevention services
Time frame: 12 months
Number of participants who utilized HHLN (Health Harming Legal Needs) ameliorative services
Contact information is provided by the study sponsor or research team.
Duke University
Other
The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services (CROSSROADS) Study
Acronym: CROSSROADS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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