The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community Paramedic Standard of Care (CP SOC), CROSSROADS.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Overdose, Drug, Overdose, Substance Use (Drugs, Alcohol). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services (CROSSROADS) Study
Overview
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.
Interventions
- Behavioral 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. - 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
Primary outcome measures
- Frequency of opioid and/or stimulant use [Time frame: 12 months]
- Number of participants with opioid and/or stimulant use [Time frame: 12 months]
- Number of participants with Criminal Legal System Involvement [Time frame: 12 months]
Secondary outcome measures (8)
- Presence of Health Harming Legal Needs (HHLN) [Time frame: 12 months]
- Number of participants with risky substance use behaviors [Time frame: 12 months]
- Risk of overdose as measured by the Opioid Overdose Risk Behavior Scale, version 2 (ORBS-2) [Time frame: 12 months]
- Number of participants who experienced a non-fatal overdose as measured by health record [Time frame: 12 months]
- Number of participants who experienced a fatal overdose [Time frame: 12 months]
- Treatment utilization [Time frame: 12 months]
- Prevention service utilization [Time frame: 12 months]
- HHLN Service Utilization [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 4 centers
- University of Miami — Miami
- Boston Medical Center — Boston
- Duke University — Durham
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07216963 · Pro00118502 · RM1DA064518