Opioid Use Disorder, Overdose, Overdose, Drug, Substance Use (Drugs, Alcohol)
Conditions
Keywords
Overdose, Community Paramedic, Medical-Legal Services, Criminal Legal System, Consolidated Framework for Implementation Research, Paramedical Personnel, Human Centered Design, Criminal Legal
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.
Interventions
BEHAVIORALCommunity 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.
BEHAVIORALCROSSROADS
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.
Sponsors
Duke University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of opioid and/or stimulant use | 12 months | As measured by the number of days of use per month per participant. |
| Number of participants with opioid and/or stimulant use | 12 months | As measured by Urine Drug Screen (UDS). |
| Number of participants with Criminal Legal System Involvement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Health Harming Legal Needs (HHLN) | 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. |
| Number of participants with risky substance use behaviors | 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. |
| Risk of overdose as measured by the Opioid Overdose Risk Behavior Scale, version 2 (ORBS-2) | 12 months | The total score on the ORBS-2 indicates the level of risk, with a higher score signifying a greater risk of overdose. |
| Number of participants who experienced a non-fatal overdose as measured by health record | 12 months | Non-fatal overdoses measured by administrative/health records. |
| Number of participants who experienced a fatal overdose | 12 months | Fatal overdoses are measured by administrative/health records. |
| Treatment utilization | 12 months | Number of participants who utilized treatment services |
| Prevention service utilization | 12 months | Number of participants who utilized overdose prevention services |
| HHLN Service Utilization | 12 months | Number of participants who utilized HHLN (Health Harming Legal Needs) ameliorative services |
Countries
United States
Contacts
CONTACTMargaret Roach, MPH
PRINCIPAL_INVESTIGATORLauren Brinkley-Rubinstein, PhD
Duke Health
Outcome results
None listed