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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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

Первичные конечные точки

• Frequency of opioid and/or stimulant use [Срок оценки: 12 months]
• Number of participants with opioid and/or stimulant use [Срок оценки: 12 months]
• Number of participants with Criminal Legal System Involvement [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Presence of Health Harming Legal Needs (HHLN) [Срок оценки: 12 months]
• Number of participants with risky substance use behaviors [Срок оценки: 12 months]
• Risk of overdose as measured by the Opioid Overdose Risk Behavior Scale, version 2 (ORBS-2) [Срок оценки: 12 months]
• Number of participants who experienced a non-fatal overdose as measured by health record [Срок оценки: 12 months]
• Number of participants who experienced a fatal overdose [Срок оценки: 12 months]
• Treatment utilization [Срок оценки: 12 months]
• Prevention service utilization [Срок оценки: 12 months]
• HHLN Service Utilization [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 4 центра

• University of Miami — Miami
• Boston Medical Center — Boston
• Duke University — Durham
• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07216963 · Pro00118502 · RM1DA064518

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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