The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services (CROSSROADS) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Frequency of opioid and/or stimulant use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- Active, severe, and untreated mental illness that would make providing consent impossible
研究组 & 干预措施
Community Paramedic Standard of Care (CP SOC)
The community paramedic (CP) standard of care (SOC) has three basic components across all study 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.
干预措施: Community Paramedic Standard of Care (CP SOC) (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 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.
干预措施: CROSSROADS (Behavioral)
结局指标
主要结局
Frequency of opioid and/or stimulant use
时间窗: 12 months
As measured by the number of days of use per month per participant.
Number of participants with opioid and/or stimulant use
时间窗: 12 months
As measured by Urine Drug Screen (UDS).
Number of participants with Criminal Legal System Involvement
时间窗: 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.
次要结局
- Treatment utilization(12 months)
- Prevention service utilization(12 months)
- HHLN Service Utilization(12 months)
- Number of participants who utilized HHLN (Health Harming Legal Needs) ameliorative services(12 months)
- Presence of Health Harming Legal Needs (HHLN)(12 months)
- Number of participants with risky substance use behaviors(12 months)
- Risk of overdose as measured by the Opioid Overdose Risk Behavior Scale, version 2 (ORBS-2)(12 months)
- Number of participants who experienced a non-fatal overdose as measured by health record(12 months)
- Number of participants who experienced a fatal overdose(12 months)
- Number of participants who utilized treatment services(12 months)
- Number of participants who utilized overdose prevention services(12 months)
- Number of participants who utilized harm reduction services(12 months)