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Preventing Overdose and Promoting Recovery Through Court Navigation (POPCORN)

2026年7月10日 更新者：Bradley Ray、RTI International

Hybrid Type I Trial of a Peer-Led Court Navigation Program to Improve Substance Use Disorder Treatment Receipt and Reduce Overdose and Incarceration Among People Passing Through Courthouses

This project is a hybrid type I clinical trial to assess the effectiveness and implementation determinants of a peer-led court navigation program for people who use drugs and are passing through county courthouses. Courthouses are a common point of contact for people with behavioral health needs, but outside of specialty court models, they remain underexplored as a setting for connecting people to substance use disorder treatment and related services. This study will test whether court navigation led by peer recovery specialists can increase receipt of substance use disorder treatment and reduce overdose and incarceration. Peer court navigators will meet with participants in courthouse settings, assess their needs, provide information and referrals, and offer follow-up support for up to 3 months. Peer recovery specialists, who have lived experience with substance use recovery, are increasingly being integrated into criminal legal and community-based settings; however, peer-led court navigation remains an innovative and understudied approach.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

600

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Indiana
      • South Bend、Indiana、美国、46601
        • St. Joseph County Courthouse 1
        • 接触：
        • 接触：
    • North Carolina
      • Research Triangle Park、North Carolina、美国、27709
        • RTI International
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged 18 years or older
  • Current resident of Indiana
  • Able to complete study procedures in English
  • Meets at least one of the following criteria: used heroin, fentanyl, methamphetamine, or cocaine in the past 12 months; is interested in resources or treatment for a substance use disorder; or experienced an opioid-related overdose in the past 12 months

Exclusion Criteria:

  • Has been sentenced to incarceration in jail or prison for the next 12 months

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Peer court navigation
CourtConnect is the intervention. It connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs. Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months.
行为的：CourtConnect
CourtConnect connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs. Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months.
有源比较器：Information only
Participants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant. They do not receive peer court navigation or follow-up support from a peer court navigator.
其他：Information Only
Participants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant. They do not receive peer court navigation or follow-up support from a peer court navigator.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Administratively documented substance use disorder treatment engagement
大体时间：90 days after baseline
This participant-level outcome will indicate whether a participant has any administratively documented substance use disorder treatment engagement within 90 days after baseline. Treatment engagement will be determined from linked state administrative records, including Medicaid claims for substance use disorder treatment services and prescription drug monitoring program records showing dispensed medications used to treat substance use disorder. For participants without administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as treatment initiation. For participants with administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as continued treatment engagement. The outcome will be reported as the proportion of participants in each study arm with administratively documented treatment engagement.
90 days after baseline

次要结果测量

结果测量
措施说明
大体时间
Number of participants with a fatal or nonfatal overdose
大体时间：12 months after baseline
Fatal and nonfatal overdose will be measured using statewide vital records and emergency medical records from ambulance services and hospital emergency departments. Participants will be classified as having experienced an overdose if records show a fatal overdose or an encounter for a nonfatal overdose during the 12 months after baseline.
12 months after baseline
Number of participants with a jail booking or prison entry
大体时间：12 months after baseline
Incarceration through jail booking or prison entry will be measured using statewide criminal legal records. Participants will be classified as having experienced incarceration if records show a booking into a jail facility or entry into the state prison system during the 12 months after baseline.
12 months after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

RTI International

合作者

National Institute on Drug Abuse (NIDA)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2030年5月1日

研究注册日期

首次提交

2026年7月3日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R01DA064492 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The investigators will enroll 600 subjects over 24 months with 12 months of follow-up data by linking administrative records (e.g., prescription fills, emergency department/emergency medical services encounters, mortality, arrests/jail bookings) to survey contents that will include demographics, substance use disorder and treatment history, criminal legal system involvement, social constructs (self-efficacy, motivation, stigma), and harmonized measures. The National Institutes of Health requires that the study team release study data. The investigators will preserve and share de-identified survey datasets (with codebooks), and project documentation (protocols, instruments); derived variables from linked administrative data will be shared, while raw state administrative source files obtained under data use agreements will not be shared. The publicly released scientific data will include only fully de-identified data.

IPD 共享时间框架

IPD and additional supporting information will be archived in the National Addiction & HIV Data Archive Program (NAHDAP), assigned persistent identifiers, and made available as soon as possible and no later than the earlier of the primary publication or the end of the performance period, whichever comes first.

IPD 共享访问标准

After project completion, only de-identified datasets will be made available as public-use files and deposited in repositories for broader research, teaching, replication. Shared data will be provided in open, non-proprietary formats, along with parallel Stata/R scripts and a README so that no specialized software is required to access or manipulate the data. Publicly shared datasets will receive a DOI to facilitate sharing, citation, and version control. Access will be controlled when there is any non-trivial re-identification risk or when required by data use agreements. In those cases, repositories will gate access under standard data use agreements that prohibit re-identification and onward sharing, require secure storage and destruction at project end, and log requestor credentials and approved uses. Raw state administrative source files received under data use agreements will not be shared; only de-identified, derived variables constructed from those sources will be deposited.

IPD 共享支持信息类型

  • 研究方案
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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