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临床试验/NCT04363320
NCT04363320已完成不适用

Fostering MAT Use in Justice Populations

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2020年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
256
试验地点
2
主要终点
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase

研究概览

简要总结

The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations.

详细描述

In this trial, the investigators will test two implementation interventions being applied to medications for opioid use disorder (MOUD) dissemination and implementation in justice settings for justice-involved populations: NIATx Coaching and the Extension for Community Healthcare Outcomes (ECHO) model. NIATx Coaches provide expertise in MOUD implementation and organizational change to help treatment organizations and staff make, sustain, and spread MOUD. The ECHO platform focuses only on the provider side by connecting the primary care provider with expert MOUD prescribers to promote high-quality MOUD practices. This will be the first trial that assesses the comparative effectiveness of these approaches overall, and in justice settings.

The trial will be conducted with a combination of 48 jails and community-based organizations that treat individuals with opioid use disorders (OUDs) post-incarceration. Sites will be randomly assigned to one of four study arms, with 12 sites in each arm: High-Dose Coaching/ECHO, Low-Dose Coaching/ECHO, High-Dose Coaching/No ECHO, and Low-Dose Coaching/No ECHO. The intervention period will be over a 12-month span with an additional 12-months for sustainability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

入选标准

  • Have an interest in embedding or increasing the use of MOUD within their site.
  • Have the funds to pay for medications for the duration of the study (24 months); whether it be from grants, insurance or private pay.
  • Sites agree to implement or continue to use at least one medication, although they will be encouraged to offer more than one medication.
  • Have leadership support at all levels.
  • Agree to provide data described in the MOU or Information Sheet.

排除标准

  • 未提供

结局指标

主要结局

Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase

时间窗: baseline to 12 months

The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.

Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase

时间窗: 13 months, 24 months

The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.

Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase

时间窗: baseline to 12 months

The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.

Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase

时间窗: 13 months to 24 months

The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.

Change in Number of Prescribers Using MOUD

时间窗: baseline, 12 months, 24 months

The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.

次要结局

  • MOUD Sustainability Measured Using the Program Sustainability Assessment Tool(baseline, 12 months, 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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