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临床试验/NCT05343793
NCT05343793已完成不适用

Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)

Stanford University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Reach

研究概览

简要总结

The purpose of this study is to expand access to medications for opioid use disorder (MOUD) in specialty addiction programs in Washington State. Sixty-four addiction treatment programs will participate in an adaptive implementation strategy trial that uses a stagewise implementation-to-target (stepped "care" type) approach whereby organizations engage in increasingly intensive implementation strategies as needed. Organizations are moved to a follow-up/sustainment arm once they have met the implementation targets described below. The design also includes an external comparator arm, which consists of 510 addiction treatment programs that are not participating in the study and will mimic as study controls.

The sequence of implementation strategies are:

  1. Enhanced Monitoring and Feedback
  2. NIATx/MAT Academy
  3. Randomization to either NIATx Internal Facilitation or NIATx External Facilitation
  4. Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm

Implementation targets are:

  1. Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months
  2. Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD
  3. Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.

Contextual moderators and mediators of performance on target outcomes as a function of the implementation strategy step will be examined, as will the costs associated with participation in the sequence of implementation strategies.

详细描述

Principal Investigator: Mark McGovern, PhD, Stanford University; Principal Investigator: James H Ford II, PhD, University of Wisconsin, Madison; Site Principal Investigator: Tony Walton, MS, Washington State Health Care Authority

研究设计

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

  • Addiction treatment programs in Washington State
  • Residential (detoxification or rehabilitation) or outpatient (intensive outpatient or outpatient) levels of care
  • Primary care clinics, including Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs)

排除标准

  • Opioid treatment programs

研究组 & 干预措施

Path 3

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation

干预措施: NIATx/MAT Academy (Other)

Path 1

Experimental

Enhanced Monitoring and Feedback

干预措施: Enhanced Monitoring and Feedback (EMF) (Other)

Path 2

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy

干预措施: Enhanced Monitoring and Feedback (EMF) (Other)

Path 3

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation

干预措施: Enhanced Monitoring and Feedback (EMF) (Other)

Path 3

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation

干预措施: NIATx-External Facilitation (NIATx-EF) (Other)

Path 4

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation

干预措施: Enhanced Monitoring and Feedback (EMF) (Other)

Path 4

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation

干预措施: NIATx/MAT Academy (Other)

Path 4

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation

干预措施: NIATx-Internal Facilitation (NIATx-IF) (Other)

Path 5

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

干预措施: Enhanced Monitoring and Feedback (EMF) (Other)

Path 5

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

干预措施: NIATx-Internal Facilitation (NIATx-IF) (Other)

Path 5

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

干预措施: NIATx-External Facilitation (NIATx-EF) (Other)

Path 5

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

干预措施: NIATx/MAT Academy (Other)

Path 2

Experimental

Enhanced Monitoring and Feedback + NIATx/MAT Academy

干预措施: NIATx/MAT Academy (Other)

结局指标

主要结局

Reach

时间窗: Quarterly ; Months 1 to 46

The proportion of program patients with OUD and receiving MOUD (buprenorphine, naltrexone) within the index quarter.

Adoption

时间窗: Quarterly ; Months 1 to 46

The number of integrated prescribers of buprenorphine and/or naltrexone, who are actively prescribing MOUD.

Effectiveness

时间窗: Quarterly ; Months 1 to 46

Access: The proportion of patients prescribed MOUD who start the medication within 72 hours of diagnosis. For patients requiring detoxification for naltrexone, Access will be operationalized as the proportion of patients who start the medication within 72 hours of when it is safe or indicated by a physician. Retention: The proportion of patients who are retained in continuous care for at least 6-months from the start of medication, or if in time limited care situations (e.g., residential detoxification) for the entire treatment episode.

Implementation - Integrating Medications for Addiction Treatment (IMAT) Index

时间窗: Months 1,7,14,24,34,46

The IMAT integrates MOUD guidelines, expert consensus recommendations, the OUD care cascade, and best practice information into a team-assessment benchmark measure of current and future state MOUD capability and practice. The IMAT is composed of 45 items, rated on a 1 to 5 scale from: 1- Not Integrated, to 3- Partially integrated, to 5- Fully integrated. Intermediate ratings of 2 and 4, are ratings not at either a 3 or 5 level respectively. The benchmark items address policy, practice and workforce factors, and are clustered into seven dimensions of: 1) Infrastructure; 2) Clinic culture and environment; 3) Patient identification and initiating care; 4) Care delivery and treatment response monitoring; 5) Care coordination; 6) Workforce; and, 7) Staff training and development. The IMAT Total Score is a composite rating from 1 to 5 of overall MOUD care quality. It takes between 1 to 2 hours to complete.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark McGovern

Professor

Stanford University

研究点 (2)

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