Pilot Test of Patient Decision Aid for Opioid Use Disorder (PtDA-MAT)
Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
研究概览
详细说明
In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial.
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Tarzana、California、美国、91356
- Tarzana Treatment Centers, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)
Exclusion Criteria:
- Significant or unstable medical or psychiatric illness that may interfere with study participation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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 |
|---|---|
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实验性的：Patient Decision Aid
Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
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PtDA-MAT 将提供有关 MAT 治疗方案和每种治疗方案的优缺点的信息，并将评估患者的首选方案。
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无干预：Record-only control group
Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes.
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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 |
|---|---|---|
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Treatment Retention
大体时间：3 months
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Treatment retention will be defined as number of days from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Drug screening results
大体时间：3 month
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Primarily opioid-negative urine testing (as collected by clinics as part of routine care) and other substance use per self-report (e.g., cannabis, benzodiazepines, cocaine, amphetamines)
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3 month
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Treatment Adherence
大体时间：3 month
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Treatment Adherence defined as proportion of clinic visits attended
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3 month
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合作者和调查者
调查人员
- 首席研究员：Yih-Ing Hser, Ph.D.、University of California, Los Angeles
- 首席研究员：Larissa Mooney, M.D.、University of California, Los Angeles
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- OPIOD1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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