TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization (TRTME)
A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial
研究概览
详细说明
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TRTME or Control. Participants will receive the assigned intervention following randomization, will complete a post-assessment following treatment receipt, and will complete a follow-up phone call at approximately one month posthospital discharge.
All participants will complete assessments of their opioid-overdose and MOUD knowledge and their risk for experiencing an opioid-overdose during baseline. TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. Control participants will be offered two SAMHSA handouts.
Enrollment is expected to take place over a period of approximately 7.5 months. Duration of study participation will be approximately 5 weeks.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lindsay Bybee, MS
- 电话号码：5135858282
- 邮箱：saskowld@uc.edu
研究联系人备份
- 姓名：Ben Kropp Kropp, MSLS
- 电话号码：5135858287
- 邮箱：kroppbn@ucmail.uc.edu
学习地点
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Ohio
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Cincinnati、Ohio、美国、45229
- 招聘中
- University of Cincinnati Addiction Sciences Division
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 18 years of age or older;
- A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team
Exclusion Criteria:
- Have a current planned discharge to a nursing facility
- be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action with high probability of incarceration or court-mandated inpatient treatment
- Unable to demonstrate adequate understanding of study procedures during the consent process
学习计划
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 |
|---|---|
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无干预：Control
Control participants will be offered two SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; and 2) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends".
These handouts can be offered as physical copies or electronically.
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实验性的：TRTME
TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors.
TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment.
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The TRTME intervention includes three elements that have all been previously studied by our research team: 1) brief, personally-tailored education to correct inaccurate, common misconceptions about MOUD and to address knowledge gaps about opioid-overdose; 2) with personally-tailored feedback on the individual's risk factors for experiencing an opioid-overdose; and 3) review of MOUD testimonial videos.
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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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Outpatient MOUD initiation
大体时间：30 days
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The primary outcome is verified enrollment in outpatient MOUD within 30 days post-discharge. Participants will be asked about their enrollment in MOUD approximately 30 days after their discharge from the hospital. Participants reporting having enrolled in treatment will be asked to provide a release of information for the treatment program to verify date of treatment enrollment. |
30 days
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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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MOUD knowledge score
大体时间：Immediately after the intervention
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The key secondary outcome is MOUD knowledge as measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation.
The OOTAS is comprised of 4 sections: 1) opioid-overdose risk factors; 2) signs of an opioid-overdose; 3) how to respond to an opioid-overdose; and 4) misconceptions about MOUD.
The OOTAS has been successfully used to measure MOUD knowledge and knowledge change in three studies.
The OOTAS includes 10 true-false questions to assess MOUD knowledge, yielding a potential score of 0-10.Secondary Outcome Measures
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Immediately after the intervention
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MOUD Stigma
大体时间：Immediately after the intervention
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There are no existing validated measures for assessing MOUD stigma in patients who are good candidates for MOUD but have not yet entered treatment. The Medication for Opioid Use Disorder Attitudes Scale (MOUD-AS) was created by OpenEvidence based on stigmatizing beliefs about MOUD among patients considering treatment. The MOUD-AS includes 16 items scored from 1 (strongly disagree) to 5 (strongly agree). The total score, which has a potential range of 16-80, is the outcome of interest. |
Immediately after the intervention
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Drug Self-efficacy
大体时间：Immediately after the intervention
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Self-efficacy in quitting drug use will be assessed with the Thoughts about abstinence (TAA) instrument.
This measure assesses the participant's desire to quit, expected success in quitting and estimated difficulty in avoiding drug use.
Our MOUD education intervention has been found to increase expected success in quitting drug use as measured by the TAA.
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Immediately after the intervention
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Opioid-overdose knowledge score
大体时间：Immediately after the intervention
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Opioid-overdose knowledge will be measured by the first three sections of the OOTAS.
The OOTAS has been successfully used to measure opioid-overdose knowledge and knowledge change in three prior studies conducted with individuals with OUD.
The OOTAS includes 31 true-false questions to assess opioid-overdose knowledge, yielding a potential score of 0-31.
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Immediately after the intervention
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合作者和调查者
调查人员
- 首席研究员：T. John Winhusen, PhD.、University of Cincinnati
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
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