Facilitating In-Hospital Opioid Treatment Program Intakes to Support Hospital to OTP Linkage Among Hospitalized Patients With Opioid Use Disorder: An Implementation Trial in Four Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,440
- 主要终点
- 7-Day Hospital-to-OTP Linkage
研究概览
简要总结
The goal of this clinical trial is to learn if a hospital-based approach can help people with opioid use disorder (OUD) connect to a methadone clinic after leaving the hospital. This study focuses on adults with OUD who are in the hospital and want to start methadone treatment. Methadone is a safe and effective treatment for OUD. It can reduce cravings, prevent withdrawal, and lower the risk of overdose and death. Even though methadone works well, many people do not receive it. For people who start treatment in the hospital, the time after discharge is a high-risk period. Many patients do not connect to a methadone clinic after they leave. This can lead to return to opioid use, overdose, repeat hospital visits, and poor health. This study tests a new approach where hospital teams help complete the methadone clinic intake during the hospital stay. This approach uses trained hospital staff and structured workflows to complete key parts of the intake process before discharge. The goal is to reduce delays and make it easier for patients to connect to care right after leaving the hospital. The main questions it aims to answer are: 1) Does completing a methadone clinic intake during the hospital stay increase the number of people who connect to a methadone clinic after discharge? 2) Does providing support to hospital teams increase how often these in-hospital intakes are completed? Researchers will compare usual hospital care (referral at discharge) to a hospital-based approach that helps complete methadone clinic intake during the hospital stay to see if this improves connection to care.
详细描述
The purpose of this study is to test whether a hospital-based approach can improve connection to methadone treatment after discharge. The approach includes completing OTP intake during hospitalization and supporting hospital teams through an implementation strategy called implementation facilitation (IF). This study also aims to understand how well the approach can be adopted and sustained across different hospitals. This is a multi-site clinical trial conducted at four hospitals. The study uses a hybrid type 2 implementation-effectiveness design, meaning it evaluates both patient outcomes and how the intervention is implemented. The study uses an incomplete stepped wedge cluster randomized design. In this design:
- All hospitals begin in a usual care phase
- Hospitals are randomly assigned a time to switch to the intervention
- Over time, each hospital transitions from usual care to the intervention phase
- This allows each hospital to serve as its own comparison
During the usual care phase, patients receive standard care, which includes referral to an OTP at discharge. During the intervention phase, hospital teams receive implementation support to help complete OTP intake during the hospital stay. The intervention is an implementation strategy designed to support hospital teams in completing OTP intake during hospitalization.
The study uses the RE-AIM framework to evaluate outcomes:
- Reach: The number and characteristics of patients who complete OTP intake and connect to care.
- Effectiveness: The primary outcome is connection to an OTP after hospital discharge (for example, within 7 days). Secondary outcomes may include engagement in treatment at 30 and 90 days, healthcare use, and mortality.
- Adoption: The proportion of hospital clinicians and teams who use the new workflows and complete OTP intake.
- Implementation: How well the intervention is delivered, including fidelity to core components, adaptations, and resources used.
- Maintenance: Whether the intervention is sustained over time after initial implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Age ≥18 years
- •Hospitalized with DSM-5 opioid use disorder, confirmed by clinical assessment
- •Eligible for methadone treatment as determined by the clinical team
- •Not currently enrolled in an Opioid Treatment Program (OTP)
- •Anticipated discharge to the community
- •Willing to initiate methadone and follow up at a partnering OTP
排除标准
- •Current enrollment in an Opioid Treatment Program (OTP)
- •Planned discharge to a correctional or institutional setting that precludes OTP follow-up
- •Medical or psychiatric instability that precludes safe methadone initiation or completion of study procedures
- •Inability to provide required information for OTP intake due to impaired cognition or altered mental status
研究组 & 干预措施
Usual Care
Standard hospital-to-OTP referral processes without implementation facilitation
干预措施: HOTPIN-IF (Behavioral)
结局指标
主要结局
7-Day Hospital-to-OTP Linkage
时间窗: Measured within 7 days following hospital discharge
The primary outcome is whether a participant successfully connects to an Opioid Treatment Program (OTP) within 7 days after hospital discharge. Connection" (linkage) is defined as: Completion of OTP intake and/or attendance at the OTP, and Receipt or continuation of methadone treatment at the OTP
次要结局
- 30-Day OTP Engagement(30 days after hospital discharge)
- 90-Day OTP Engagement (Retention)(Within 90 days after hospital discharge)
研究者
Susan L. Calcaterra, MD, MPH
Physician Scientist
University of Colorado, Denver