Improving Hospital-To-Methadone Clinic Connection Using Implementation Support for Patients With Opioid Use Disorder

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

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.

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.

The study will also assess implementation costs and identify barriers and facilitators to adoption.

Participants are adults with OUD who are hospitalized and interested in starting methadone treatment. Participants must be willing to connect to a methadone clinic after discharge.

Data will be collected from multiple sources, including:

• Electronic health records (EHRs) from participating hospitals
• Data from opioid treatment programs (when available)
• Study questionnaires completed during enrollment
• Administrative data on healthcare use
• National Death Index data for mortality outcomes
• Data will be combined across sites using a structured data approach to ensure consistency.

The analysis will evaluate:

• Differences in OTP connection rates
• Changes in treatment engagement over time
• Variation across hospitals
• Implementation outcomes and costs
• Qualitative data from interviews and observations may also be used to understand how the intervention works in real-world settings.

This study addresses a major gap in care for people with OUD. Improving connection to methadone treatment after hospitalization has the potential to reduce overdose deaths, improve health outcomes, and reduce healthcare use. By testing both effectiveness and implementation, this study will provide practical information for scaling this approach across hospitals.

If successful, this model could be widely adopted to improve access to life-saving treatment for people with OUD.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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