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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA063733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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:
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:
The analysis will evaluate:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Standard hospital-to-OTP referral processes without implementation facilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOTPIN-IF | Behavioral | Participants receive care at sites after rollout of Implementation Facilitation (IF) to support HOTPIN workflows. Focus on completing in-hospital OTP intake, including: Medical assessment Screening labs Methadone initiation Transportation coordination Supported by: External facilitators Learning collaboratives Workflow integration into the EHR |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Hospital-to-OTP Linkage | 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 | Measured within 7 days following hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Day OTP Engagement | Description: Proportion of participants who remain engaged in methadone treatment at an Opioid Treatment Program (OTP) within 30 days after hospital discharge. Defined by ongoing dosing or documented attendance at the OTP Reflects short-term treatment retention | 30 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization After Discharge | Description: Rates of emergency department visits and hospital readmissions following the index hospitalization. Assessed using hospital administrative and EHR data | 90 days following hospital discharge |
| All-cause mortality following hospital discharge. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan L Calcaterra, MD, MPH, MS | Contact | 2487035947 | susan.calcaterra@cuanschutz.edu | |
| Sarah Mann, MA | Contact | sarah.mann@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan L Calcaterra, MD, MPH, MS | University of Colorado, Denver | Principal Investigator |
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We will share de-identified individual participant data (IPD) using a controlled access process (not open download)
We will require:
Data Use Agreement (DUA) IRB approval or exemption data security plan
We will exclude:
Direct identifiers Anything restricted under 42 CFR Part 2 without proper authorization
Time Frame:
Data will be available beginning 12 months after publication of the primary results and ending 5 years after publication.
Data will be shared with investigators who provide a methodologically sound proposal. Access will require execution of a Data Use Agreement (DUA), Institutional Review Board (IRB) approval or exemption, and adherence to data security requirements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2026 | Apr 24, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2026 | Apr 24, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 90-Day OTP Engagement (Retention) |
Description: Proportion of participants who remain engaged in methadone treatment at an OTP within 90 days after hospital discharge. Defined by continued dosing records or clinic attendance Reflects longer-term treatment retention |
| Within 90 days after hospital discharge |
Assessed using linkage to the National Death Index (NDI) |
| 90 days after hospital disharge |