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

NCT07568847 | Not Yet Recruiting

• 2 other identifiers: 26-04551R01DA063733-01A1
• Study Type: interventional
• Target: 1,440
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

implementation facilitation; hospital based care; opioid use disorder; methadone; opioid treatment program

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 30-Day OTP Engagement

  30 days after hospital discharge

• 90-Day OTP Engagement (Retention)

  Within 90 days after hospital discharge

Other Outcomes (2)

• Healthcare Utilization After Discharge

  90 days following hospital discharge

• All-cause mortality following hospital discharge.

  90 days after hospital disharge

Study Arms (1)

Usual Care

ACTIVE COMPARATOR

Standard hospital-to-OTP referral processes without implementation facilitation

Behavioral: HOTPIN-IF

Interventions

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Susan L Calcaterra, MD, MPH, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan L Calcaterra, MD, MPH, MS

CONTACT

2487035947; susan.calcaterra@cuanschutz.edu

Sarah Mann, MA

CONTACT

sarah.mann@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Scientist

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Time Frame: Data will be available beginning 12 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: 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.