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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: HOTPIN-IF

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan L Calcaterra, MD, MPH, MS; Phone Number: 2487035947; Email: susan.calcaterra@cuanschutz.edu
• Study Contact Backup: Name: Sarah Mann, MA; Email: sarah.mann@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Standard hospital-to-OTP referral processes without implementation facilitation	Behavioral: HOTPIN-IF; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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.	Assessed using linkage to the National Death Index (NDI)	90 days after hospital disharge

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Susan L Calcaterra, MD, MPH, MS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: opioid use disorder; methadone; implementation facilitation; hospital based care; opioid treatment program
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 26-0455; 1R01DA063733-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

IPD Sharing Time Frame

Time Frame:

Data will be available beginning 12 months after publication of the primary results and ending 5 years after publication.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No