EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder, Severe; Opioid Use Disorder, Moderate; Substance Use Disorders
• Interventions: Other: Low Intensity; Other: High Intensity

• Registration Number: NCT04921787
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.

Detailed Description

The study will randomize approximately 24 community hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD. Community hospitals will be randomized 1:1 to implement a low- or high-intensity strategy. Hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in HBOT. The randomization will be stratified by site/hub. Participants will be assessed for "engagement with MOUD", measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention. Further outcomes will be assessed during the entire 4-year study period.

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Study Start: 2021-10-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Be a community hospital deemed by the lead investigators to be in the region of a site/hub. Region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant Medicaid data.
2. Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
3. Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
4. Commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge OUD treatment, or available direct entry into outpatient MOUD with methadone or buprenorphine.
5. Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
6. Be willing to be randomized to low-intensity or high-intensity implementation support.
7. Provide inpatient general medical care.
8. Have sufficient numbers of Medicaid OUD discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). Medicaid data must capture at least 3 discharge diagnoses, outpatient MOUD, and be available within no more than 12 months of discharge.

Exclusion Criteria

1. Have an ACS routinely prescribing MOUD at discharge.
2. Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team.
3. Be a Veterans Affairs hospital.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Intensity	Low Intensity	MOUD training and support through the use of educational materials.
High Intensity	High Intensity	MOUD training and support through the use of educational materials in addition to practice facilitation.

Primary Outcome Measures

Name	Time	Method
Engagement with MOUD	34 days following hospital discharge	measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention.

Trial Locations

Locations (4)

Boston University; 🇺🇸 Boston, Massachusetts, United States

Hennepin Healthcare Research Institute; 🇺🇸 Minneapolis, Minnesota, United States

New York University; 🇺🇸 New York, New York, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States