EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Running, not enrolling · Not applicable

Conditions studied: Substance Use Disorders, Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate

In brief

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.

Key facts

Study ID

NCT04921787

Run by

Gavin Bart

People needed

24

Starts

2021-10-22

Expected to finish

2026-12-21

Last updated by the study team

2026-04-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
• Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
• 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.
• Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
• Be willing to be randomized to low-intensity or high-intensity implementation support.
• Provide inpatient general medical care.
• 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.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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