EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Implementation Trial of High Intensity Versus Low Intensity Strategy for Supporting Hospital-Based Opioid Use Disorder Treatment

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

Intervention / Treatment
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* Other: Low Intensity
* Other: High Intensity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This 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. Approximately 24 hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD, 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Intensity<br>MOUD training and support through the use of educational materials. | Other: Low Intensity<br>* Training and education only, a low-intensity strategy inclusive of an HBOT manual, one-time live training on how to use the HBOT manual, and 7 video conference presentations.<br>* Other names: Training and education;|
| Experimental: High Intensity<br>MOUD training and support through the use of educational materials in addition to practice facilitation. | Other: High Intensity<br>* Practice facilitation, a high-intensity strategy inclusive of low-intensity training, plus practice facilitation that is based in part on a program planning model. This study is a hybrid implementation effectiveness design, testing an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes.<br>* Other names: Practice Facilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 34 days following hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBOT, MOUD, OUD, SUD, OTP, ED