EXHITENTRE: EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04921787

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), The Emmes Company, LLC (Industry)

Enrollment

Locations

Arms

35.3

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders Opioid Use Disorder, Severe Opioid Use Disorder, Moderate	Other: Low Intensity Other: High Intensity	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 22, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low Intensity MOUD training and support through the use of educational materials.	Other: Low Intensity 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. Other Names: Training and education
Experimental: High Intensity MOUD training and support through the use of educational materials in addition to practice facilitation.	Other: High Intensity 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. Other Names: Practice Facilitation

Arm

Intervention/Treatment

Active Comparator: Low Intensity

MOUD training and support through the use of educational materials.

Other: Low Intensity

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.

Other Names:

Training and education

Experimental: High Intensity

MOUD training and support through the use of educational materials in addition to practice facilitation.

Other: High Intensity

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.

Other Names:

Practice Facilitation

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University	Boston	Massachusetts	United States	02119
2	Hennepin Healthcare Research Institute	Minneapolis	Minnesota	United States	55404
3	New York University	New York	New York	United States	10016
4	Oregon Health & Science University	Portland	Oregon	United States	97239