EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Substance Use Disorders Clinical Trial

— EXHITENTRE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921787
• Other study ID #: NIDA CTN 0098B
• Secondary ID: 2UG1DA040316-06
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: Hennepin Healthcare Research Institute
• Contact: Paulette Baukol
• Phone: 612-873-6993
• Email: pbaukol[@]bermancenter.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder, Moderate
• Opioid Use Disorder, Severe
• Opioid-Related Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1. — View Citation

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View Citation

Trowbridge P, Weinstein ZM, Kerensky T, Roy P, Regan D, Samet JH, Walley AY. Addiction consultation services - Linking hospitalized patients to outpatient addiction treatment. J Subst Abuse Treat. 2017 Aug;79:1-5. doi: 10.1016/j.jsat.2017.05.007. Epub 2017 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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