EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

NCT04921787 | Active Not Recruiting DMC

• 2 other identifiers: NIDA CTN 0098B2UG1DA040316-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

HBOT; MOUD; OUD; SUD; OTP; ED

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low Intensity

ACTIVE COMPARATOR

MOUD training and support through the use of educational materials.

Other: Low Intensity

High Intensity

EXPERIMENTAL

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

Other: High Intensity

Interventions

Low Intensity OTHER

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.

Also known as: Training and education

Low Intensity

High Intensity OTHER

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.

Also known as: Practice Facilitation

High Intensity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Emmes Company, LLC: collaborator
• Gavin Bart: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Boston University

Boston, Massachusetts, 02119, United States

Location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55404, United States

Location

New York University

New York, New York, 10016, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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.

  PMID: 28673521 BACKGROUND

• 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.

  PMID: 20957426 BACKGROUND

• 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.

  PMID: 25889199 BACKGROUND

• Bart G, Korthuis PT, Donohue JM, Hagedorn HJ, Gustafson DH, Bazzi AR, Enns E, McNeely J, Ghitza UE, Magane KM, Baukol P, Vena A, Harris J, Voronca D, Saitz R. Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder. Addict Sci Clin Pract. 2024 Apr 11;19(1):29. doi: 10.1186/s13722-024-00455-9.

  PMID: 38600571 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Lymphoma, Follicular

Interventions

Ultrasonic Waves; Educational Status

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Gavin Bart, MD,PhD

  Hennepin Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gavin Bart, MD PhD FACP DFASAM

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: June 10, 2021
• Study Start: October 22, 2021
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be shared after the primary outcome paper has been accepted for publication, or 18 months after data lock, whichever comes first. The data will remain indefinitely.
• Access Criteria: Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.

Locations

US (4)