EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy (EXHITENTRE)

April 19, 2023 updated by: Hennepin Healthcare Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02119
        • Recruiting
        • Boston University
        • Contact:
        • Principal Investigator:
          • Zoe Weinstein, MD
        • Sub-Investigator:
          • Alyssa Peterkin, MD
        • Sub-Investigator:
          • Alexander Walley, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Hennepin Healthcare Research Institute
        • Contact:
          • Gavin Bart, MD, PhD.
        • Principal Investigator:
          • JoAn Laes, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University
        • Contact:
        • Principal Investigator:
          • Jennifer McNeely, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Honora Englander, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement with MOUD
Time Frame: 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.
34 days following hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA CTN 0098B
  • 2UG1DA040316-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on the National Institute on Drug Abuse (NIDA) Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. De-identified individual participant data is expected to be made available.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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