ACTIVE_NOT_RECRUITING

EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Conditions

Substance Use Disorders Opioid Use Disorder, Severe Opioid Use Disorder, Moderate HBOT MOUD OUD SUD OTP ED

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-10-22

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04921787

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.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Gavin Bart, MD,PhD

PRINCIPAL_INVESTIGATOR

Hennepin Healthcare

Study Locations (Sites)

Boston University

Boston, Massachusetts, 02119

United States

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55404

United States

New York University

New York, New York, 10016

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Gavin Bart

Gavin Bart, MD,PhD, PRINCIPAL_INVESTIGATOR, Hennepin Healthcare

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 Registration Dates

Study Start Date2021-10-22

Study Completion Date2026-04

Study Record Updates

Study Start Date2021-10-22

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

HBOT
MOUD
OUD
SUD
OTP
ED

Additional Relevant MeSH Terms

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