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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Intensity
High Intensity
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders focused on measuring HBOT, MOUD, OUD, SUD, OTP, ED

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston UniversityRecruiting
  • Hennepin Healthcare Research InstituteRecruiting
  • New York UniversityRecruiting
  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low Intensity

High Intensity

Arm Description

MOUD training and support through the use of educational materials.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2021
Last Updated
April 19, 2023
Sponsor
Hennepin Healthcare Research Institute
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04921787
Brief Title
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
Keywords
HBOT, MOUD, OUD, SUD, OTP, ED

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Intensity
Arm Type
Active Comparator
Arm Description
MOUD training and support through the use of educational materials.
Arm Title
High Intensity
Arm Type
Experimental
Arm Description
MOUD training and support through the use of educational materials in addition to practice facilitation.
Intervention Type
Other
Intervention Name(s)
Low Intensity
Other Intervention Name(s)
Training and education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High Intensity
Other Intervention Name(s)
Practice Facilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Engagement with MOUD
Description
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.
Time Frame
34 days following hospital discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulette Baukol
Phone
612-873-6993
Email
pbaukol@bermancenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jayati Vohra, PT, MS
Phone
6124269433
Email
jvohra@bermancenter.org
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Weinstein, MD
Phone
617-414-7399
Email
zoe.weinstein@bmc.org
First Name & Middle Initial & Last Name & Degree
Zoe Weinstein, MD
First Name & Middle Initial & Last Name & Degree
Alyssa Peterkin, MD
First Name & Middle Initial & Last Name & Degree
Alexander Walley, MD
Facility Name
Hennepin Healthcare Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gavin Bart, MD, PhD.
First Name & Middle Initial & Last Name & Degree
JoAn Laes, MD
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McNeely, MD
Phone
917-334-5877
Email
jennifer.mcneely@nyulagone.org
First Name & Middle Initial & Last Name & Degree
Jennifer McNeely, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honora Englander, MD
Phone
503-494-9000
Email
englandh@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Honora Englander, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://datashare.nida.nih.gov/
Citations:
PubMed Identifier
28673521
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.
Results Reference
background
PubMed Identifier
20957426
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.
Results Reference
background
PubMed Identifier
25889199
Citation
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.
Results Reference
background

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EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

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