Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921787
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2021-03-11
Brief Title:
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXHITENTRE
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 11 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 sitehub 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2UG1DA040316-06 | NIH | None | httpsreporternihgovquickSearch2UG1DA040316-06 |