Status:
COMPLETED
Emergency Department Outcomes for Patients With Opioid Use Disorder
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Brief Summary
Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, s...
Detailed Description
The ancillary study will use mixed-methods combining quantitative and qualitative inquiry (interview/focus group and field notes) with administrative and health record data with some analyses includin...
Eligibility Criteria
Inclusion
- Qualitative Population:
- Key stakeholder or opinion leader for ED-initiated BUP
- 18 years of age or older
- Full Study Population \& Limited Study Population:
- Be able to speak English sufficiently to understand study procedures
- Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria:
- Clinical determination: patient is a willing and eligible candidate for ED-initiated BUP or for whom this can be reasonably inferred, including any patient who is administered and/or prescribed BUP as part of the index ED visit.
- Research determination: Both a and b below must be true at the time of study enrollment:
- a) Assessment conducted by an RA indicates that the patient- (all must be true): i. has had nonmedical opioid use within the last 7 days, ii. meets DSM-5 criteria for moderate or severe opioid use disorder (OUD), iii. denies methadone use within 72 hours of ED visit registration, iv. is not engaged in formal medications for opioid use disorder (MOUD) treatment, v. is not prescribed opioids for chronic pain management, vi. reports being interested or "not sure" if interested in receiving BUP as elicited on the ED Health Survey during the index ED visit.
- b) Absence of clinical documentation associated with the ED visit indicating that the patient is not a candidate for ED-initiated BUP.
Exclusion
- Qualitative Population:
- Unwilling or unable to provide consent
- currently in jail, prison, or any inpatient overnight facility
- Full Study Population:
- Unwilling or unable to provide written/electronic informed consent
- Currently engaged in formal MOUD treatment at the time of index ED visit
- Currently in jail, prison or any inpatient overnight facility as required by court of law
- Previous participation as a patient- participant in CTN-0079 or previous participation as a Full Study participant in the current study
- Presents from a medical-based extended care facility
- Current research participant in a substance use intervention study
- Inadequate locator information (unable or unwilling to provide 2 unique means of contact)
- Unable or unwilling to complete research visits at baseline and Day 30.
- Limited Study Population:
- Unwilling or unable to provide written/electronic informed consent
- Currently engaged in formal MOUD treatment at the time of index ED visit
- Currently in jail, prison or any inpatient overnight facility as required by court of law
- Previous participation in the current study as a Limited study or Full study participant
- Presents from a medical-based extended care facility
Key Trial Info
Start Date :
November 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04289363
Start Date
November 25 2020
End Date
February 18 2022
Last Update
July 6 2023
Active Locations (2)
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1
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
2
Bellevue Hospital Center
New York, New York, United States, 10016