Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
170 participants
INTERVENTIONAL
2022-04-21
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard visit
Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.
No interventions assigned to this group
Extended visit with Observation
Participants will have extended Emergency Department visit by having an observation (which could be up to 23 hours) time in addition to the standard ED visit. In addition, information will be gathered about about the participants, use of opioids, healthcare visits, the quality of health, life, and treatment, and other topics. Urine or saliva or both may also be collected.
Observation
Emergency Department Observation Units (EDOU) would allow the highest risk patients - those presenting for nonfatal overdose - to receive their first dose of BUP before leaving the ED.
Operationally defined to include placement in an observation unit and/or placement under observation status with care provided by Emergency Medicine and/or other services (e.g., Internal medicine, Psychiatry)
Interventions
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Observation
Emergency Department Observation Units (EDOU) would allow the highest risk patients - those presenting for nonfatal overdose - to receive their first dose of BUP before leaving the ED.
Operationally defined to include placement in an observation unit and/or placement under observation status with care provided by Emergency Medicine and/or other services (e.g., Internal medicine, Psychiatry)
Eligibility Criteria
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Inclusion Criteria
* Is able to speak English sufficiently to understand study procedures
* Has a history of non-medical opioid use
* Is a potential candidate for ED-based MOUD treatment initiation and referral at the site as confirmed by clinical staff
* s not receiving MOUD through ongoing formal addiction treatment or pain management at the time of index ED visit
* Is willing to receive either standard ED care or enhanced ED care in EDOU depending on random assignment
* Presents to the ED during study screening hours
Exclusion Criteria
* Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
* Presents from a medical-based extended care facility (e.g., skilled nursing facility)
* Previous participation in the current study
* Inadequate locator information (unable or unwilling to provide one unique mean of contact).
* Has acute, severe medical, psychiatric, or concurrent substance use problem or meets other criteria that would exclude the patient (clinically) from placement in EDOU according to EDOU placement clinical protocols.
18 Years
100 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Ryan McCormack, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Rutgers University-University Hospital
Newark, New Jersey, United States
NYULH-Brooklyn
Brooklyn, New York, United States
Northwell Health - Long Island Jewish Medical Center
New Hyde Park, New York, United States
Bellevue
New York, New York, United States
NYULH-Tisch
New York, New York, United States
Northwell Health - Staten Island University Hospital
Staten Island, New York, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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19-A0-00-1002485
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20-01951
Identifier Type: -
Identifier Source: org_study_id