ED Observation for Opioid Use Disorder

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    230
  • sponsor
    NYU Langone Health
Updated on 11 July 2022

Summary

This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU).

Description

In this hybrid implementation-effectiveness study, there is no direct research intervention. Rather, clinical care with well-documented effectiveness will be delivered at the discretion of clinical staff guided by clinical protocols for the management of OUD with MOUD (Medications for Opioid Use Disorder) introduced at each site prior to study enrollment. Enrolled patients will be randomized to ED vs. EDOU and to participate in assessments conducted at the index visit and at 30 days and 90 days. Patient level data will also be matched with Medicaid claims data for more robust analyses and to support the development of clinical quality measures.

Details
Condition Opiod Use Disorder
Treatment Observation
Clinical Study IdentifierNCT05064826
SponsorNYU Langone Health
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Is 18 years of age or older
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

Unwilling or unable to provide written/electronic informed consent/HIPAA Authorization for research procedures, including research visits at baseline and Day 30 and Day 90, and/or consent for the release of health records and data matching for a period of 2 years following enrollment and 1 year prior to enrollment
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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