ED Observation for Opioid Use Disorder

NYU Langone Health

Status: Enrolling

Conditions: Opiod Use Disorder

Treatments: Other: Observation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05064826

20-01951

19-A0-00-1002485 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Standard visit

No Intervention group

Description:

Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.

Extended visit with Observation

Experimental group

Description:

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.

Treatment:

Other: Observation