230 Participants Needed

ED Observation for Opioid Use Disorder

Recruiting at 5 trial locations
RM
SS
Overseen BySoo-Min Shin
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on people not already receiving formal addiction treatment or pain management, so it's best to discuss your specific situation with the trial staff.

How is the ED Observation treatment for opioid use disorder different from other treatments?

ED Observation treatment is unique because it involves short-term care in a specialized unit within the emergency department, allowing for extended monitoring and assessment without immediate hospital admission. This approach can help determine the need for further treatment and optimize resource use, unlike traditional inpatient or outpatient care.12345

What data supports the effectiveness of the treatment ED Observation for Opioid Use Disorder?

ED Observation Units (EDOUs) have been shown to efficiently manage patients with various conditions by providing short-term care, which can improve patient satisfaction, reduce hospital stays, and lower costs. While not specific to opioid use disorder, these benefits suggest that EDOUs could be effective in managing this condition by offering timely assessment and treatment.12367

Who Is on the Research Team?

RM

Ryan McCormack, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who visit the ED with untreated Opioid Use Disorder (OUD), can speak English, and are not currently in formal addiction treatment. They must be willing to receive standard or extended care based on random assignment and have a history of non-medical opioid use.

Inclusion Criteria

Presents to the ED during study screening hours
I am considered a candidate for starting medication treatment for opioid use in the emergency department.
Is not receiving MOUD through ongoing formal addiction treatment or pain management at the time of index ED visit
See 2 more

Exclusion Criteria

Presents from a medical-based extended care facility (e.g., skilled nursing facility)
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
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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard or extended Emergency Department visits for management of OUD with MOUD

1 day
1 visit (in-person)

Follow-up

Participants are monitored for engagement in formal addiction treatment and health-related quality of life

90 days
Day 30 and Day 90 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ED Observation
Trial Overview The study compares two approaches for managing patients with OUD in the emergency department: standard care versus an extended visit through observation. Participants will be randomly placed into one of these two groups at several New York hospitals.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Extended visit with ObservationExperimental Treatment1 Intervention
Group II: Standard visitActive Control1 Intervention

ED Observation is already approved in United States for the following indications:

🇺🇸
Approved in United States as ED Observation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Published Research Related to This Trial

In a study analyzing 4.65 million emergency department visits to observation units in the U.S. from 2009 to 2010, 40.4% of patients were admitted to the hospital after receiving care in these units.
Older age was identified as a significant predictor of hospital admission, with patients over 65 being more than five times more likely to be admitted compared to those under 18, indicating that age is an important factor in determining the need for inpatient care after EDOU treatment.
Predictors of hospital admission after ED observation unit care.Napoli, AM., Mullins, PM., Pines, JM.[2014]
ED-based observation units can effectively manage patients who do not need full inpatient care, leading to better patient assessment and treatment.
These units can enhance patient satisfaction, decrease hospital stays, reduce unnecessary admissions, and improve overall efficiency and cost-effectiveness in emergency departments.
The role of the emergency department observational unit.Dick, R.[2019]
The Emergency Department Observation Unit (EDOU) is an effective alternative to inpatient admission for managing acute gastrointestinal conditions, which can lead to reduced resource use and lower radiation exposure.
Implementing evidence-based criteria for patient selection and treatment in the EDOU enhances the quality of care and patient satisfaction, with specific protocols for conditions like appendicitis and pancreatitis serving as useful frameworks.
Care of Acute Gastrointestinal Conditions in the Observation Unit.Ham, JJ., Ordonez, E., Wilkerson, RG.[2017]

Citations

Predictors of hospital admission after ED observation unit care. [2014]
The role of the emergency department observational unit. [2019]
Care of Acute Gastrointestinal Conditions in the Observation Unit. [2017]
Additional Conditions Amenable to Observation Care. [2017]
Emergency department observation units and the older patient. [2021]
Observation medicine: the expanded role of the nurse practitioner in a pediatric emergency department extended care unit. [2005]
Use of observation care in US emergency departments, 2001 to 2008. [2022]
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