ED Observation for Opioid Use Disorder

Recruiting at 5 trial locations

Overseen By Soo-Min Shin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Severe medical, psychiatric, substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 1 day

230 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

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

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

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?

Group I: Extended visit with Observation Experimental Treatment 1 Intervention

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.

Group II: Standard visit Active Control 1 Intervention

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

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

Approved in United States as ED Observation for:

• Opioid Use Disorder (OUD)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care of Acute Gastrointestinal Conditions in the Observation Unit. Ham, JJ., Ordonez, E., Wilkerson, RG.[2017]

ED observation units (EDOUs) are effective for managing patients who need further diagnostics or treatment after their initial emergency department visit, ensuring appropriate care before deciding on hospital admission.

The article highlights specific conditions, such as abnormal uterine bleeding and acetaminophen overdose, that may benefit from EDOU care even if they don't fit standard treatment protocols, suggesting flexibility in patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional Conditions Amenable to Observation Care. Wheatley, MA.[2017]

Emergency departments are increasingly using extended care observation units (EDOUs) to provide better monitoring and care for older adults, serving as a safer alternative to hospitalization.

EDOUs allow for therapeutic interventions and reassessment of older patients whose need for immediate outpatient care is uncertain, helping to ensure appropriate treatment and risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department observation units and the older patient. Moseley, MG., Hawley, MP., Caterino, JM.[2021]

The Emergency Department Extended Care Unit (EDECU) at The Children's Hospital of Philadelphia has effectively reduced hospital admissions and improved patient satisfaction by allowing for extended observation periods of 4 to 23 hours.

Incorporating nurse practitioners (NPs) into the EDECU team has enhanced patient care efficiency and satisfaction, demonstrating a successful model for optimizing resource allocation in pediatric emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observation medicine: the expanded role of the nurse practitioner in a pediatric emergency department extended care unit. Silvestri, A., McDaniel-Yakscoe, N., O'Neill, K., et al.[2005]

In 2007-2008, 34.1% of emergency departments (EDs) in the US had dedicated observation units (OUs), with a significant increase in observation care usage from 642,000 visits in 2001 to 2,318,000 visits in 2008, indicating a growing reliance on this care model.

Chest pain was the most common reason for patients being placed in observation, highlighting the need for effective management of this condition in emergency settings, and hospitals with longer ED visits and non-profit or government ownership were more likely to have OUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of observation care in US emergency departments, 2001 to 2008. Venkatesh, AK., Geisler, BP., Gibson Chambers, JJ., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of hospital admission after ED observation unit care. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

The role of the emergency department observational unit. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Care of Acute Gastrointestinal Conditions in the Observation Unit. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Additional Conditions Amenable to Observation Care. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Emergency department observation units and the older patient. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Observation medicine: the expanded role of the nurse practitioner in a pediatric emergency department extended care unit. [2005]

7. United States pubmed.ncbi.nlm.nih.gov

Use of observation care in US emergency departments, 2001 to 2008. [2022]