ED Observation for Opioid Use Disorder

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which approach is more effective for patients with untreated opioid use disorder (OUD) visiting the emergency department: a standard short visit or an extended stay for observation (ED Observation). The extended observation involves staying up to 23 hours, during which additional information about the participant’s health and opioid use is collected. Individuals with a history of non-medical opioid use who are not currently receiving formal addiction treatment might be suitable for this study. The trial takes place at several hospitals, including those within the Northwell Health system. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance emergency care for OUD patients.

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.

What prior data suggests that ED Observation is safe for patients with opioid use disorder?

Research has shown that keeping patients with opioid use disorder (OUD) in the emergency department (ED) for observation can be safe. Studies have examined patient outcomes when they remain in the ED longer for monitoring. These studies suggest that this approach can help ensure patients receive necessary follow-up care.

No specific reports of serious safety issues have emerged with ED observation for OUD patients, indicating it might be well-tolerated. However, it's important to understand that ED observation differs from trying a new medication. It mainly involves staying in the hospital longer for monitoring and support, which usually presents lower risks compared to taking a new drug.

Prospective participants can feel somewhat reassured that ED observation is generally considered safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ED Observation approach for opioid use disorder because it offers a unique method of care in the Emergency Department (ED) setting. Unlike the standard ED visit, which typically lasts 3-5 hours, this approach extends the visit up to 23 hours, allowing more time for observation and assessment. This extended observation period provides a valuable opportunity to gather detailed information on a participant's opioid use, healthcare needs, and overall well-being. Additionally, it enables healthcare providers to collect biological samples like urine or saliva, which can offer deeper insights into the patient's condition and response to treatment. This comprehensive approach could lead to more personalized and effective care strategies for individuals struggling with opioid use disorder.

What evidence suggests that ED Observation is effective for opioid use disorder?

Research has shown that treating opioid use disorder (OUD) in the emergency department observation unit (EDOU) can lead to better health outcomes. In this trial, participants will either have a standard Emergency Department visit or an extended visit with observation in the EDOU. Studies have found that patients with OUD who receive care in an EDOU are more likely to continue treatment and improve their health. For example, starting treatment with buprenorphine, a medication that helps reduce opioid cravings, in the emergency department is both possible and effective for short-term benefits. Another study found that using the EDOU for OUD patients can effectively support their recovery. Overall, these findings suggest that spending more time in the emergency department might help manage OUD better than a standard visit alone. ^{1 3 4 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

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]

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]

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]

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]

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 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]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40112682/

The promising use of an emergency department ...

This study aims to evaluate the outcomes of patients with opioid use disorder (OUD) who were managed in our EDOU. Methods: This was a ...

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annemergmed.com

annemergmed.com/article/S0196-0644(23)00265-2/fulltext

Impact of Universal Screening and Automated Clinical ...

Emergency department (ED)–initiated buprenorphine improves outcomes in patients with opioid use disorder; however, adoption varies widely.

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aspe.hhs.gov

aspe.hhs.gov/sites/default/files/documents/4da0bd61a6c21dafaf58459b1de79718/ed-interventions-oud.pdf

Emergency Department Interventions for Opioid Use Disorder

It showed that initiating buprenorphine in the ED is feasible and effective, resulting in follow-up treatment, at least in the short-term.5 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04523792

Study Details | NCT04523792 | Virginia Opioid Treatment ...

The current study seeks to test the feasibility of an alternative treatment for patients with opioid use disorder who present to the emergency department ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0735675723000992

The impact of an emergency department peer navigator ( ...

This study aims to evaluate the outcomes of patients with opioid use disorder (OUD) who were managed in our EDOU. This was a retrospective study of patients ...

6.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2835884

Disparities in Treatment and Referral After an Opioid ...

These findings suggest that Black patients presenting to the ED with opioid overdose may be less likely to receive outpatient treatment referrals.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6414819/

Computerized Clinical Decision Support System for ...

This study aimed to design and formatively evaluate a user-centered decision support tool for ED initiation of BUP for patients with OUD.