ED Observation for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen ByRyan McCormack, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: NYU Langone Health
Disqualifiers: Severe medical, psychiatric, substance use, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345How 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.
14567Eligibility Criteria
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
Is able to speak English sufficiently to understand study procedures
Presents to the ED during study screening hours
I am considered a candidate for starting medication treatment for opioid use in the emergency department.
+4 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
+3 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Extended visit with ObservationExperimental Treatment1 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 visitActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell Health - Staten Island University HospitalStaten Island, NY
Rutgers University-University HospitalNewark, NJ
NYULH-BrooklynBrooklyn, NY
NYULH-TischNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Predictors of hospital admission after ED observation unit care. [2014]Emergency department observation units (EDOUs) represent an opportunity to efficiently manage patients with common conditions requiring short-term hospital care. Understanding which patients are ultimately admitted to the hospital after care in an EDOU may enhance patient selection for EDOU care.
The role of the emergency department observational unit. [2019]ED-based observation units are becoming increasingly used for the assessment and treatment of patients who may not require inpatient management or monitoring. Although not a substitute for an inpatient unit, the ED-based observation unit can be of great value in the more efficient management of certain groups of patients. The continued patient management in the ED observational unit offers the opportunity for a better definition of the patient's problem. ED-based observation units have the potential to increase patient satisfaction, reduce length of stay, reduce inappropriate admissions, improve efficiency of the ED, and improve cost effectiveness.
Care of Acute Gastrointestinal Conditions in the Observation Unit. [2017]The Emergency Department Observation Unit (EDOU) provides a viable alternative to inpatient admission for the management of many acute gastrointestinal conditions with additional opportunities of reducing resource utilization and reducing radiation exposure. Using available evidence-based criteria to determine appropriate patient selection, evaluation, and treatment provides higher-quality medical care and improved patient satisfaction. Discussions of factors involved in creating an EDOU capable of caring for acute gastrointestinal conditions and clinical protocol examples of acute appendicitis, gastrointestinal hemorrhage, and acute pancreatitis provide a framework from which a successful EDOU can be built.
Additional Conditions Amenable to Observation Care. [2017]ED observation units (EDOUs) are designed for patients who require diagnostics or therapeutics beyond the initial ED visit to determine the need for hospital admission. Best evidence is that this care be delivered via ordersets or protocols. Occasionally, patients present with conditions that are amenable to EDOU care but fall outside the commonly used protocols. This article details a few of these conditions: abnormal uterine bleeding, allergic reaction, alcohol intoxication, acetaminophen overdose and sickle cell vaso-occlusive crisis. It is not meant to be exhaustive as patient care needs can vary hospital to hospital.
Emergency department observation units and the older patient. [2021]An increasing number of emergency departments (EDs) are providing extended care and monitoring of patients in ED observation units (EDOUs). EDOUs can be useful for older adults as an alternative to hospitalization and as a means of risk stratification for older adults with unclear presentations. They can also provide a period of therapeutic intervention and reassessment for older patients in whom the appropriateness and safety of immediate outpatient care are unclear. This article discusses the general characteristics of EDOUs, reviews appropriate entry and exclusion criteria for older adults in EDOUs, and discusses regulatory implications of observation status for patients with Medicare.
Observation medicine: the expanded role of the nurse practitioner in a pediatric emergency department extended care unit. [2005]The use of observational units (OUs) in pediatric emergency departments (EDs) has become an important adjunct to emergency care. An extended observation period (4 to 23 hours) in the ED has decreased both the number of admissions and prolonged use of acute ED beds. This serves to increase patient satisfaction as well as optimizing care. The use of OUs allows for the most appropriate allocation of resources. These units are typically located within the ED or immediately adjacent to it. The ED physicians are the gatekeepers of the unit and serve as the medical supervision for these patients. The Children's Hospital of Philadelphia developed an OU known in the hospital as the Emergency Department Extended Care Unit (EDECU) approximately 5 years ago. In order for the EDECU to function at its fullest potential, the ED at The Children's Hospital of Philadelphia has opted to use the ED nurse practitioners (NPs) to enhance the care for these patients.
Use of observation care in US emergency departments, 2001 to 2008. [2022]Observation care is a core component of emergency care delivery, yet, the prevalence of emergency department (ED) observation units (OUs) and use of observation care after ED visits is unknown. Our objective was to describe the 1) prevalence of OUs in United States (US) hospitals, 2) clinical conditions most frequently evaluated with observation, and 3) patient and hospital characteristics associated with use of observation.