RECRUITING

ED Observation for Opioid Use Disorder

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation

Quick Facts

Study Start:2022-04-21

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05064826

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Ryan McCormack, MD

CONTACT

212-263-2863

Ryan.McCormack@nyulangone.org

Soo-Min Shin

CONTACT

646-501-4038

Soo-Min.Shin@nyulangone.org

Principal Investigator

Ryan McCormack, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

Rutgers University-University Hospital

Newark, New Jersey, 07103

United States

NYULH-Brooklyn

Brooklyn, New York, 11220

United States

Northwell Health - Long Island Jewish Medical Center

New Hyde Park, New York, 11040

United States

Bellevue

New York, New York, 10016

United States

NYULH-Tisch

New York, New York, 10016

United States

Northwell Health - Staten Island University Hospital

Staten Island, New York, 10305

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Ryan McCormack, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-21

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2022-04-21

Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

Opiod Use Disorder