ED Observation for Opioid Use Disorder

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

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).

Study Overview

• Status: Recruiting
• Conditions: Opiod Use Disorder
• Intervention / Treatment: Other: Observation

Detailed Description

In this hybrid implementation-effectiveness study, there is no direct research intervention. Rather, clinical care with well-documented effectiveness will be delivered at the discretion of clinical staff guided by clinical protocols for the management of OUD with MOUD (Medications for Opioid Use Disorder) introduced at each site prior to study enrollment. Enrolled patients will be randomized to ED vs. EDOU and to participate in assessments conducted at the index visit and at 30 days and 90 days. Patient level data will also be matched with Medicaid claims data for more robust analyses and to support the development of clinical quality measures.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ryan McCormack, MD; Phone Number: 212-263-2863; Email: Ryan.McCormack@nyulangone.org
• Study Contact Backup: Name: Soo-Min Shin; Phone Number: 646-501-4038; Email: soo-min.shin@nyulangone.org

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Recruiting
      • Rutgers University-University Hospital
      • Contact: Tiffany Brown; Phone Number: 973-404-0785
      • Principal Investigator: Lewis Nelson, MD
      • Principal Investigator: Cynthia Santos, MD
  • New York
    • Brooklyn, New York, United States, 11220
      • Not yet recruiting
      • NYULH-Brooklyn
      • Principal Investigator: Ryan McCormack, MD
      • Contact: Soo-Min Shin; Phone Number: 646-501-4038; Email: soo-min.shin@nyulangone.org
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Northwell Health - Long Island Jewish Medical Center
      • Contact: Laura Harrison; Phone Number: 347-684-1166; Email: Lharrison1@northwell.edu
      • Principal Investigator: Sandeep Kapoor, MD
    • New York, New York, United States, 10016
      • Recruiting
      • Bellevue
      • Principal Investigator: Ryan McCormack, MD
      • Contact: Soo-Min Shin; Phone Number: 646-501-4038; Email: soo-min.shin@nyulangone.org
      • Contact: Phone Number: 646-501-4038
    • New York, New York, United States, 10016
      • Not yet recruiting
      • NYULH-Tisch
      • Principal Investigator: Ryan McCormack, MD
      • Contact: Soo-Min Shin; Phone Number: 646-501-4038; Email: soo-min.shin@nyulangone.org
    • Staten Island, New York, United States, 10305
      • Recruiting
      • Northwell Health - Staten Island University Hospital
      • Contact: Laura Harrison; Phone Number: 347-684-1166; Email: Lharrison1@northwell.edu
      • Principal Investigator: Nicole Berman, MD
      • Principal Investigator: Nirma Majlesi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard visit; Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.
Experimental: Extended visit with Observation; 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.	Other: Observation; Emergency Department Observation Units (EDOU) would allow the highest risk patients - those presenting for nonfatal overdose - to receive their first dose of BUP before leaving the ED. Operationally defined to include placement in an observation unit and/or placement under observation status with care provided by Emergency Medicine and/or other services (e.g., Internal medicine, Psychiatry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants initiated on BUP in ED directly via administration or prescription	Receipt of ED-initiated BUP will be operationally defined to include administration of BUP and/or prescription for BUP as part of the ED/EDOU visit. This measure will be abstracted from the health record primarily.	Day 1 visit
Proportion of participants initiated on BUP in ED directly via administration or prescription	Receipt of ED-initiated BUP will be operationally defined to include administration of BUP and/or prescription for BUP as part of the ED/EDOU visit. This measure will be abstracted from the health record primarily.	Day 30 visit
Proportion of participants initiated on BUP in ED directly via administration or prescription	Receipt of ED-initiated BUP will be operationally defined to include administration of BUP and/or prescription for BUP as part of the ED/EDOU visit. This measure will be abstracted from the health record primarily.	Day 90 visit
Proportion of participants initiated on BUP in ED directly via administration or prescription or indirectly via expedited referral	Receipt of ED-initiated/expedited BUP will be operationally defined to include the provision of a specific "warm" referral or transfer of care to a provider, clinic, or treatment setting with the capacity to administer and/or prescribe BUP within 24 hours of completion of the ED/EDOU visit.	Day 1 visit
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week	Successful linkage to formal addiction treatment will be defined as confirmed attendance at formal addiction treatment for OUD following completion of the ED/EDOU visit.	Day 1 visit
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week	Successful linkage to formal addiction treatment will be defined as confirmed attendance at formal addiction treatment for OUD following completion of the ED/EDOU visit.	Day 30 visit
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week	Successful linkage to formal addiction treatment will be defined as confirmed attendance at formal addiction treatment for OUD following completion of the ED/EDOU visit.	Day 90 Visit
Proportion of participants confirmed to be engaged in formal addiction treatment at 30 days	Engagement in treatment for OUD will be defined as confirmed enrollment in formal addiction treatment for OUD on the 30th day following completion of the ED/EDOU visit.	Day 30 visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of opioid and other drug use	measured by the Timeline Follow-Back (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances at baseline and throughout study participation.	Day 1 visit
Days of opioid and other drug use	measured by the Timeline Follow-Back (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances at baseline and throughout study participation.	Day 30 visit
Proportion of participants who tested positive for illicit opioids/substances		Day 90 visit
Number of overdose events and risk behaviors		Day 1 visit
Number of overdose events and risk behaviors		Day 30 visit
Number of overdose events and risk behaviors		Day 90 visit
Score on EuroQol-5 Dimensions (EQ-5D) Scale	EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status.	Day 1 visit
Score on EuroQol-5 Dimensions (EQ-5D) cale	EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status.	Day 30 visit
Score on EuroQol-5 Dimensions (EQ-5D) Scale	EuroQol-5 Dimensions (EQ-5D): The EuroQol is a structured interview that collects general health information applicable to a wide range of health conditions and treatment, providing a simple descriptive profile and a single index value for health status.	Day 90 visit
Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale	Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)	Day 1 visit
Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale	Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)	Day 30 visit
Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale	Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)	Day 90 visit
Score on Patient Health Questionnaire (PHQ)-9 Scale	The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. It can be entirely self-administered, and incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms	Day 1 visit
Score on Patient Health Questionnaire (PHQ)-9 Scale	The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. It can be entirely self-administered, and incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms	Day 30 visit
Score on Patient Health Questionnaire (PHQ)-9 Scale	The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. It can be entirely self-administered, and incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms	Day 90 visit
Score on Treatment Effectiveness Assessment (TEA) Scale	Treatment Effectiveness Assessment (TEA): This form will be completed at the baseline and the Day 30 and Day 90 follow-up visits.	Day 1 visit
Score on Treatment Effectiveness Assessment (TEA) Scale	Treatment Effectiveness Assessment (TEA): This form will be completed at the baseline and the Day 30 and Day 90 follow-up visits.	Day 30 visit
Score on Treatment Effectiveness Assessment (TEA) Scale	Treatment Effectiveness Assessment (TEA): This form will be completed at the baseline and the Day 30 and Day 90 follow-up visits.	Day 90 visit
Proportion of participants who reported treatment satisfaction		Day 1 visit
Proportion of participants who reported treatment satisfaction		Day 30 visit
Proportion of participants who reported treatment satisfaction		Day 90 visit
Proportion of participants who reported changes in social determinants of health		Day 1 visit
Proportion of participants who reported changes in social determinants of health		Day 30 visit
Proportion of participants who reported changes in social determinants of health		Day 90 visit

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ryan McCormack, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 20-01951; 19-A0-00-1002485 (Other Grant/Funding Number: nih)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to ryan.mccormack@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No