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ED Observation for Opioid Use Disorder

Primary Purpose

Opiod Use Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Observation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiod Use Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers University-University HospitalRecruiting
  • NYULH-Brooklyn
  • Northwell Health - Long Island Jewish Medical CenterRecruiting
  • BellevueRecruiting
  • NYULH-Tisch
  • Northwell Health - Staten Island University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard visit

Extended visit with Observation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Proportion of participants who tested positive for illicit opioids/substances
Number of overdose events and risk behaviors
Number of overdose events and risk behaviors
Number of overdose events and risk behaviors
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.
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.
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.
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)
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)
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)
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
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
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
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.
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.
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.
Proportion of participants who reported treatment satisfaction
Proportion of participants who reported treatment satisfaction
Proportion of participants who reported treatment satisfaction
Proportion of participants who reported changes in social determinants of health
Proportion of participants who reported changes in social determinants of health
Proportion of participants who reported changes in social determinants of health

Full Information

First Posted
September 14, 2021
Last Updated
July 10, 2023
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05064826
Brief Title
ED Observation for Opioid Use Disorder
Official Title
Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiod Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard visit
Arm Type
No Intervention
Arm Description
Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.
Arm Title
Extended visit with Observation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Proportion of participants initiated on BUP in ED directly via administration or prescription
Description
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.
Time Frame
Day 1 visit
Title
Proportion of participants initiated on BUP in ED directly via administration or prescription
Description
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.
Time Frame
Day 30 visit
Title
Proportion of participants initiated on BUP in ED directly via administration or prescription
Description
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.
Time Frame
Day 90 visit
Title
Proportion of participants initiated on BUP in ED directly via administration or prescription or indirectly via expedited referral
Description
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.
Time Frame
Day 1 visit
Title
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
Description
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.
Time Frame
Day 1 visit
Title
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
Description
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.
Time Frame
Day 30 visit
Title
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
Description
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.
Time Frame
Day 90 Visit
Title
Proportion of participants confirmed to be engaged in formal addiction treatment at 30 days
Description
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.
Time Frame
Day 30 visit
Secondary Outcome Measure Information:
Title
Days of opioid and other drug use
Description
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.
Time Frame
Day 1 visit
Title
Days of opioid and other drug use
Description
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.
Time Frame
Day 30 visit
Title
Proportion of participants who tested positive for illicit opioids/substances
Time Frame
Day 90 visit
Title
Number of overdose events and risk behaviors
Time Frame
Day 1 visit
Title
Number of overdose events and risk behaviors
Time Frame
Day 30 visit
Title
Number of overdose events and risk behaviors
Time Frame
Day 90 visit
Title
Score on EuroQol-5 Dimensions (EQ-5D) Scale
Description
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.
Time Frame
Day 1 visit
Title
Score on EuroQol-5 Dimensions (EQ-5D) cale
Description
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.
Time Frame
Day 30 visit
Title
Score on EuroQol-5 Dimensions (EQ-5D) Scale
Description
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.
Time Frame
Day 90 visit
Title
Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Description
Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
Day 1 visit
Title
Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Description
Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
Day 30 visit
Title
Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
Description
Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
Day 90 visit
Title
Score on Patient Health Questionnaire (PHQ)-9 Scale
Description
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
Time Frame
Day 1 visit
Title
Score on Patient Health Questionnaire (PHQ)-9 Scale
Description
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
Time Frame
Day 30 visit
Title
Score on Patient Health Questionnaire (PHQ)-9 Scale
Description
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
Time Frame
Day 90 visit
Title
Score on Treatment Effectiveness Assessment (TEA) Scale
Description
Treatment Effectiveness Assessment (TEA): This form will be completed at the baseline and the Day 30 and Day 90 follow-up visits.
Time Frame
Day 1 visit
Title
Score on Treatment Effectiveness Assessment (TEA) Scale
Description
Treatment Effectiveness Assessment (TEA): This form will be completed at the baseline and the Day 30 and Day 90 follow-up visits.
Time Frame
Day 30 visit
Title
Score on Treatment Effectiveness Assessment (TEA) Scale
Description
Treatment Effectiveness Assessment (TEA): This form will be completed at the baseline and the Day 30 and Day 90 follow-up visits.
Time Frame
Day 90 visit
Title
Proportion of participants who reported treatment satisfaction
Time Frame
Day 1 visit
Title
Proportion of participants who reported treatment satisfaction
Time Frame
Day 30 visit
Title
Proportion of participants who reported treatment satisfaction
Time Frame
Day 90 visit
Title
Proportion of participants who reported changes in social determinants of health
Time Frame
Day 1 visit
Title
Proportion of participants who reported changes in social determinants of health
Time Frame
Day 30 visit
Title
Proportion of participants who reported changes in social determinants of health
Time Frame
Day 90 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan McCormack, MD
Phone
212-263-2863
Email
Ryan.McCormack@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Soo-Min Shin
Phone
646-501-4038
Email
Soo-Min.Shin@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan McCormack, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University-University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Brown
Phone
973-404-0785
First Name & Middle Initial & Last Name & Degree
Lewis Nelson, MD
First Name & Middle Initial & Last Name & Degree
Cynthia Santos, MD
Facility Name
NYULH-Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Min Shin
Phone
646-501-4038
Email
soo-min.shin@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ryan McCormack, MD
Facility Name
Northwell Health - Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Harrison
Phone
347-684-1166
Email
Lharrison1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Kapoor, MD
Facility Name
Bellevue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Min Shin
Phone
646-501-4038
Email
soo-min.shin@nyulangone.org
Phone
646-501-4038
First Name & Middle Initial & Last Name & Degree
Ryan McCormack, MD
Facility Name
NYULH-Tisch
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Min Shin
Phone
646-501-4038
Email
soo-min.shin@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ryan McCormack, MD
Facility Name
Northwell Health - Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Harrison
Phone
347-684-1166
Email
Lharrison1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Nicole Berman, MD
First Name & Middle Initial & Last Name & Degree
Nirma Majlesi, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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ED Observation for Opioid Use Disorder

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