ED Observation for Opioid Use Disorder

Opiod Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064826
• Other study ID #: 20-01951
• Secondary ID: 19-A0-00-1002485
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 21, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Ryan McCormack, MD
• Phone: 212-263-2863
• Email: Ryan.McCormack[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opiod Use Disorder
• Opioid-Related Disorders

Intervention

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)

Locations

Country	Name	City	State
United States	NYULH-Brooklyn	Brooklyn	New York
United States	Northwell Health - Long Island Jewish Medical Center	New Hyde Park	New York
United States	Bellevue	New York	New York
United States	NYULH-Tisch	New York	New York
United States	Rutgers University-University Hospital	Newark	New Jersey
United States	Northwell Health - Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Proportion of participants who tested positive for illicit opioids/substances		Day 90 visit
Secondary	Number of overdose events and risk behaviors		Day 1 visit
Secondary	Number of overdose events and risk behaviors		Day 30 visit
Secondary	Number of overdose events and risk behaviors		Day 90 visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of participants who reported treatment satisfaction		Day 1 visit
Secondary	Proportion of participants who reported treatment satisfaction		Day 30 visit
Secondary	Proportion of participants who reported treatment satisfaction		Day 90 visit
Secondary	Proportion of participants who reported changes in social determinants of health		Day 1 visit
Secondary	Proportion of participants who reported changes in social determinants of health		Day 30 visit
Secondary	Proportion of participants who reported changes in social determinants of health		Day 90 visit