Clinical trial NCT05064826: 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
Overall status: RECRUITING
Phase: NA
Conditions: Opiod Use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-10-01
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of participants initiated on BUP in ED directly via administration or prescription
timeFrame: Day 1 visit
measure: Proportion of participants initiated on BUP in ED directly via administration or prescription
timeFrame: Day 30 visit
measure: Proportion of participants initiated on BUP in ED directly via administration or prescription
timeFrame: Day 90 visit
measure: Proportion of participants initiated on BUP in ED directly via administration or prescription or indirectly via expedited referral
timeFrame: Day 1 visit
measure: Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
timeFrame: Day 1 visit
measure: Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
timeFrame: Day 30 visit
measure: Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
timeFrame: Day 90 Visit
measure: Proportion of participants confirmed to be engaged in formal addiction treatment at 30 days
timeFrame: Day 30 visit
Secondary outcomes:
measure: Days of opioid and other drug use
timeFrame: Day 1 visit
measure: Days of opioid and other drug use
timeFrame: Day 30 visit
measure: Proportion of participants who tested positive for illicit opioids/substances
timeFrame: Day 90 visit
measure: Number of overdose events and risk behaviors
timeFrame: Day 1 visit
measure: Number of overdose events and risk behaviors
timeFrame: Day 30 visit
measure: Number of overdose events and risk behaviors
timeFrame: Day 90 visit
measure: Score on EuroQol-5 Dimensions (EQ-5D) Scale
timeFrame: Day 1 visit
measure: Score on EuroQol-5 Dimensions (EQ-5D) cale
timeFrame: Day 30 visit
measure: Score on EuroQol-5 Dimensions (EQ-5D) Scale
timeFrame: Day 90 visit
measure: Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
timeFrame: Day 1 visit
measure: Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
timeFrame: Day 30 visit
measure: Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
timeFrame: Day 90 visit
measure: Score on Patient Health Questionnaire (PHQ)-9 Scale
timeFrame: Day 1 visit
measure: Score on Patient Health Questionnaire (PHQ)-9 Scale
timeFrame: Day 30 visit
measure: Score on Patient Health Questionnaire (PHQ)-9 Scale
timeFrame: Day 90 visit
measure: Score on Treatment Effectiveness Assessment (TEA) Scale
timeFrame: Day 1 visit
measure: Score on Treatment Effectiveness Assessment (TEA) Scale
timeFrame: Day 30 visit
measure: Score on Treatment Effectiveness Assessment (TEA) Scale
timeFrame: Day 90 visit
measure: Proportion of participants who reported treatment satisfaction
timeFrame: Day 1 visit
measure: Proportion of participants who reported treatment satisfaction
timeFrame: Day 30 visit
measure: Proportion of participants who reported treatment satisfaction
timeFrame: Day 90 visit
measure: Proportion of participants who reported changes in social determinants of health
timeFrame: Day 1 visit
measure: Proportion of participants who reported changes in social determinants of health
timeFrame: Day 30 visit
measure: Proportion of participants who reported changes in social determinants of health
timeFrame: Day 90 visit
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers University-University Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: NYULH-Brooklyn
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health - Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Bellevue
state: New York
city: New York
country: United States
facility: NYULH-Tisch
state: New York
city: Staten Island
country: United States
facility: Northwell Health - Staten Island University Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ryan McCormack, MD
role: PRINCIPAL_INVESTIGATOR
References: