NCT Number: NCT05064826
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).
This study is active but is not currently recruiting participants.
18 year–100 year
All sexes
Interventional
Not applicable
Rutgers University-University Hospital, Newark, New Jersey, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Week 1 (~7-10 days)
Receipt of ED-initiated BUP will be operationally defined to include administration of BUP and/or prescription for BUP as part of the ED/Emergency Department Observation (Units) (EDOU) visit. This measure will be abstracted from the health record primarily.
Time frame: Week 1 (~7-10 days)
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. Eligible transition of care will be will described further in the Manual of Operations (MOP) and will include direct transport or handoff to an outpatient provider immediately from the ED, provision of an appointment within 24 hours (with a specific time and location), transfer to general inpatient or inpatient OUD/addiction treatment. Neither confirmation of a completed appointment (i.e., patient shows up and is seen) nor receipt of BUP at the dedicated follow-up appointment will be required as the patient and treating provider may elect to treat with alternative regimes (e.g., methadone, naltrexone). This measure will be abstracted from the health record primarily.
Time frame: Week 1 (~7-10 days)
Receipt of ED-initiated MOUD, inclusive of BUP, methadone, or naltrexone.
Time frame: Week 1 (~7-10 days)
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. Formal addiction treatment will be those treatments consistent with the American Society of Addiction Medicine's (ASAM) level of care (1-4) and will include a range of clinical settings, including office-based providers of BUP or naltrexone, Opioid Treatment Programs (OTPs), intensive outpatient, inpatient, or residential treatments. Means of confirmation will include direct contact with the facility and/or treating clinician or other objective means (e.g., medical record review).
Time frame: Day 30
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. Attendance at two or more visits for formal addiction treatment within the 30-day period also constitutes engagement.
Time frame: Baseline, Day 30
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, Day 90
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: Baseline, Day 30
Time frame: Day 30, Day 90
Time frame: Baseline, Day 30
Time frame: Day 30, Day 90
Time frame: Baseline, Day 30
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 between 0 (dead) and 1 (full health).
Time frame: Day 30, Day 90
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 between 0 (dead) and 1 (full health).
Time frame: Baseline, Day 30
Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms.
Time frame: Day 30, Day 90
Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms.
Time frame: Baseline, Day 30
The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Scores are interpreted as follows: Minimal Depression: 0-4, Mild depression: 5-9, Moderate depression: 10-14, Moderately severe depression: 15-19, Severe depression: 20-27.
Time frame: Day 30, Day 90
The PHQ-9 is a 9-item instrument used for screening, diagnosing, monitoring and measuring the severity of depression. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Scores are interpreted as follows: Minimal Depression: 0-4, Mild depression: 5-9, Moderate depression: 10-14, Moderately severe depression: 15-19, Severe depression: 20-27.
Time frame: Baseline, Day 30
Treatment Effectiveness Assessment (TEA) scale is comprised of 4 questions about substance use, health, lifestyle, and community. Participants respond the questions on how they have improved in that area on a scale from 1 (not better at all) to 10 (very much better). Higher scores indicate overall improvement and effectiveness of treatment.
Time frame: Day 30, Day 90
Treatment Effectiveness Assessment (TEA) scale is comprised of 4 questions about substance use, health, lifestyle, and community. Participants respond the questions on how they have improved in that area on a scale from 1 (not better at all) to 10 (very much better). Higher scores indicate overall improvement and effectiveness of treatment.
Time frame: Baseline, Day 30
Time frame: Day 30, Day 90
Time frame: Baseline, Day 30
Self reported by participants.
Time frame: Day 30, Day 90
Self reported by participants.
NYU Langone Health
Other
Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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