ED Observation for Opioid Use Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opiod Use Disorder

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard visit<br>Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours. | |
| Experimental: Extended visit with Observation<br>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<br>* 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)<br>|

What is the study measuring?
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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 |