Measuring Improvement in the Quality of Emergency Department-initiated Treatment for Opioid Use Disorders Using Observation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 12
- 主要终点
- Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP)
时间窗: 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.
Proportion of participants who receive ED-initiated or ED-expedited BUP
时间窗: 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.
Proportion of participants who receive ED-initiated or ED-expedited Medications for Opioid Use Disorder (MOUD)
时间窗: Week 1 (~7-10 days)
Receipt of ED-initiated MOUD, inclusive of BUP, methadone, or naltrexone.
The proportion of participants who are successfully linked to formal addiction treatment within one week following the completion of their index ED/EDOU visit
时间窗: 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).
The proportion of participants who are confirmed to be engaged in formal addiction treatment for OUD on the 30th day following the completion of their index ED/EDOU visit
时间窗: 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.
次要结局
- Change in proportion of participants who tested positive for illicit opioids/substances(Day 30, Day 90)
- Change in score on EuroQol-5 Dimensions (EQ-5D) Scale(Day 30, Day 90)
- Change in number of days of opioid and other drug use(Day 30, Day 90)
- Change in proportion of participants who reported treatment satisfaction(Day 30, Day 90)
- Change in number of overdose events and risk behaviors(Day 30, Day 90)
- Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale(Day 30, Day 90)
- Change in score on Patient Health Questionnaire (PHQ)-9 Scale(Day 30, Day 90)
- Change in score on Treatment Effectiveness Assessment (TEA) Scale(Day 30, Day 90)
- Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)(Day 30, Day 90)