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阿片类药物使用障碍的 ED 观察

2026年10月30日 更新者:NYU Langone Health

使用观察测量急诊科发起的阿片类药物使用障碍治疗质量的改善

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).

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

170

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • Newark、New Jersey、美国、07103
        • Rutgers University-University Hospital
    • New York
      • Brooklyn、New York、美国、11220
        • NYULH-Brooklyn
      • New Hyde Park、New York、美国、11040
        • Northwell Health - Long Island Jewish Medical Center
      • New York、New York、美国、10016
        • Bellevue
      • New York、New York、美国、10016
        • NYULH-Tisch
      • Staten Island、New York、美国、10305
        • Northwell Health - Staten Island University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Standard visit

Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.

Standard visit

实验性的:Extended visit with Observation

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.

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)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants who receive Emergency Department (ED)-initiated Buprenorphine (BUP)
大体时间: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.

Week 1 (~7-10 days)
Proportion of participants who receive ED-initiated or ED-expedited BUP
大体时间: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.

Week 1 (~7-10 days)
Proportion of participants who receive ED-initiated or ED-expedited Medications for Opioid Use Disorder (MOUD)
大体时间:Week 1 (~7-10 days)

Receipt of ED-initiated MOUD, inclusive of BUP, methadone, or naltrexone.

Week 1 (~7-10 days)
The proportion of participants who are successfully linked to formal addiction treatment within one week following the completion of their index ED/EDOU visit
大体时间: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).

Week 1 (~7-10 days)
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
大体时间: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.

Day 30

次要结果测量

结果测量
措施说明
大体时间
检测出非法阿片类药物/物质呈阳性的参与者比例变化
大体时间:基线,第30天
基线,第30天
对非法阿片类药物/物质检测呈阳性的参与者比例变化
大体时间:第30天,第90天
第30天,第90天
过量事件和风险行为数量的变化
大体时间:基线,第30天
基线,第30天
过量事件和风险行为数量的变化
大体时间:第30天,第90天
第30天,第90天
报告治疗满意度的参与者比例变化
大体时间:基线,第30天
基线,第30天
报告治疗满意度的参与者比例变化
大体时间:第30天,第90天
第30天,第90天
Change in number of days of opioid and other drug use
大体时间: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.

Baseline, Day 30
Change in number of days of opioid and other drug use
大体时间: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.

Day 30, Day 90
Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
大体时间: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).

Baseline, Day 30
Change in score on EuroQol-5 Dimensions (EQ-5D) Scale
大体时间: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).

Day 30, Day 90
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
大体时间: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.

Baseline, Day 30
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS-29) Scale
大体时间: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.

Day 30, Day 90
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
大体时间: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.

Baseline, Day 30
Change in score on Patient Health Questionnaire (PHQ)-9 Scale
大体时间: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.

Day 30, Day 90
Change in score on Treatment Effectiveness Assessment (TEA) Scale
大体时间: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.

Baseline, Day 30
Change in score on Treatment Effectiveness Assessment (TEA) Scale
大体时间: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.

Day 30, Day 90
Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
大体时间:Baseline, Day 30

Self reported by participants.

Baseline, Day 30
Change in proportion of participants who reported changes in social determinants of health (e.g., homelessness, employment)
大体时间:Day 30, Day 90

Self reported by participants.

Day 30, Day 90

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ryan McCormack, MD、NYU Langone Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年4月21日

初级完成 (实际的)

2025年6月1日

研究完成 (实际的)

2026年7月31日

研究注册日期

首次提交

2021年9月14日

首先提交符合 QC 标准的

2021年9月23日

首次发布 (实际的)

2021年10月1日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20-01951
  • 5R33DA049265-03 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD 共享时间框架

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD 共享访问标准

The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to ryan.mccormack@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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