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Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 2

2026年8月25日 更新者:Yale University
This study is stage 2, round 2 of a larger study which refines and optimizes the EMBED clinical decision support (CDS); see NCT03658642 to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder.

研究概览

详细说明

This study is stage 2, rapid response testing (RRT), of the optimization phase of a larger study which refines and optimizes the EMBED* clinical decision support (CDS); see NCT03658642 to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. Investigators will use a Multiphase Optimization Strategy (MOST) framework with preparation, optimization, and confirmatory phases.

In stage 2, optimization phase, investigators will conduct serial rapid-cycle randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures with the goal of improving CDS usability.

Five rounds of A-B testing are expected. The more successful condition will be tested in the subsequent round against a novel test condition. In this second round we will randomize an alert to providers to order a consult with addiction counselors. Future rounds will be planned, with arms and interventions added, as the project progresses in order to build on insights gained in each round.

Phase 3, the evaluation phase will consist of a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial.

*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community

This study does not have open enrollment.

研究类型

介入性

注册 (实际的)

379

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

    • Connecticut
      • Guilford、Connecticut、美国、06437
        • Yale New Haven Shoreline Medical Center
      • New Haven、Connecticut、美国、06510
        • Yale New Haven Hospital
      • New Haven、Connecticut、美国、06510
        • Yale New Haven Hospital- St. Raphael

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Emergency department patient
  • 18 years of age or older
  • Moderate to severe opioid use disorder

Exclusion Criteria:

  • Under 18 years of age
  • Pregnant
  • Currently receiving medication for opioid use disorder

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:顺序分配
  • 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:精炼的EMBED CDS
基于先前结果优化的嵌入式CDS
精炼式EMBED CDS
实验性的:Refined EMBED plus provider alert in Epic to order a consult with an addiction counselor
Provider alert in Epic to order a consult with an addiction counselor to assess for eligibility and initiation of MOUD
精炼式EMBED CDS
Provider alert to order consult with addiction counselor

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 encounters with an order for an addiction counselor consult
大体时间:Trial round start to end up to 3 months
Proportion of encounters with documentation of a clinician order for an addiction counselor consult specifically to assess for eligibility and initiation of MOUD.
Trial round start to end up to 3 months

次要结果测量

结果测量
措施说明
大体时间
COWS完成的遭遇比例
大体时间:试验轮次开始到结束最长3个月
合格就诊中由任何团队成员通过任何工作流程(EMBED内部和外部)完成的COWS比例。 来自EHR数据。
试验轮次开始到结束最长3个月
Proportion of encounters with Buprenorphine initiation in the ED
大体时间:试验疗程开始至结束最长3个月
在急诊科(ED)中给予丁丙诺啡和/或出院时开具丁丙诺啡的符合条件就诊比例。 从EHR数据获取。
试验疗程开始至结束最长3个月
具有CDS参与资格的遭遇比例
大体时间:试验周期开始至结束最多3个月
合格就诊中记录或完成任何部分 EMBED 工作流程的比例。
试验周期开始至结束最多3个月
通过EMBED系统与外部系统订购丁丙诺啡的遭遇事件比例
大体时间:试验轮次开始到结束最多3个月
使用EMBED(即通过EMBED医嘱集)下达丁丙诺啡医嘱的合格就诊比例
试验轮次开始到结束最多3个月
在EMBED上花费的时间
大体时间:试验周期开始到结束最长3个月
总体及按组成部分在 EMBED 上所花费的时间(秒)。
试验周期开始到结束最长3个月
Teamwork on ED initiation of buprenorphine
大体时间:Trial round start to end up to 3 months
Proportion of encounters with multi-team-member use of EMBED for buprenorphine initiation, out of encounters with any team member use of EMBED for buprenorphine initiation
Trial round start to end up to 3 months
Task Completion: Proportion of Encounters with COWS Score Entered
大体时间:Trial round start to end up to 3 months
Proportion of encounters where EMBED was opened in which a COWS score was entered.
Trial round start to end up to 3 months
Task completion: Buprenorphine order or prescription placed
大体时间:Trial round start to end up to 3 months
Proportion of encounters where EMBED was opened in which a buprenorphine order or prescription was placed.
Trial round start to end up to 3 months
Task Completion: Proportion of encounters with OUD diagnosis was recorded
大体时间:Trial round start to end up to 3 months
Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.
Trial round start to end up to 3 months

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:Edward Edward, MD, MHS、Yale University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2026年5月26日

初级完成 (实际的)

2026年7月13日

研究完成 (实际的)

2026年7月13日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2000038624-B2
  • 5R33DA059884-02 (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

De-identified data related to EHR use measurements in various levels of aggregation. e.g., time spent on the CDS or threshold outcomes such as dismissal of the CDS without action under a specific amount of time or the time spent on CDS that exceeds what was expected based on the patient's clinical opioid withdrawal (COWS) score, time in the ED, or level of acuity, patient acuity, chief complaints or diagnoses, clinician, interruptions (such as orders started but not finished), task switching, seasonality, and variation in shift timing (such as nights and weekends). Data shared will include variables relating to patient demographics, medical history, prescription information, clinician facing clinical decision support (CDS) firing and clinician action information, and clinician prescribing decisions and historical prescribing.

IPD 共享时间框架

De-identified data will be shared with NAHDAP as soon as possible upon completion of quality control procedures, analysis, and at the time of associated publication or end of performance period. Data will be released by NAHDAP at the time of receipt and will be available indefinitely.

IPD 共享访问标准

De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified.

Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

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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