Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3
研究概览
详细说明
This study is stage 3, 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 investigators 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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Edward Melnick, MD, MHS
- 电话号码:203-785-4363
- 邮箱:edward.melnick@yale.edu
研究联系人备份
- 姓名:Laurel Buchanan, MA
- 电话号码:203-785-4363
- 邮箱:laurel.buchanan@yale.edu
学习地点
-
-
Connecticut
-
Guilford、Connecticut、美国、06437
- Yale New Haven Shoreline Medical Center
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New Haven、Connecticut、美国、06520
- Yale New Haven Hospital
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New Haven、Connecticut、美国、06510
- Yale New Haven Hospital- St. Raphael
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
Provider alert that nurse completed COWS
|
|
实验性的:Refined EMBED plus provider alert the nurse completed COWS
Alert to provider in Epic that the nurse completed COWS
|
Provider alert that nurse completed COWS
|
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 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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
|
|
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
|
|
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
|
|
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally
大体时间:Trial round start to end up to 3 months
|
Proportion of eligible encounters in which buprenorphine order is placed through EMBED (i.e., using EMBED order set).
|
Trial round start to end up to 3 months
|
合作者和调查者
调查人员
- 首席研究员:Edward Mel, MD, MHS、Yale University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2000038624-B3
- 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)?
IPD 计划说明
IPD 共享时间框架
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
研究美国 FDA 监管的设备产品
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