跳至主要内容
临床试验/NCT07793383
NCT07793383招募中不适用

Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3

Yale University6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
6
主要终点
Proportion of encounters with Buprenorphine initiation in the ED

研究概览

简要总结

This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Refined EMBED CDS

Active Comparator

EMBED CDS refined based on previous results

干预措施: Refined EMBED CDS (Other)

Refined EMBED CDS

Active Comparator

EMBED CDS refined based on previous results

干预措施: Provider alert that nurse completed COWS (Other)

Refined EMBED plus provider alert the nurse completed COWS

Experimental

Alert to provider in Epic that the nurse completed COWS

干预措施: Provider alert that nurse completed COWS (Other)

结局指标

主要结局

Proportion of encounters with Buprenorphine initiation in the ED

时间窗: Trial round start to end up to 3 months

Proportion of eligible encounters with buprenorphine administered in the Emergency Department (ED) and/or prescribed buprenorphine on discharge from the ED. Obtained from EHR data.

次要结局

  • Proportion of eligible encounters with CDS engagement(Trial round start to end up to 3 months)
  • Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally(Trial round start to end up to 3 months)
  • Time spent on EMBED(Trial round start to end up to 3 months)
  • Task Completion: Proportion of encounters with OUD diagnosis was recorded(Trial round start to end up to 3 months)
  • Task completion: Buprenorphine order or prescription placed(Trial round start to end up to 3 months)

研究者

发起方
Yale University
申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验

Adaptive Decision Support for Addiction Treatment... | 临床试验