Adaptive Decision Support for Addiction Treatment (ADAPT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,912
- 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 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.
This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases.
Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial 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 in serial randomized tests.
Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.
*EMBED is a user user-centered, clinician 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
详细描述
Computerized clinical decision support (CDS) is a scalable strategy to standardize evidence-
based practices and respond efficiently to the evolving operational demands of the opioid crisis.
Effective practice change requires CDS tools that are usable (easy to learn, efficient to navigate, support task completion with minimal errors, and provide a satisfactory user experience), well-
integrated into clinical workflows and supported by coordinated implementation strategies. We
will refine and evaluate the uptake, usability, and reach of a nationally disseminated multicomponent CDS intervention to improve treatment initiation during emergency care for individuals with opioid use disorder.
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 —（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
Optimization Phase, Stage1: Factorial Trial
Successful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.
干预措施: EMBED CDS (Other)
Optimization Phase, Stage1: Factorial Trial
Successful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.
干预措施: Nurse prompt to complete COWS (Other)
Optimization Phase, Stage1: Factorial Trial
Successful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.
干预措施: Provider Prompt (Other)
Optimization Phase, Stage1: Factorial Trial
Successful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.
干预措施: Patient facing materials (Other)
Optimization Phase, Stage 2: Rapid serialized testing
Successful completion of Optimization Phase, Stage 2: Improve CDS usability via serial 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 in serial randomized tests.
干预措施: EMBED CDS (Other)
Optimization Phase, Stage 2: Rapid serialized testing
Successful completion of Optimization Phase, Stage 2: Improve CDS usability via serial 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 in serial randomized tests.
干预措施: Name of Intervention (Other)
Evaluation Phase
Successful completion of the Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.
干预措施: EMBED CDS (Other)
Evaluation Phase
Successful completion of the Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.
干预措施: Optimized EMBED (Other)
结局指标
主要结局
Proportion of encounters with Buprenorphine initiation in the ED
时间窗: Upon discharge from the ED, 1 day
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.
Proportion of alerted encounters with CDS engagement
时间窗: From ED visit through end of trial stage/cycle, up to 18 months
Proportion of eligible encounters in the Emergency Department with an alert fired (silent or active) with CDS engagement. CDS engagement is defined as: OUD diagnosis entered via CDS, withdrawal assessment, readiness assessment, buprenorphine order/prescription placed, referral placed, or any flowsheet item completed.
次要结局
未报告次要终点