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临床试验/NCT06793696
NCT06793696已完成不适用

Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

Yale University3 个研究点 分布在 1 个国家目标入组 1,129 人开始时间: 2025年3月21日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,129
试验地点
3
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 1 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.

This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they 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.

Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: 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
Factorial
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

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

EMBED CDS and patient facing materials

Experimental

EMBED CDS and patient materials at patient discharge from ED

干预措施: Patient facing materials (Other)

EMBED CDS and patient facing materials

Experimental

EMBED CDS and patient materials at patient discharge from ED

干预措施: EMBED (Other)

EMBED CDS and nurse prompt and provider prompt

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS

干预措施: Nurse prompt (Other)

EMBED CDS and nurse prompt and provider prompt

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS

干预措施: Provider prompt (Other)

EMBED CDS and nurse prompt and provider prompt

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS

干预措施: EMBED (Other)

EMBED CDS

Active Comparator

Provider receives EMBED CDS

干预措施: EMBED (Other)

EMBED CDS and nurse prompt

Experimental

EMBED CDS and nurse receives prompt to complete COWS

干预措施: Nurse prompt (Other)

EMBED CDS and nurse prompt

Experimental

EMBED CDS and nurse receives prompt to complete COWS

干预措施: EMBED (Other)

EMBED CDS and provider prompt

Experimental

EMBED CDS and provider prompt for EMBED CDS

干预措施: Provider prompt (Other)

EMBED CDS and provider prompt

Experimental

EMBED CDS and provider prompt for EMBED CDS

干预措施: EMBED (Other)

EMBED CDS and nurse prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED

干预措施: Nurse prompt (Other)

EMBED CDS and nurse prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED

干预措施: Patient facing materials (Other)

EMBED CDS and nurse prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED

干预措施: EMBED (Other)

EMBED CDS and provider prompt and patient facing materials

Experimental

EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED

干预措施: Provider prompt (Other)

EMBED CDS and provider prompt and patient facing materials

Experimental

EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED

干预措施: Patient facing materials (Other)

EMBED CDS and provider prompt and patient facing materials

Experimental

EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED

干预措施: EMBED (Other)

EMBED CDS and nurse prompt and provider prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED

干预措施: Nurse prompt (Other)

EMBED CDS and nurse prompt and provider prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED

干预措施: Provider prompt (Other)

EMBED CDS and nurse prompt and provider prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED

干预措施: Patient facing materials (Other)

EMBED CDS and nurse prompt and provider prompt and patient facing materials

Experimental

EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED

干预措施: 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: Trial start to end 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

  • Proportion of attending physicians initiating BUP in the ED for at least one eligible patient(Trial start to end up to 18 months)
  • Proportion of encounters with patient referral to ongoing MOUD treatment(Upon discharge from the ED, 1 day)
  • Proportion of encounters with Naloxone prescription upon ED discharge(Upon discharge from the ED, 1 day)
  • Proportion of encounters with patient receipt of appropriate opioid related discharge instructions(Upon discharge from the ED, 1 day)
  • Proportion of attending physician referral to ongoing MOUD treatment(Trial start to end up to 18 months)
  • Proportion of attending physician prescribing naloxone upon ED discharge(Trial start to end up to18 months)
  • Proportion of attending physicians giving appropriate opioid related discharge instructions(Trial start to end up to 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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