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临床试验/NCT06996626
NCT06996626进行中(未招募)不适用

Real-time Evaluation of an Outlier-based Alerting System

David T Huang4 个研究点 分布在 1 个国家目标入组 7,445 人开始时间: 2025年6月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
7,445
试验地点
4
主要终点
Rate of Clinical Actions Following Revealed vs. Non-Revealed Alerts

研究概览

简要总结

Alerts related to outlier clinician behavior are generated in real-time by an intelligent system continuously scraping EHR (electronic health record) data. These alerts are passed to the bedside and their potential impact on bedside clinical behavior is evaluated.

详细描述

A clinician-informed AI model will generate outlier alerts from real-time review of the EHR (electronic health record) of UPMC Presbyterian/Montefiore ICU patients. These alerts will first be reviewed by an ICU clinician, along with the patients' EHR, for clinical relevance. For those alerts deemed potentially relevant, the ICU clinician will contact the treating ICU clinician (eg, an ICU pharmacist, physician, advanced practice provider) and discuss the alert. The treating ICU clinician will take whatever action, including no action, they deem best.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients in the Presbyterian and Montefiore ICUs

排除标准

  • 未提供

研究组 & 干预措施

Revealed Alerts

Experimental

干预措施: Revealed Alerts (Device)

Unrevealed Alerts

Active Comparator

干预措施: Unrevealed Alerts (Device)

结局指标

主要结局

Rate of Clinical Actions Following Revealed vs. Non-Revealed Alerts

时间窗: From time of ICU admission until ICU discharge

The primary outcome compares the proportion of alerts that lead to documented clinical actions when revealed to treating ICU clinicians versus when not revealed. Alerts are generated by a decision support system and reviewed daily by ICU study clinicians. On average, 30 alerts are reviewed per ICU per day, with approximately 5 alerts revealed to the treating clinicians. The analysis uses a stepped wedge design with ICU beds as the unit of analysis, where each ICU acts as its own control. The outcome will assess whether revealing alerts increases the rate of appropriate clinical actions taken, as compared to when alerts are withheld.

次要结局

  • Hospital Length of Stay(up to 90 days after hospital admission)
  • In-Hospital Mortality(Up to 90 days after hospital admission)
  • Rate of Any Clinically Responsive Action Following Alerts(Up to 90 days after ICU admission)
  • True Positive Alert Rate (TPAR) by Study Group and Alert Type(Up to 90 days after ICU admission)
  • Rate of Non-Responsive Actions Following Alerts(Up to 90 days after ICU admission)
  • Overall Alert Rate(Through study completion, an average of 2 years)
  • Alert Rate per Alerting Model(Daily, up to 90 days)
  • Delay Between Alert Generation and First Responsive Action(Measured continuously through study completion, an average of 2 years)
  • ICU Length of Stay(Up to 90 days after ICU admission)
  • Time Trend of True Positive Alert Rate (TPAR)(Through study completion, an average of 2 years)

研究者

发起方
David T Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David T Huang

Professor

University of Pittsburgh

研究点 (4)

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