跳至主要内容
临床试验/NCT06771830
NCT06771830招募中不适用

A Rapid Diagnostic of Risk in Hospitalized Pediatric Patients to Improve Outcomes Using Machine Learning

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2025年12月1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
入组人数
30,000
试验地点
1
主要终点
In Hospital Mortality

研究概览

简要总结

This is a study comparing 3 years of retrospective data (pre-implementation) to 2 years of prospective data after the implementation of a pediatric version of Electronic Cardiac Arrest Risk Triage (pediatric eCART), a clinical decision support (CDS) tool that uses electronic health records (EHR) to identify patients with high risk for life threatening outcomes. Up to 30,000 encounters with pediatric patients will be assessed. Acceptability of the pediatric eCART intervention will also be measured from pediatric nurse clinicians.

详细描述

Pediatric eCART draws upon readily available EHR data and rapidly quantifies disease severity, predicting the likelihood of critical illness onset. Currently, no consistently available system continuously tracks the risk of critical illness in children admitted to UW Health. While AFCH has an implementation of Pediatric Early Warning Scores (PEWS) available for risk monitoring, internal reports indicate limited usage. Therefore, AFCH/UW Health clinicians or care providers do not have a reliable mechanism to risk-stratify patients for effective clinical decision-making.

This proposal leverages the AgileMD clinical decision support engine and a machine learning analytic developed in a dataset of over 30,000 patients. Pediatric eCART was explicitly designed to draw attention to patients at increased risk of deterioration and optimize patient management, including the timing of and need for ICU-level care.

Preliminary studies indicate that pediatric eCART implementation at the University of Chicago has led to improved outcomes. Similar improvements among children admitted to UW Health will lead to decreased morbidity and mortality among the pediatric population.

Further, a significant gap in understanding of nurse acceptance of data-driven CDS tools remains. Nurses are the largest workforce of clinicians in the health system and play a primary role in the detection of clinical deterioration as the clinicians that spend the most time observing and assessing patients; however, AI-driven CDS acceptability has not been measured to assess nurse acceptance of these emerging tools. Acceptability is essential to increase sustained use and to decrease suboptimal outcomes such as alert fatigue or increased cognitive load so that these tools ultimately mediate nurse well-being. One study assessed nurse perceptions of the usefulness of a sepsis early warning system and found that less than half of nurses perceived the alerts to be helpful and only a third of nurses reported that the alerts impacted patient care. Understanding nurse acceptance will inform AgileMD's design strategies to foster uptake and use so that predictive tools may be leveraged to improve the cognitive burden of nurse clinicians. In the end, the study will evaluate pediatric eCART on two pediatric groups: (1) screened pediatric patients; (2) pediatric nurse clinician end-users.

Study Design: This is a pre- and post- interventional study of a machine learning algorithm integrated into the electronic health record as a clinical decision support tool. The "pre" participants are hospitalized children (less than 18 years old) who were admitted to UW Health between January 1, 2022, and the date of pediatric eCART implementation in 2025. Pediatric eCART scores will be retrospectively calculated for the "pre" participants by feeding a patient's labs and vital sign observation into the pediatric eCART tool. The "post" participants are hospitalized children (less than18 years old) who will be admitted to UW Health within the two years following pediatric eCART implementation (expected 2025-2027). Pediatric eCART scores will be calculated in real-time for these patients.

研究设计

研究类型
干预性
分配方式
不适用
干预模型
单组
主要目的
卫生服务研究
盲法
开放(无盲法)

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • (pediatric patients):
  • All pediatric patients scored on pediatric eCART (or eligible for scoring on either algorithm in the pre-implementation period) will be screened for study eligibility.
  • Patients eligible for pediatric eCART scoring include pediatric (<18 years of age) patients
  • Inpatient locations

排除标准

  • (pediatric patients):
  • Patients who are ineligible for pediatric eCART scoring
  • Neonates and birth encounters will be excluded from the pediatric eCART study
  • Inclusion Criteria (nurse clinicians):
  • UW Health nurses who interact with eCART during patient care
  • Exclusion Criteria (nurse clinician):
  • UW Health nurses no longer employed at UW Health

研究组 & 干预措施

Pediatric eCART

Experimental

干预措施: Pediatric eCART (Device)

结局指标

主要结局

In Hospital Mortality

时间窗: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)

Intensive Care Unit (ICU) free days

时间窗: up to 28 days

Defined as the number of days patients were both alive and discharged from the ICU out of the first 28 days of hospitalization. Because death is biased toward fewer ICU days and is a competing outcome, patients who die prior to day 28 are assigned with 0 ICU-free days.

次要结局

  • Median 30-day Ventilator-Free Days(assessed through hospital stay (typically up to 5 days on average, but may be over 60 days))
  • Summary of Critical Events(assessed through hospital stay (typically up to 5 days on average, but may be over 60 days))
  • Total Hospital Length of Stay (LOS)(assessed through hospital stay (typically up to 5 days on average, but may be over 60 days))
  • Number of ICU transfers(assessed through hospital stay (typically up to 5 days on average, but may be over 60 days))
  • Usability of Pediatric eCART: System Usability Scale (SUS) score(Surveys automatically sent to nurses within a week of eCART interface, responses collected up to 1 month)
  • Acceptability of Pediatric eCART: Perceived Usefulness Scale(Surveys automatically sent to nurses within a week of eCART interface, responses collected up to 1 month)

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

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标识符

NCT 编号
NCT06771830
其他研究编号
2024-1835, A531200, Protocol Version 8/3/26

日期

首次提交
(去年)
首次发布
(去年)
主要完成日期
(明年)
研究完成日期
(明年)
最近核实
(3个月前)
最近更新
(上个月)

监管与共享

FDA 监管药物
否
FDA 监管器械
是
个体参与者数据共享计划
是
是否有结果
否

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