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Recruiting NCT06771830

Evaluation of Pediatric eCART Implementation

No phase Interventional Pediatric ALL Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pediatric eCART.
Who it may be relevant to
Registry conditions: Pediatric ALL, Sepsis. Basic parameters: up to 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device Pediatric eCART
    Integration of the pediatric version of electronic Cardiac Arrest Risk Triage as a clinical decision support tool within Epic for use by clinicians

Primary outcome measures

  • In Hospital Mortality [Time frame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)]
  • Intensive Care Unit (ICU) free days [Time frame: up to 28 days]
Secondary outcome measures (6)
  • Median 30-day Ventilator-Free Days [Time frame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)]
  • Summary of Critical Events [Time frame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)]
  • Total Hospital Length of Stay (LOS) [Time frame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)]
  • Number of ICU transfers [Time frame: 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 [Time frame: Surveys automatically sent to nurses within a week of eCART interface, responses collected up to 1 month]
  • Acceptability of Pediatric eCART: Perceived Usefulness Scale [Time frame: Surveys automatically sent to nurses within a week of eCART interface, responses collected up to 1 month]

Eligibility criteria

Inclusion Criteria (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

Exclusion Criteria (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • American Family Children's Hospital — Madison

Identifiers

NCT: NCT06771830 · 2024-1835 · A531200 · Protocol Version 3/6/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗