Evaluation of Pediatric eCART Implementation

NCT ID: NCT06771830

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Pediatric ALL Sepsis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

interrupted time series approach
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pediatric eCART

Group Type EXPERIMENTAL

Pediatric eCART

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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electronic Cardiac Arrest Risk Triage

Eligibility Criteria

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Inclusion Criteria

* 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


* UW Health nurses who interact with eCART during patient care

Exclusion Criteria

* Patients who are ineligible for pediatric eCART scoring
* Neonates and birth encounters will be excluded from the pediatric eCART study


* UW Health nurses no longer employed at UW Health
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AgileMD, Inc.

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anoop Mayampurath, PhD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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American Family Children's Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anoop Mayampurath, PhD

Role: CONTACT

608-261-1028

Other Identifiers

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A531200

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 3/6/25

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1835

Identifier Type: -

Identifier Source: org_study_id