Evaluation of Pediatric eCART Implementation

NCT06771830 | Recruiting DMC FDA Device

• 3 other identifiers: 2024-1835A531200Protocol Version 3/6/25
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric ALL; Sepsis

Keywords

machine learning; artificial intelligence; clinical decision support; triage; electronic medical records

Outcome Measures

Primary Outcomes (2)

• In Hospital Mortality

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

• Intensive Care Unit (ICU) free 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.

  up to 28 days

Secondary Outcomes (6)

• 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

Study Arms (1)

Pediatric eCART

EXPERIMENTAL

Device: Pediatric eCART

Interventions

Pediatric eCART DEVICE

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

Also known as: electronic Cardiac Arrest Risk Triage

Pediatric eCART

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients who are ineligible for pediatric eCART scoring
• Neonates and birth encounters will be excluded from the pediatric eCART study
• UW Health nurses who interact with eCART during patient care
• UW Health nurses no longer employed at UW Health

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• AgileMD, Inc.: collaborator

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sepsis

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anoop Mayampurath, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anoop Mayampurath, PhD

CONTACT

608-261-1028; mayampurath@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interrupted time series approach

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)