Pediatric eCART for High-Risk Outcomes

Overseen By Anoop Mayampurath, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Neonates, Birth encounters, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests pediatric eCART, a tool that predicts life-threatening events in children using electronic health records. Researchers aim to compare past data with new data collected after implementing this tool to determine if it improves outcomes. The trial will also evaluate nurse clinicians' perceptions of using the tool. It seeks pediatric patients in hospitals who might be at risk and nurse clinicians who use the tool during patient care. Neonates and birth encounters are excluded from this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance pediatric care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this clinical decision support tool is safe for pediatric patients?

Research has shown limited direct safety data on the Pediatric eCART tool. Designed to identify children at high risk for serious health problems using electronic health records, the tool aims to catch issues early and prevent life-threatening situations.

Although specific safety findings for Pediatric eCART in children remain undocumented, it is crucial to understand that this tool is not a medication or surgery. As a decision support tool, it aids healthcare professionals by providing important information for better decision-making.

No direct reports of problems caused by Pediatric eCART have appeared in available sources. However, similar tools in healthcare aim to improve patient safety by providing timely alerts to healthcare providers.

Since this tool guides decision-making rather than serving as a direct treatment, it is generally considered low-risk. The real test of its "safety" lies in how accurately and effectively it assists healthcare teams in patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pediatric eCART trial because it aims to transform how high-risk outcomes in children are identified and managed. Unlike traditional methods that rely heavily on manual monitoring and subjective assessment, Pediatric eCART utilizes advanced algorithms and real-time data analysis from electronic health records to predict deterioration early. This approach could lead to quicker interventions, potentially improving outcomes and reducing the burden on healthcare providers. By integrating cutting-edge technology, this trial could pave the way for a new standard in pediatric care.

What evidence suggests that the pediatric eCART is effective for identifying high-risk outcomes?

Research has shown that the pediatric eCART, a decision-support tool, effectively identifies children at high risk for serious health problems. One study comparing patient outcomes before and after eCART use found it significantly improved the identification of high-risk patients. The tool analyzes electronic health records to detect early warning signs, helping to prevent serious issues. Additionally, studies indicate that tools like eCART can accurately predict the risk of death, leading to better care in emergencies. This evidence suggests that pediatric eCART could improve health outcomes for children in critical conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Anoop Mayampurath, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for pediatric patients who have had encounters with healthcare services and are at risk of sepsis or acute lymphoblastic leukemia. The study will look at data before and after the use of a tool called pediatric eCART.

Inclusion Criteria

UW Health nurses who interact with eCART during patient care

I am under 18 years old.

Inpatient locations

Exclusion Criteria

Patients who are ineligible for pediatric eCART scoring

UW Health nurses no longer employed at UW Health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation Retrospective Analysis

Retrospective analysis of pediatric patients admitted between January 1, 2022, and the date of pediatric eCART implementation in 2025

3 years

Post-implementation Prospective Analysis

Prospective analysis of pediatric patients admitted within two years following pediatric eCART implementation

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pediatric eCART

Trial Overview The study tests the effectiveness of pediatric eCART, a tool designed to help clinicians identify children at high risk for life-threatening events using their health records. It compares outcomes from before and after its implementation.

How Is the Trial Designed?

Group I: Pediatric eCART Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

AgileMD, Inc.

Industry Sponsor

Trials

2

Recruited

60,000+

Published Research Related to This Trial

In a study of 6,376 children treated in pediatric emergency departments, 3.0% experienced at least one adverse event related to their care, highlighting a significant safety risk in this setting.

Most of these adverse events (76.5%) were deemed preventable, primarily due to management and diagnostic issues, indicating that there are clear opportunities for improving patient safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe are paediatric emergency departments? A national prospective cohort study. Plint, AC., Newton, AS., Stang, A., et al.[2022]

There is a significant lack of knowledge regarding the long-term health impacts of novel targeted and immunotherapy agents used in children with cancer, despite advancements in understanding the toxicities of traditional treatments like surgery, radiation, and chemotherapy.

The ACCELERATE initiative aims to create an international registry to collect long-term follow-up data on these therapies, which will help ensure safety, support regulatory requirements, and guide treatment decisions for pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. Kieran, MW., Caron, H., Winther, JF., et al.[2022]

The Pediatric Terminology Harmonization Initiative developed a comprehensive adverse event (AE) terminology specifically for pediatric care, containing over 1000 terms related to pediatric diseases and disorders, to improve international reporting and understanding of AEs.

This new terminology is designed for easy integration with existing biomedical vocabularies and is applicable in various healthcare settings, making it a valuable resource for enhancing pediatric clinical research and safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. Gipson, DS., Kirkendall, ES., Gumbs-Petty, B., et al.[2019]

In a study of 102 children admitted to intensive care for acute alcohol intoxication, 57% required intubation, with the need for intubation linked to lower Glasgow Coma Scale scores, lower body temperature, and higher blood alcohol concentrations.

The majority of patients were male adolescents, and while metabolic disturbances like high lactate levels and hyperglycemia were common, serious complications typically seen in adults, such as electrolyte imbalances and aspiration pneumonia, were rare in this pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Acute Alcohol Intoxication Admitted to the ICU: A Review of 102 Cases in France. Ruetsch, V., Zarka, J., Vanel, B., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-sepsis-2-2025-6ef5a

Pediatric eCART for High-Risk Outcomes In a study of 6,376 children treated in pediatric emergency departments, 3.0% experienced at least one adverse event related to their care, highlighting a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110635/

Characteristics, Outcomes and Mortality Risk Factors of ... Among survivors, 86.13% exhibited favorable neurological outcomes, as assessed by the PCPC, aligning with international studies reporting ...

3. agilemd.com agilemd.com/publications-ecart

Publications eCART Machine Learning-Based Pediatric Early Warning Score: Patient Outcomes in a Pre- Versus Post-Implementation Study, 2019–2023.

4. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-025-01347-0

Mortality predictors in pediatric emergency department ... The results highlight the effectiveness of PEWS as a reliable tool for ruling out mortality risk in pediatric emergency settings, especially ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0828282X23018810

Treprostinil Effectiveness in Higher-Risk Pediatric Patients ... The present study shows that in combination with oral PAH-specific medications, treprostinil can significantly improve the outcomes of paediatric IPAH/HPAH ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6303084/

Identifying Pediatric Patients at High Risk for Adverse ... Other studies have revealed that obesity, race, insurance status, and age are potentially associated with patient safety, although some of these results have ...

7. hdsi.uchicago.edu hdsi.uchicago.edu/wp-content/uploads/2021/09/Gonzalez_Implementation-of-Pediatric-eCART-on-Comer-5-and-6.pdf

Implementation of Pediatric eCART on Comer 5 & 6 The project aims to implement pediatric eCART on Comer 5/6 to better identify patients at risk of clinical deterioration, using AgileMD in EPIC.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813917

Adverse Safety Events in EMS Care of Children With Out ... 60% of patients experienced at least 1 severe adverse safety event. Neonates had increased odds of a severe adverse safety event compared with adolescents.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37698357/

Frequency, Type, and Degree of Potential Harm of Adverse ... EMS chart review has been used to identify adverse safety events (ASEs) in high-acuity and high-risk pediatric encounters. The objective of this work was to ...