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

30000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What safety data exists for Pediatric eCART or similar treatments in children?

There is a lack of specific safety data on Pediatric eCART or similar treatments in children, as there is a wide gap in knowledge about the long-term health impact of novel targeted and immune therapies in children. ^{1 2 3 4 5}

How is the Pediatric eCART treatment different from other treatments for high-risk outcomes in children?

The Pediatric eCART treatment is unique because it likely involves a specialized scoring system to predict and manage high-risk outcomes in children, particularly those with serious conditions like cancer. This approach focuses on early identification and intervention, which is different from standard treatments that may not use such predictive tools. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Anoop Mayampurath, PhD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. [2022]

2. England pubmed.ncbi.nlm.nih.gov

How safe are paediatric emergency departments? A national prospective cohort study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Adverse Events in Pediatric Inpatients: The Japan Adverse Event Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Assessing the risk of mortality in paediatric cancer patients admitted to the paediatric intensive care unit: a novel risk score? [2018]

7. United States pubmed.ncbi.nlm.nih.gov

The Cardiac Children's Hospital Early Warning Score (C-CHEWS). [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Pediatric Acute Alcohol Intoxication Admitted to the ICU: A Review of 102 Cases in France. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

Risk classification of children and adolescents: priority of care in the emergency unit. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Identifying the critically ill paediatric oncology patient: a study protocol for a prospective observational cohort study for validation of a modified Bedside Paediatric Early Warning System score in hospitalised paediatric oncology patients. [2022]