Clinical trial NCT06771830: Evaluation of Pediatric eCART Implementation
Official title: A Rapid Diagnostic of Risk in Hospitalized Pediatric Patients to Improve Outcomes Using Machine Learning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric ALL
Sepsis
Keywords: machine learning
artificial intelligence
clinical decision support
triage
electronic medical records
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: AgileMD, Inc.
First posted: 2025-01-13
Enrollment: 30000
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interrupted time series approach
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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

Primary outcomes:
measure: In Hospital Mortality
timeFrame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)
measure: Intensive Care Unit (ICU) free days
timeFrame: up to 28 days
Secondary outcomes:
measure: Median 30-day Ventilator-Free Days
timeFrame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)
measure: Summary of Critical Events
timeFrame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)
measure: Total Hospital Length of Stay (LOS)
timeFrame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)
measure: Number of ICU transfers
timeFrame: assessed through hospital stay (typically up to 5 days on average, but may be over 60 days)
measure: Usability of Pediatric eCART: System Usability Scale (SUS) score
timeFrame: Surveys automatically sent to nurses within a week of eCART interface, responses collected up to 1 month
measure: Acceptability of Pediatric eCART: Perceived Usefulness Scale
timeFrame: Surveys automatically sent to nurses within a week of eCART interface, responses collected up to 1 month
Other outcomes:
Locations:
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Anoop Mayampurath, PhD
role: PRINCIPAL_INVESTIGATOR
References: