1000 Participants Needed

Machine Learning Model for Pediatric Cardiology

LS
AW
Overseen ByAgata Wolochacz, BMSc
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The goal of this trial is to determine the effectiveness of a machine-learning (ML) model predicting a serious cardiac event within the next three months, when compared pre- versus post-deployment, in pediatric cardiac inpatients. The main questions it aims to answer are whether deployment of the ML model: 1. Increases PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days 2. Increases PACT consultation or visit within the next three months among those who experience a serious cardiac event during this period 3. Decreases time to PACT consultation or visit among those seen by PACT during this period 4. Decreases the incidence of death in the intensive care unit (ICU) 5. Increases documentation of goals of care High-risk cardiology patients will be identified by an ML model each morning. If the patient has been seen by the PACT team within the past year, the update will go to the PACT team members. If the patient hasn't been seen by the PACT team, the email will be sent to the cardiology physician in charge of the patient. This physician will decide whether a PACT consultation is necessary based on their clinical judgment. If so, a referral will be made using the usual process. Outcomes of the identified patients will be compared pre- and post-deployment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ML-based intervention treatment for pediatric cardiology?

The research shows that machine learning models can accurately predict risk factors and complications in pediatric heart surgeries, which can help doctors make better treatment decisions. For example, one study achieved 85% accuracy in predicting risk factors for a specific heart surgery, and another model effectively predicted complications after surgery, helping improve patient care.12345

Is the machine learning model for pediatric cardiology generally safe for humans?

Research shows that computational models, like those used in machine learning, are being evaluated for cardiac safety by analyzing health records to predict risks like arrhythmia (irregular heartbeat). These models are being used to improve drug safety assessments, suggesting they are considered safe enough for use in evaluating treatment risks.678910

How does the machine learning model treatment for pediatric cardiology differ from other treatments?

This treatment is unique because it uses machine learning to analyze patient data and predict outcomes, offering personalized treatment plans based on genetic profiles and risk factors. Unlike traditional methods, it provides tailored recommendations for drug therapy, surgical plans, and imaging schedules, enhancing decision-making in pediatric cardiology.1351112

Research Team

LS

Lillian Sung, MD, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for pediatric inpatients admitted to cardiology. It's designed to help doctors predict serious heart events and improve care with a machine-learning tool. The study excludes patients who don't meet the specific age and condition requirements.

Inclusion Criteria

I am a child admitted to the hospital for heart-related issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-deployment Observation

Patient outcomes are observed for a 12-month period before the deployment of the ML model

12 months

Post-deployment Observation

Patient outcomes are observed for a 12-month period following the deployment of the ML model

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

  • ML-based intervention
Trial Overview The trial tests a machine-learning model that predicts cardiac events in children hospitalized for heart conditions. It checks if this tool helps increase timely consultations, reduce ICU deaths, and improve care planning by comparing outcomes before and after its use.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ML modelExperimental Treatment1 Intervention
Cardiac patients identified by an ML model for having the highest risk of serious cardiac outcomes.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Findings from Research

Using electronic health records from 21,460 patients, a new personalized algorithm called ML4CAD was developed, which significantly improves health outcomes for managing Coronary Artery Disease (CAD) by predicting adverse events with an 81.5% accuracy.
The ML4CAD algorithm increases the expected time from diagnosis to adverse events by 24.11%, particularly benefiting male and Hispanic patients, and provides physicians with an interactive tool for personalized treatment recommendations.
Personalized treatment for coronary artery disease patients: a machine learning approach.Bertsimas, D., Orfanoudaki, A., Weiner, RB.[2021]

References

Prediction of One-Year Transplant-Free Survival after Norwood Procedure Based on the Pre-Operative Data. [2020]
Explainable machine-learning predictions for complications after pediatric congenital heart surgery. [2021]
A primer on artificial intelligence for the paediatric cardiologist. [2021]
Machine Learning-Based Systems for the Anticipation of Adverse Events After Pediatric Cardiac Surgery. [2022]
Machine Learning for Mortality Prediction in Pediatric Myocarditis. [2021]
Use of Patient Health Records to Quantify Drug-Related Pro-arrhythmic Risk. [2022]
A computational method to quantitatively measure pediatric drug safety using electronic medical records. [2021]
Personalized treatment for coronary artery disease patients: a machine learning approach. [2021]
Adverse drug events and medication errors: detection and classification methods. [2022]
Data-mining-based detection of adverse drug events. [2013]
Prediction of arrhythmia after intervention in children with atrial septal defect based on random forest. [2021]
Explainable machine learning model for predicting the occurrence of postoperative malnutrition in children with congenital heart disease. [2022]
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