Clinical trial NCT06886529: PACT Involvement in Cardiology Patients
Official title: Early PACT Involvement in Cardiology Patients Using Machine Learning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Machine Learning
Cardiovascular Outcome
Pediatric Palliative Care
Pediatric Cardiology
Keywords: quality of life
cardiovascular outcomes
machine learning
prediction models
pediatric
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: At The Hospital for Sick Children (SickKids), the collaboration between cardiology and palliative care is much stronger than other centers, with routine involvement in patients being considered for heart transplant. Despite this, earlier involvement of palliative care would be advantageous. Our cardiology co-investigators identified patients who would benefit from earlier palliative care team involvement as those receiving advanced heart therapies (defined as ventricular assist device (VAD) and being wait listed for heart transplant) and those who die. The study team created a clinical deployment environment named SickKids Enterprise-wide Data in Azure Repository (SEDAR). \[1\] SEDAR is a modular and robust approach to deliver foundational data that is re-usable across multiple ML projects. It offers validated EHR data in a standardized and curated schema. ML is a promising approach to identify cardiac patients at the highest risk of these serious cardiac outcomes who may benefit from earlier palliative care team involvement. To assess the effectiveness of this approach, patient outcomes will be compared pre- and post-deployment of the ML model. The pre-period will include patients admitted for a 12-month period before deployment (starting 15 months prior to deployment). The post-period will include patients admitted for a 12-month period following deployment starting 3 months post-deployment start.

Eligibility criteria: Inclusion Criteria:

* Pediatric inpatients admitted to cardiology

Exclusion Criteria:

* Expected to be discharged prior to midnight on the day of admission

Primary outcomes:
measure: Proportion of admissions with PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days
timeFrame: Time of enrolment to 3 months
Secondary outcomes:
measure: PACT consultation or visit within the next three months among those with a positive model prediction
timeFrame: Time of enrolment to 3 months
measure: Time to PACT consultation or visit among those seen by PACT
timeFrame: Time of enrolment to 3 months
measure: Death in the ICU
timeFrame: Time of enrolment to 3 months
measure: Documentation of goals of care
timeFrame: Time of enrolment to 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel P, Robinson PD, Phillips R, Baggott C, Devine K, Gibson P, Guilcher GMT, Holdsworth MT, Neumann E, Orsey AD, Spinelli D, Thackray J, van de Wetering M, Cabral S, Sung L, Dupuis LL. Treatment of breakthrough and prevention of refractory chemotherapy-induced nausea and vomiting in pediatric cancer patients: Clinical practice guideline update. Pediatr Blood Cancer. 2023 Aug;70(8):e30395. doi: 10.1002/pbc.30395. Epub 2023 May 13.