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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ML model | Experimental | Cardiac patients identified by an ML model for having the highest risk of serious cardiac outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ML-based intervention | Other | ML model predicting a serious cardiac event in cardiac patients, defined as VAD procedure, being wait listed for heart transplant or death within the next three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of admissions with PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days | The primary outcome will be the proportion of admissions with PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days. This variable will be measured using SEDAR. | Time of enrolment to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PACT consultation or visit within the next three months among those with a positive model prediction | PACT consultation or visit within the next three months among those with a positive model prediction will be measured using SEDAR. | Time of enrolment to 3 months |
| Time to PACT consultation or visit among those seen by PACT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lillian Sung, MD, PhD | Contact | 4168135287 | lillian.sung@sickkids.ca | |
| Agata Wolochacz, BMSc | Contact | 4168137654 | 309976 | agata.wolochacz@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lillian Sung, MD, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | M5G1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37178438 | Background | 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. |
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Time to PACT consultation or visit among those seen by PACT will be measured using SEDAR. |
| Time of enrolment to 3 months |
| Death in the ICU | Death in the ICU will be measured using SEDAR. | Time of enrolment to 3 months |
| Documentation of goals of care | Goals of care will be abstracted via chart review. | Time of enrolment to 3 months |