Early PACT Involvement in Cardiology Patients Using Machine Learning
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Proportion of admissions with PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days
研究概览
简要总结
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:
- Increases PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days
- Increases PACT consultation or visit within the next three months among those who experience a serious cardiac event during this period
- Decreases time to PACT consultation or visit among those seen by PACT during this period
- Decreases the incidence of death in the intensive care unit (ICU)
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric inpatients admitted to cardiology
排除标准
- •Expected to be discharged prior to midnight on the day of admission
研究组 & 干预措施
ML model
Cardiac patients identified by an ML model for having the highest risk of serious cardiac outcomes.
干预措施: ML-based intervention (Other)
结局指标
主要结局
Proportion of admissions with PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days
时间窗: Time of enrolment to 3 months
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.
次要结局
- PACT consultation or visit within the next three months among those with a positive model prediction(Time of enrolment to 3 months)
- Time to PACT consultation or visit among those seen by PACT(Time of enrolment to 3 months)
- Death in the ICU(Time of enrolment to 3 months)
- Documentation of goals of care(Time of enrolment to 3 months)
研究者
Lillian Sung
Chief Clinical Data Scientist, Paediatric Oncologist
The Hospital for Sick Children