Telemedicine Notifications With Machine Learning for Postoperative Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 3,375
- 主要终点
- Unplanned ICU admission
研究概览
简要总结
The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.
详细描述
This will be a single center, randomized, controlled, pragmatic clinical trial. The investigators will screen surgical patients enrolled in TECTONICS (NCT03923699) and randomized to intraoperative contact. Near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as TECTONICS, and enroll patients if all of the following are true: (1) No ICU admission is intended (2) ML mortality risk forecast is in top 15% of historical PACU patients.
Patients will be randomized 1:1:1 to no contact, brief contact, and full contact. The postoperative provider (PACU physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ML outputs will be provided. The intention-to-treat principle will be followed for all analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in TECTONICS Study (ID 201903026, NCT03923699), in OR randomized to contact
- •workweek hours
- •preoperative assessment completed
- •estimated risk of mortality in top 15% of historical PACU patients
排除标准
- •Not enrolled in TECTONICS Study
- •Operating room randomized to non-contact in TECTONICS
- •Planned ICU admission
研究组 & 干预措施
Non-Contact
Participants in the non-contact group will be monitored by anesthesia control tower clinicians who will utilize AlertWatch and integrating machine-learning forecasting algorithms for adverse outcomes predictions, but who will not contact the postoperative provider unless it is clinically necessary for patient safety purposes.
Brief contact
PACU and ward providers caring for participants in the brief contact group will be notified by Anesthesia Control Tower clinicians before arrival if the patient's forecast for mortality is in the top 15% of historical PACU patients. The notification will contain a brief summary of the patient's forecast risk of major adverse events.
干预措施: Anesthesia Control Tower Notification (Device)
Full contact
PACU and ward providers caring for participants in the full contact group will be notified by Anesthesia Control Tower clinicians before arrival if the patient's forecast for mortality is in the top 15% of historical PACU patients. The notification will contain a report card of the patient's forecast risk of major adverse events, explanatory machine-learning outputs, most influential pre- and intraoperative data, and predicted treatments.
干预措施: Anesthesia Control Tower Notification (Device)
结局指标
主要结局
Unplanned ICU admission
时间窗: 7 days post-op
Admission to a "critical care" bed regardless of rationale or duration at any point in the follow up time frame. Patients who expire without transfer to ICU will be marked as positive.
次要结局
- Acute Kidney Injury(7 days post-op)
- Hospital length of stay(30 days post-op)
研究者
Christopher King
Principal Investigator
Washington University School of Medicine