Telemedicine Notifications With Machine Learning for Postoperative Care (ODIN-Report)

The Washington University

Status: Begins enrollment in 1 month

Conditions: Acute Kidney Injury; Perioperative/Postoperative Complications; Surgery--Complications; Hospital Mortality

Treatments: Device: Anesthesia Control Tower Notification

Study type: Interventional

Funder types: Other

Identifiers

NCT03974828

201905127

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Not enrolled in TECTONICS Study
• Operating room randomized to non-contact in TECTONICS
• Planned ICU admission

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,375 participants in 3 patient groups

Non-Contact

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Device: Anesthesia Control Tower Notification

Full contact

Experimental group

Description:

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.

Treatment:

Device: Anesthesia Control Tower Notification