Telemedicine Notifications With Machine Learning for Postoperative Care

Not Applicable

Not yet recruiting

• Conditions: Surgery--Complications; Acute Kidney Injury; Hospital Mortality; Perioperative/Postoperative Complications
• Interventions: Device: Anesthesia Control Tower Notification

• Registration Number: NCT03974828
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Study Start: 2025-07-01
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3375

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full contact	Anesthesia Control Tower Notification	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.
Brief contact	Anesthesia Control Tower Notification	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.

Primary Outcome Measures

Name	Time	Method
Unplanned ICU admission	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.

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	30 days post-op	The duration in days between end of anesthesia care and discharge from the performing hospital.
Acute Kidney Injury	7 days post-op	Postoperative laboratory values and urine output will be used to calculate Kidney Disease Improving Global Outcomes grades of acute kidney injury. Where unavailable, baseline Glomerular filtration rate will be assumed to be age, sex, and body size normal.