Telemedicine Notifications With Machine Learning for Postoperative Care

Acute Kidney Injury Clinical Trial

— ODIN-Report  

Official title:

Telemedicine Notifications With Machine Learning for Postoperative Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03974828
• Other study ID #: 201905127
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Sherry McKinnon, BS
• Phone: 314-221-7764
• Email: smckinnon[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3375
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hospital Mortality
• Perioperative/Postoperative Complications
• Postoperative Complications
• Surgery--Complications

Intervention

Device:
• Anesthesia Control Tower Notification
Real-time data will be monitored through the AlertWatch system as well as the electronic health record. Risk forecasts of adverse events (30 day mortality, acute kidney injury, postoperative delirium, respiratory failure), PACU length of stay, and hospital length of stay will be generated by a machine learning algorithm. Additional outputs identifying the most important predictors and their effects will be combined with risk forecasts to form a report card.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned ICU admission	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.	7 days post-op
Secondary	Acute Kidney Injury	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.	7 days post-op
Secondary	Hospital length of stay	The duration in days between end of anesthesia care and discharge from the performing hospital.	30 days post-op