Telemedicine Notifications With Machine Learning for Postoperative Care

NCT03974828 | Withdrawn DMC FDA Device

• 1 other identifier: 201905127
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Telemedicine; Anesthesia Control Tower; Machine Learning; Forecasting Algorithms; Randomized Controlled Trial; PACU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acute Kidney Injury

  7 days post-op

• Hospital length of stay

  30 days post-op

Study Arms (3)

Non-Contact

NO INTERVENTION

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

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.

Device: Anesthesia Control Tower Notification

Full contact

EXPERIMENTAL

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.

Device: Anesthesia Control Tower Notification

Interventions

Anesthesia Control Tower Notification DEVICE

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.

Brief contact; Full contact

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Postoperative Complications; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christopher R King, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 5, 2019
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share