Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
10000

Summary

Conditions
  • Acute Kidney Injury
  • Hospital Mortality
  • Perioperative/Postoperative Complications
  • Surgery- Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).Masking: Double (Participant, Outcomes Assessor)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03974828
Collaborators
Not Provided
Investigators
Principal Investigator: Christopher R King, MD, PhD Washington University School of Medicine