Clinical trial NCT05042804: Perioperative Outcome Risk Assessment With Computer Learning Enhancement
Official title: Perioperative Outcome Risk Assessment With Computer Learning Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morality
Acute Kidney Injury
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Foundation for Anesthesia Education and Research
First posted: 2021-09-13
Enrollment: 5114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will test whether anesthesiology clinicians working in a telemedicine setting can predict patient risk for postoperative complications (death and acute kidney injury) more accurately with access to a machine learning display than without it.

Detailed description: The Perioperative Outcome Risk Assessment with Computer Learning Enhancement (Periop ORACLE) study will be a sub-study nested within the ongoing TECTONICS trial (NCT03923699). TECTONICS is a single-center randomized clinical trial assessing the impact of an anesthesiology control tower (ACT) on postoperative 30-day mortality, delirium, respiratory failure, and acute kidney injury. As part of the TECTONICS trial, investigators in the ACT perform medical record case reviews during the early part of surgery and document how likely they feel each patient is to experience postoperative death and acute kidney injury (AKI). In Periop ORACLE, these case reviews will be randomized to be performed with or without access to machine learning (ML) predictions.

Investigators in the ACT will conduct all case reviews by viewing the patient's records in AlertWatch (AlertWatch, Ann Arbor, MI) and Epic (Epic, Verona, WI). AlertWatch is an FDA-approved patient monitoring system designed for use in the operating room. The version of AlertWatch used in this study has been customized for use in a telemedicine setting. Epic is the electronic health record system utilized at Barnes-Jewish Hospital. Each case review will be randomized in a 1:1 fashion to be completed with or without ML assistance. If the case review is randomized to ML assistance, the investigator will access a display interface (currently deployed as a web application on a secure server) that shows real-time ML predicted likelihood for postoperative death and postoperative AKI. If the case review is not randomized to ML assistance, the investigator will not access this display. After viewing the patient's data, the investigator will predict how likely the patient is to experience postoperative death and postoperative AKI and will document this prediction. The area under the receiver operating characteristic curves for predictions made with ML assistance and without ML assistance will be compared.

Eligibility criteria: Inclusion Criteria:

* Surgery in the main operating suite at Barnes-Jewish Hospital
* Surgery during hours of ACT operation (weekdays 7:00am-4:00pm)
* Enrolled in the TECTONICS randomized clinical trial (NCT03923699)

Exclusion Criteria:

* None

Primary outcomes:
measure: Area under receiver-operating characteristic curve of clinician prediction for postoperative death
timeFrame: 30 days
measure: Area under receiver-operating characteristic curve of clinician prediction for postoperative acute kidney injury
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Bradley A Fritz, MD
role: PRINCIPAL_INVESTIGATOR
References: