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Perioperative Outcome Risk Assessment With Computer Learning Enhancement (ORACLE)

Primary Purpose

Morality, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Machine learning models predicting postoperative death and acute kidney injury
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Morality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Machine Learning Assistance

No Assistance

Arm Description

Clinicians in the Anesthesia Control Tower will review patient data using the electronic health record and using AlertWatch, and they will also view the machine learning display. They will then predict how likely the patient is to experience postoperative death and postoperative acute kidney injury.

Clinicians in the Anesthesia Control Tower will review patient data using the electronic health record and using AlertWatch, but they will not view the machine learning display. They will then predict how likely the patient is to experience postoperative death and postoperative acute kidney injury.

Outcomes

Primary Outcome Measures

Area under receiver-operating characteristic curve of clinician prediction for postoperative death
Clinicians will predict the likelihood of postoperative death for each case using a categorical scale. A logistic regression will be constructed using the clinician predictions as inputs, and the area under the receiver-operating characteristic curve will be determined.
Area under receiver-operating characteristic curve of clinician prediction for postoperative acute kidney injury
Clinicians will predict the likelihood of postoperative acute kidney injury for each case using a categorical scale. A logistic regression will be constructed using the clinician predictions as inputs, and the area under the receiver-operating characteristic curve will be determined.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
November 11, 2022
Sponsor
Washington University School of Medicine
Collaborators
Foundation for Anesthesia Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05042804
Brief Title
Perioperative Outcome Risk Assessment With Computer Learning Enhancement
Acronym
ORACLE
Official Title
Perioperative Outcome Risk Assessment With Computer Learning Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Foundation for Anesthesia Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morality, Acute Kidney Injury

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Machine Learning Assistance
Arm Type
Experimental
Arm Description
Clinicians in the Anesthesia Control Tower will review patient data using the electronic health record and using AlertWatch, and they will also view the machine learning display. They will then predict how likely the patient is to experience postoperative death and postoperative acute kidney injury.
Arm Title
No Assistance
Arm Type
No Intervention
Arm Description
Clinicians in the Anesthesia Control Tower will review patient data using the electronic health record and using AlertWatch, but they will not view the machine learning display. They will then predict how likely the patient is to experience postoperative death and postoperative acute kidney injury.
Intervention Type
Other
Intervention Name(s)
Machine learning models predicting postoperative death and acute kidney injury
Intervention Description
The machine learning display uses data from the electronic health record to predict the likelihood of postoperative death and postoperative acute kidney injury.
Primary Outcome Measure Information:
Title
Area under receiver-operating characteristic curve of clinician prediction for postoperative death
Description
Clinicians will predict the likelihood of postoperative death for each case using a categorical scale. A logistic regression will be constructed using the clinician predictions as inputs, and the area under the receiver-operating characteristic curve will be determined.
Time Frame
30 days
Title
Area under receiver-operating characteristic curve of clinician prediction for postoperative acute kidney injury
Description
Clinicians will predict the likelihood of postoperative acute kidney injury for each case using a categorical scale. A logistic regression will be constructed using the clinician predictions as inputs, and the area under the receiver-operating characteristic curve will be determined.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley A Fritz, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Perioperative Outcome Risk Assessment With Computer Learning Enhancement

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