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Telemedicine Notifications With Machine Learning for Postoperative Care (ODIN-Report)

Primary Purpose

Surgery--Complications, Perioperative/Postoperative Complications, Acute Kidney Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anesthesia Control Tower Notification
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgery--Complications focused on measuring Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Randomized Controlled Trial, PACU

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Non-Contact

    Brief contact

    Full contact

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Hospital length of stay
    The duration in days between end of anesthesia care and discharge from the performing hospital.

    Full Information

    First Posted
    June 2, 2019
    Last Updated
    April 25, 2023
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03974828
    Brief Title
    Telemedicine Notifications With Machine Learning for Postoperative Care
    Acronym
    ODIN-Report
    Official Title
    Telemedicine Notifications With Machine Learning for Postoperative Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgery--Complications, Perioperative/Postoperative Complications, Acute Kidney Injury, Hospital Mortality
    Keywords
    Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Randomized Controlled Trial, PACU

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3375 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-Contact
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Brief contact
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Full contact
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Anesthesia Control Tower Notification
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Unplanned ICU admission
    Description
    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.
    Time Frame
    7 days post-op
    Secondary Outcome Measure Information:
    Title
    Acute Kidney Injury
    Description
    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.
    Time Frame
    7 days post-op
    Title
    Hospital length of stay
    Description
    The duration in days between end of anesthesia care and discharge from the performing hospital.
    Time Frame
    30 days post-op

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sherry McKinnon, BS
    Phone
    314-221-7764
    Email
    smckinnon@wustl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher R King, MD, PhD
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data are a subset of TECTONICS and will be have the same sharing plan / restrictions.

    Learn more about this trial

    Telemedicine Notifications With Machine Learning for Postoperative Care

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