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ML-based report card for Surgery Complications
N/A
Recruiting
Led By Christopher R King, MD, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned non-ICU disposition ("floor" and "observation unit" collectively "ward" patients).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours postop
Awards & highlights
Study Summary
This trial will study whether showing report cards with machine-learned risk profiles to postoperative providers can help interpretation, communication, and workflow.
Who is the study for?
This trial is for surgeons in the Acute and Critical Care Surgery division or those with patients in the 16300 observation unit. It's specifically for a subset of TECTONICS study participants who are adults undergoing surgery at BJH South campus, excluding certain suites, and not planned for ICU after surgery.Check my eligibility
What is being tested?
The study tests how useful ML-based report cards are when given to postoperative providers. These report cards show risk profiles created from data collected before and during surgery to see if they help with understanding patient risks, fitting into workflow, and improving communication.See study design
What are the potential side effects?
Since this trial involves an information tool rather than a medical treatment, there aren't direct physical side effects like you'd expect with drugs or surgeries. However, it could impact decision-making processes in postoperative care.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am planned to be cared for in a regular hospital unit, not intensive care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 hours postop
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours postop
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Provider self-reported handoff effectiveness.
Secondary outcome measures
Direct observation of handoff
Provider information value of ML report card
Workflow effectiveness of the interventions
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
ML will be used to create a report card for each patient that summarizes the preoperative assessment and intraoperative data. Report card data will be made available to providers through multiple methods: integration into electronic health records workflows, electronic health records notifications, mobile device notifications, and print outs in the paper chart
Group II: Pre-interventionActive Control1 Intervention
The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,492 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,389 Total Patients Enrolled
Christopher R King, MD, PhDPrincipal InvestigatorWashington Univeristy School of Medicine
1 Previous Clinical Trials
3,375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planned to be cared for in a regular hospital unit, not intensive care.I am an adult scheduled for surgery.I am scheduled for an ICU admission.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Pre-intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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