Machine Learning Sepsis Alert Notification Using Clinical Data
NCT04005001 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37986
Last updated 2022-05-03
Summary
Machine learning is a powerful method to create clinical decision support (CDS) tools, when training labels reflect the desired alert behavior. In our Phase I work for this project, we developed HindSight, an encoding software that was designed to examine discharged patients' electronic health records (EHRs), identify clinicians' sepsis treatment decisions and patient outcomes, and pass those labeled outcomes and treatment decisions to an online algorithm for retraining of our machine-learning-based CDS tool for real-time sepsis alert notification, InSight. HindSight improved the performance of InSight sepsis alerts in retrospective work. In this study, we propose to assess the clinical utility of HindSight by conducting a multicenter prospective randomized controlled trial (RCT) for more accurate sepsis alerts.
Conditions
- Sepsis
- Severe Sepsis
- Septic Shock
Interventions
- OTHER
-
HindSight
HindSight will examine the dynamic trends of clinical measurements taken from a patient's EHR and analyzes correlations between vital signs to alert for the onset of sepsis.This machine learning based tool is optimized by encoder and utilizes periodic retraining to improve its performance over time.
- OTHER
-
InSight
Compared to the ability of the InSight software's recognition of sepsis onset to HindSight's performance. The study determines if the HindSight software has equivalent or better performance than the InSight software.
Sponsors & Collaborators
-
Cape Regional Medical Center
collaborator UNKNOWN -
Cooper University Medical Center
collaborator UNKNOWN -
Baystate Health
collaborator OTHER -
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
Dascena
lead INDUSTRY
Principal Investigators
-
Jana Hoffman, PhD · Dascena
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-25
- Primary Completion
- 2022-08-31
- Completion
- 2022-08-31
Countries
- United States
Study Locations
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