Machine Learning Sepsis Alert Notification Using Clinical Data

NCT04005001 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37986

Last updated 2022-05-03

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04005001 on ClinicalTrials.gov