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Implementation and Evaluations of Sepsis Watch

NCT03655626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32003

Last updated 2019-08-01

No results posted yet for this study

Summary

The purpose of this study is to study the implementation and impact of an early warning system to detect and treat sepsis in the emergency room. We are observing the implementation of a Sepsis Machine Learning Model on all Adult patients. All data (observations field notes, interview recording \& transcripts, and survey responses) will be stored on HIPAA-compliant Duke servers behind the Duke firewall, and requiring password-protected user authentication to access. The risk to patients is minimal. The two risks to interviewed clinical staff we have identified involve loss of work time and anonymity.

Conditions

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Interventions

OTHER

Sepsis Watch

The operational intervention comprises of a sepsis machine learning model, custom dashboard to present risk scores, and a rapid response team to monitor patients at-risk of sepsis and deliver sepsis treatment. Sepsis Watch was developed under operational management. The rapid response team will utilize information presented on the dashboard and follow a protocol that will enable them to support the primary teams of hospitalized patients.

Sponsors & Collaborators

  • Data & Society Research Institute

    collaborator UNKNOWN

  • Duke Clinical Research Institute

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Cara O'Brien, MD · Duke Health

  • Mark Sendak, MD · Duke Institute for Health Innovation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-07-05
Completion
2019-07-05

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03655626 on ClinicalTrials.gov