Implementation and Evaluations of Sepsis Watch

NCT03655626 | Completed DMC

• 1 other identifier: Pro00093721
• Study Type: interventional
• Target: 32,003
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Machine Learning; Sepsis; Implementation Science; Health Information Technology

Outcome Measures

Primary Outcomes (1)

• Rate of Centers for Medicare and Medicaid Services (CMS) bundle completion for patients with sepsis

  Proportion of patients with sepsis that complete Center for Medicare and Medicaid Services treatment bundle

  Within 96 hours of emergency department arrival

Secondary Outcomes (14)

• Mean time from ED arrival to sepsis for patients with sepsis

  Within 96 hours of emergency department arrival

• Average number of patients who develop sepsis per day and month

  Within 96 hours of emergency department arrival

• Average number of patients who develop sepsis and are not treated per day and month

  Within 96 hours of emergency department arrival

• Mean ED length of stay for patients with sepsis

  Within 96 hours of emergency department arrival

• Mean Hospital length of stay for patients with sepsis

  Within 30 days of emergency department arrival

Other Outcomes (7)

• Number of antibiotic orders in Duke University Hospital emergency department per month

  Within 96 hours of emergency department arrival

• Number of antibiotic days in Duke University Hospital emergency department per month

  Within 96 hours of emergency department arrival

• Number of blood culture orders in Duke University Hospital emergency department per month

  Within 96 hours of emergency department arrival

Study Arms (1)

Sepsis Watch on Duke University Hospital ED Adults

EXPERIMENTAL

Patients older than 18 years old at time of presentation to Duke University Hospital emergency department.

Other: Sepsis Watch

Interventions

Sepsis Watch OTHER

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.

Sepsis Watch on Duke University Hospital ED Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arrival to Duke University Hospital emergency department pods A, B, and C, or resuscitation bay

You may not qualify if:

• Under 18 years old at time of emergency department arrival

Sponsors & Collaborators

• Duke University: lead
• Data & Society Research Institute: collaborator
• Duke Clinical Research Institute: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Links

• Learning to Detect Sepsis with a Multitask Gaussian Process Recurrent Neural Network Classifier
• An Improved Multi-Output Gaussian Process Recurrent Neural Network with Real-Time Validation for Early Sepsis Detection
• Society of Hospital Medicine Abstract

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Cara O'Brien, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

• Mark Sendak, MD

  Duke Institute for Health Innovation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: November 5, 2018
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)