NCT02694159

Brief Summary

The study goal is to improve the value of care and reduce health disparities by developing a targeted set of sophisticated and powerful algorithms to improve upon human clinical judgments. The plan is to use the test case of detecting sepsis in patients in the emergency department (ED) as the first step in improving the value of care and reducing health disparities by developing a targeted set of sophisticated and powerful algorithms to improve upon human clinical judgments. This work will be performed using data from the University of Pennsylvania Health System where a preliminary Early Warning and Response System for Sepsis monitors clinical parameters. The premise underlying all this work is that by improving decision-making, it will both reduce low-value care and health disparities.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5.9 years

First QC Date

February 18, 2016

Last Update Submit

July 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients developing sepsis

    The primary outcome variable is whether patients developed sepsis.

    Two years

Secondary Outcomes (2)

  • Under- and over-diagnosis of sepsis

    Two years

  • Treatment decisions among patients in the emergency department

    Two years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical data on tens of thousands of patients presented to ED and transferred to ICUs or general hospital units within the University of Pennsylvania Health System from 2008 to 2014.

You may qualify if:

  • Patients presented to EDs and transferred to ICUs or general hospital units within the University of Pennsylvania Health System

You may not qualify if:

  • Children and adolescents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amol Navathe, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 29, 2016

Study Start

February 1, 2016

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share