NCT02755025

Brief Summary

The SOFA score is a severity of illness and prognostic score used in the ICU. It has also recently been adopted as part of the definition of sepsis. This study will prospectively evaluate the usability of automated SOFA scoring for ICU patients within an electronic patient monitoring dashboard. It will also assess for changes in physician ordering (volume and types of orders) after automatic scoring is implemented.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

March 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

March 15, 2016

Last Update Submit

March 27, 2017

Conditions

Sepsis

Keywords

SepsisSOFA scoreAutomated calculation

Outcome Measures

Primary Outcomes (1)

  • SOFA related laboratory order volume

    The total number of SOFA related laboratory orders on all patients in the ICU during the intervention period

    2 months

Secondary Outcomes (1)

  • Module usability

    2 months

Study Arms (1)

Prospective cohort

This group will include ICU patients for the two month period after the automated SOFA score has been activated within the electronic patient care dashboard.

Other: Automated SOFA scoring calculator

Interventions

Automated SOFA scoring calculatorOTHER

Automated SOFA scoring will be activated within an existing electronic patient care dashboard for ICU patients.

Prospective cohort

Eligibility Criteria

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

Adult patients admitted to the medical intensive care unit during the 2 month time period after the automated SOFA scoring module is activated within the electronic dashboard.

You may qualify if:

  • Patients admitted to the medical intensive care unit within 2 months of automated SOFA scoring module activation.

You may not qualify if:

  • Refusal to allow medical records to be used for clinical research.

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

  • Christopher A Aakre, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 28, 2016

Study Start

July 1, 2016

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share