Clinical Score Usefulness and EHR Integration (ScoreInt)

March 27, 2017 updated by: Christopher Aakre, Mayo Clinic

Evaluation of Clinical Score Usefulness and Feasibility of Integration Into Electronic Health Record Interfaces

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Automated SOFA scoring will be activated within an existing electronic patient care dashboard for ICU patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOFA related laboratory order volume
Time Frame: 2 months
The total number of SOFA related laboratory orders on all patients in the ICU during the intervention period
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Module usability
Time Frame: 2 months
Providers will be surveyed on the usability of the automated scoring module
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Christopher A Aakre, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

August 31, 2016

Study Completion (ACTUAL)

August 31, 2016

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (ESTIMATE)

April 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-009228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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