Clinical Score Usefulness and EHR Integration | NCT02755025

Studies
Clinical Score Usefulness and EHR Integration

NCT02755025

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 29, 2017Actual

Enrollment

215Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Automated SOFA scoring calculator

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Aug 31, 2016Actual

Completion Date

Aug 31, 2016Actual

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Apr 26, 2016

First Posted Date

Apr 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Automated SOFA scoring calculator	Other	Automated SOFA scoring will be activated within an existing electronic patient care dashboard for ICU patients.	Prospective cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Christopher A Aakre, MD	Mayo Clinic	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

Not provided