Evaluation of the Patient Safety Screening Tool (PSST) for Sepsis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 12, 2008

Last Updated Date

December 12, 2008

Start Date ^†

May 2008

Current Primary Outcome Measures ^†

Demonstrate a reduction in time to detection of sepsis using the PSST Alert System [ Time Frame: 6 and 24 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698542 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Determine the accuracy of the PSST Alert System [ Time Frame: 6 and 24 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Evaluation of the Patient Safety Screening Tool (PSST) for Sepsis

Official Title ^†

A Validation of a Patient Safety Screening Tool for Sepsis

Brief Summary

The Patient Safety Screening Tool (PSST) for Sepsis solution is a tool to assist with the early detection of Sepsis and management of the administration of bundle packages as defined by the Institute for Healthcare Improvement (IHI). This web based application relies on integration with bedside medical equipment (BME) data as well as Lab and Registration data so that clinical workflow items can be automated in the fight against Sepsis.

Detailed Description

The workflow that is automated by the PSST for Sepsis solution is tightly integrated with Registration, Bedside Monitoring Equipment (BME), and Lab data.

As patients arrive in the unit, workflow activities are started with patient context. Typical implementations of the IHI guidelines for Sepsis screening dictate that patients are rescreened on regular intervals to detect Sepsis. The PSST for Sepsis solution will monitor Lab and BME data stores and continually update the screening forms for a particular patient. It will also alert clinicians when a manual screen is required in the Microsoft InfoPath form. The constant screening loop is managed by the PSST for Sepsis solution and will continue to run until the patient screens positive for Severe Sepsis, or moves to the next workflow of auditing a patient with Sever Sepsis.

When patients reach a state of "positive screen" (either manually, or through the automated data monitors) the PSST for Sepsis solution will move this patient from a screening workflow to an auditing workflow automatically. The PSST for Sepsis solution will then monitor the treatment process through Microsoft InfoPath form posts and alert clinicians when treatment goals have not been met. After a successful auditing process and completion of the 6 and 24 hour bundles, the patient will be placed back into a screening workflow. The end result is that patients will remain in a screening/auditing workflow loop until the patient is discharged from the unit.

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Sepsis

Intervention ^†

Study Arms / Comparison Groups

Patients in the NCU at VUH

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Enrolling by invitation

Estimated Enrollment ^†

200

Estimated Completion Date

July 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patients that are hospitalized in the Neuro Care Unit (NCU)
Patients that are hospitalized in the Vanderbilt Burn Center
Patients must be > 18 years of age

Exclusion Criteria:

Patients < 18 years of age

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698542

Responsible Party

John A Barwise, M.D.,, Vanderbilt University

Secondary IDs ^††

Study Sponsor ^†

Vanderbilt University

Collaborators ^††

Investigators ^†

Principal Investigator:

John A Barwise, M.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.