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

Sepsis Clinical Trial

Official title:

A Validation of a Patient Safety Screening Tool for Sepsis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00698542
• Other study ID #: 80093
• Status: Terminated
• Phase: N/A
• First received: June 12, 2008
• Last updated: April 19, 2017
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 221
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate a reduction in time to detection of sepsis using the PSST Alert System		6 and 24 hours
Secondary	Determine the accuracy of the PSST Alert System		6 and 24 hours

External Links

•   Vanderbilt University Medical Center Department of Anesthesiology