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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00698542
First received: June 12, 2008
Last updated: December 12, 2008
Last verified: December 2008
  Purpose

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.


Condition
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Validation of a Patient Safety Screening Tool for Sepsis

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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 ]

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

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients in the NCU at VUH

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will be located in the 22 bed Vanderbilt University Medical Center Neuro Care Unit (NCU). Every patient will be screened for sepsis according to the following workflow upon admission to the NCU. The patient population of the NCU is generally bimodal; the first group consists of post-operative patients with an average length of stay of three to five days. The second group consists of subarachnoid hemorrhage patients with an average length of stay of 45 days.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698542

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: John A Barwise, M.D. Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: John A Barwise, M.D.,, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00698542     History of Changes
Other Study ID Numbers: 80093
Study First Received: June 12, 2008
Last Updated: December 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
PSST
sepsis
Neuro Care Unit
Surviving Sepsis Campaign
SSC

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014