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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698542
Recruitment Status : Terminated (The study design failed and the data was not able to be analyzed.)
First Posted : June 17, 2008
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
John Allan Barwis, Vanderbilt University

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 221 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Validation of a Patient Safety Screening Tool for Sepsis
Study Start Date : May 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Patients in the NCU at VUH

Primary Outcome Measures :
  1. Demonstrate a reduction in time to detection of sepsis using the PSST Alert System [ Time Frame: 6 and 24 hours ]

Secondary Outcome Measures :
  1. Determine the accuracy of the PSST Alert System [ Time Frame: 6 and 24 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698542

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: John A Barwise, M.D. Vanderbilt University Medical Center
Additional Information:
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Responsible Party: John Allan Barwis, Asssistant Professor, Vanderbilt University Identifier: NCT00698542    
Other Study ID Numbers: 80093
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by John Allan Barwis, Vanderbilt University:
Neuro Care Unit
Surviving Sepsis Campaign
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes