- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00698542
Evaluation of the Patient Safety Screening Tool (PSST) for Sepsis
A Validation of a Patient Safety Screening Tool for Sepsis
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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1
Patients in the NCU at VUH
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Demonstrate a reduction in time to detection of sepsis using the PSST Alert System
Time Frame: 6 and 24 hours
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6 and 24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Determine the accuracy of the PSST Alert System
Time Frame: 6 and 24 hours
|
6 and 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John A Barwise, M.D., Vanderbilt University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80093
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