SepsisNCT00698542
Evaluation of the Patient Safety Screening Tool (PSST) for Sepsis
An observational study of Sepsis, run by Vanderbilt University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients < 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: A Validation of a Patient Safety Screening Tool for Sepsis
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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- PSST, sepsis, Neuro Care Unit, Surviving Sepsis Campaign, SSC
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients in the NCU at VUH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate a reduction in time to detection of sepsis using the PSST Alert System
Measured: 6 and 24 hours
Secondary outcomes (1)
Determine the accuracy of the PSST Alert System
Measured: 6 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: The study design failed and the data was not able to be analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Allan Barwis, Vanderbilt University
- Investigators
- John A Barwise, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698542
- Sponsor's protocol ID
- 80093
- Status last verified
- Apr 2017
- First submitted
- 12 Jun 2008
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of a Patient Safety Screening Tool for Sepsis
- ClinicalTrials.gov ID
- NCT00698542
- Acronym / sponsor ID
- 80093
- Conditions
- Sepsis
- Keywords
- PSST, sepsis, Neuro Care Unit, Surviving Sepsis Campaign, SSC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study design failed and the data was not able to be analyzed.
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients in the NCU at VUH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstrate a reduction in time to detection of sepsis using the PSST Alert System
Time frame: 6 and 24 hours
1 secondary outcome
Determine the accuracy of the PSST Alert System
Time frame: 6 and 24 hours
Results and safety
The study was stopped early (reason given: The study design failed and the data was not able to be analyzed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Vanderbilt University Medical Center Department of AnesthesiologyLink provided by the sponsor.
Related trials for Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Barwise, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study design failed and the data was not able to be analyzed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate a reduction in time to detection of sepsis using the PSST Alert System (time frame: 6 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.