Electronic Application of a Severe Sepsis Screening Tool and Management Bundle (eASSIST-M)
Thousands of children die from Sepsis following routine infections. Many of these deaths can be prevented with earlier recognition and focused management. No tools are currently available to recognize the signs of early sepsis in children. The investigators have developed a electronic health record-based tool that will recognize children with sepsis early and trigger an alert to their hospital caregivers. The caregivers will be prompted to launch a focused management bundle that can stabilize these children, prevent further deterioration and reduce their chances of sepsis related complications and death. The proposed study will test the validity and effectiveness of this electronic tool in reducing sepsis mortality rates.
Systemic Inflammatory Response Syndrome (SIRS)
Other: Severe Sepsis Management Bundle
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes|
- Validity of the Pediatric Severe Sepsis Screening Tool [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ] [ Designated as safety issue: Yes ]Proportion of correctly diagnosed patients with severe sepsis among those presenting with SIRS will be assessed to prospectively validate the sensitivity, specificity, positive and negative predictive values of the PSSST tool.
- Time delay from diagnostic identification to critical therapeutic intervention in patients with Severe Sepsis. [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ] [ Designated as safety issue: Yes ]Sepsis Recognition Lag Time will be defined as the time elapsed from the first electronic alert to the first therapeutic intervention. Therapeutic interventions will be defined as Cardiopulmonary Resuscitation (CPR), fluid resuscitation, initiation of cardiotonic agents, or request for transfer to the ICU. Since this is an intent-to-diagnose study, outcomes defined above will be compared with those for the same period in the preceding year.
- Morbidity and Mortality Rates from Severe Sepsis [ Time Frame: Average 60 days - Patients will be followed up until hospital discharge ] [ Designated as safety issue: No ]Morbidity will be defined as the number of ventilator days, days on vasopressor or inotropic agents, days of Extracorporeal Membrane Oxygenation (ECMO) support, need for tracheostomy, need for Gastrostomy tube. Mortality will be defined as the proportion of deaths in children with severe sepsis.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Electronically Screened Sepsis Patients
Patients between the ages 1 month and 18 years admitted to the hospital or presenting to the Emergency Department (ED) with clinical signs of Systemic Inflammatory Response Syndrome (SIRS) electronically screened for severe sepsis. Patients screened as positive will receive an evidence based goal directed severe sepsis management bundle.
Other: Severe Sepsis Management Bundle
Management Bundle includes:
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724463
|Contact: Samir H Shah, MBBS, MBAfirstname.lastname@example.org|
|Contact: Kanwaljeet S Anand, MBBS, FCCMemail@example.com|
|United States, Tennessee|
|University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Samir H Shah, MBBS FRCPC 901-287-6303 firstname.lastname@example.org|
|Contact: Kanwaljeet S Anand, MBBS FCCM 9012876303 email@example.com|
|Principal Investigator: Samir H Shah, MBBS FRCPC|
|Principal Investigator:||Samir H Shah, MBBS MBA||University of Tennessee Health Sciences Center|
|Study Director:||Kanwaljeet S Anand, MBBS FCCM||University of Tennessee Health Sciences Center|