Clinical trial NCT01724463: Electronic Application of a Severe Sepsis Screening Tool and Management Bundle
Official title: Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle Study to Improve Sepsis Related Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Severe Sepsis
Septic Shock
Keywords: Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Severe Sepsis
Septic Shock
Electronic Health Record
Health Screening
Goal Directed Therapy
Infant
Child
Pediatric
Adolescent
Critical Illness
Outcomes Research
Resource Utilization
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 30000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.

Detailed description: Project: Application of a Severe Sepsis Electronic Health Record Integrated Screening Tool and Management Bundle (eASSIST-M) Study

Study Type: Prospective Cohort Outcomes Study

Background: Early recognition of severe sepsis is critical for the institution of goal- directed therapy and for improving patient outcomes. Barriers to early recognition include the lack of standardized tools to identify children with severe sepsis. The investigators will study the potential impact of applying a novel Pediatric Severe Sepsis Screening Tool (PSSST) integrated with the Electronic Health Record (EHR) to facilitate earlier detection and effective management of severe sepsis.

Population: 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).

Primary Hypothesis: Prospective application of a PSSST electronically integrated with the EHR can accurately diagnose pediatric patients with early signs of severe sepsis.

Primary Outcome Measure: 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.

Secondary Hypothesis 1: Application of the PSSST will reduce lag-time for the administration of a goal-directed sepsis therapy bundle by 50%.

Outcome Measure: Time delay from diagnostic identification to critical therapeutic intervention. 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.

Secondary Hypothesis 2: Application of a severe sepsis management bundle will reduce mortality and morbidity.

Outcome Measure: Proportion of deaths in the study population due to severe sepsis. 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.

Proposed Study Design:

The investigators will conduct a prospective study where patients within the ED and inpatient units are electronically screened using the PSSST during a 3-year study period. Patients will be screened using a novel electronic tracking tool designed locally, using pre-defined severe sepsis variables and validated on patients with severe sepsis. Patients screened as positive for severe sepsis using the electronic tracking tool will be treated prospectively with a standardized severe sepsis management bundle. Data will be collected prospectively on all patients admitted to the ED and inpatient units. For the ED and each inpatient unit, the outcomes defined above will be compared with those for the same period in the preceding year.

Covariates: Demographic, clinical characteristics and sepsis-specific factors that could potentially influence the effect of the alerts on critical intervention.

Statistical Analysis:

To assess the effectiveness of this tool, we will compare the proportions of the population with each variable of interest between the intervention and prior periods.

1. To assess the efficacy of the PSSST, we will compare the changes over time in the proportion of patients diagnosed severe sepsis adjusting for key covariates of interest.
2. To assess the effectiveness of the PSSST in reducing treatment delays, we will compare changes in the Sepsis Recognition Lag Time between the intervention and control periods, while adjusting for key covariates of interest.
3. To assess the efficacy of the PSSST in reducing mortality, we will compare the changes in the age and risk adjusted mortality rates over time between the intervention and control periods.

The investigators will use a robust variance estimate for all analyses to account for the clustering of patients within units. We will also use propensity scores to control for differences in patient characteristics and diagnostic categories.

Eligibility criteria: Inclusion Criteria:

1. Age 1 month - 18 years
2. Clinical Suspicion of Infection
3. Patients in the Hospital or Emergency Department

Exclusion Criteria:

1. Status Asthmaticus patients on active bronchodilator therapy
2. Patients receiving Anesthesia
3. Day Surgery Patients
4. Outpatient Clinic Patients
5. Congenital Heart Disease Patients
6. Myocarditis Neonates Patients older than 18 years

Primary outcomes:
measure: Validity of the Pediatric Severe Sepsis Screening Tool
timeFrame: Average 60 days - Patients will be followed up until hospital discharge
Secondary outcomes:
measure: Time delay from diagnostic identification to critical therapeutic intervention in patients with Severe Sepsis.
timeFrame: Average 60 days - Patients will be followed up until hospital discharge
Other outcomes:
measure: Morbidity and Mortality Rates from Severe Sepsis
timeFrame: Average 60 days - Patients will be followed up until hospital discharge
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee Health Sciences Center
name: Samir H Shah, MBBS MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee Health Sciences Center
name: Kanwaljeet S Anand, MBBS FCCM
role: STUDY_DIRECTOR
References:
citation: Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
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citation: Cruz AT, Perry AM, Williams EA, Graf JM, Wuestner ER, Patel B. Implementation of goal-directed therapy for children with suspected sepsis in the emergency department. Pediatrics. 2011 Mar;127(3):e758-66. doi: 10.1542/peds.2010-2895. Epub 2011 Feb 21.
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