Electronic Application of a Severe Sepsis Screening Tool and Management Bundle

• Conditions: Sepsis; Systemic Inflammatory Response Syndrome (SIRS); Severe Sepsis; Septic Shock
• Interventions: Other: Severe Sepsis Management Bundle

• Registration Number: NCT01724463
• Lead Sponsor: University of Tennessee

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.

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-09
• Study Start: 2013-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electronically Screened Sepsis Patients	Severe Sepsis Management Bundle	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.

Primary Outcome Measures

Name	Time	Method
Validity of the Pediatric Severe Sepsis Screening Tool	Average 60 days - Patients will be followed up until hospital discharge	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 Outcome Measures

Name	Time	Method
Time delay from diagnostic identification to critical therapeutic intervention in patients with Severe Sepsis.	Average 60 days - Patients will be followed up until hospital discharge	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.

Trial Locations

Locations (1)

University of Tennessee Health Sciences Center / Le Bonheur Children's Hospital; 🇺🇸 Memphis, Tennessee, United States