Electronic Application of a Severe Sepsis Screening Tool and Management Bundle

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.

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