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Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children

Completed
Conditions
Bacteremia
Sepsis
Interventions
Other: Multicenter Quality Improvement program
Registration Number
NCT03441126
Lead Sponsor
Johns Hopkins University
Brief Summary

This study will test the hypothesis that reliable implementation of an evidence-based clinical practice guideline for evaluation of patients with signs and symptoms of sepsis will decrease antibiotic use in pediatric intensive care units (PICUs).

Detailed Description

The Bright STAR Collaborative (BSC), or Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children Collaborative, is a multicenter quality improvement program to reduce blood culture use within pediatric intensive care units. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.

Greater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).

Aim 1: To determine if reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can decrease blood culture use in pediatric intensive care units.

Aim 2: To determine if reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can decrease central line-associated bloodstream infections in pediatric intensive care units.

Aim 3. To determine if reliable implementation of clinical practice guidelines for evaluation of patients with signs and symptoms of sepsis can reduce antibiotic use and Clostridium difficile infection.

Aim 4. To determine whether a clinical practice guideline for evaluation of patients with signs and symptoms of sepsis in the PICU has an unintended consequence of patient harm.

Aim 5. To evaluate the implementation of a multi-institutional quality improvement initiative and identify strategies for successful scale-up and adoption of similar practice guidelines in other clinical settings.

Variables: blood cultures and central line-associated blood stream infections (CLABSIs), antibiotic use, , episodes of Clostridium difficile infection mortality, length of stay, ICU readmission, hospital readmission, episodes of sepsis, and episodes of septic shock.

Analyses: The analytic approach equates to estimating and comparing the blood culture incidence during the "baseline/pre-implementation" and "post-implementation" periods, using a generalized linear mixed model (GLMM) assuming a Poisson distribution for the monthly number of blood cultures with the monthly number of patient days as an offset. Similar analyses will be conducted to evaluate the incidence of blood cultures drawn from central lines and CLABSIs. Due to the expected low incidence of CLABSIs, investigators will define time in quarters, not months, for that outcome. Similar analyses will be performed for secondary outcomes.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Institutions that plan to develop and implement a quality improvement program to reduce blood culture use in their ICUs
Exclusion Criteria
  • No exclusion criteria

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Multicenter Quality Improvement programMulticenter Quality Improvement programLocally developed and reliably implemented ICU Quality Improvement program to reduce blood culture use.
Primary Outcome Measures
NameTimeMethod
Blood culture rateChange in blood cultures per 100 patient days per month at 42 months

The primary outcome of interest is blood culture rate in participating PICUs. A blood culture will be defined as any blood culture processed by the clinical microbiology laboratory.

Secondary Outcome Measures
NameTimeMethod
Central line-associated bloodstream infections (CLABSI).42 months

The secondary outcome of interest is CLABSIs in participating PICUs. The outcome measurement will include a denominator of catheter days in the participating units.We will measure the change in CLABSI rate per month.

Clostridium difficile infection42 months

Incidence of infections per 1000 patient days per quarter

Mortality42 months

Death per hospital total ICU admissions comparing pre and post-intervention periods

Sepsis42 months

Defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions

Septic shock42 months

Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions

Hospital readmission42 months

Readmission to hospital within 7 days of discharge where we measured change in rate of hospital readmission comparing pre and post-intervention periods at

Length of ICU stay42 months

Days in ICU; median number of days comparing pre and post-intervention periods

Broad spectrum antibiotic use42 months

Use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter

ICU readmission42 months

Readmission to the ICU within 7 days of discharge. We will measure the change in rate of readmission per total ICU admissions comparing pre and post-intervention periods

Trial Locations

Locations (5)

Rainbow Babies & Children's Hospital

🇺🇸

Cleveland, Ohio, United States

St. Louis Children's Hospital, Washington University

🇺🇸

Saint Louis, Missouri, United States

OHSU Doernbecher Children's Hospital

🇺🇸

Portland, Oregon, United States

Dell Children's Medical Center of Central Texas

🇺🇸

Austin, Texas, United States

Seattle Children's Hospital

🇺🇸

Seattle, Washington, United States

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