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Completed

NCT Number: NCT03441126

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

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Louis Children's Hospital, Washington University, St Louis, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multicenter Quality Improvement program

Other

Participating institutions will not participate in an intervention study. Sites will design and implement local QI programs to improve care within their unit. Local healthcare teams, who are interested in directly and immediately improving patient outcomes, will devise customized tools. The Bright STAR Team will assess the impact of these local QI initiatives on patient health outcomes, using data that are collected as part of the QI programs or through routine clinical care.

Primary outcomes

  1. Blood culture rate

    Time frame: Change 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 outcomes

  1. Central line-associated bloodstream infections (CLABSI).

    Time frame: 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.

  2. Broad spectrum antibiotic use

    Time frame: 42 months

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

  3. Clostridium difficile infection

    Time frame: 42 months

    Incidence of infections per 1000 patient days per quarter

  4. Mortality

    Time frame: 42 months

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

  5. Length of ICU stay

    Time frame: 42 months

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

  6. ICU readmission

    Time frame: 42 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

  7. Hospital readmission

    Time frame: 42 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

  8. Sepsis

    Time frame: 42 months

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

  9. Septic shock

    Time frame: 42 months

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: Bright STAR

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2018
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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