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

Sepsis Clinical Trial

— Bright STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441126
• Other study ID #: IRB00147182
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: December 28, 2021

Study information

• Verified date: March 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Sepsis

Intervention

Other:
• Multicenter Quality Improvement program
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.

Locations

Country	Name	City	State
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Rainbow Babies & Children's Hospital	Cleveland	Ohio
United States	OHSU Doernbecher Children's Hospital	Portland	Oregon
United States	St. Louis Children's Hospital, Washington University	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Woods-Hill CZ, Fackler J, Nelson McMillan K, Ascenzi J, Martinez DA, Toerper MF, Voskertchian A, Colantuoni E, Klaus SA, Levin S, Milstone AM. Association of a Clinical Practice Guideline With Blood Culture Use in Critically Ill Children. JAMA Pediatr. 2017 Feb 1;171(2):157-164. doi: 10.1001/jamapediatrics.2016.3153. — View Citation

Xie A, Woods-Hill CZ, King AF, Enos-Graves H, Ascenzi J, Gurses AP, Klaus SA, Fackler JC, Milstone AM. Work System Assessment to Facilitate the Dissemination of a Quality Improvement Program for Optimizing Blood Culture Use: A Case Study Using a Human Factors Engineering Approach. J Pediatric Infect Dis Soc. 2019 Mar 28;8(1):39-45. doi: 10.1093/jpids/pix097. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood culture rate	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.	Change in blood cultures per 100 patient days per month at 42 months
Secondary	Central line-associated bloodstream infections (CLABSI).	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.	42 months
Secondary	Broad spectrum antibiotic use	Use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter	42 months
Secondary	Clostridium difficile infection	Incidence of infections per 1000 patient days per quarter	42 months
Secondary	Mortality	Death per hospital total ICU admissions comparing pre and post-intervention periods	42 months
Secondary	Length of ICU stay	Days in ICU; median number of days comparing pre and post-intervention periods	42 months
Secondary	ICU readmission	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	42 months
Secondary	Hospital readmission	Readmission to hospital within 7 days of discharge where we measured change in rate of hospital readmission comparing pre and post-intervention periods at	42 months
Secondary	Sepsis	Defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions	42 months
Secondary	Septic shock	Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions	42 months