Clinical trial NCT03441126: Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children
Official title: Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Bacteremia
Keywords: Diagnostic Stewardship
Pediatric
Blood Culture Test
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patient populations from units that develop and implement a quality improvement program to reduce blood culture use

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood culture rate
timeFrame: Change in blood cultures per 100 patient days per month at 42 months
Secondary outcomes:
measure: Central line-associated bloodstream infections (CLABSI).
timeFrame: 42 months
measure: Broad spectrum antibiotic use
timeFrame: 42 months
measure: Clostridium difficile infection
timeFrame: 42 months
measure: Mortality
timeFrame: 42 months
measure: Length of ICU stay
timeFrame: 42 months
measure: ICU readmission
timeFrame: 42 months
measure: Hospital readmission
timeFrame: 42 months
measure: Sepsis
timeFrame: 42 months
measure: Septic shock
timeFrame: 42 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital, Washington University
state: Missouri
city: Cleveland
country: United States
facility: Rainbow Babies & Children's Hospital
state: Ohio
city: Portland
country: United States
facility: OHSU Doernbecher Children's Hospital
state: Oregon
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Aaron Milstone, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.