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

NCT03441126 | Completed

• 1 other identifier: IRB00147182
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 5

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).

Conditions

Sepsis; Bacteremia

Keywords

Diagnostic Stewardship; Pediatric; Blood Culture Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Central line-associated bloodstream infections (CLABSI).

  42 months

• Broad spectrum antibiotic use

  42 months

• Clostridium difficile infection

  42 months

• Mortality

  42 months

• Length of ICU stay

  42 months

Study Arms (1)

Multicenter Quality Improvement program

Locally developed and reliably implemented ICU Quality Improvement program to reduce blood culture use.

Other: Multicenter Quality Improvement program

Interventions

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.

Multicenter Quality Improvement program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Institutions that plan to develop and implement a quality improvement program to reduce blood culture use in their ICUs

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (5)

St. Louis Children's Hospital, Washington University

St Louis, Missouri, 63110, United States

Location

Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

OHSU Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• 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.

  PMID: 27942705 BACKGROUND

• 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.

  PMID: 29165616 BACKGROUND

• Woods-Hill CZ, Koontz DW, Xie A, Colantuoni EA, Sick-Samuels A, Miller MR, Arthur A, Aneja A, Kumar U, Milstone AM; Brigh T STAR authorship group. Diagnostic stewardship for blood cultures in the pediatric intensive care unit: lessons in implementation from the BrighT STAR Collaborative. Antimicrob Steward Healthc Epidemiol. 2024 Sep 25;4(1):e148. doi: 10.1017/ash.2024.416. eCollection 2024.

  PMID: 39346668 DERIVED

MeSH Terms

Conditions

Sepsis; Bacteremia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Aaron Milstone, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 22, 2018
• Study Start: April 1, 2018
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)