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Trial record 73 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children (Bright STAR)

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ClinicalTrials.gov Identifier: NCT03441126
Recruitment Status : Active, not recruiting
First Posted : February 21, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Sepsis Bacteremia Other: Multicenter Quality Improvement program

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.


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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Multicenter Quality Improvement program
Locally developed and reliably implemented ICU Quality Improvement program to reduce blood culture use.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441126


Locations
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United States, Missouri
St. Louis Children's Hospital, Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Oregon
OHSU Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Aaron Milstone, MD, MHS Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03441126     History of Changes
Other Study ID Numbers: IRB00147182
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not collect any. We will only gather summary-level non Patient Health Information (PHI) from participating sites.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Diagnostic Stewardship
Pediatric
Blood Culture Test
Additional relevant MeSH terms:
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Bacteremia
Pathologic Processes
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Anti-Bacterial Agents
Anti-Infective Agents