SepsisBright STARNCT03441126
Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children
An observational study of Sepsis and Bacteremia, run by Johns Hopkins University at 5 sites in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Bacteremia
- What is being tested?
- Multicenter Quality Improvement program
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2018to 28 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ICU patient populations from units that develop and implement a quality improvement program to reduce blood culture use
Who may be able to join
- Institutions that plan to develop and implement a quality improvement program to reduce blood culture use in their ICUs
Who cannot join
- No exclusion criteria
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
OHSU Doernbecher Children's Hospital
Portland, Oregon, 97239
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital, Washington University
St Louis, Missouri, 63110
About this study
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).
Read the 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.
- Conditions
- Sepsis, Bacteremia
- Being tested
- Multicenter Quality Improvement program
- Keywords
- Diagnostic Stewardship, Pediatric, Blood Culture Test
- Medical subject headings
- Sepsis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicenter Quality Improvement programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicenter Quality Improvement program | Locally developed and reliably implemented ICU Quality Improvement program to reduce blood culture use. Receives: Other: Multicenter Quality Improvement program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in blood cultures per 100 patient days per month at 42 months
Secondary outcomes (9)
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.
Measured: 42 months
Broad spectrum antibiotic use
Use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter
Measured: 42 months
Clostridium difficile infection
Incidence of infections per 1000 patient days per quarter
Measured: 42 months
Mortality
Death per hospital total ICU admissions comparing pre and post-intervention periods
Measured: 42 months
Length of ICU stay
Days in ICU; median number of days comparing pre and post-intervention periods
Measured: 42 months
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
Measured: 42 months
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
Measured: 42 months
Sepsis
Defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions
Measured: 42 months
Septic shock
Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Apr 2018
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Milstone, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441126
- Sponsor's protocol ID
- IRB00147182
- Acronym
- Bright STAR
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not collect any. We will only gather summary-level non Patient Health Information (PHI) from participating sites.
Publications
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.
PubMed 27942705Xie 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.
PubMed 29165616Woods-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.
PubMed 39346668
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children
- ClinicalTrials.gov ID
- NCT03441126
- Acronym / sponsor ID
- Bright STAR / IRB00147182
- Conditions
- Sepsis, Bacteremia
- Keywords
- Diagnostic Stewardship, Pediatric, Blood Culture Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicenter Quality Improvement program | – | Other: Multicenter Quality Improvement programLocally developed and reliably implemented ICU Quality Improvement program to reduce blood culture use. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patient populations from units that develop and implement a quality improvement program to reduce blood culture use
Key inclusion criteria (1 listed)
- Institutions that plan to develop and implement a quality improvement program to reduce blood culture use in their ICUs
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicenter Quality Improvement programParticipating 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. | Other | Multicenter Quality Improvement program |
Primary outcome
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.
9 secondary outcomes
Central line-associated bloodstream infections (CLABSI).
Time frame: 42 months
Broad spectrum antibiotic use
Time frame: 42 months
Clostridium difficile infection
Time frame: 42 months
Mortality
Time frame: 42 months
Length of ICU stay
Time frame: 42 months
ICU readmission
Time frame: 42 months
Hospital readmission
Time frame: 42 months
Sepsis
Time frame: 42 months
Septic shock
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 27942705Woods-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.
- Background: PubMed 29165616Xie 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.
- Derived from this study: PubMed 39346668Woods-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.
- Individual participant dataSharing planned: No. We will not collect any. We will only gather summary-level non Patient Health Information (PHI) from participating sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Milstone, MD, MHS principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Bacteremia, run by Johns Hopkins University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood culture rate (time frame: Change in blood cultures per 100 patient days per month at 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03441126, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.