- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05975671
Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP)
Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP-Sepsis)
The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU).
There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include:
- Implementation of a clinical guideline indicating when vancomycin should and should not be used
- Unit-level feedback on overall vancomycin use within and across centers
- Clinician education.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Vancomycin is among the most commonly prescribed antibiotics in United States children's hospitals, and inappropriate use of vancomycin is common. Given the high prevalence of acute kidney injury associated with vancomycin of up to 25%, reducing vancomycin overuse is a key opportunity to reduce preventable patient harm.
The primary objective of this study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care PICUs. This intervention will be informed by baseline data surrounding vancomycin use and infections due to organisms requiring vancomycin therapy which will allow selective use of vancomycin, as well as a concurrent mixed methods process and formative evaluation to inform implementation of the intervention.
During the baseline period, Electronic Health Record (EHR) data will be used to retrospectively quantify unit-level vancomycin use over 24 months (measured as vancomycin days of therapy [DOT]/1000 patient days), as well as the frequency of vancomycin use and prevalence of infections due to organisms requiring vancomycin therapy among patients with suspected and confirmed sepsis.
During the post-intervention period, which will last approximately 24 months, a multifaceted stewardship intervention to reduce vancomycin use informed by these baseline data, including:
- The creation of a consensus guideline for vancomycin use;
- Ad hoc education related to vancomycin overuse, and;
- Unit-level feedback on vancomycin prescribing. The feedback on vancomycin use will be provided to clinicians at each site, both within their site (to compare to past performance) and across sites (to compare local performance to the performance of other sites).
This intervention will be locally adapted by the investigative team and sepsis stakeholders at each site. Data from the EHR will be used to assess vancomycin use (DOT/1000 patient days), as well as the secondary outcomes. Investigators will perform semi-structured interviews and repeat surveys 9 months after the implementation of the intervention. This mixed-methods process and formative evaluation will help investigators understand which elements of implementation were successful and which were not.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathleen Chiotos, MD, MSCE
- Phone Number: 215-590-5505
- Email: chiotosk@chop.edu
Study Contact Backup
- Name: Didien Meyahnwi, MD
- Phone Number: 215-590-5505
- Email: meyahnwid@chop.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta
-
Contact:
- Preeti Jaggi, MD
- Phone Number: 404-727-4807
- Email: preeti.jaggi@emory.edu
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Children's Center
-
Contact:
- Pranita Tamma, MD, MPH
- Email: ptamma1@jhmi.edu
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- St. Louis Children's Hospital
-
Contact:
- Jason Newland, MD, MEd
- Phone Number: 314-747-5128
- Email: jgnewland@wustl.edu
-
Contact:
- Luke Starnes, PhD
- Phone Number: 314-286-2092
- Email: garys@wustl.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19146
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Kathleen Chiotos, MD, MSCE
- Phone Number: 215-590-5505
- Email: chiotosk@chop.edu
-
Principal Investigator:
- Kathleen Chiotos
-
Sub-Investigator:
- Rebecca Same
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Patient Inclusion Criteria:
- Admitted to one of the participating PICUs during the study period
Patient Exclusion Criteria:
- None
Clinician Inclusion Criteria:
- PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed
- Age ≥ 18 years old
- Employed by one of the participating sites
Clinician Exclusion Criteria:
- Volunteers or other non-employee hospital staff
- Limited English proficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PICU Clinicians and Sepsis stakeholders
Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention:
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Other Names:
|
No Intervention: PICU Patients with suspected sepsis
Research procedures involving patients will be limited to medical record review.
This medical record review will help inform the intervention directed at PICU clinicians/stakeholders and the assessment of study outcomes.
Approximately 50,000 patients will participate in the study.
Data elements will be collected at each site and stored as password-protected Comma-separated values (CSV) files.
These files will not contain any direct Protected Health Information (PHI) but will contain elements of date (e.g., date of admission, date of suspected sepsis episode).
The study Identification (ID) number will be used to identify each unique patient.
Each site will collect and store data in compliance with the Children's Hospital of Philadelphia (CHOP) and local Institutional Review Board (IRB) policies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vancomycin use
Time Frame: Baseline to 5 years
|
Vancomycin use will be measured as DOT per 1000 PICU patient days, measured monthly.
Every day in which one or more doses of parenteral vancomycin is administered is classified as one vancomycin DOT.
Every day or portion of a day a patient is admitted to the PICU is classified as one PICU patient day.
|
Baseline to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days.
Time Frame: Baseline to 5 years
|
Change in the rate of suspected and confirmed sepsis episodes in which new or persistent respiratory, renal, cardiovascular, or hematologic organ dysfunction occur at day 3 and at day 7.
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Baseline to 5 years
|
PICU all-cause mortality
Time Frame: Up to 3 years
|
All-cause mortality will be measured at 30 days following sepsis onset as a proportion of suspected and confirmed sepsis episodes.
Only one episode of suspected or confirmed sepsis will be counted in this measure.
|
Up to 3 years
|
PICU length of stay
Time Frame: Up to 3 years
|
Time elapsed between a patient's admission into the PICU and discharge from the PICU.
|
Up to 3 years
|
Hospital length of stay
Time Frame: Up to 3 years
|
Time elapsed between a patient's hospital admittance and discharge.
|
Up to 3 years
|
30-day PICU readmission
Time Frame: Within 30 days of discharge from a PICU admission
|
Readmission to the PICU is defined as an admission to the PICU occurring within 30 days following discharge from an admission in which there was one or more episodes of suspected or confirmed sepsis.
Only one episode of suspected or confirmed sepsis will be counted in this measure.
Patients without a readmission to the index hospital or health system will be counted as no readmission, due to the inability to assess readmissions to outside institutions.
|
Within 30 days of discharge from a PICU admission
|
30-day hospital readmission
Time Frame: Within 30 days of discharge from a hospital admission
|
The percentage of patients that are readmitted to the hospital within 30 days following discharge from an admission in which there was one or more episodes of suspected or confirmed sepsis.
Only one episode of suspected or confirmed sepsis will be counted in this measure.
|
Within 30 days of discharge from a hospital admission
|
Use of other broad-spectrum antibiotics
Time Frame: Up to 5 years
|
Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable).
|
Up to 5 years
|
Use of other anti-MRSA antibiotics
Time Frame: Up to 5 years
|
Linezolid, Ceftaroline, clindamycin, and trimethoprim-sulfamethoxazole in DOT/1000 patient days, measured monthly (as a balancing measure to evaluate any increase in other anti-MRSA antibiotics that may occur as an unintended consequence of reducing vancomycin use).
|
Up to 5 years
|
Prevalence of infections due to organisms requiring vancomycin
Time Frame: Up to 5 years
|
Microbiologic outcome measures will focus on the prevalence of vancomycin-requiring organisms in the suspected and confirmed sepsis cohorts, and will also be measured relative to the frequency of empiric vancomycin administration and compliance with the guideline.
|
Up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adoption of intervention
Time Frame: Onset of intervention to 2 years
|
Adoption, the decision to adhere to the guideline for vancomycin use, will be measured as the proportion of sepsis episodes in which the clinician adhered to the guideline based on medical record review.
Adoption will be evaluated in a 10% random sample of sepsis episodes each month by chart review.
|
Onset of intervention to 2 years
|
Appropriateness of intervention
Time Frame: Onset of intervention to 2 years
|
Appropriateness, the perceived compatibility of the intervention to the PICU practice setting, will be measured during surveys and semi-structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.
|
Onset of intervention to 2 years
|
Acceptability of intervention
Time Frame: Onset of intervention to 2 years
|
Acceptability, how well the intervention was received by the PICU clinicians will be measured during surveys and semi-structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.
|
Onset of intervention to 2 years
|
Measure of feasibility of intervention
Time Frame: Onset of intervention to 2 years
|
Feasibility, the extent to which the intervention can be carried out in the setting, will be determined in collaboration with our local stakeholders but may include the proportion of PICU clinicians who attend educational sessions and/or unit-based meetings during which vancomycin use data is reviewed.
|
Onset of intervention to 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kathleen Chiotos, MD, MSCE, Children's Hospital of Philadelphia
Publications and helpful links
General Publications
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- Fridkin SK, Edwards JR, Courval JM, Hill H, Tenover FC, Lawton R, Gaynes RP, McGowan JE Jr; Intensive Care Antimicrobial Resistance Epidemiology (ICARE) Project and the National Nosocomial Infections Surveillance (NNIS) System Hospitals. The effect of vancomycin and third-generation cephalosporins on prevalence of vancomycin-resistant enterococci in 126 U.S. adult intensive care units. Ann Intern Med. 2001 Aug 7;135(3):175-83. doi: 10.7326/0003-4819-135-3-200108070-00009.
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- Norton WE, Chambers DA, Kramer BS. Conceptualizing De-Implementation in Cancer Care Delivery. J Clin Oncol. 2019 Jan 10;37(2):93-96. doi: 10.1200/JCO.18.00589. Epub 2018 Nov 8. No abstract available.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-019410
- U54CK000610-02-00 (Other Grant/Funding Number: Centers for Disease Control)
- U54CK000610 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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