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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52,500
* Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site. * The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews. * The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGJohns Hopkins Children's Center
Baltimore, Maryland, United States
RECRUITINGSt. Louis Children's Hospital
St Louis, Missouri, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGChange in vancomycin use
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.
Time frame: Baseline to 5 years
Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days.
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.
Time frame: Baseline to 5 years
PICU all-cause mortality
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.
Time frame: Up to 3 years
PICU length of stay
Time elapsed between a patient's admission into the PICU and discharge from the PICU.
Time frame: Up to 3 years
Hospital length of stay
Time elapsed between a patient's hospital admittance and discharge.
Time frame: Up to 3 years
30-day PICU readmission
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.
Time frame: Within 30 days of discharge from a PICU admission
30-day hospital readmission
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.
Time frame: Within 30 days of discharge from a hospital admission
Use of other broad-spectrum antibiotics
Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable).
Time frame: Up to 5 years
Use of other anti-MRSA antibiotics
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).
Time frame: Up to 5 years
Prevalence of infections due to organisms requiring vancomycin
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.
Time frame: Up to 5 years
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