About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to one of the participating PICUs during the study period
Disqualifiers
None
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
Trial design
Single group
Treatments tested in this trial
Multifaceted de-implementation strategy to reduce vancomycin overuse
Behavioral* 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.
Treatment groups
Trial outcomes
Primary outcomes
Change 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.
Secondary outcomes
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.
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.
PICU length of stay
Time elapsed between a patient's admission into the PICU and discharge from the PICU.
Hospital length of stay
Time elapsed between a patient's hospital admittance and discharge.
Other outcomes
Adoption of intervention
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.
Appropriateness of intervention
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.
Acceptability of intervention
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.
Measure of feasibility of intervention
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.
Sponsors and contacts
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Children's Hospital of Philadelphia
Lead sponsor
Children's Healthcare of Atlanta
Collaborator
St. Louis Children's Hospital
Collaborator
Johns Hopkins University
Collaborator
University of Pennsylvania
Collaborator
Centers for Disease Control and Prevention
Collaborator