Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Hospital of Philadelphia

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 volunteers

Qualifiers

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

Design model

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

52,500 Participants
are divided into 2 treatment groups
Group A: PICU Clinicians and Sepsis stakeholdersOther 1 intervention
Group B: PICU Patients with suspected sepsisNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 5 years

Secondary outcomes

1

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
2

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
3

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
4

Hospital length of stay

Time elapsed between a patient's hospital admittance and discharge.

Time frame
Up to 3 years

Other outcomes

1

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.

Time frame
Onset of intervention to 2 years
2

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.

Time frame
Onset of intervention to 2 years
3

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.

Time frame
Onset of intervention to 2 years
4

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.

Time frame
Onset of intervention to 2 years

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