Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

Last updated: September 17, 2024
Sponsor: Children's Hospital of Philadelphia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Soft Tissue Infections

Sepsis And Septicemia

Treatment

Multifaceted de-implementation strategy to reduce vancomycin overuse

Clinical Study ID

NCT05975671
21-019410
U54CK000610
U54CK000610-02-00
  • All Genders

Study Summary

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

Inclusion

Patient Inclusion Criteria:

  • Admitted to one of the participating PICUs during the study period

Exclusion

Patient Exclusion Criteria:

  • None

Clinician Inclusion Criteria:

  1. PICU prescribing clinician (including attending physicians, fellows, residents,nurse practitioners, and physician assistants) OR sepsis stakeholder (leader ofsepsis quality improvement work, medical director) at one of the participating sitesat the time the survey is deployed

  2. Age ≥ 18 years old

  3. Employed by one of the participating sites

Clinician Exclusion Criteria:

  1. Volunteers or other non-employee hospital staff

  2. Limited English proficiency

Study Design

Total Participants: 52500
Treatment Group(s): 1
Primary Treatment: Multifaceted de-implementation strategy to reduce vancomycin overuse
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Johns Hopkins Children's Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19146
    United States

    Active - Recruiting

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