Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Antimicrobial - Induced Nephropathy; Sepsis Mrsa; Sepsis, Severe; Sepsis Bacteremia; Septic Shock; Septic Syndrome; Sepsis

Treatments: Behavioral: Multifaceted de-implementation strategy to reduce vancomycin overuse

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05975671

U54CK000610 (U.S. NIH Grant/Contract)

21-019410

U54CK000610-02-00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

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

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 of sepsis quality improvement work, medical director) at one of the participating sites at 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52,500 participants in 2 patient groups

PICU Clinicians and Sepsis stakeholders

Other group

Description:

Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention: * All the PICU (Pediatric Intensive Care Unit) prescribing clinicians and sepsis stakeholders in the participating sites will receive clinical guidelines, unit-level feedback reports, and education on Vancomycin use during the intervention. * Investigators will perform semi-structured interviews with 90 PICU clinicians and sepsis stakeholders. * Surveys will be sent to all eligible clinicians, estimated to be up to 2500 individuals across the 4 sites. These structured surveys will be done at baseline and at 9 months post-implementation.

Treatment:

Behavioral: Multifaceted de-implementation strategy to reduce vancomycin overuse

PICU Patients with suspected sepsis

No Intervention group

Description:

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.