Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP-Sepsis)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

⁃ 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

Locations
United States
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Maryland
Johns Hopkins Children's Center
RECRUITING
Baltimore
Missouri
St. Louis Children's Hospital
RECRUITING
St Louis
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Kathleen Chiotos, MD, MSCE
chiotosk@chop.edu
215-590-5505
Backup
Kai Inoki, MPH
meyahnwid@chop.edu
215-590-5505
Time Frame
Start Date: 2023-08-21
Estimated Completion Date: 2026-05
Participants
Target number of participants: 52500
Treatments
Other: PICU Clinicians and Sepsis stakeholders
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.
No_intervention: PICU Patients with suspected sepsis
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.
Sponsors
Collaborators: Centers for Disease Control and Prevention, Children's Healthcare of Atlanta, Johns Hopkins University, St. Louis Children's Hospital, University of Pennsylvania
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov