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Recruiting NCT06772675

Vancomycin Reduction Practices (VRP) in the NICU

No phase Interventional Antibiotic Stewardship Neonatal Sepsis, Late-Onset Vancomycin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: External Facilitation.
Who it may be relevant to
Registry conditions: Antibiotic Stewardship, Neonatal Sepsis, Late-Onset, Vancomycin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants

Overview

This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs). Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit \& feedback, and use of a clinical decision support tool.

Interventions

  • Behavioral External Facilitation
    Designated external facilitators will conduct monthly meetings with local champions at each site. Designated facilitators will follow the developed facilitation guide, that includes content area to cover in each meeting, case scenarios as examples, and tips on how to communicate and support the internal facilitators. The goal is to enable problem-solving and support the local champion in implementing VRP with fidelity

Primary outcome measures

  • Fidelity of VRP use [Time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase]
Secondary outcome measures (1)
  • Appropriateness/acceptability [Time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase]

Eligibility criteria

Inclusion criteria

  • Level III NICU
  • Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)
  • Recruited by study team

Exclusion criteria

  • Site not recruited for the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 13 centers
  • Kaiser Permanente Modesto Medical Center — Modesto
  • Kaiser Permanente East Bay - Oakland Medical Center — Oakland
  • Kaiser Permanente Roseville Medical Center — Roseville
  • Kaiser Permanente San Francisco Medical Center — San Francisco
  • Kaiser Permanente San Leandro Medical Center — San Leandro
  • Kaiser Permanente Santa Clara Medical Center — Santa Clara
  • Kaiser Permanente Walnut Creek Medical Center — Walnut Creek
  • Medical Center of Princeton — Plainsboro
  • … and 5 more centers

Identifiers

NCT: NCT06772675 · 24-021976 · GRT-00003877

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗