Clinical trial NCT06772675: Vancomycin Reduction Practices (VRP) in the NICU
Official title: Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antibiotic Stewardship
Neonatal Sepsis, Late-Onset
Vancomycin
Keywords: implementation study
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2025-01-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized study of external facilitation as an implementation strategy
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: Fidelity of VRP use
timeFrame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Secondary outcomes:
measure: Appropriateness/acceptability
timeFrame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Other outcomes:
Locations:
city: Modesto
country: United States
facility: Kaiser Permanente Modesto Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente East Bay - Oakland Medical Center
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Medical Center
state: California
city: Plainsboro
country: United States
facility: Medical Center of Princeton
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Voorhees
state: New Jersey
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sagori Mukhopadhyay, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: