Vancomycin Reduction Practices (VRP) in the NICU

Part of paid clinical trials in Modesto, California.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06772675
Status
Recruiting

Conditions

  • Antibiotic Stewardship
  • Neonatal Sepsis, Late-Onset
  • Vancomycin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • External Facilitation — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Sites receiving external facilitation
    Sites will receive guidance from an external facilitator to support uptake of the VRP.
  • No Intervention: Sites not receiving external facilitation
    Sites will not receive guidance from an external facilitator.

Primary Outcome Measure

Fidelity of VRP use [ Time Frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Modesto Medical CenterModestoCalifornia95356
Dr. Michael W. Kuzniewicz
415-279-5427
Kaiser Permanente East Bay - Oakland Medical CenterOaklandCalifornia94611
Dr. Michael W. Kuzniewicz
415-279-5427
Kaiser Permanente Roseville Medical CenterRosevilleCalifornia95661
Dr. Michael W. Kuzniewicz
415-279-5427
Kaiser Permanente San Francisco Medical CenterSan FranciscoCalifornia94115
Dr. Michael W. Kuzniewicz
415-279-5427
Kaiser Permanente San Leandro Medical CenterSan LeandroCalifornia94577
Dr. Michael W. Kuzniewicz
415-279-5427
Kaiser Permanente Santa Clara Medical CenterSanta ClaraCalifornia95051
Dr. Michael W. Kuzniewicz
415-279-5427
Kaiser Permanente Walnut Creek Medical CenterWalnut CreekCalifornia94596
Dr. Michael W. Kuzniewicz
415-279-5427
Medical Center of PrincetonPlainsboroNew Jersey08536
Dr. Sagori Mukhopadhyay
215-829-3301
Virtua VoorheesVoorhees TownshipNew Jersey08043
Dr. Sagori Mukhopadhyay
215-829-3301
Lancaster General HospitalLancasterPennsylvania17602
Dr. Sagori Mukhopadhyay
215-829-3301
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Dr. Sagori Mukhopdhyay
215-829-3301
Pennsylvania HospitalPhiladelphiaPennsylvania19107
Dr. Sagori Mukhopadhyay
215-829-3301
Chester County HospitalWest ChesterPennsylvania19380
Dr. Sagori Mukhopadhyay
215-829-3301

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