Vancomycin Reduction Practices (VRP) in the NICU

Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Antibiotic Stewardship; Vancomycin; Neonatal Sepsis, Late-Onset
• Intervention / Treatment: Behavioral: External Facilitation

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayla Gilpin; Phone Number: 215-573-3976; Email: kayla.gilpin@pennmedicine.upenn.edu
• Study Contact Backup: Name: Morgan Gabbert; Phone Number: 267-233-3150; Email: gabbertm@chop.edu

Study Locations

• United States
  • California
    • Modesto, California, United States, 95356
      • Recruiting
      • Kaiser Permanente Modesto Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
    • Oakland, California, United States, 94611
      • Recruiting
      • Kaiser Permanente East Bay - Oakland Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
    • Roseville, California, United States, 95661
      • Recruiting
      • Kaiser Permanente Roseville Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
    • San Francisco, California, United States, 94115
      • Recruiting
      • Kaiser Permanente San Francisco Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
    • San Leandro, California, United States, 94577
      • Recruiting
      • Kaiser Permanente San Leandro Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
    • Santa Clara, California, United States, 95051
      • Recruiting
      • Kaiser Permanente Santa Clara Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Kaiser Permanente Walnut Creek Medical Center
      • Contact: Dr. Michael W. Kuzniewicz; Phone Number: 415-279-5427; Email: michael.w.kuzniewicz@kp.org
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Recruiting
      • Medical Center of Princeton
      • Contact: Dr. Sagori Mukhopadhyay; Phone Number: 215-829-3301; Email: mukhopadhs@chop.edu
    • Voorhees Township, New Jersey, United States, 08043
      • Recruiting
      • Virtua Voorhees
      • Contact: Dr. Sagori Mukhopadhyay; Phone Number: 215-829-3301; Email: mukhopadhs@chop.edu
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Recruiting
      • Lancaster General Hospital
      • Contact: Dr. Sagori Mukhopadhyay; Phone Number: 215-829-3301; Email: mukhopadhs@chop.edu
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Pennsylvania Hospital
      • Contact: Dr. Sagori Mukhopadhyay; Phone Number: 215-829-3301; Email: mukhopadhs@chop.edu
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Dr. Sagori Mukhopdhyay; Phone Number: 215-829-3301; Email: mukhopadhs@chop.edu
    • West Chester, Pennsylvania, United States, 19380
      • Recruiting
      • Chester County Hospital
      • Contact: Dr. Sagori Mukhopadhyay; Phone Number: 215-829-3301; Email: mukhopadhs@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sites receiving external facilitation; Sites will receive guidance from an external facilitator to support uptake of the VRP.	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
No Intervention: Sites not receiving external facilitation; Sites will not receive guidance from an external facilitator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity of VRP use	Proportion of late onset sepsis (LOS) evaluations performed with high fidelity. High fidelity is defined when the evaluation follows all three core components of VRP use.	2.5 years - From beginning of implementation phase to the end of the sustainment phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriateness/acceptability	Response to questions about whether vancomycin reducing practices (VRP) was agreeable and/or a good fit for the unit measured using validated instruments comprising of 5-point Likert scales (Weiner et al). Participants are offered options ranging from completely disagree (1) to completely agree (5), with higher scores indicating a higher degree of acceptability or feasibility.	2.5 years - From beginning of implementation phase to the end of the sustainment phase

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Sagori Mukhopadhyay, MD, MMSc, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: implementation study
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Neonatal Sepsis
• Other Study ID Numbers: 24-021976; GRT-00003877 (Other Grant/Funding Number: Agency for Health Care Research and Quality)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Participants here are the clinicians at the sites randomized to external facilitation. The investigators obtain survey (de-identified) and interview data from representative group of the clinicians. Since the investigators will be gathering richly detailed qualitative data that, even if de-identified of names or locations, can still be linked back to sites or individuals, the investigators will not share interview data for secondary analysis or use beyond the purposes of the proposal. The investigators will maintain de-identified (for both site and respondent identifiers) survey output that can be shared upon appropriate request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No