Vancomycin Reduction Practices (VRP) in the NICU

NCT06772675 | Recruiting

• 2 other identifiers: 24-021976GRT-00003877
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 13

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.

Conditions

Antibiotic Stewardship; Vancomycin; Neonatal Sepsis, Late-Onset

Keywords

implementation study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Appropriateness/acceptability

  2.5 years - From beginning of implementation phase to the end of the sustainment phase

Study Arms (2)

Sites receiving external facilitation

EXPERIMENTAL

Sites will receive guidance from an external facilitator to support uptake of the VRP.

Behavioral: External Facilitation

Sites not receiving external facilitation

NO INTERVENTION

Sites will not receive guidance from an external facilitator.

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

Sites receiving external facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Site not recruited for the study

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (13)

Kaiser Permanente Modesto Medical Center

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente East Bay - Oakland Medical Center

Oakland, California, 94611, United States

RECRUITING

Kaiser Permanente Roseville Medical Center

Roseville, California, 95661, United States

RECRUITING

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94115, United States

RECRUITING

Kaiser Permanente San Leandro Medical Center

San Leandro, California, 94577, United States

RECRUITING

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

RECRUITING

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

RECRUITING

Medical Center of Princeton

Plainsboro, New Jersey, 08536, United States

RECRUITING

Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States

RECRUITING

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sagori Mukhopadhyay, MD, MMSc

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla Gilpin

CONTACT

215-573-3976; kayla.gilpin@pennmedicine.upenn.edu

Morgan Gabbert

CONTACT

267-233-3150; gabbertm@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Attending Neonatologist, Associate Professor of Pediatrics

Model Details: Cluster randomized study of external facilitation as an implementation strategy

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-06

Locations

US (13)