Vancomycin Reduction Practices (VRP) in the NICU

Not Applicable

Not yet recruiting

• Conditions: Antibiotic Stewardship; Neonatal Sepsis, Late-Onset; Vancomycin

• Registration Number: NCT06772675
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-04
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fidelity of VRP use	2.5 years - From beginning of implementation phase to the end of the sustainment phase	Proportion of LOS evaluations performed with high fidelity. High fidelity is defined when the evaluation follows all three core components of VRP use.

Secondary Outcome Measures

Name	Time	Method
Appropriateness/acceptability	2.5 years - From beginning of implementation phase to the end of the sustainment phase	Response to questions about whether VRP was agreeable and/or a good fit fot the unit measured using validated instruments comprising of 4-point Likert scales. (Weiner et al)