Vancomycin Reduction Practices (VRP) in the NICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Hospital of Philadelphia
About this trial
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
This trial does not accept healthy volunteersQualifiers
Level III NICU
Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)
Recruited by study team
Disqualifiers
Site not recruited for the study
Trial design
Design model
Parallel
Treatments tested in this trial
External Facilitation
BehavioralDesignated 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
Treatment groups
13 Participants
are divided into 2 treatment groupsGroup A: Sites receiving external facilitationExperimental treatment 1 intervention
Group B: Sites not receiving external facilitationNo intervention 0 interventions
Trial outcomes
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.
Time frame
2.5 years - From beginning of implementation phase to the end of the sustainment phaseSecondary outcomes
1
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.
Time frame
2.5 years - From beginning of implementation phase to the end of the sustainment phaseSponsors and contacts
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Children's Hospital of Philadelphia
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
Source ClinicalTrials.gov