To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post study was performed in 4 NICUs.
Antimicrobial stewardship can improve the safety and quality of healthcare, reduce antimicrobial resistance, and reduce healthcare costs. However, the optimal strategies for the NICU population are unknown and few studies have evaluated the impact of stewardship in this population. To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the NICU. The investigators hypothesized that the bundle using all three interdisciplinary antimicrobial stewardship strategies (education, computer decision support and prescriber audit and feedback) would more effectively reduce overall and inappropriate antimicrobial use compared to usual care. A pre-post intervention study (one baseline year without interventions - May 1, 2009 - April 30, 2010, followed by two years of interventions - May 1, 2010 - April 30, 2012) was performed in 4 academically affiliated, level III NICUs. The sites were randomly assigned to usual care, one intervention, two interventions, or three interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
6,184
Education Plus was an intervention developed by the study team based on the Center for Disease Control (CDC) 12 Step Campaign to Prevent Antimicrobial Resistance in Healthcare Settings. The study team provided Education Plus quarterly to prescribers at the three sites (NICU A, B, C) randomized to this intervention. Examples of topics presented were an overview of antimicrobial stewardship principles, epidemiology of healthcare-associated infections (HAIs), prevention of surgical site infections, antimicrobial susceptibility testing, and pharmacokinetic principles. Educational formats included didactic lectures, participation via the audience response system, case vignettes, and panel discussions.
The CDS tool was an intervention developed in consultation with neonatologists and pediatric infectious disease physicians from NICU A and B. Algorithms for empiric and targeted antimicrobial therapy for common pathogens and common clinical scenarios using local antimicrobial susceptibility patterns were developed. The CDS tool also provided additional components to facilitate antimicrobial prescribing, e.g., patient weight, day of life, previous culture results, antimicrobial orders, and selected laboratory results including white blood cell and platelet count, C-reactive protein, creatinine, and therapeutic drug levels. NICUs A and B also received E+
Christiana Care Health Sciences
Wilmington, Delaware, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell University Medical Center
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Overall Antimicrobial Use measured as days of therapy per 100 patient-days
The indications for initiation of intravenous antimicrobials were categorized as initiation of empiric therapy (antibiotics started prior to culture results), definitive therapy (culture results available prior to initiation of antibiotics), or prophylaxis (e.g., antibiotics for postoperative prophylaxis).
Time frame: Through study completion for 2 years
Length of therapy per 100 patient-days
2 agents received on same day counted as one day
Time frame: Through study completion for 2 years
Inappropriate Antimicrobial Use
Determined on 4th calendar-day of treatment as redundant therapy and failure to target the pathogen
Time frame: Through study completion for 2 years
Number of infants initiated on ineffective empiric therapy
Initiation of ineffective empiric therapy for infants thought to be infected
Time frame: Through study completion for 2 years
Proportion of infants treated for culture negative late onset sepsis
The proportion of infants treated for culture negative late onset sepsis lasting more than 7 days
Time frame: Through study completion for 2 years
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The prescriber audit and feedback (PAF) intervention was developed by the study team which held focus groups with neonatologists at NICU A (the site randomized to this intervention) to determine the feedback parameters and feedback format as previously described. Neonatologists at NICU A were provided aggregated prescribing data bimonthly that described inappropriate use as described below and prolonged therapy (\>7 days) for culture-negative late onset sepsis. NICU A also received CDS and E+.