Improving Antimicrobial Prescribing Practices in the Neonatal ICU

Not Applicable

Completed

• Conditions: Infants in Neonatal Intensive Care Units
• Interventions: Other: Education Plus (E+); Other: Clinical Decision Support; Other: Prescriber Audit and Feedback

• Registration Number: NCT03079245
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-05-01
• Primary Completion: 2012-04-30
• Study Completion: 2012-04-30
• Status Verified: 2017-03
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Study First Posted: 2017-03-14
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6184

Inclusion Criteria

• infants admitted to study NICUs <7 days of age who remained hospitalized 4 days or more days

Read More

Exclusion Criteria

• Infants admitted to study NICUs 7 days of age and older who were hospitalized less than 4 days

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NICU A - E+, CDS, and PAF	Education Plus (E+)	This site was assigned to three interventions, Education Plus (E+), Clinical Decision Support (CDS), and Prescriber Audit and Feedback (PAB).
NICU B - E+ and CDS	Clinical Decision Support	This site was assigned to two interventions, Education Plus (E+) and Clinical Decision Support (CDS).
NICU B - E+ and CDS	Education Plus (E+)	This site was assigned to two interventions, Education Plus (E+) and Clinical Decision Support (CDS).
NICU C - E+	Education Plus (E+)	This site was assigned to one intervention, Education Plus (E+).
NICU A - E+, CDS, and PAF	Prescriber Audit and Feedback	This site was assigned to three interventions, Education Plus (E+), Clinical Decision Support (CDS), and Prescriber Audit and Feedback (PAB).
NICU A - E+, CDS, and PAF	Clinical Decision Support	This site was assigned to three interventions, Education Plus (E+), Clinical Decision Support (CDS), and Prescriber Audit and Feedback (PAB).

Primary Outcome Measures

Name	Time	Method
Overall Antimicrobial Use measured as days of therapy per 100 patient-days	Through study completion for 2 years	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).

Secondary Outcome Measures

Name	Time	Method
Length of therapy per 100 patient-days	Through study completion for 2 years	2 agents received on same day counted as one day
Inappropriate Antimicrobial Use	Through study completion for 2 years	Determined on 4th calendar-day of treatment as redundant therapy and failure to target the pathogen
Number of infants initiated on ineffective empiric therapy	Through study completion for 2 years	Initiation of ineffective empiric therapy for infants thought to be infected
Proportion of infants treated for culture negative late onset sepsis	Through study completion for 2 years	The proportion of infants treated for culture negative late onset sepsis lasting more than 7 days

Trial Locations

Locations (4)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Christiana Care Health Sciences; 🇺🇸 Wilmington, Delaware, United States

Weill Cornell University Medical Center; 🇺🇸 New York, New York, United States