Improving Antimicrobial Prescribing Practices in the Neonatal ICU

Infants in Neonatal Intensive Care Units Clinical Trial

— iNAP  

Official title:

Improving Antimicrobial Prescribing Practices in the Neonatal Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079245
• Other study ID #: AAAC6366
• Secondary ID: 1R01NR010821-011
• Status: Completed
• Phase: N/A
• First received: March 2, 2017
• Last updated: March 8, 2017
• Start date: May 1, 2009
• Est. completion date: April 30, 2012

Study information

• Verified date: March 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6184
• Est. completion date: April 30, 2012
• Est. primary completion date: April 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infants in Neonatal Intensive Care Units

Intervention

Other:
• Education Plus (E+)
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.
• Clinical Decision Support
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+
• Prescriber Audit and Feedback
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+.

Locations

Country	Name	City	State
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	Christiana Care Health Sciences	Wilmington	Delaware

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Children's Hospital of Philadelphia, Christiana Care Health Services, National Institute of Nursing Research (NINR), Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Clock SA, Ferng YH, Tabibi S, Alba L, Patel SJ, Jia H, DeLaMora P, Perlman JM, Paul DA, Zaoutis T, Larson EL, Saiman L. Colonization With Antimicrobial-Resistant Gram-Negative Bacilli at Neonatal Intensive Care Unit Discharge. J Pediatric Infect Dis Soc. — View Citation

Ferng YH, Clock SA, Wong-Mcloughlin J, DeLaMora PA, Perlman JM, Gray KS, Paul DA, Prasad PA, Zaoutis TE, Alba LR, Whittier S, Larson EL, Saiman L. Multicenter Study of Hand Carriage of Potential Pathogens by Neonatal ICU Healthcare Personnel. J Pediatric — View Citation

Hum RS, Cato K, Sheehan B, Patel S, Duchon J, DeLaMora P, Ferng YH, Graham P, Vawdrey DK, Perlman J, Larson E, Saiman L. Developing clinical decision support within a commercial electronic health record system to improve antimicrobial prescribing in the n — View Citation

Larson EL, Patel SJ, Evans D, Saiman L. Feedback as a strategy to change behaviour: the devil is in the details. J Eval Clin Pract. 2013 Apr;19(2):230-4. doi: 10.1111/j.1365-2753.2011.01801.x. Review. — View Citation

Patel SJ, Green N, Clock SA, Paul DA, Perlman JM, Zaoutis T, Ferng YH, Alba L, Jia H, Larson EL, Saiman L. Gram-negative Bacilli in Infants Hospitalized in The Neonatal Intensive Care Unit. J Pediatric Infect Dis Soc. 2016 Jun 14. pii: piw032. [Epub ahead — View Citation

Patel SJ, Saiman L, Duchon JM, Evans D, Ferng YH, Larson E. Development of an antimicrobial stewardship intervention using a model of actionable feedback. Interdiscip Perspect Infect Dis. 2012;2012:150367. doi: 10.1155/2012/150367. — View Citation

Prasad PA, Wong-McLoughlin J, Patel S, Coffin SE, Zaoutis TE, Perlman J, DeLaMora P, Alba L, Ferng YH, Saiman L. Surgical site infections in a longitudinal cohort of neonatal intensive care unit patients. J Perinatol. 2016 Apr;36(4):300-5. doi: 10.1038/jp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Through study completion for 2 years
Secondary	Length of therapy per 100 patient-days	2 agents received on same day counted as one day	Through study completion for 2 years
Secondary	Inappropriate Antimicrobial Use	Determined on 4th calendar-day of treatment as redundant therapy and failure to target the pathogen	Through study completion for 2 years
Secondary	Number of infants initiated on ineffective empiric therapy	Initiation of ineffective empiric therapy for infants thought to be infected	Through study completion for 2 years
Secondary	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	Through study completion for 2 years