Improving Antimicrobial Prescribing Practices in the Neonatal ICU

NCT03079245 | Completed

• 3 other identifiers: AAAC63661R01NR010821-011R21NR010823-01
• Study Type: interventional
• Target: 6,184
• Locations: 1 country
• Sites: 4

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.

Conditions

Infants in Neonatal Intensive Care Units

Keywords

Neonatal ICU; antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of therapy per 100 patient-days

  Through study completion for 2 years

• Inappropriate Antimicrobial Use

  Through study completion for 2 years

• Number of infants initiated on ineffective empiric therapy

  Through study completion for 2 years

• Proportion of infants treated for culture negative late onset sepsis

  Through study completion for 2 years

Study Arms (4)

NICU A - E+, CDS, and PAF

OTHER

This site was assigned to three interventions, Education Plus (E+), Clinical Decision Support (CDS), and Prescriber Audit and Feedback (PAB).

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

NICU B - E+ and CDS

OTHER

This site was assigned to two interventions, Education Plus (E+) and Clinical Decision Support (CDS).

Other: Education Plus (E+); Other: Clinical Decision Support

NICU C - E+

OTHER

This site was assigned to one intervention, Education Plus (E+).

Other: Education Plus (E+)

NICU D - Usual Care

NO INTERVENTION

This site was not introduced to an interdisciplinary intervention.

Interventions

Education Plus (E+) OTHER

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.

NICU A - E+, CDS, and PAF; NICU B - E+ and CDS; NICU C - E+

Clinical Decision Support OTHER

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+

NICU A - E+, CDS, and PAF; NICU B - E+ and CDS

Prescriber Audit and Feedback OTHER

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+.

NICU A - E+, CDS, and PAF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator
• Weill Medical College of Cornell University: collaborator
• Children's Hospital of Philadelphia: collaborator
• Christiana Care Health Services: collaborator

Study Sites (4)

Christiana Care Health Sciences

Wilmington, Delaware, 19899, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell University Medical Center

New York, New York, 10065, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• 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. Epub 2011 Nov 29.

  PMID: 22128773 RESULT

• 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. Epub 2012 Feb 21.

  PMID: 22500166 RESULT

• 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 neonatal ICU. Appl Clin Inform. 2014 Apr 9;5(2):368-87. doi: 10.4338/ACI-2013-09-RA-0069. eCollection 2014.

  PMID: 25024755 RESULT

• 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.2015.191. Epub 2015 Dec 10.

  PMID: 26658124 RESULT

• 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. 2017 Sep 1;6(3):227-230. doi: 10.1093/jpids/piw032.

  PMID: 27302327 RESULT

• 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. 2017 Sep 1;6(3):219-226. doi: 10.1093/jpids/piw014.

  PMID: 27021036 RESULT

• 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 Infect Dis Soc. 2015 Sep;4(3):276-9. doi: 10.1093/jpids/piu022. Epub 2014 Mar 30.

  PMID: 26336605 RESULT

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Lisa Saiman, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: A pre-post intervention study followed by two years of use of randomly assigned interventions

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 14, 2017
• Study Start: May 1, 2009
• Primary Completion: April 30, 2012
• Study Completion: April 30, 2012
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)