Clinical trial NCT03079245: Improving Antimicrobial Prescribing Practices in the Neonatal ICU
Official title: Improving Antimicrobial Prescribing Practices in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants in Neonatal Intensive Care Units
Keywords: Neonatal ICU
antimicrobial stewardship
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Weill Medical College of Cornell University
name: Children's Hospital of Philadelphia
name: Christiana Care Health Services
First posted: 2017-03-14
Enrollment: 6184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pre-post intervention study followed by two years of use of randomly assigned interventions
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Antimicrobial Use measured as days of therapy per 100 patient-days
timeFrame: Through study completion for 2 years
Secondary outcomes:
measure: Length of therapy per 100 patient-days
timeFrame: Through study completion for 2 years
measure: Inappropriate Antimicrobial Use
timeFrame: Through study completion for 2 years
measure: Number of infants initiated on ineffective empiric therapy
timeFrame: Through study completion for 2 years
measure: Proportion of infants treated for culture negative late onset sepsis
timeFrame: Through study completion for 2 years
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Christiana Care Health Sciences
state: Delaware
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Lisa Saiman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2011 Nov 29.
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. Epub 2012 Feb 21.
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 neonatal ICU. Appl Clin Inform. 2014 Apr 9;5(2):368-87. doi: 10.4338/ACI-2013-09-RA-0069. eCollection 2014.
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.2015.191. Epub 2015 Dec 10.
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. 2017 Sep 1;6(3):227-230. doi: 10.1093/jpids/piw032.
citation: 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.
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 Infect Dis Soc. 2015 Sep;4(3):276-9. doi: 10.1093/jpids/piu022. Epub 2014 Mar 30.