- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079245
Improving Antimicrobial Prescribing Practices in the Neonatal ICU (iNAP)
March 8, 2017 updated by: Lisa Saiman, Columbia University
Improving Antimicrobial Prescribing Practices in the Neonatal Intensive Care Unit
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6184
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19899
- Christiana Care Health Sciences
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
New York, New York, United States, 10065
- Weill Cornell University Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: NICU A - E+, CDS, and PAF
This site was assigned to three interventions, Education Plus (E+), Clinical Decision Support (CDS), and Prescriber Audit and Feedback (PAB).
|
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+
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+.
|
Other: NICU B - E+ and CDS
This site was assigned to two interventions, Education Plus (E+) and Clinical Decision Support (CDS).
|
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+
|
Other: NICU C - E+
This site was assigned to one intervention, 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.
|
No Intervention: NICU D - Usual Care
This site was not introduced to an interdisciplinary intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Antimicrobial Use measured as days of therapy per 100 patient-days
Time Frame: 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).
|
Through study completion for 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of therapy per 100 patient-days
Time Frame: Through study completion for 2 years
|
2 agents received on same day counted as one day
|
Through study completion for 2 years
|
Inappropriate Antimicrobial Use
Time Frame: Through study completion for 2 years
|
Determined on 4th calendar-day of treatment as redundant therapy and failure to target the pathogen
|
Through study completion for 2 years
|
Number of infants initiated on ineffective empiric therapy
Time Frame: Through study completion for 2 years
|
Initiation of ineffective empiric therapy for infants thought to be infected
|
Through study completion for 2 years
|
Proportion of infants treated for culture negative late onset sepsis
Time Frame: Through study completion for 2 years
|
The proportion of infants treated for culture negative late onset sepsis lasting more than 7 days
|
Through study completion for 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa Saiman, MD, MPH, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2009
Primary Completion (Actual)
April 30, 2012
Study Completion (Actual)
April 30, 2012
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 8, 2017
First Posted (Actual)
March 14, 2017
Study Record Updates
Last Update Posted (Actual)
March 14, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAC6366
- 1R01NR010821-01 (U.S. NIH Grant/Contract)
- 1R21NR010823-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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