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Improving Antimicrobial Prescribing Practices in the Neonatal ICU (iNAP)

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ClinicalTrials.gov Identifier: NCT03079245
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : March 14, 2017
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Weill Medical College of Cornell University
Children's Hospital of Philadelphia
Christiana Care Health Services
Information provided by (Responsible Party):
Lisa Saiman, 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.

Condition or disease Intervention/treatment Phase
Infants in Neonatal Intensive Care Units Other: Education Plus (E+) Other: Clinical Decision Support Other: Prescriber Audit and Feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pre-post intervention study followed by two years of use of randomly assigned interventions
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Antimicrobial Prescribing Practices in the Neonatal Intensive Care Unit
Actual Study Start Date : May 1, 2009
Actual Primary Completion Date : April 30, 2012
Actual Study Completion Date : April 30, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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).
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.

Other: 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+

Other: 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+.

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

Other: 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+

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

No Intervention: NICU D - Usual Care
This site was not introduced to an interdisciplinary intervention.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079245


Locations
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United States, Delaware
Christiana Care Health Sciences
Wilmington, Delaware, United States, 19899
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell University Medical Center
New York, New York, United States, 10065
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Columbia University
National Institute of Nursing Research (NINR)
Weill Medical College of Cornell University
Children's Hospital of Philadelphia
Christiana Care Health Services
Investigators
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Principal Investigator: Lisa Saiman, MD, MPH Columbia University

Publications of Results:

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Responsible Party: Lisa Saiman, Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT03079245     History of Changes
Other Study ID Numbers: AAAC6366
1R01NR010821-01 ( U.S. NIH Grant/Contract )
1R21NR010823-01 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Saiman, Columbia University:
Neonatal ICU
antimicrobial stewardship
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents