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Infants in Neonatal Intensive Care UnitsiNAPNCT03079245

Improving Antimicrobial Prescribing Practices in the Neonatal ICU

A study testing Education Plus (E+), Clinical Decision Support and Prescriber Audit and Feedback in people with Infants in Neonatal Intensive Care Units, run by Columbia University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Infants in Neonatal Intensive Care Units
What is being tested?
Education Plus (E+), Clinical Decision Support and Prescriber Audit and Feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,184 participants
Where
4 sitesUnited States
Study dates
1 May 2009to 30 Apr 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell University Medical Center

    New York, New York, 10065

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Christiana Care Health Sciences

    Wilmington, Delaware, 19899

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Education Plus (E+), Clinical Decision Support, Prescriber Audit and Feedback
Keywords
Neonatal ICU, antimicrobial stewardship

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Clinical Decision SupportOther

    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 FeedbackOther

    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+.

Study groups in NCT03079245
Study groupRoleWhat they receive
NICU A - E+, CDS, and PAFOtherThis site was assigned to three interventions, Education Plus (E+), Clinical Decision Support (CDS), and Prescriber Audit and Feedback (PAB).
Receives: Other: Education Plus (E+); Other: Clinical Decision Support; Other: Prescriber Audit and Feedback
NICU B - E+ and CDSOtherThis site was assigned to two interventions, Education Plus (E+) and Clinical Decision Support (CDS).
Receives: Other: Education Plus (E+); Other: Clinical Decision Support
NICU C - E+OtherThis site was assigned to one intervention, Education Plus (E+).
Receives: Other: Education Plus (E+)
NICU D - Usual CareNo interventionThis site was not introduced to an interdisciplinary intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Through study completion for 2 years

Secondary outcomes (4)

  1. Length of therapy per 100 patient-days

    2 agents received on same day counted as one day

    Measured: Through study completion for 2 years

  2. Inappropriate Antimicrobial Use

    Determined on 4th calendar-day of treatment as redundant therapy and failure to target the pathogen

    Measured: Through study completion for 2 years

  3. Number of infants initiated on ineffective empiric therapy

    Initiation of ineffective empiric therapy for infants thought to be infected

    Measured: Through study completion for 2 years

  4. 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

    Measured: Through study completion for 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start1 May 2009
  3. Primary completion30 Apr 2012
  4. Study completion30 Apr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A pre-post intervention study followed by two years of use of randomly assigned interventions
Masking
None (open label)
Enrolment
6,184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079245
Sponsor's protocol ID
AAAC6366
Other IDs
1R01NR010821-01, 1R21NR010823-01
Acronym
iNAP
Status last verified
Mar 2017
First submitted
2 Mar 2017
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22128773

  • 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.

    PubMed 22500166

  • 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.

    PubMed 25024755

  • 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.

    PubMed 26658124

  • 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.

    PubMed 27302327

  • 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.

    PubMed 27021036

  • 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.

    PubMed 26336605

Questions about this trial

What is this clinical trial studying?

A study testing Education Plus (E+), Clinical Decision Support and Prescriber Audit and Feedback in people with Infants in Neonatal Intensive Care Units, run by Columbia University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Antimicrobial Use measured as days of therapy per 100 patient-days (time frame: Through study completion for 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03079245, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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