Improving Antimicrobial Prescribing Practices in the Neonatal ICU (iNAP)

Columbia University

Status: Completed

Conditions: Infants in Neonatal Intensive Care Units

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03079245

1R21NR010823-01 (U.S. NIH Grant/Contract)

1R01NR010821-01 (U.S. NIH Grant/Contract)

AAAC6366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,184 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,184 participants in 4 patient groups

NICU A - E+, CDS, and PAF

Other group

Description:

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

Treatment:

Other: Education Plus (E+)

Other: Prescriber Audit and Feedback

Other: Clinical Decision Support

NICU B - E+ and CDS

Other group

Description:

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

Treatment:

Other: Education Plus (E+)

Other: Clinical Decision Support

NICU C - E+

Other group

Description:

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

Treatment:

Other: Education Plus (E+)

NICU D - Usual Care

No Intervention group

Description:

This site was not introduced to an interdisciplinary intervention.