Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality

Fudan University

Status: Completed

Conditions: Nosocomial Infections

Treatments: Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method

Study type: Interventional

Funder types: Other

Identifiers

NCT02600195

14-194

Details and patient eligibility

About

This 4-year cluster randomized controlled trial aims to determine whether implementation of Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired infection in Chinese Neonatal Intensive Care Units (NICUs).

Full description

Following randomization into two groups, the intervention NICUs (n = 12) will receive training in the EPIQ method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support. Control NICUs (n = 12) will collect neonatal data and continue to provide standard care. Study subjects will be all preterm infants born at <34 weeks' gestation and admitted to participating NICUs during the trial (estimated n = 5,200 per year). Data analysis will be conducted to compare neonatal outcomes and health-care resources used between the intervention and control groups.

Enrollment: 15,600 estimated patients

Sex: All

Ages: Under 120 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants born at <34 weeks' gestation
• Admitted to the participating NICUs within 7 days after birth
• Admitted to the participating NICUs between May 1, 2015 and April 30, 2018

Exclusion criteria

• Infants with major congenital anomalies
• Infants who are moribund on admission (a decision is made to provide only palliative care)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15,600 participants in 2 patient groups

EPIQ sites

Experimental group

Description:

Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection

Treatment:

Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method

Control sites

No Intervention group

Description:

Continue current practices