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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial

Conditions
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Nosocomial Infections

Intervention / Treatment
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* Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPIQ sites<br>Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection | Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method<br>* The intervention NICUs (n = 12) will receive training in the Evidence-based Practice for Improving Quality (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.<br>|
| No Intervention: Control sites<br>Continue current practices | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital-acquired infection | Combined cases of following types of hospital-acquired infection: ventilation associated pneumonia, central line-associated blood stream infection (CLABSI), blood stream infections excluding CLABSI, urinary tract infections, meningitis, clinical sepsis | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ventilation associated pneumonia |  | Three years | 
| Incidence of central line-associated blood stream infection |  | Three years | 
| Incidence of blood stream infection excluding CLABSI |  | Three years | 
| Incidence of meningitis |  | Three years | 
| Incidence of clinical sepsis |  | Three years | 
| Incidence of urinary tract infections |  | Three years | 
| Incidence of stage ≥2 necrotizing enterocolitis |  | Three years | 
| Days on ventilation support |  | Three years | 
| Days on total parenteral nutrition |  | Three years | 
| Days on antibiotics |  | Three years | 
| Days on inotropes |  | Three years | 
| All cause mortality |  | Three years | 
| Infection-related mortality |  | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care, Neonatal, Nosocomial Infections, Quality Improvement