NCT02598609

SEPREVEN: a Stepped-wedge Randomised Controlled Trial

Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,000 (estimated)
• Sponsor: Dr Caeymaex Laurence · Academic / Other
• Sex: All
• Age: 1 Day – 20 Weeks
• Healthy volunteers: Not accepted

Summary

Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator and catheter associated adverse events and medication errors. Severity of the patient's outcome after an adverse event can be classified using the National Coordinating Council for Medication Error Reporting and Preventing (NCC MERP) Index for categorizing medication errors. The study will test the hypothesis that rates of adverse events in NICU patients will be reduced by the implementation of an educational program for the NICU caregivers (nurses and physicians), consisting of strategies for recognizing and preventing adverse events in their unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal complications and ventilator and catheter-associated adverse events. This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France will be randomized to the timing of implementation of the educational program. In order to describe the adverse events occurring during the study period, an anonymous voluntary adverse event reporting system will be provided to the caregivers of the participating units. A nested study will examine how caregivers communicate with the patients' parents in case of adverse event (disclosure or not, and caregivers' reasons). The rates of adverse events will be measured retrospectively using a neonatal NICU trigger tool.

Conditions

• Intensive Care Units, Neonatal
• Misadventures to Patients During Surgical and Medical Care
• Catheter-related Bloodstream Infection (CRBSI) Nos
• Quality of Healthcare
• Ventilator Adverse Event
• Nosocomial Pneumonia
• Immature Newborn
• Skin Lesion
• Extravasation Injury
• Nasal Injury
• Intubation Complication
• Medication Administered in Error
• IV Catheter Nos Deep Venous Thrombosis

Interventions

Type	Name	Description
BEHAVIORAL	Education program for NICU caregivers	* standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory) * implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory) * poster for prevention of extravasation injuries

Timeline

• Start date: 2015-11-23
• Primary completion: 2020-03-30
• Completion: 2020-12-08
• First posted: 2015-11-06
• Last updated: 2020-12-29

Locations

12 sites across 1 country: France