SEPREVEN: a Stepped-wedge Randomised Controlled Trial

Dr Caeymaex Laurence

Status: Completed

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

Treatments: Behavioral: Education program for NICU caregivers

Study type: Interventional

Funder types: Other

Identifiers

NCT02598609

SEPREVEN

Details and patient eligibility

About

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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 1 day to 20 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Patients hospitalized during the study period in one of the 12 participating Neonatal Intensive Care Units
• Corrected Gestational age not exceeding 42 weeks +6 days at the time of admission in the NICU
• Length of hospitalisation in the NICU > 2 days
• No parental objection to the anonymous data collection of their newborn(s)' clinical data, after written information

Exclusion Criteria:

• More than 42 weeks +6 days of corrected gestational age on admission in the NICU
• Length of hospitalization in the NICU < or = 2 days
• Parental objection to the anonymous data collection of their newborn(s)' clinical data

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

8,000 participants in 3 patient groups

Cluster A

Other group

Description:

Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster A. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 4 months. The intervention is implemented during 4 months. The length of the post interventional period is 12 months.

Treatment:

Behavioral: Education program for NICU caregivers

Cluster B

Other group

Description:

Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster B. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 8 months. The intervention is implemented during 4 months. The length of the post interventional period is 8 months.

Treatment:

Behavioral: Education program for NICU caregivers

Cluster C

Other group

Description:

Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster C. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 12 months. The intervention is implemented during 4 months. The length of the post interventional period is 4 months.

Treatment:

Behavioral: Education program for NICU caregivers