Clinical trial NCT02598609: SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Official title: Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: Adverse event
Neonatal Intensive Care Unit
Catheter-related Bloodstream Infection (CRBSI) nos
Extravasation injury
Medication error
Central venous catheter complication
Unprogrammed extubation
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Paris 12 Val de Marne University
name: Ministry of Health, France
First posted: 2015-11-06
Enrollment: 8000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Rates of adverse events (total number/1000 patient-days)
timeFrame: 20 months
Secondary outcomes:
measure: Rate of adverse events (Percentage of patient admissions with an adverse event) over time during the study period
timeFrame: 20 months
measure: Rate of adverse events (number of adverse events per 100 NICU admissions) over time during the study period
timeFrame: 20 months
measure: Rates of preventable adverse events (total number/1000 patient-days)
timeFrame: 20 months
measure: Rates of CLABSI, number per 1000 catheter-days in the 12 participating NICUs in France
timeFrame: 20 months
measure: Rates of unplanned extubations, number per 100 ventilator-days and number per 100 ventilator-hours in the 12 participating NICUs in France.
timeFrame: 20 months
measure: Identify factors associated with and consequences of Unprogrammed extubation in NICU patients
timeFrame: 20 months
measure: Rates of severe adverse events
timeFrame: 20 months
measure: Describe rates of medication errors in NICU patients
timeFrame: 20 months
measure: Identify factors associated with and consequences of medication errors in NICU patients
timeFrame: 20 months
measure: Identify factors associated with and consequences of catheter-related adverse in the NICU
timeFrame: 20 months
measure: Rates of catheter-related adverse events, number per 1000 catheter-days
timeFrame: 20 months
measure: Identify number and types of medical errors collected in the 12 NICUs in France
timeFrame: 20 months
measure: Identify Severity of adverse events in the 12 participating NICUs in France
timeFrame: 20 months
measure: Describe late-onset infections types and characteristics in NICU patients in France
timeFrame: 20 months
measure: Skin tolerance to cutaneous antisepsis : Dermatitis score results before and after an antisepsis procedure for umbilical and/or PICC catheter insertion in premature neonates born less than 32 weeks gestational age and aged less than 15 days.
timeFrame: 20 months
measure: Description of Nasal scores results during the use of noninvasive nasal ventilation interfaces in neonates born less than 32 weeks of gestational age and aged less than 15 days
timeFrame: 20 months
measure: Identify characteristics ad factors associated with severe extravasation injuries in the 12 NICUs
timeFrame: 20 months
measure: Description of characteristics of disclosed and undisclosed adverse events to the patients' parents, caregivers' motivations, and perceived parental reactions
timeFrame: 20 months
measure: Economical impact of the program
timeFrame: 20 months
measure: Economical impact of the program
timeFrame: 20 months
measure: Economical impact of the program
timeFrame: 20 months
measure: Economical impact of the program
timeFrame: 20 months
measure: Rate of positive and negative blood cultures in NICU patients suspected of late onset infection according to volume of blood culture
timeFrame: 20 months
measure: Description of safety culture in each of the 12 participating NICUs before and after patients' inclusion period
timeFrame: 20 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg Hautepierre
state: Alsace
city: Grenoble
country: France
facility: CHU Grenoble
state: Auvergne Rhône Alpes
city: Lille
country: France
facility: CHU Lille Jeanne de Flandres
state: Hauts De France
city: Creteil
country: France
facility: CHI Creteil
state: Ile De France
city: Le Kremlin Bicêtre
country: France
facility: CHU Bicêtre, APHP
state: Ile De France
city: Paris
country: France
facility: CHU Robert Debré, APHP
state: Ile De France
city: Poissy
country: France
facility: CH Poissy
state: Ile De France
city: Pontoise
country: France
facility: CH Pontoise René Dubos
state: Ile De France
city: St Denis
country: France
facility: Centre Hospitalier Delafontaine
state: Ile De France
city: Caen
country: France
facility: CHU Caen
state: Normandie
city: Angers
country: France
facility: CHU Angers
state: Pays De La Loire
city: Nice
country: France
facility: CHU Nice Archet
state: Provence Alpes Cote d'Azur
Study officials:
affiliation: CHI Creteil, Paris Est University
name: Laurence Caeymaex, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Caeymaex L, Lebeaux C, Roze JC, Danan C, Reynaud A, Jung C, Audureau E. Study on preventing adverse events in neonates (SEPREVEN): A stepped-wedge randomised controlled trial to reduce adverse event rates in the NICU. Medicine (Baltimore). 2020 Jul 31;99(31):e20912. doi: 10.1097/MD.0000000000020912.