Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,000
- 试验地点
- 24
- 主要终点
- Rates of adverse events (total number/1000 patient-days)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 20 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Rates of adverse events (total number/1000 patient-days)
时间窗: 20 months
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment.(Trigger tool kit, Raju Ped Research). Preventable adverse events and non preventable adverse events secondary to expected complications or side effects are both included.
次要结局
- Identify factors associated with and consequences of Unprogrammed extubation in NICU patients(20 months)
- Describe rates of medication errors in NICU patients(20 months)
- Identify factors associated with and consequences of catheter-related adverse in the NICU(20 months)
- Rate of adverse events (Percentage of patient admissions with an adverse event) over time during the study period(20 months)
- Identify factors associated with and consequences of medication errors in NICU patients(20 months)
- Rate of positive and negative blood cultures in NICU patients suspected of late onset infection according to volume of blood culture(20 months)
- Rate of adverse events (number of adverse events per 100 NICU admissions) over time during the study period(20 months)
- Rates of preventable adverse events (total number/1000 patient-days)(20 months)
- Rates of CLABSI, number per 1000 catheter-days in the 12 participating NICUs in France(20 months)
- Rates of unplanned extubations, number per 100 ventilator-days and number per 100 ventilator-hours in the 12 participating NICUs in France.(20 months)
- Rates of severe adverse events(20 months)
- Rates of catheter-related adverse events, number per 1000 catheter-days(20 months)
- Description of characteristics of disclosed and undisclosed adverse events to the patients' parents, caregivers' motivations, and perceived parental reactions(20 months)
- Identify number and types of medical errors collected in the 12 NICUs in France(20 months)
- Identify Severity of adverse events in the 12 participating NICUs in France(20 months)
- 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(20 months)
- Identify characteristics ad factors associated with severe extravasation injuries in the 12 NICUs(20 months)
- Description of safety culture in each of the 12 participating NICUs before and after patients' inclusion period(20 months)
- Describe late-onset infections types and characteristics in NICU patients in France(20 months)
- 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.(20 months)
- Economical impact of the program(20 months)
研究者
Dr Caeymaex Laurence
Dr, PhD
Centre Hospitalier Intercommunal Creteil