跳至主要内容
临床试验/NCT03036449
NCT03036449已完成不适用

Efficacy of Tools Associated With a Multifaceted Education Intervention Directed to Health Professionals to Reduce Medication Preparation and Administration Error Rates in Neonatal Intensive Care Units

University Hospital, Bordeaux3 个研究点 分布在 1 个国家目标入组 5,143 人开始时间: 2017年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,143
试验地点
3
主要终点
Medication administration error rates in the patients

研究概览

简要总结

The purpose of this study is to determine whether an educational program for caregivers associated with convenient tools is effective to reduce medication preparation and administration errors in the Neonatal Intensive Care Units (NICU).

详细描述

Medication errors are frequent in neonatal intensive care units and consequences are more severe than in adults. Although errors happen in each step of medication management process, a large proportion of errors occur during medication preparation and administration.

This study will test the hypothesis that rates of medication errors during preparation and administration will be reduced by implementing an education program for NICU caregivers (Nurses) and providing convenient tools.

The trial has a stepped wedge design, in which the NICU's from three hospitals in France will be randomized (Group A, B and C) to the timing of implementation of the educational intervention.

According to the allocation (Group A, B or C), the education intervention will include a complete main program of nine weeks and one to three maintenance educational periods.

Medication administration errors rates will be measured before (baseline measurements) and after each educational interventions (main or maintenance interventions).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All nurses working in the intensive care units in the day time.

排除标准

  • Nurses working as a float or pool nurses.
  • Nurses working at night.

结局指标

主要结局

Medication administration error rates in the patients

时间窗: Baseline and up to 49 weeks

Assessment of the efficacy of the intervention on reducing the rates of medication administration errors. Error rate: Number of identified errors/Number of observed acts of administration\*100, measured by direct observation of nurse's acts by specifically trained external observers.

次要结局

  • Acceptance of the educational program(Baseline and up to 49 weeks)
  • Levels of medication errors reported by caregivers.(Baseline and up to 49 weeks)
  • Levels of safety culture among the caregivers (Nurses)(Baseline and up to 49 weeks)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (3)

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