Prévention Des Erreurs médicamenteuses liées Aux Interruptions de tâches Des Soignants Lors de la préparation et de l'Administration Des médicaments : Essai contrôlé randomisé Multicentrique en Clusters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,000
- 试验地点
- 2
- 主要终点
- Medication administration errors rate
研究概览
简要总结
Serious medication administration errors are common in hospitals and nurse's interruptions during medication preparation and administration is associated with errors. Various interventions were developed to help prevention of errors such as visual intervention. Investigators aimed to study the effect of a medication safety vest to reduce medication errors. The vest serves as a visible signal to inform others that the nurse is preparing and administering medications and should not be disturbed. Patients and visitors are provided with an informational flyer to inform them about the use of medication safety vests.
The hypothesis is that the vest will reduce nurse's interruptions during medication preparation and administration, and ultimately reduce medication errors.
The study is a randomized controlled trial in 30 care units of four hospitals in France. Each unit will be randomized in either the control group or the experimental group using the medication safety vest. Nurses of the unit will be selected at random to determine who will be observed during the administration rounds.The observation method will be used to evaluate the error rates in the 2 groups. The number of interruptions and error rates will be evaluated.
详细描述
Serious medication administration errors are common in hospitals. Significant association between medication administration errors rate and the frequency of nurse's interruptions was shown. The estimated risk of error without interruption during preparation and administration is 2.3% whereas it doubles with 4 or more interruptions.
Various interventions were developed to help prevention of errors such as visual interventions and technology interventions.
Investigators aimed to study the effect of a medication safety vest to reduce medication errors. The vest serves as a visible signal to inform others that the nurse is preparing and administering medications and should not be disturbed. On the back of the vest is written "Do not disturb me. I am preparing medications". Patients and visitors are provided with an informational flyer to inform them about the use of medication safety vests The hypothesis is that the vest will reduce nurse's interruptions during medication preparation and administration, and ultimately reduce medication errors.
The study is a randomized controlled trial in 30 care units of four hospitals in France. Each unit will be randomized in either the control group or the experimental group using the medication safety vest. Nurses of the unit will be randomized to determine who will be observed during the administration rounds.The observation method will be used to evaluate the error rates in the 2 groups. The number of interruptions and error rates will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary nurses of the 30 care units who have drugs to deliver during medication administration rounds will be included.
排除标准
- •Nurses who refuse to be observed during medication administration rounds and nurses replacement that did not work usually in the studied units will not be included.
- •Nurses in the European G. Pompidou hospital who work in the 4 units involved in an other research project.
- •Medication administrations during emergencies (e.g., cardiopulmonary resuscitation) will also be excluded from this study.
结局指标
主要结局
Medication administration errors rate
时间窗: two weeks after implementation of the medication safety vests and flyers
The primary outcome is the medication errors rate measured by the observation technique (technique of reference). Observers will follow nurses during drug distribution (preparation and administration) to patients, without knowing the physician's medication orders, and will record details about the drugs and interruptions. After completing the observation session, medication administration errors will be assessed blinded to the unit allocation, by comparing the observed medication administered to the medication intended for that patient. The rate of medication administration errors will be calculated by dividing the number of preparation/administration with at least one error by the total opportunities for errors (TOE).
次要结局
- Percentage of wearing medication safety vest(two weeks after implementation of the medication safety vests and flyers)
- Type of medication errors(two weeks after implementation of the medication safety vests and flyers)
- Percentage of nurse's interruptions(two weeks after implementation of the medication safety vests and flyers)
- Description of nurse's interruptions(two weeks after implementation of the medication safety vests and flyers)
- Severity of error(two weeks after implementation of the medication safety vests and flyers)