Effect of Bar-code-assisted Medication Administration on Medication Error Rates: a Controlled Randomized Multicentre Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Medication administration errors rate
研究概览
简要总结
Serious medication administration errors are common in hospitals. Various interventions were developed to help prevention of such errors such as bar-code technology. Investigators aimed to study the effect of bar-code-assisted medication administration (BCMA) system on the rate of medication errors in two hospitals.
They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris, France. Each unit will be randomized in either the control group or the intervention group using the bar-code system to help drug administration. The observation method will be used to evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses of the unit will be randomized to determine who will be observed during the administration rounds.
Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative reduction of 45% of error rate.
详细描述
The ADIM system (Aide a la Distribution Informatisee des Medicaments) consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service.
The system ADIM preparation consists of a working area with 2 reader devices (a RFID reader and a bar code reader) and a touch screen . It allows selection from the list of patients, the patient's prescription for which the preparation will be made. It is linked to the drug data base.
The system ADIM administration is composed of a laptop with touch screen, 2 readers (a RFID reader and a barcode reader) , the elements needed to care and a work plan and drawers containing unit dose drugs for patients for a specific nurse. The nurse scans her/his badge, the patient's wristband and each dose administered and prepared by the pharmacy. If the dose is not prepared by the pharmacy, the nurse takes the dose in the automat cabinet. The nurse scans the drug's barcode or select on the touch screen the drug and the required dose of the drug. In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Nurses of the 6 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.
- •Medication administrations during emergencies (e.g., cardiopulmonary resuscitation) will also be excluded from this study.
研究组 & 干预措施
bar-code-assisted administration
during administration rounds, nurses will use the BCMA system to help preventing administration errors
干预措施: BCMA (bar-code-assisted medication administration) (Device)
control
during administration rounds, nurses will administer drugs as usual
结局指标
主要结局
Medication administration errors rate
时间窗: one month after the intervention
Investigators will use the direct-observation method to measure error rates. Observers will shadow staff nurses while administering drugs to patients, without knowing the physician's medication orders, and will record details about the administration. After completing the observation session, medication administration errors will be assessed, by two senior pharmacists, 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 errors by the total opportunities for errors (TOE). The TOE is defined as the sum of observed administrations and omitted medications. As wrong-time errors are generally considered less severe, overall error rate will be calculated without this type of error.
次要结局
- type of errors(one month after the intervention)
- Severity of error(One month after intervention)
- Satisfaction of nurses(One month after intervention)
- Relevance of the system(One month after intervention)