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临床试验/NCT02614638
NCT02614638已完成不适用

Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
129
试验地点
1
主要终点
The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission

研究概览

简要总结

The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.

This is a before-after study consisting of three sequential phases:

Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department

详细描述

The secondary objectives of this study are:

A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.

B- To characterize detected medication errors.

C- To identify and evaluate the potential causes of medication errors.

D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patient must be insured or beneficiary of a health insurance plan
  • •The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital

排除标准

  • •The patient is under judicial protection
  • •The patient, or his/her legal guardian, expresses opposition to participation in the study
  • •It is impossible to correctly inform the patient

研究组 & 干预措施

1st observational period (before experimental intervention)

Active Comparator

Patients in this arm are included during a first month of observation before the intervention is implemented.

Intervention: One month of department-wide observation

干预措施: One month of department-wide observation (Other)

2nd obs. period (during experimental intervention)

Experimental

Following a one-month wash-out period, patients in this arm are included during a second month of observation during which the intervention is implemented.

Intervention: Pharm Tech participates in department

干预措施: Pharm Tech participates in department (Other)

结局指标

主要结局

The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission

时间窗: 5 days

Primary Outcome Measure as given in protocol: Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (during month 1 versus during month 3).

次要结局

  • Nursing staff time dedicated to: stock management and exceptional orders(5 days)
  • For each medication error: the evolution of the adverse drug event, if occurred(5 days)
  • Nursing staff time dedicated to: the management of expired drugs(5 days)
  • The number of calls made to the central pharmacy(5 days)
  • Staff time dedicated to managing exceptional requests(5 days)
  • Number of patients with at least one medication error / total number of hospitalized patients included in the service(5 days)
  • For each medication error: the name of the drug(5 days)
  • For each medication error: the type of error(5 days)
  • For each medication error: the severity index(5 days)
  • For each medication error: when (which step) the error occurred during the drug pathway(5 days)
  • For each medication error: the criticality of the error(5 days)
  • The potential causes of medication errors(5 days)
  • The average number of interruptions per hour during preparation or administration of drug doses by nurses(5 days)
  • The number of patients for whom personal treatments were managed by the nursing staff on admission / number of patients who brought their personal treatments to the care unit(5 days)
  • The number of patients for whom personal treatments were returned by the nursing staff at hospital discharge / number of patients who brought their personal treatments to the care unit(5 days)
  • Nursing staff time dedicated to: the preparation of individual doses(5 days)
  • Nursing staff time dedicated to: ordering health products(5 days)
  • Nursing staff time dedicated to: the delivery, receipt and storage of health products(5 days)
  • Nursing staff time dedicated to: cabinet inventories(5 days)
  • The number of drugs consumed(5 days)
  • The number of medical devices consumed(5 days)
  • The number of immobilized drugs(5 days)
  • The number of immobilized medical devices(5 days)
  • The cost of adverse drug events care(5 days)
  • Care staff satisfaction questionnaire(5 days)
  • Pharmacy technician satisfaction questionnaire(5 days)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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