Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy (OPTI-PP)
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
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
研究概览
地位
条件
详细说明
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.
E- To evaluate the economic impact of the presence of a pharmacy technician.
F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nîmes Cedex 09、法国、30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：1st observational period (before experimental intervention)
Patients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation |
A pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only.
During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses.
He / she will collect medication errors and other observational data.
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实验性的：2nd obs. period (during experimental intervention)
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 |
Following a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month.
He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：5 days
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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).
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5 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of patients with at least one medication error / total number of hospitalized patients included in the service
大体时间：5 days
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5 days
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For each medication error: the name of the drug
大体时间：5 days
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5 days
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For each medication error: the type of error
大体时间：5 days
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Errors are classifies as one of the following types: Omission; Drug; Dosage form; Expired or damaged drug; Dose; Concentration; Frequency of administration; Administration technique; Route of Administration; Rate of administration; Duration of administration; Administration Time; Patient; Drug interaction. |
5 days
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For each medication error: the severity index
大体时间：5 days
|
5 days
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For each medication error: when (which step) the error occurred during the drug pathway
大体时间：5 days
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The considered steps are: Writing the prescription Medical decision for the prescription Transcription Pharmaceutical analysis Deliverance Preparation / reconstitution Pillbox Administration Procurement Storage Compliance Therapeutic and clinical follow-up |
5 days
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For each medication error: the evolution of the adverse drug event, if occurred
大体时间：5 days
|
5 days
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For each medication error: the criticality of the error
大体时间：5 days
|
Criticality is graded according to the following classes:
3E: treatment or surgery with temporary harm 3F: longer duration of hospitalization with temporary harm 3G: permanent harm 3H: involving a life-threatening harm 3I: death Criticality is determined by the concordance of two, independent expert opinions; or, in case of discordance, the concordance of 2 out 3 expert opinions. |
5 days
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The potential causes of medication errors
大体时间：5 days
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5 days
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The average number of interruptions per hour during preparation or administration of drug doses by nurses
大体时间：5 days
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5 days
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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
大体时间：5 days
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5 days
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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
大体时间：5 days
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5 days
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Nursing staff time dedicated to: the preparation of individual doses
大体时间：5 days
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5 days
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Nursing staff time dedicated to: ordering health products
大体时间：5 days
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5 days
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Nursing staff time dedicated to: stock management and exceptional orders
大体时间：5 days
|
5 days
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Nursing staff time dedicated to: the delivery, receipt and storage of health products
大体时间：5 days
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5 days
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Nursing staff time dedicated to: cabinet inventories
大体时间：5 days
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5 days
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Nursing staff time dedicated to: the management of expired drugs
大体时间：5 days
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5 days
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The number of calls made to the central pharmacy
大体时间：5 days
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5 days
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Staff time dedicated to managing exceptional requests
大体时间：5 days
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5 days
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The number of drugs consumed
大体时间：5 days
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5 days
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The number of medical devices consumed
大体时间：5 days
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5 days
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The number of immobilized drugs
大体时间：5 days
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5 days
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The number of immobilized medical devices
大体时间：5 days
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5 days
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The cost of adverse drug events care
大体时间：5 days
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5 days
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Care staff satisfaction questionnaire
大体时间：5 days
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5 days
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Pharmacy technician satisfaction questionnaire
大体时间：5 days
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5 days
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合作者和调查者
调查人员
- 研究主任：Géraldine Leguelinel-Blache, PharmD, PhD、Centre Hospitalier Universitaire De Nimes
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- LOCAL/2015/GL-01
- 2015-A01309-40 (其他标识符：RCB number)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.