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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Nîmes Cedex 09, Франция, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Нерандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of patients with at least one medication error / total number of hospitalized patients included in the service
Временное ограничение: 5 days
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5 days
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For each medication error: the name of the drug
Временное ограничение: 5 days
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5 days
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For each medication error: the type of error
Временное ограничение: 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
Временное ограничение: 5 days
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5 days
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For each medication error: when (which step) the error occurred during the drug pathway
Временное ограничение: 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
Временное ограничение: 5 days
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5 days
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For each medication error: the criticality of the error
Временное ограничение: 5 days
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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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 5 days
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5 days
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Nursing staff time dedicated to: the preparation of individual doses
Временное ограничение: 5 days
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5 days
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Nursing staff time dedicated to: ordering health products
Временное ограничение: 5 days
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5 days
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Nursing staff time dedicated to: stock management and exceptional orders
Временное ограничение: 5 days
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5 days
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Nursing staff time dedicated to: the delivery, receipt and storage of health products
Временное ограничение: 5 days
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5 days
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Nursing staff time dedicated to: cabinet inventories
Временное ограничение: 5 days
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5 days
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Nursing staff time dedicated to: the management of expired drugs
Временное ограничение: 5 days
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5 days
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The number of calls made to the central pharmacy
Временное ограничение: 5 days
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5 days
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Staff time dedicated to managing exceptional requests
Временное ограничение: 5 days
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5 days
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The number of drugs consumed
Временное ограничение: 5 days
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5 days
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The number of medical devices consumed
Временное ограничение: 5 days
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5 days
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The number of immobilized drugs
Временное ограничение: 5 days
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5 days
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The number of immobilized medical devices
Временное ограничение: 5 days
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5 days
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The cost of adverse drug events care
Временное ограничение: 5 days
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5 days
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Care staff satisfaction questionnaire
Временное ограничение: 5 days
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5 days
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Pharmacy technician satisfaction questionnaire
Временное ограничение: 5 days
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5 days
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Соавторы и исследователи
Следователи
- Директор по исследованиям: Géraldine Leguelinel-Blache, PharmD, PhD, Centre Hospitalier Universitaire de Nîmes
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- LOCAL/2015/GL-01
- 2015-A01309-40 (Другой идентификатор: RCB number)
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