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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Nîmes Cedex 09, Francie, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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).
|
5 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of patients with at least one medication error / total number of hospitalized patients included in the service
Časové okno: 5 days
|
5 days
|
|
|
For each medication error: the name of the drug
Časové okno: 5 days
|
5 days
|
|
|
For each medication error: the type of error
Časové okno: 5 days
|
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
|
|
For each medication error: the severity index
Časové okno: 5 days
|
5 days
|
|
|
For each medication error: when (which step) the error occurred during the drug pathway
Časové okno: 5 days
|
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
|
|
For each medication error: the evolution of the adverse drug event, if occurred
Časové okno: 5 days
|
5 days
|
|
|
For each medication error: the criticality of the error
Časové okno: 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
|
|
The potential causes of medication errors
Časové okno: 5 days
|
5 days
|
|
|
The average number of interruptions per hour during preparation or administration of drug doses by nurses
Časové okno: 5 days
|
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
Časové okno: 5 days
|
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
Časové okno: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: the preparation of individual doses
Časové okno: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: ordering health products
Časové okno: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: stock management and exceptional orders
Časové okno: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: the delivery, receipt and storage of health products
Časové okno: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: cabinet inventories
Časové okno: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: the management of expired drugs
Časové okno: 5 days
|
5 days
|
|
|
The number of calls made to the central pharmacy
Časové okno: 5 days
|
5 days
|
|
|
Staff time dedicated to managing exceptional requests
Časové okno: 5 days
|
5 days
|
|
|
The number of drugs consumed
Časové okno: 5 days
|
5 days
|
|
|
The number of medical devices consumed
Časové okno: 5 days
|
5 days
|
|
|
The number of immobilized drugs
Časové okno: 5 days
|
5 days
|
|
|
The number of immobilized medical devices
Časové okno: 5 days
|
5 days
|
|
|
The cost of adverse drug events care
Časové okno: 5 days
|
5 days
|
|
|
Care staff satisfaction questionnaire
Časové okno: 5 days
|
5 days
|
|
|
Pharmacy technician satisfaction questionnaire
Časové okno: 5 days
|
5 days
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Géraldine Leguelinel-Blache, PharmD, PhD, Centre Hospitalier Universitaire de Nîmes
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- LOCAL/2015/GL-01
- 2015-A01309-40 (Jiný identifikátor: RCB number)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .