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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nîmes Cedex 09, Francia, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of patients with at least one medication error / total number of hospitalized patients included in the service
Lasso di tempo: 5 days
|
5 days
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For each medication error: the name of the drug
Lasso di tempo: 5 days
|
5 days
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For each medication error: the type of error
Lasso di tempo: 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
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For each medication error: the severity index
Lasso di tempo: 5 days
|
5 days
|
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For each medication error: when (which step) the error occurred during the drug pathway
Lasso di tempo: 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
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For each medication error: the evolution of the adverse drug event, if occurred
Lasso di tempo: 5 days
|
5 days
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For each medication error: the criticality of the error
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 5 days
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5 days
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Nursing staff time dedicated to: the preparation of individual doses
Lasso di tempo: 5 days
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5 days
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Nursing staff time dedicated to: ordering health products
Lasso di tempo: 5 days
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5 days
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Nursing staff time dedicated to: stock management and exceptional orders
Lasso di tempo: 5 days
|
5 days
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Nursing staff time dedicated to: the delivery, receipt and storage of health products
Lasso di tempo: 5 days
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5 days
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Nursing staff time dedicated to: cabinet inventories
Lasso di tempo: 5 days
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5 days
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Nursing staff time dedicated to: the management of expired drugs
Lasso di tempo: 5 days
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5 days
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The number of calls made to the central pharmacy
Lasso di tempo: 5 days
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5 days
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Staff time dedicated to managing exceptional requests
Lasso di tempo: 5 days
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5 days
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The number of drugs consumed
Lasso di tempo: 5 days
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5 days
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The number of medical devices consumed
Lasso di tempo: 5 days
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5 days
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The number of immobilized drugs
Lasso di tempo: 5 days
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5 days
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The number of immobilized medical devices
Lasso di tempo: 5 days
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5 days
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The cost of adverse drug events care
Lasso di tempo: 5 days
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5 days
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Care staff satisfaction questionnaire
Lasso di tempo: 5 days
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5 days
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Pharmacy technician satisfaction questionnaire
Lasso di tempo: 5 days
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5 days
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Géraldine Leguelinel-Blache, PharmD, PhD, Centre Hospitalier Universitaire de Nīmes
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- LOCAL/2015/GL-01
- 2015-A01309-40 (Altro identificatore: RCB number)
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