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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Nîmes Cedex 09, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of patients with at least one medication error / total number of hospitalized patients included in the service
Délai: 5 days
|
5 days
|
|
|
For each medication error: the name of the drug
Délai: 5 days
|
5 days
|
|
|
For each medication error: the type of error
Délai: 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
Délai: 5 days
|
5 days
|
|
|
For each medication error: when (which step) the error occurred during the drug pathway
Délai: 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
Délai: 5 days
|
5 days
|
|
|
For each medication error: the criticality of the error
Délai: 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
Délai: 5 days
|
5 days
|
|
|
The average number of interruptions per hour during preparation or administration of drug doses by nurses
Délai: 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
Délai: 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
Délai: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: the preparation of individual doses
Délai: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: ordering health products
Délai: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: stock management and exceptional orders
Délai: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: the delivery, receipt and storage of health products
Délai: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: cabinet inventories
Délai: 5 days
|
5 days
|
|
|
Nursing staff time dedicated to: the management of expired drugs
Délai: 5 days
|
5 days
|
|
|
The number of calls made to the central pharmacy
Délai: 5 days
|
5 days
|
|
|
Staff time dedicated to managing exceptional requests
Délai: 5 days
|
5 days
|
|
|
The number of drugs consumed
Délai: 5 days
|
5 days
|
|
|
The number of medical devices consumed
Délai: 5 days
|
5 days
|
|
|
The number of immobilized drugs
Délai: 5 days
|
5 days
|
|
|
The number of immobilized medical devices
Délai: 5 days
|
5 days
|
|
|
The cost of adverse drug events care
Délai: 5 days
|
5 days
|
|
|
Care staff satisfaction questionnaire
Délai: 5 days
|
5 days
|
|
|
Pharmacy technician satisfaction questionnaire
Délai: 5 days
|
5 days
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Géraldine Leguelinel-Blache, PharmD, PhD, Centre Hospitalier Universitaire de Nîmes
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- LOCAL/2015/GL-01
- 2015-A01309-40 (Autre identifiant: RCB number)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .