Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy

NCT ID: NCT02614638

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-16

Brief Summary

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

Detailed Description

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.

Conditions

Hospitalization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

One month of department-wide observation

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Pharm Tech participates in department

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Géraldine Leguelinel-Blache, PharmD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2015-A01309-40

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/GL-01

Identifier Type: -

Identifier Source: org_study_id