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

NCT02614638 | Completed

• 2 other identifiers: LOCAL/2015/GL-012015-A01309-40
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Conditions

Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (26)

• Number of patients with at least one medication error / total number of hospitalized patients included in the service

  5 days

• For each medication error: the name of the drug

  5 days

• For each medication error: the type of error

  5 days

• For each medication error: the severity index

  5 days

• For each medication error: when (which step) the error occurred during the drug pathway

  5 days

Study Arms (2)

1st observational period (before experimental intervention)

ACTIVE COMPARATOR

Patients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation

Other: One month of department-wide observation

2nd obs. period (during experimental intervention)

EXPERIMENTAL

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

Other: Pharm Tech participates in department

Interventions

One month of department-wide observation 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.

1st observational period (before experimental intervention)

Pharm Tech participates in department 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.

2nd obs. period (during experimental intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Study Officials

• Géraldine Leguelinel-Blache, PharmD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 25, 2015
• Study Start: September 1, 2016
• Primary Completion: December 16, 2016
• Study Completion: December 16, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

FR (1)