Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly

Not Applicable

Completed

• Conditions: Health Services for the Aged; Geriatrics; Residence for Dependent Elderly
• Interventions: Other: Before-after study

• Registration Number: NCT02118259
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of the study is to show that the multidisciplinary review of drug prescriptions changes the adverse drug event (ADE) geriatric risk score (according to Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital Residence for Dependent Elderly.

Detailed Description

The secondary objectives of this study are to assess and compare the following criteria before and after multidisciplinary review of drug prescriptions for patients in the Nîmes University Hospital Residence for Dependent Elderly:

A. the number of patients with at least one potentially inappropriate drug prescribed

B. the number of hospitalizations

C. death rate

D. the number of falls per patient and the rate of fallers

E. qualitative criteria describing the drug review

F. associated care costs

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• The patient (or his/her legal representative) must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 6 months of follow-up
• The patient has resided at the Nîmes University Hospital Residence for Dependent Elderly for at least the past 6 months

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection
• The patient (or his/her legal representative) refuses to sign the consent
• It is impossible to correctly inform the patient (or his/her legal representative)
• The patient has resided at the Nîmes University Hospital Residence for Dependent Elderly for less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population	Before-after study	See inclusion and exclusion criteria. Intervention: Before-after study

Primary Outcome Measures

Name	Time	Method
Adverse Drug Events Geriatric Risk Score	change from Baseline to 6 months	according to Trivalle and Ducimetière 2013

Secondary Outcome Measures

Name	Time	Method
The number of patients taking at least 1 potentially inappropriate drug according to Laroche criteria	During the proactive phase. Day 0.	Laroche et al 2007.
Number of hospitalizations in the public sector (higher level care)	second observational phase (day 0 to month 6)
Days of hospitalization in the public sector (higher level care)	second observational phase (day 0 to month 6)
Mortality	second observational phase (day 0 to month 6)
The number of falls per patient	second observational phase (day 0 to month 6)
The percentage of patients who fell	second observational phase (day 0 to month 6)
The Anatomical Therapeutic Chemical classification for each revised drug	during the proactive phase (day 0)
The type of errors detected during drug review	during the proactive phase (day 0)	Contra-indication, dosing, route, etc
The type of modification suggested during drug review	during the proactive phase (day 0)	discontinuation, addition, substitution...
The acceptation rate for modifications suggested during drug review	during the proactive phase (day 0)
Associated care costs (€)	second observational phase (day 0 to month 6)

Trial Locations

Locations (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier; 🇫🇷 Nîmes, France