Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly (Rev-EHPAD)

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.

Study Overview

• Status: Completed
• Conditions: Geriatrics; Health Services for the Aged; Residence for Dependent Elderly
• Intervention / Treatment: Other: Before-after study

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: The study population; See inclusion and exclusion criteria. Intervention: Before-after study

Other: Before-after study; The before-after study is composed of a first observational phase followed by a proactive phase, and then finally by a second observational phase. The first observational phase corresponds to retrospective data-collecting for the information necessary for calculating the baseline ADE geriatric risk score. The proactive phase corresponds to a multidisciplinary review of drug prescriptions (especially long-term drugs) for all included patients in the residence. During the second observational phase, the same data as in the first observational phase will be collected a second time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Drug Events Geriatric Risk Score	according to Trivalle and Ducimetière 2013	change from Baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Géraldine Leguelinel, Pharm-D, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (ESTIMATE): April 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Multidisciplinary review of drug prescriptions; Adverse drug events geriatric risk score; Residence for dependent elderly
• Other Study ID Numbers: LOCAL/2013/GL-01; 2013-A01590-45 (OTHER: RCB number)