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

Geriatrics Clinical Trial

— Rev-EHPAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118259
• Other study ID #: LOCAL/2013/GL-01
• Secondary ID: 2013-A01590-45
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: May 5, 2015
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Geriatrics
• Health Services for the Aged
• Residence for Dependent Elderly

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier	Nîmes
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Drug Events Geriatric Risk Score	according to Trivalle and Ducimetière 2013	change from Baseline to 6 months	Yes
Secondary	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.	Yes
Secondary	Number of hospitalizations in the public sector (higher level care)		first observational phase (month -6 to day 0)	Yes
Secondary	Number of hospitalizations in the public sector (higher level care)		second observational phase (day 0 to month 6)	Yes
Secondary	Days of hospitalization in the public sector (higher level care)		first observational phase (month -6 to day 0)	Yes
Secondary	Days of hospitalization in the public sector (higher level care)		second observational phase (day 0 to month 6)	Yes
Secondary	Mortality		first observational phase (month -6 to day 0)	Yes
Secondary	Mortality		second observational phase (day 0 to month 6)	Yes
Secondary	The number of falls per patient		first observational phase (month -6 to day 0)	Yes
Secondary	The number of falls per patient		second observational phase (day 0 to month 6)	Yes
Secondary	The percentage of patients who fell		first observational phase (month -6 to day 0)	Yes
Secondary	The percentage of patients who fell		second observational phase (day 0 to month 6)	Yes
Secondary	The Anatomical Therapeutic Chemical classification for each revised drug		during the proactive phase (day 0)	No
Secondary	The type of errors detected during drug review	Contra-indication, dosing, route, etc	during the proactive phase (day 0)	Yes
Secondary	The type of modification suggested during drug review	discontinuation, addition, substitution...	during the proactive phase (day 0)	Yes
Secondary	The acceptation rate for modifications suggested during drug review		during the proactive phase (day 0)	Yes
Secondary	Associated care costs (€)		first observational phase (month -6 to day 0)	Yes
Secondary	Associated care costs (€)		second observational phase (day 0 to month 6)	Yes