Clinical trial NCT02118259: Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly
Official title: Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatrics
Residence for Dependent Elderly
Health Services for the Aged
Keywords: Multidisciplinary review of drug prescriptions
Adverse drug events geriatric risk score
Residence for dependent elderly
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 49
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Drug Events Geriatric Risk Score
timeFrame: change from Baseline to 6 months
Secondary outcomes:
measure: The number of patients taking at least 1 potentially inappropriate drug according to Laroche criteria
timeFrame: During the proactive phase. Day 0.
measure: Number of hospitalizations in the public sector (higher level care)
timeFrame: first observational phase (month -6 to day 0)
measure: Number of hospitalizations in the public sector (higher level care)
timeFrame: second observational phase (day 0 to month 6)
measure: Days of hospitalization in the public sector (higher level care)
timeFrame: first observational phase (month -6 to day 0)
measure: Days of hospitalization in the public sector (higher level care)
timeFrame: second observational phase (day 0 to month 6)
measure: Mortality
timeFrame: first observational phase (month -6 to day 0)
measure: Mortality
timeFrame: second observational phase (day 0 to month 6)
measure: The number of falls per patient
timeFrame: first observational phase (month -6 to day 0)
measure: The number of falls per patient
timeFrame: second observational phase (day 0 to month 6)
measure: The percentage of patients who fell
timeFrame: first observational phase (month -6 to day 0)
measure: The percentage of patients who fell
timeFrame: second observational phase (day 0 to month 6)
measure: The Anatomical Therapeutic Chemical classification for each revised drug
timeFrame: during the proactive phase (day 0)
measure: The type of errors detected during drug review
timeFrame: during the proactive phase (day 0)
measure: The type of modification suggested during drug review
timeFrame: during the proactive phase (day 0)
measure: The acceptation rate for modifications suggested during drug review
timeFrame: during the proactive phase (day 0)
measure: Associated care costs (€)
timeFrame: first observational phase (month -6 to day 0)
measure: Associated care costs (€)
timeFrame: second observational phase (day 0 to month 6)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes
country: France
facility: CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Géraldine Leguelinel, Pharm-D
role: STUDY_DIRECTOR
References: