NCT02118259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

April 16, 2014

Last Update Submit

May 5, 2015

Conditions

GeriatricsResidence for Dependent ElderlyHealth Services for the Aged

Keywords

Multidisciplinary review of drug prescriptionsAdverse drug events geriatric risk scoreResidence for dependent elderly

Outcome Measures

Primary Outcomes (1)

  • Adverse Drug Events Geriatric Risk Score

    according to Trivalle and Ducimetière 2013

    change from Baseline to 6 months

Secondary Outcomes (17)

  • The number of patients taking at least 1 potentially inappropriate drug according to Laroche criteria

    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)

  • +12 more secondary outcomes

Study Arms (1)

The study population

OTHER

See inclusion and exclusion criteria. Intervention: Before-after study

Other: Before-after study

Interventions

Before-after studyOTHER

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.

The study population

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, 30029, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Interventions

Controlled Before-After Studies

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Géraldine Leguelinel, Pharm-D

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-04

Locations

FR(2)