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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT02118259
Collaborator
(none)
49
2
1
9.1
24.5
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Before-after study
N/A

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

  2. the number of hospitalizations

  3. death rate

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

  5. qualitative criteria describing the drug review

  6. associated care costs

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adverse Drug Events Geriatric Risk Score [change from Baseline to 6 months]

    according to Trivalle and Ducimetière 2013

Secondary Outcome Measures

  1. 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.

  2. Number of hospitalizations in the public sector (higher level care) [first observational phase (month -6 to day 0)]

  3. Number of hospitalizations in the public sector (higher level care) [second observational phase (day 0 to month 6)]

  4. Days of hospitalization in the public sector (higher level care) [first observational phase (month -6 to day 0)]

  5. Days of hospitalization in the public sector (higher level care) [second observational phase (day 0 to month 6)]

  6. Mortality [first observational phase (month -6 to day 0)]

  7. Mortality [second observational phase (day 0 to month 6)]

  8. The number of falls per patient [first observational phase (month -6 to day 0)]

  9. The number of falls per patient [second observational phase (day 0 to month 6)]

  10. The percentage of patients who fell [first observational phase (month -6 to day 0)]

  11. The percentage of patients who fell [second observational phase (day 0 to month 6)]

  12. The Anatomical Therapeutic Chemical classification for each revised drug [during the proactive phase (day 0)]

  13. The type of errors detected during drug review [during the proactive phase (day 0)]

    Contra-indication, dosing, route, etc

  14. The type of modification suggested during drug review [during the proactive phase (day 0)]

    discontinuation, addition, substitution...

  15. The acceptation rate for modifications suggested during drug review [during the proactive phase (day 0)]

  16. Associated care costs (€) [first observational phase (month -6 to day 0)]

  17. Associated care costs (€) [second observational phase (day 0 to month 6)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029
2 CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier Nîmes France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Géraldine Leguelinel, Pharm-D, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02118259
Other Study ID Numbers:
  • LOCAL/2013/GL-01
  • 2013-A01590-45
First Posted:
Apr 21, 2014
Last Update Posted:
May 6, 2015
Last Verified:
Apr 1, 2015

Study Results

No Results Posted as of May 6, 2015