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Completed

NCT Number: NCT02118259

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

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.

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Key information

Conditions

Geriatrics Health Services for the Aged Residence for Dependent Elderly

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier, Nîmes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Before-after study

Other

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.

Primary outcomes

  1. Adverse Drug Events Geriatric Risk Score

    Time frame: change from Baseline to 6 months

    according to Trivalle and Ducimetière 2013

Secondary outcomes

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

    Time frame: During the proactive phase. Day 0.

    Laroche et al 2007.

  2. Number of hospitalizations in the public sector (higher level care)

    Time frame: first observational phase (month -6 to day 0)

  3. Number of hospitalizations in the public sector (higher level care)

    Time frame: second observational phase (day 0 to month 6)

  4. Days of hospitalization in the public sector (higher level care)

    Time frame: first observational phase (month -6 to day 0)

  5. Days of hospitalization in the public sector (higher level care)

    Time frame: second observational phase (day 0 to month 6)

  6. Mortality

    Time frame: first observational phase (month -6 to day 0)

  7. Mortality

    Time frame: second observational phase (day 0 to month 6)

  8. The number of falls per patient

    Time frame: first observational phase (month -6 to day 0)

  9. The number of falls per patient

    Time frame: second observational phase (day 0 to month 6)

  10. The percentage of patients who fell

    Time frame: first observational phase (month -6 to day 0)

  11. The percentage of patients who fell

    Time frame: second observational phase (day 0 to month 6)

  12. The Anatomical Therapeutic Chemical classification for each revised drug

    Time frame: during the proactive phase (day 0)

  13. The type of errors detected during drug review

    Time frame: during the proactive phase (day 0)

    Contra-indication, dosing, route, etc

  14. The type of modification suggested during drug review

    Time frame: during the proactive phase (day 0)

    discontinuation, addition, substitution...

  15. The acceptation rate for modifications suggested during drug review

    Time frame: during the proactive phase (day 0)

  16. Associated care costs (€)

    Time frame: first observational phase (month -6 to day 0)

  17. Associated care costs (€)

    Time frame: second observational phase (day 0 to month 6)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: Rev-EHPAD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2014
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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