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GeriatricsRev-EHPADNCT02118259

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

A study testing Before-after study in people with Geriatrics and Residence for Dependent Elderly, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Before-after study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesFrance
Study dates
May 2014to Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

    Nîmes, 30029

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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.

Read the 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
Being tested
Before-after study
Keywords
Multidisciplinary review of drug prescriptions, Adverse drug events geriatric risk score, Residence for dependent elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02118259
Study groupRoleWhat they receive
The study populationOtherSee inclusion and exclusion criteria. Intervention: Before-after study
Receives: Other: Before-after study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Drug Events Geriatric Risk Score

    according to Trivalle and Ducimetière 2013

    Measured: change from Baseline to 6 months

Secondary outcomes (17)

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

    Laroche et al 2007.

    Measured: During the proactive phase. Day 0.

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

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

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

    Measured: second observational phase (day 0 to month 6)

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

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

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

    Measured: second observational phase (day 0 to month 6)

  6. Mortality

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

  7. Mortality

    Measured: second observational phase (day 0 to month 6)

  8. The number of falls per patient

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

  9. The number of falls per patient

    Measured: second observational phase (day 0 to month 6)

  10. The percentage of patients who fell

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

  11. The percentage of patients who fell

    Measured: second observational phase (day 0 to month 6)

  12. The Anatomical Therapeutic Chemical classification for each revised drug

    Measured: during the proactive phase (day 0)

  13. The type of errors detected during drug review

    Contra-indication, dosing, route, etc

    Measured: during the proactive phase (day 0)

  14. The type of modification suggested during drug review

    discontinuation, addition, substitution...

    Measured: during the proactive phase (day 0)

  15. The acceptation rate for modifications suggested during drug review

    Measured: during the proactive phase (day 0)

  16. Associated care costs (€)

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

  17. Associated care costs (€)

    Measured: second observational phase (day 0 to month 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02118259
Sponsor's protocol ID
LOCAL/2013/GL-01
Other IDs
2013-A01590-45
Acronym
Rev-EHPAD
Status last verified
Apr 2015
First submitted
16 Apr 2014
Last updated
6 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Before-after study in people with Geriatrics and Residence for Dependent Elderly, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Drug Events Geriatric Risk Score (time frame: change from Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02118259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.

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