Optimization of Drug Treatment in Hospitalized Elderly (OMAGE) (OMAGE)

November 30, 2011 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial

A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Drug treatment in elderly is not yet optimal. 20 to 30% of admissions of elderly aged over 80 are related to drug problems, most of them being preventable. To decrease drug related hospitalizations need iatrogenic prevention, compliance improvement, and underuse decrease. A multifaceted intervention has been designed, included three dimensions : 1/ drug optimization 2/ patient and/or caregiver education and 3/ better coordination with home health professionals before discharge.

A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.

Study Type

Interventional

Enrollment (Actual)

665

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Chu Bichat Claude Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients hospitalized as a matter of urgency in unity(unit) of geriatrics acute
  • Patients of more than 70 years old
  • Hospitalization in the Unity(Unit) of Geriatrics foreseen(planned) superior acute in 5 days
  • enlightened assent writing and signed
  • preliminary medical examination

Exclusion Criteria:

  • Patients in scheduled(programmed) hospitalization
  • Patient in palliative care
  • Patient whose vital forecast is engaged(opened) in 3 months
  • Patient already include during a previous hospitalization Patient already included in a study concerning the therapeutic care
  • Followed medical impossible (refusal of care, absence of alive regular, patient doctor abroad)
  • not membership to a regime of Social Security or CMU
  • Patient not speaking French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: drug - oriented multifaceted intervention
oriented multifaceted intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of unplanned readmissions, including emergency consultations,
Time Frame: during the study
during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality at 6 months,
Time Frame: at 6 months
at 6 months
delay before readmission,
Time Frame: before readmission
before readmission
number of drug events related readmissions.
Time Frame: readmissions
readmissions
Data collected at 3 and 6 months
Time Frame: at 3 and 6 months
at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Sylvie LEGRAIN, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Estimate)

December 1, 2011

Last Update Submitted That Met QC Criteria

November 30, 2011

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P060247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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