- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450034
Optimization of Drug Treatment in Hospitalized Elderly (OMAGE) (OMAGE)
Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75018
- Chu Bichat Claude Bernard
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Investigators
- Principal Investigator: Sylvie LEGRAIN, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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