CompletedNCT00450034OMAGEUpdated Dec 1, 2011

Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)

An interventional study of drug - oriented multifaceted intervention in Global Medical Assessment of Elderly Frail Patients, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2011-12-01.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 665
Allocation: Randomized
Ages: 70 Years and older
Sex: All

Study summary

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.

Read the 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.

Conditions studied

Global Medical Assessment of Elderly Frail Patients

Keywords

Frail Elderly
Patient Education
Drug optimization
Underuse
Vulnerable
Drug related hospitalization
Medical intervention

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 70 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 665 participants (actual)

Study arms

Experimental
1
Procedure: drug - oriented multifaceted intervention

Interventions

Proceduredrug - oriented multifaceted intervention
oriented multifaceted intervention

What researchers measure

Primary outcomes

Rate of unplanned readmissions, including emergency consultations,
Time frame: during the study

Secondary outcomes

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

Study locations

1 site

Chu Bichat Claude Bernard
Paris, 75018, France

References and documents

Publications

Legrain S, Tubach F, Bonnet-Zamponi D, Lemaire A, Aquino JP, Paillaud E, Taillandier-Heriche E, Thomas C, Verny M, Pasquet B, Moutet AL, Lieberherr D, Lacaille S. A new multimodal geriatric discharge-planning intervention to prevent emergency visits and rehospitalizations of older adults: the optimization of medication in AGEd multicenter randomized controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2017-28. doi: 10.1111/j.1532-5415.2011.03628.x. Epub 2011 Sep 27. PubMed 22091692 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00450034
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Responsible party: Sponsor
First posted: Mar 21, 2007
Start date: Apr 2007
Primary completion: Jun 2009
Completion: Jun 2009
Last update: Dec 1, 2011

Study contacts

Sylvie LEGRAIN, MD,PhD

principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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