Clinical trial NCT00450034: Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)
Official title: Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Global Medical Assessment of Elderly Frail Patients
Keywords: Frail Elderly
Patient Education
Drug optimization
Underuse
Vulnerable
Drug related hospitalization
Medical intervention
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 665
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of unplanned readmissions, including emergency consultations,
timeFrame: during the study
Secondary outcomes:
measure: Mortality at 6 months,
timeFrame: at 6 months
measure: delay before readmission,
timeFrame: before readmission
measure: number of drug events related readmissions.
timeFrame: readmissions
measure: Data collected at 3 and 6 months
timeFrame: at 3 and 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Chu Bichat Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sylvie LEGRAIN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.