Optimization of Drug Treatment in Hospitalized Elderly (OMAGE) - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00450034

Purpose

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.

Condition	Intervention
Global Medical Assessment of Elderly Frail Patients	Procedure: drug - oriented multifaceted intervention

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Rate of unplanned readmissions, including emergency consultations, [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mortality at 6 months, [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
delay before readmission, [ Time Frame: before readmission ] [ Designated as safety issue: No ]
number of drug events related readmissions. [ Time Frame: readmissions ] [ Designated as safety issue: No ]
Data collected at 3 and 6 months [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: drug - oriented multifaceted intervention oriented multifaceted intervention

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

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450034

Contacts

Contact: Sylvie LEGRAIN, MD,PhD

+33(0) 1 40 25 87 48

sylvie.legrain@bch.aphp.fr

Locations

France
Chu Bichat Claude Bernard	Recruiting
PARIS, France, 75018
Contact: Sylvie LEGRAIN, MD,PhD +33(0) 1 40 25 87 48 sylvie.legrain@bch.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Sylvie LEGRAIN, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Saliha DJANE )
Study ID Numbers:	P060247, AOM06077
Study First Received:	March 19, 2007
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00450034 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Frail Elderly
Patient Education
Drug optimization
Underuse

Vulnerable
Drug related hospitalization
Medical intervention

ClinicalTrials.gov processed this record on May 07, 2009