Optimization of Drug Treatment in Hospitalized Elderly (O... | NCT00450034

Studies
Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)

NCT00450034

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Dec 1, 2011Estimated

Enrollment

665Actual

Phase

Not Applicable

Conditions

Global Medical Assessment of Elderly Frail Patients

Interventions

drug - oriented multifaceted intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2011

Last Update Posted Date

Dec 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

665Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: drug - oriented multifaceted intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drug - oriented multifaceted intervention	Procedure	oriented multifaceted intervention	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mortality at 6 months,		at 6 months
delay before readmission,		before readmission
number of drug events related readmissions.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sylvie LEGRAIN, MD,PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Bichat Claude Bernard		Paris		75018	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22091692	Result	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.