Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00450034
First received: March 19, 2007
Last updated: November 30, 2011
Last verified: March 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 665
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: drug - oriented multifaceted intervention
oriented multifaceted intervention
Other Name: drug - 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

Locations
France
Chu Bichat Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Sylvie LEGRAIN, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00450034     History of Changes
Other Study ID Numbers: P060247
Study First Received: March 19, 2007
Last Updated: November 30, 2011
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 April 15, 2014