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OpenTrials
Completed

NCT Number: NCT00450034

Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Bichat Claude Bernard

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drug - oriented multifaceted intervention

Procedure

oriented multifaceted intervention

Primary outcomes

  1. Rate of unplanned readmissions, including emergency consultations,

    Time frame: during the study

Secondary outcomes

  1. Mortality at 6 months,

    Time frame: at 6 months

  2. delay before readmission,

    Time frame: before readmission

  3. number of drug events related readmissions.

    Time frame: readmissions

  4. Data collected at 3 and 6 months

    Time frame: at 3 and 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial

Acronym: OMAGE

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 21, 2007
Registry last updated
Dec 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.