- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279656
Benefit of a Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients
Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients - Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Widespread evidence reveals frequent inadequate use of medicines in elderly patients. This includes inappropriate prescribing (overuse, underuse, misuse) that can lead to adverse drug events and drug-related admissions to hospital. In addition, when a patient is transferred from acute care settings to ambulatory care settings, discrepancies in medicines used often occur and can be hazardous.
Despite this, only limited data exist on the effectiveness of optimization strategies targeted at frail elderly inpatients.
Comparison: elderly inpatients receiving geriatric evaluation and management (GEM) care versus elderly inpatients receiving pharmaceutical care in addition to GEM care.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1200
- Université Catholique de Louvain
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient admitted on the acute geriatric unit of the university teaching hospital Mont-Godinne, Belgium
Exclusion Criteria:
- a terminal illness and life expectancy of less than 3 month
- expected length of stay of 2 days or less
- transfer from another unit where the patient had already been cared for by a GEM team
- refusal to participate
- inclusion during previous admission
- no time for the clinical pharmacist to compound the abstracted chart within 3 days of admission
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Appropriateness of prescribing (using the Medication Appropriateness Index, the Beers criteria, and the ACOVE criteria of underuse) on admission, at discharge, and 3 months post-discharge
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Secondary Outcome Measures
Outcome Measure |
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Polymedication on admission, at discharge, and 1,3,12 months after discharge
|
Mortality, readmission to hospital and visit to the emergency department 1,3,12 months after discharge
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Satisfaction with information received on medicines
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Spinewine, MSc, Université Catholique de Louvain
- Study Chair: Christian Swine, MD, Université Catholique de Louvain
- Study Director: Paul M Tulkens, PhD, Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- om050-40/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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