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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00279656
Other study ID # om050-40/2003
Secondary ID
Status Completed
Phase Phase 4
First received January 17, 2006
Last updated January 17, 2006
Start date November 2003
Est. completion date June 2005

Study information

Verified date June 2004
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of a collaborative approach (geriatric care involving the collaboration with a clinical pharmacist) to optimize the prescription of medicines for elderly inpatients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
Pharmaceutical care


Locations

Country Name City State
Belgium Université catholique de Louvain Brussels

Sponsors (2)

Lead Sponsor Collaborator
Université Catholique de Louvain Fonds National de la Recherche Scientifique

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Polymedication on admission, at discharge, and 1,3,12 months after discharge
Secondary Mortality, readmission to hospital and visit to the emergency department 1,3,12 months after discharge
Secondary Satisfaction with information received on medicines