Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00279656
Status:
COMPLETED
Last Update Posted:
2006-01-19
First Post:
2006-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of a Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-06', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2006-01-17', 'studyFirstSubmitDate': '2006-01-17', 'studyFirstSubmitQcDate': '2006-01-17', 'lastUpdatePostDateStruct': {'date': '2006-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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'}], 'secondaryOutcomes': [{'measure': 'Polymedication on admission, at discharge, and 1,3,12 months after discharge'}, {'measure': 'Mortality, readmission to hospital and visit to the emergency department 1,3,12 months after discharge'}, {'measure': 'Satisfaction with information received on medicines'}]}, 'conditionsModule': {'keywords': ['Frail elderly', 'Pharmaceutical services', 'Drug therapy', 'Geriatrics', 'Randomized controlled trial', 'Hospitals, teaching'], 'conditions': ['Frail Elderly Inpatient']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDespite this, only limited data exist on the effectiveness of optimization strategies targeted at frail elderly inpatients.\n\nComparison: elderly inpatients receiving geriatric evaluation and management (GEM) care versus elderly inpatients receiving pharmaceutical care in addition to GEM care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted on the acute geriatric unit of the university teaching hospital Mont-Godinne, Belgium\n\nExclusion Criteria:\n\n* a terminal illness and life expectancy of less than 3 month\n* expected length of stay of 2 days or less\n* transfer from another unit where the patient had already been cared for by a GEM team\n* refusal to participate\n* inclusion during previous admission\n* no time for the clinical pharmacist to compound the abstracted chart within 3 days of admission'}, 'identificationModule': {'nctId': 'NCT00279656', 'briefTitle': 'Benefit of a Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients - Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'om050-40/2003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pharmaceutical care', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Université catholique de Louvain', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Anne Spinewine, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université Catholique de Louvain'}, {'name': 'Christian Swine, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Université Catholique de Louvain'}, {'name': 'Paul M Tulkens, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds National de la Recherche Scientifique', 'class': 'OTHER'}]}}}