Viewing Study NCT02165618


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Study NCT ID: NCT02165618
Status: COMPLETED
Last Update Posted: 2014-06-17
First Post: 2014-05-26
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Rationalisation of Polypharmacy by the Geriatric Consultation Team
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090143', 'term': 'Medication Review'}], 'ancestors': [{'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of medication-related recommendations by the geriatric consultation team.', 'timeFrame': 'The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.'}], 'secondaryOutcomes': [{'measure': 'Number of potentially inappropriate drugs at discharge, as identified by the RASP list.', 'timeFrame': 'The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.'}, {'measure': 'Number of drugs at discharge, relative to the drugs on admission.', 'timeFrame': 'The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.'}, {'measure': 'Acceptance rate of the GCT interventions by the treating physician.', 'timeFrame': 'Up to 72 hours after the GCT had given its recommendations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['frailty', 'geriatric, elderly', 'polypharmacy'], 'conditions': ['Iatrogenic Disease']}, 'referencesModule': {'references': [{'pmid': '29970005', 'type': 'DERIVED', 'citation': 'Van der Linden L, Hias J, Dreessen L, Milisen K, Flamaing J, Spriet I, Tournoy J. Medication review versus usual care to improve drug therapies in older inpatients not admitted to geriatric wards: a quasi-experimental study (RASP-IGCT). BMC Geriatr. 2018 Jul 3;18(1):155. doi: 10.1186/s12877-018-0843-y.'}]}, 'descriptionModule': {'briefSummary': "Polypharmacy is a common problem in elderly, leading among others to increased adverse drug events. The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on admission by an adjusted STOPP\\*-list in older patients) list could reduce inappropriate prescribing for elderly admitted patients, admitted to non-geriatric departments.\n\n(\\* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)", 'detailedDescription': 'Polypharmacy and (potentially) inappropriate prescribing is highly prevalent in the older population, associated with increase health care expenditures, morbidity and avoidable adverse events .\n\nThe aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team (GCT) using the RASP (Rationalisation of drugs on admission by an adjusted STOPP-list in older patients) list could reduce inappropriate prescribing for older admitted patients, admitted to non-geriatric departments. The GCT could offer the ideal format to deliver the intervention to a broad older hospitalised population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a non-geriatric ward\n* 75 years or older\n* Dutch speaking\n* Consultation by the GCT\n\nExclusion Criteria:\n\n* End-of-life\n* No drugs on admission'}, 'identificationModule': {'nctId': 'NCT02165618', 'acronym': 'RASP-GCT', 'briefTitle': 'Rationalisation of Polypharmacy by the Geriatric Consultation Team', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Rationalisation of Polypharmacy by the Geriatric Consultation Team Using the RASP List: a Pilot Study', 'orgStudyIdInfo': {'id': 'S-54896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'GCT', 'description': 'In a before phase, data on how the GCT operated (i.e. good clinical practice) was gathered.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GCT-RASP', 'description': 'Medication review, based on but not limited to the RASP list', 'interventionNames': ['Other: Medication review, based on but not limited to the RASP list']}], 'interventions': [{'name': 'Medication review, based on but not limited to the RASP list', 'type': 'OTHER', 'otherNames': ['RASP', 'RASP list', 'Systematic medication review'], 'description': 'Systematic approach:\n\n1. Medication reconciliation\n2. Applying the RASP list\n3. Expert review (not based on the RASP list)\n4. Multidisciplinary discussion', 'armGroupLabels': ['GCT-RASP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Flemish Brabant', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Lorenz R Van der Linden, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Johan Flamaing, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Jos Tournoy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}