Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-04-17 @ 3:19 PM
Study NCT ID:
NCT02339792
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2014-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-learning to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 697}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of drug prescribing', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 12 days', 'description': "The primary study objective is to evaluate whether an integrated e-learning program of medical education, focused on teaching and implementing CGA added to GPNs (intervention) is superior to delivering GPNs only (control) in reducing the prescription of potentially inappropriate medications (PID) or of potential drug-drug interactions (PDDI) during hospitalization and at hospital discharge in hospitalized elderly.\n\nThe primary outcome is the change in prescription of PID,as defined by Beers' criteria , or of PDDI related to the 20 drugs most frequently prescribed during hospital stay and at discharge."}], 'secondaryOutcomes': [{'measure': 'clinical outcomes (lenght of hospitalization, mortality, rehospitalization)', 'timeFrame': '12 months', 'description': 'Secondary objectives are the assessment of:\n\n\\- the impact of the integrated e-learning intervention in terms of length of hospitalization, in-hospital and overall mortality, re-hospitalization and institutionalization during a follow-up of 12 months; - the persistence and the clinical impact on the enrolled patients of the effect of the integrated e-learning intervention on the improvement of quality of drug prescribing during a follow-up of 12 months.\n\nSecondary outcomes are the persistence and the clinical impact of the integrated e-learning intervention on duration of hospitalization, rate of in-hospital and overall mortality, re-hospitalization and institutionalization during 12 months of follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COMPREHENSIVE GERIATRIC ASSESSMENT (CGA)', 'MEDICATION APPROPRIATENESS PRESCRIBING', 'DRUG INTERACTIONS', 'E-LEARNING'], 'conditions': ['Drug Use']}, 'referencesModule': {'references': [{'pmid': '26922904', 'type': 'DERIVED', 'citation': 'Franchi C, Tettamanti M, Djade CD, Pasina L, Mannucci PM, Onder G, Gussoni G, Manfellotto D, Bonassi S, Salerno F, Nobili A; ELICADHE Investigators. E-learning in order to improve drug prescription for hospitalized older patients: a cluster-randomized controlled study. Br J Clin Pharmacol. 2016 Jul;82(1):53-63. doi: 10.1111/bcp.12922. Epub 2016 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled pragmatic study is aimed to set-up, assess and implement an integrated e-learning program of medical education in an hospital setting, focused on teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve the quality of drug prescribing in elderly patients', 'detailedDescription': 'The integrated e-learning program (intervention group) is focused on teaching and implementing knowledge on CGA and GPNs to help clinicians to improve the quality of drug prescribing in the elderly.The GPNs is focused on pharmaco-epidemiological issues of drug prescribing, pharmacokinetic and pharmacodynamic changes during aging, topics in evaluating and managing polypharmacy, criteria to review the appropriateness of drug therapies and the clinical relevance of PDDI in the elderly. The control group receives only GPNs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people aged 75 years or older\n\nExclusion Criteria:\n\n* people aged 75 years or older\n* refusal of consent to participate\n* a life expectancy of less than 6 months'}, 'identificationModule': {'nctId': 'NCT02339792', 'briefTitle': 'E-learning to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mario Negri Institute for Pharmacological Research'}, 'officialTitle': 'Effect of an Integrated E-learning Intervention, Focused on Comprehensive Geriatric Assessment to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients', 'orgStudyIdInfo': {'id': 'FARM87SA2B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs)', 'interventionNames': ['Other: E-learning']}, {'type': 'OTHER', 'label': 'Control', 'description': 'e-learning program of medical education, focused on teaching only geriatric pharmacological notions (GPNs)', 'interventionNames': ['Other: E-learning']}], 'interventions': [{'name': 'E-learning', 'type': 'OTHER', 'description': 'e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs)', 'armGroupLabels': ['Control', 'Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agenzia Italiana del Farmaco', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Paola Boccardo', 'investigatorAffiliation': 'Mario Negri Institute for Pharmacological Research'}}}}