Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT02118259
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065187', 'term': 'Controlled Before-After Studies'}], 'ancestors': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Drug Events Geriatric Risk Score', 'timeFrame': 'change from Baseline to 6 months', 'description': 'according to Trivalle and Ducimetière 2013'}], 'secondaryOutcomes': [{'measure': 'The number of patients taking at least 1 potentially inappropriate drug according to Laroche criteria', 'timeFrame': 'During the proactive phase. Day 0.', 'description': 'Laroche et al 2007.'}, {'measure': 'Number of hospitalizations in the public sector (higher level care)', 'timeFrame': 'first observational phase (month -6 to day 0)'}, {'measure': 'Number of hospitalizations in the public sector (higher level care)', 'timeFrame': 'second observational phase (day 0 to month 6)'}, {'measure': 'Days of hospitalization in the public sector (higher level care)', 'timeFrame': 'first observational phase (month -6 to day 0)'}, {'measure': 'Days of hospitalization in the public sector (higher level care)', 'timeFrame': 'second observational phase (day 0 to month 6)'}, {'measure': 'Mortality', 'timeFrame': 'first observational phase (month -6 to day 0)'}, {'measure': 'Mortality', 'timeFrame': 'second observational phase (day 0 to month 6)'}, {'measure': 'The number of falls per patient', 'timeFrame': 'first observational phase (month -6 to day 0)'}, {'measure': 'The number of falls per patient', 'timeFrame': 'second observational phase (day 0 to month 6)'}, {'measure': 'The percentage of patients who fell', 'timeFrame': 'first observational phase (month -6 to day 0)'}, {'measure': 'The percentage of patients who fell', 'timeFrame': 'second observational phase (day 0 to month 6)'}, {'measure': 'The Anatomical Therapeutic Chemical classification for each revised drug', 'timeFrame': 'during the proactive phase (day 0)'}, {'measure': 'The type of errors detected during drug review', 'timeFrame': 'during the proactive phase (day 0)', 'description': 'Contra-indication, dosing, route, etc'}, {'measure': 'The type of modification suggested during drug review', 'timeFrame': 'during the proactive phase (day 0)', 'description': 'discontinuation, addition, substitution...'}, {'measure': 'The acceptation rate for modifications suggested during drug review', 'timeFrame': 'during the proactive phase (day 0)'}, {'measure': 'Associated care costs (€)', 'timeFrame': 'first observational phase (month -6 to day 0)'}, {'measure': 'Associated care costs (€)', 'timeFrame': 'second observational phase (day 0 to month 6)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multidisciplinary review of drug prescriptions', 'Adverse drug events geriatric risk score', 'Residence for dependent elderly'], 'conditions': ['Geriatrics', 'Residence for Dependent Elderly', 'Health Services for the Aged']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to show that the multidisciplinary review of drug prescriptions changes the adverse drug event (ADE) geriatric risk score (according to Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital Residence for Dependent Elderly.', 'detailedDescription': 'The secondary objectives of this study are to assess and compare the following criteria before and after multidisciplinary review of drug prescriptions for patients in the Nîmes University Hospital Residence for Dependent Elderly:\n\nA. the number of patients with at least one potentially inappropriate drug prescribed\n\nB. the number of hospitalizations\n\nC. death rate\n\nD. the number of falls per patient and the rate of fallers\n\nE. qualitative criteria describing the drug review\n\nF. associated care costs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient (or his/her legal representative) must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 6 months of follow-up\n* The patient has resided at the Nîmes University Hospital Residence for Dependent Elderly for at least the past 6 months\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection\n* The patient (or his/her legal representative) refuses to sign the consent\n* It is impossible to correctly inform the patient (or his/her legal representative)\n* The patient has resided at the Nîmes University Hospital Residence for Dependent Elderly for less than 6 months'}, 'identificationModule': {'nctId': 'NCT02118259', 'acronym': 'Rev-EHPAD', 'briefTitle': 'Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly', 'orgStudyIdInfo': {'id': 'LOCAL/2013/GL-01'}, 'secondaryIdInfos': [{'id': '2013-A01590-45', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'The study population', 'description': 'See inclusion and exclusion criteria.\n\nIntervention: Before-after study', 'interventionNames': ['Other: Before-after study']}], 'interventions': [{'name': 'Before-after study', 'type': 'OTHER', 'description': 'The before-after study is composed of a first observational phase followed by a proactive phase, and then finally by a second observational phase.\n\nThe first observational phase corresponds to retrospective data-collecting for the information necessary for calculating the baseline ADE geriatric risk score.\n\nThe proactive phase corresponds to a multidisciplinary review of drug prescriptions (especially long-term drugs) for all included patients in the residence.\n\nDuring the second observational phase, the same data as in the first observational phase will be collected a second time.', 'armGroupLabels': ['The study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Géraldine Leguelinel, Pharm-D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}