Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-28 @ 6:40 PM
Study NCT ID:
NCT03666793
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2018-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}], 'ancestors': [{'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-10', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of readmission at 30 days', 'timeFrame': '30 days', 'description': 'Evaluate the impact of optimizing drug prescriptions on re-admissions of elderly patients within 30 days of return to home.Only direct re-admissions to emergency and geriatric short-stay services in participating centres will be counted.'}], 'secondaryOutcomes': [{'measure': 'Time between discharge and first readmission', 'timeFrame': '30 days', 'description': 'Evaluate the impact of medication management on the time required for the first re-admission to hospital, if it takes place before 30 days.'}, {'measure': 'Rate of changes in the prescription after hospital discharge by the general practitioner', 'timeFrame': '30 days', 'description': 'Estimate the impact of this process on the preservation of the prescription after hospital discharge by general practitioner within the 30 days following the return home actual number of discrepancies, what may have caused the change and which are the concerned drugs'}, {'measure': 'Identification of Seniors at Risk (ISAR) score', 'timeFrame': '30 days', 'description': 'This score is based on 6 yes/no questions. T e total scale range is from 0 to 6. Each item is scored 1 if there is a problem or 0 if there is not, being the maximum score =6.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly', 'Medication Reconciliation', 'Patient Readmission'], 'conditions': ['Elderly', 'Medication Reconciliation', 'Patient Readmission']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of optimizing drug prescriptions on re-admissions of elderly patients within 30 days after hospital discharge. It compares a group of patients receiving comprehensive care (medication reconciliation at hospital entry, multidisciplinary medication review, and medication reconciliation at discharge), versus another group that does not benefit from the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized in the department of short geriatric stay\n\nExclusion Criteria:\n\n* Patients already included in the study, and readmitted in the same service.'}, 'identificationModule': {'nctId': 'NCT03666793', 'acronym': 'OPTISORT', 'briefTitle': "Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care", 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': "Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care, From Hospital to Home: Impact on Readmission at 30 Days After Delivery", 'orgStudyIdInfo': {'id': 'RC-P0069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard healthcare procedures'}, {'type': 'EXPERIMENTAL', 'label': 'experimental: Reconciliation group', 'description': 'medical reconciliation at admission, multidisciplinary medication review, medical reconciliation at discharge of the hospital', 'interventionNames': ['Other: global care']}], 'interventions': [{'name': 'global care', 'type': 'OTHER', 'description': 'Medication Reconciliation at admission, Multidisciplinary medication review, Medication Reconciliation at discharge', 'armGroupLabels': ['experimental: Reconciliation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lomme', 'country': 'France', 'facility': 'GHICL', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'overallOfficials': [{'name': 'Fabien Visade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHICL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}