Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 8:45 PM
Study NCT ID:
NCT04513834
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2020-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPI deprescribing', 'timeFrame': '12 months', 'description': 'Proportion of patients achieving a 50% decrease in their reimbursement of PPI (Defined Daily Dose (DDD)/year) at the end of the intervention compared to baseline (estimated with reimbursement databases)'}], 'secondaryOutcomes': [{'measure': 'Characteristics of patients engaging in the deprescription process', 'timeFrame': '12 months', 'description': 'Sex, age, long-term illness, universal health insurance, complementary health insurance, medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proton pump inhibitors', 'Deprescription', 'Multi-faceted intervention', 'Patient-centered', 'Primary health care', 'Pharmacoepidemiology'], 'conditions': ['Proton Pump Inhibitors', 'Deprescription']}, 'descriptionModule': {'briefSummary': 'Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.\n\nDeprescrIPP DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General practitioners (GP)\n\n • All GP settled in the French region Pays-de-la-Loire having seen more than 100 different patients in the year before baseline, will be eligible.\n* Patients\n\n * Aged more than 18 years old\n * Affiliated to the French health insurance CPAM\n * Treated with PPI\\> 300DDD/year in the year before baseline (estimated with reimbursement databases).\n * Whose GP is included in the study\n\nExclusion Criteria:\n\n* General practitioners (GPs) :\n\n • Participation refusal\n* Patients\n\n * Participation refusal\n * Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors\n * Patients under legal protection'}, 'identificationModule': {'nctId': 'NCT04513834', 'acronym': 'DeprescrIPPDAM', 'briefTitle': 'Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RC20_0339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-faceted intervention', 'description': "Patient education material on PPI deprescribing will be sent to the patients and their general practitioner (GP) will receive an educational outreach visit by a Delegue d'Assurance Maladie (DAM, healthcare representative )", 'interventionNames': ['Other: GP will receive the educational outreach visit by a DAM (healthcare representative).', 'Other: Patient education material on PPI deprescribing will be sent to the patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational outreach visit to GPs', 'description': 'GP will receive the educational outreach visit by a DAM (healthcare representative). Their patients will not receive any patient education material.', 'interventionNames': ['Other: GP will receive the educational outreach visit by a DAM (healthcare representative).']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Neither the patients nor their GP will receive any information.'}], 'interventions': [{'name': 'GP will receive the educational outreach visit by a DAM (healthcare representative).', 'type': 'OTHER', 'description': 'GP will receive the educational outreach visit by a DAM (healthcare representative).', 'armGroupLabels': ['Educational outreach visit to GPs', 'Multi-faceted intervention']}, {'name': 'Patient education material on PPI deprescribing will be sent to the patients', 'type': 'OTHER', 'description': 'Patient education material on PPI deprescribing will be sent to the patients', 'armGroupLabels': ['Multi-faceted intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}