Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 11:24 PM
Study NCT ID:
NCT04020692
Status:
TERMINATED
Last Update Posted:
2024-11-12
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists.\n\nThe scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'whyStopped': 'Delays were caused by the covid-19 pandemic and a lack of staff on the saint vincent hospital site to take charge of the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Compliance of patients' medication intake at 45 days (D45) compared to the discharge prescription (D0): drugs prescribed and taken by patients (chronic disease treatments only)", 'timeFrame': '45 days', 'description': 'Compliance is defined as the absence of discrepancies between D0 and D+45. Conversely, the presence of a discrepancy is defined as the presence of at least one deviation of drug intake at D+45 from D0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multicenter study', 'Before-and-after type study', 'Minimal risks and constraints'], 'conditions': ['Older Adult', 'Chronic Disease', 'Clinical Pharmacy', 'Surgery', 'Ambulatory Care']}, 'descriptionModule': {'briefSummary': "The hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization.\n\nThe main objective of the study is to demonstrate that the intervention of an EOPC in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay.\n\nThe secondary objectives are to measure the impacts of EOPC's intervention on:\n\n* unexpected readmissions, emergency use, medical complications and adverse drug reactions;\n* patient and health professional satisfactions (community pharmacists and physicians);\n* the costs of drug treatments in ambulatory care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient (man or woman)\n* age ≥ 65 years with more than 3 drugs taken for 3 months, stay in surgery with a duration of ≥ 1 days including urgent surgery;\n* affiliated to a social health insurance scheme;\n* for whom a return home is possible;\n* able to understand the objectives of the research and give informed, dated and signed consent.\n\nExclusion Criteria:\n\n* Patient (man or woman)\n* with as a hospital discharge an entry into a nursing home or long-term care called "important medical and technical care (SMTI);\n* with cognitive or other problems preventing consent (at the discretion of the geriatric expertise team);\n* under the safeguard of justice;\n* under tutorship or curatorship.'}, 'identificationModule': {'nctId': 'NCT04020692', 'acronym': "IATRO'MED", 'briefTitle': 'Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization', 'orgStudyIdInfo': {'id': '7363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"intervention " group', 'description': "Patient At D0, the patient receives his discharge drugs prescription and benefits from a pharmaceutical counselling.\n\nAt D+3, he benefits from a telephone follow-up (good understanding of the methods of taking drugs, collection of difficulties).\n\nCommunity pharmacist At D0, he receives the discharge drugs prescription. At D+3, he is contacted to collect information relating to drugs 'dispensation.\n\nThe attending physician At D0, he is informed of the patient's discharge and his drugs treatment\n\nAt D45, the data collection is based on telephone interviews \\[attending physician, pharmacist and patient (and if applicable the caregiver)\\].\n\nIt makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.).", 'interventionNames': ['Behavioral: EOPC Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'At D0, the patient receives his discharge drugs prescription.\n\nAt D45, the data collection is based on telephone interviews \\[attending physician, pharmacist and patient (and if applicable the caregiver)\\].\n\nIt makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.).'}], 'interventions': [{'name': 'EOPC Intervention', 'type': 'BEHAVIORAL', 'description': 'The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists.\n\nThe scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization.', 'armGroupLabels': ['"intervention " group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Groupe Hospitalier Saint Vincent', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}