Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-05 @ 11:50 PM
Study NCT ID:
NCT05327634
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the obstacles to the withdrawal of medication in patients over 75 years of age in the geriatric sector', 'timeFrame': 'Baseline', 'description': 'The main evaluation criterion will be measured using the self-questionnaire: a revised form of the 5-point Likert-type "Revised Patients\' Attitude Toward Deprescribing" (rPATD), validated in French.\n\nDiscouragement will be assessed on the basis of the overall score of questions 1 to 20 of the self-questionnaire, with regard to questions 21 and 22.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the relationship between patient burden and acceptance (or refusal) of deprescribing.', 'timeFrame': 'Baseline', 'description': 'They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients\' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items.\n\nThey will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients\' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items.'}, {'measure': 'Assessment of the relationship between the benefit of the treatment experienced by the patient and the acceptance (or refusal) of the deprescribing', 'timeFrame': 'Baseline', 'description': "They will be measured using the self-questionnaire given to patients. Responses to the questions concerning the perceived benefit of treatment (questions 6 to 10) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items"}, {'measure': 'Assessment of the relationship between concern about possible negative effects of discontinuing treatment and acceptance (or refusal) of deprescribing', 'timeFrame': 'Baseline', 'description': "They will be measured using the self-questionnaire given to patients. Responses to questions concerning concern about possible negative effects of stopping treatment (questions 11 to 15) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items."}, {'measure': "Assessment of the relationship between the patient's good knowledge of their treatments and acceptance (or refusal) of the deprescribing.", 'timeFrame': 'Baseline', 'description': "They will be measured using the self-questionnaire given to patients. The answers to the questions concerning the patient's good knowledge of their treatments (questions 16 to 20) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items.."}, {'measure': 'Assessment of the relationship between certain families of treatments and acceptance (or refusal) of deprescribing', 'timeFrame': 'Baseline', 'description': 'They will be measured using the self-questionnaire given to patients. Responses concerning the acceptance of deprescribing according to the different treatment families will be measured using simple questions 26 to 29 of the self-questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly patient', 'Inappropriate drugs', 'Deprescribing', 'Obstacles', 'French'], 'conditions': ['Medication Abuse']}, 'referencesModule': {'references': [{'pmid': '33317980', 'type': 'BACKGROUND', 'citation': "Roux B, Sirois C, Niquille A, Spinewine A, Ouellet N, Petein C, Sibille FX, Csajka C, Reeve E, Villeneuve C, Laroche ML. Cross-cultural adaptation and psychometric validation of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in French. Res Social Adm Pharm. 2021 Aug;17(8):1453-1462. doi: 10.1016/j.sapharm.2020.11.004. Epub 2020 Nov 10."}, {'pmid': '40374894', 'type': 'DERIVED', 'citation': 'Antoniazzi C, Cnockaert X, Michel P. Description of barriers to the deprescription of inappropriate drugs in French hospitalized geriatric services. Sci Rep. 2025 May 15;15(1):16837. doi: 10.1038/s41598-025-99752-9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process.', 'detailedDescription': 'For several years now, the proportion of senior citizens in our country has been rising steadily. There are now 6.4 million people over the age of 75 in France.\n\nIt is therefore important to take into account the needs and specificities of this part of the population. One of its particularities is polypathology. Indeed, from the age of 70 onwards, 93% of elderly subjects have at least 2 diseases and 85% have at least 3. This polypathology will lead to a large number of different prescribers with an increased risk of having more than 5 molecules in their personal treatment. This is known as polypharmacy.\n\nIn the elderly, polypharmacy is harmful. It increases the risk of adverse effects and drug interactions. In France, 20% of patients over 75 years old and 25% of those over 85 years old consult the emergency room because of adverse drug reactions.\n\nThe literature shows that we can act on these adverse events by "deprescribing". De-prescribing is defined as intentionally stopping the prescription of an unnecessary or potentially dangerous drug for a patient.\n\nThe expected benefit for the patient is to reduce the iatrogenic risks induced by treatments that would no longer be useful for him/her or that have a negative benefit/risk balance. To achieve this objective, the patient must understand this risk, understand the benefit he or she can derive from it and be an actor in this process.\n\nFor carers, the expected benefit is greater involvement of the patient in the process, better adherence to the approach, which can be organised and carried out in a safer way.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 75 and over hospitalised in geriatric short stay or geriatric rehabilitation units', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 75 years and over\n* Hospitalized in geriatric short-stay or geriatric rehabilitation units\n* Patients who did not object to participation in the study\n\nExclusion Criteria:\n\n* Patient refusal\n* Patients not able to understand and fill in the questionnaire: Cognitive disorders, Confusion, Unstable clinical state, Sensory disorders, not speaking French.\n* Patient under protective supervision (guardianship or curatorship)'}, 'identificationModule': {'nctId': 'NCT05327634', 'acronym': 'OUTMEDIC-FR', 'briefTitle': 'Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network', 'orgStudyIdInfo': {'id': 'CHRD2921'}, 'secondaryIdInfos': [{'id': '2022-A00136-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Deprescribing', 'description': 'Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units', 'interventionNames': ['Other: self-questionnaire']}], 'interventions': [{'name': 'self-questionnaire', 'type': 'OTHER', 'description': 'Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units', 'armGroupLabels': ['Deprescribing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'Short stay Geriatric department - Hospital Simone Veil', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'SSR Geriatric department - Hospital Simone Veil', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'Short stay Geriatric department - Hospital René Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'SSR Geriatric department - Hospital René Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}], 'overallOfficials': [{'name': 'Christophe Antoniazzi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital René Dubos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}