Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:17 AM
Study NCT ID:
NCT07474532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attitudes and Beliefs Related to Benzodiazepine Deprescribing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in responses to items on the rPATD Benzo between T0 and T1, classified into three categories (no variation, more favorable attitudes and beliefs, less favorable attitudes and beliefs)', 'timeFrame': 'at 0day and 9 days', 'description': 'As part of the primary endpoint, each item is studied individually as an ordinal variable matched between T0 and T1.\n\nTo facilitate clinical interpretation and limit instability related to minor variations in response, the responses are grouped into three levels of agreement:\n\n* Somewhat disagree (responses: "strongly disagree" and "disagree")\n* Neutral (response: "Neither agree nor disagree")\n* Somewhat agree (responses: "agree" and "strongly agree")\n\nThe variation is defined for each item as follows:\n\n* Change to a higher level of agreement;\n* Change to a lower level of agreement;\n* Stability (maintaining the level of agreement).'}], 'secondaryOutcomes': [{'measure': "Analysis of patients' open-ended responses to additional questions at the end of last 2 items of the rPATD Benzo at T1.", 'timeFrame': 'during 9 days', 'description': 'For the last two items of the rPATD Benzo, the pharmacy team member will ask the patient an additional question if their response differs significantly from the initial assessment.\n\n* Additional question: "What made you change your mind since the first assessment?" "\n* Definition of a significantly different response: A response is considered significantly different if it differs by at least two levels on the Likert scale.\n\nThis threshold differentiates between minor fluctuations in positioning and a significant change in the patient\'s attitudes or beliefs.'}, {'measure': 'Comparative responses from patients and physicians to the last two items of the rPATD Benzo.', 'timeFrame': 'during 3 days', 'description': "A member of the pharmaceutical team will ask the hospital physician how he thinks his patient answered the last two questions of the rPATD Benzo. The physician's answer will then be compared to the patient's. Responses will be classified into three categories: identical response, overestimation of patient agreement level, underestimation of patient agreement level."}, {'measure': "Association between the rPTAD Benzo score at T0 and the patient's sociodemographic, medical, and medication factors", 'timeFrame': 'during 3days', 'description': 'For rPATD Benzo, the Likert scale will be converted to a score between 0 and 5 to obtain a total rPATD Benzo score ranging from 13 (unfavorable to deprescribing) to 65 (favorable to deprescribing). This score will then be statistically compared to patient factors (age, gender, type of residence, level of education, reason for hospitalization, history of falls, polypharmacy, indication, international nonproprietary name, and duration of benzodiazepine/related drug prescription) to determine if there is a statistical association.'}, {'measure': "Contents of the patient's discharge order compared to their responses to the last two items of the rPATD Benzo at T0", 'timeFrame': "Patient's discharge (more than 9 days)", 'description': "Patient's discharge order will be screened at T2 to search for any change in the benzodiazepine prescription (no change, discontinuation, dose reduction, switch). A statistical association will be searched between the discharge order and the patient's answer to the last two items of the rPATD Benzo at T0."}, {'measure': "Contents of the patient's discharge order compared to their responses to the last two items of the rPATD Benzo at T1", 'timeFrame': 'during 9 days', 'description': "Patient's discharge order will be screened at T2 to search for any change in the benzodiazepine prescription (no change, discontinuation, dose reduction, switch). A statistical association will be searched between the discharge order and the patient's answer to the last two items of the rPATD Benzo at T1."}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction', 'timeFrame': 'during 9 days', 'description': 'dose reduction'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - duration', 'timeFrame': 'during 9 days', 'description': 'duration'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - medication', 'timeFrame': 'during 9 days', 'description': 'potentially inappropriate medication'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - person initiating deprescribing', 'timeFrame': 'during 9 days', 'description': 'patient, physician, pharmacist'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - dose', 'timeFrame': 'during 9 days', 'description': 'dose step'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - reassessment', 'timeFrame': 'during 9 days', 'description': 'reassessment'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - lack of indication', 'timeFrame': 'during 9 days'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - adverse effects', 'timeFrame': 'during 9 days', 'description': 'adverse effects'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction', 'timeFrame': 'during 9 days', 'description': 'discontinuation'}, {'measure': 'Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - switch', 'timeFrame': 'during 9 days', 'description': 'switch'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benzodiazepine', 'Z-drugs', 'deprescribing', 'rPATD'], 'conditions': ['Geriatric Patients']}, 'descriptionModule': {'briefSummary': "The use of benzodiazepines in older adults is associated with an increased risk of adverse effects due to age-related physiological changes. Several studies have reported a higher risk of falls and fractures, with a significant impact on quality of life, morbidity, mortality, and healthcare costs.\n\nBenzodiazepines may also cause cognitive impairment, including reduced alertness, memory deficits, and impaired psychomotor function, increasing the risk of confusion and delirium, particularly in hospital settings. These effects can further compromise quality of life and functional independence in older patients.\n\nChronic use also exposes patients to physical and psychological dependence, with potential withdrawal symptoms when the dose is reduced or the treatment discontinued. This contributes to the difficulty of implementing deprescribing in this population. Deprescribing is defined as a planned and supervised process aimed at reducing or stopping a medication when its risks outweigh The use of benzodiazepines in older adults is associated with an increased risk of adverse effects due to age-related physiological changes. Several studies have reported a higher risk of falls and fractures, with a significant impact on quality of life, morbidity, mortality, and healthcare costs.\n\nBenzodiazepines may also cause cognitive impairment, including reduced alertness, memory deficits, and impaired psychomotor function, increasing the risk of confusion and delirium, particularly in hospital settings. These effects can further compromise quality of life and functional independence in older patients.\n\nChronic use also exposes patients to physical and psychological dependence, with potential withdrawal symptoms when the dose is reduced or the treatment discontinued. This contributes to the difficulty of implementing deprescribing in this population. Deprescribing is defined as a planned and supervised process aimed at reducing or stopping a medication when its risks outweigh its potential benefits, through an individualized, patient-centered approach.\n\nHealth authorities therefore recommend limiting benzodiazepine use to short durations, regularly reassessing treatment appropriateness, and implementing gradual, supervised tapering whenever possible. Nevertheless, despite these recommendations, benzodiazepine use remains high among older adults, with treatment durations often exceeding recommended timeframes despite an unfavorable benefit-risk balance. Data from national databases, including the French National Health Data System (SNDS), confirm that consumption remains substantial despite existing guidelines.\n\nIn this context, deprescribing represents a key strategy. However, implementing deprescribing in clinical practice remains complex. Several studies have shown that attachment to the medication, fear of rebound anxiety or recurrence of insomnia, and concern about withdrawal symptoms are major cognitive and emotional barriers to discontinuation, both for healthcare professionals and for patients.\n\nThese barriers highlight the importance of better understanding patients' attitudes, beliefs, and perceptions regarding their treatment. The revised Patients' Attitudes Towards Deprescribing questionnaire specific to benzodiazepines (rPATD Benzo) is a validated tool, available in French, that assesses these dimensions, including treatment attachment and willingness to reduce or stop medication.\n\nIn our geriatric institution, an educational information leaflet (the EMPOWER brochure ) is routinely provided to patients treated with benzodiazepines or related drugs. This validated tool is intended to open discussion about benzodiazepine use during hospitalization, should patients wish to engage. Several studies have shown that access to structured, tailored educational information is a key determinant of deprescribing acceptability and can significantly influence older patients' attitudes toward discontinuing benzodiazepines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on elderly patients, hospitalized in a geriatric ward, who were treated with a benzodiazepine (or related drug) long-term before their admission to the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients hospitalized in a geriatric hospital;\n* Receiving long-term treatment with benzodiazepines or related drugs;\n* Having received, upon admission to the hospital, as part of routine care, educational information focused on the deprescribing of benzodiazepines and related drugs (EMPOWER brochure);\n* Able to communicate and participate in the questionnaires provided for in the protocol;\n* Able to indicate their non-opposition to participating in the study.\n\nExclusion Criteria:\n\n* Opposition to participation in the study;\n* Subject participating in another interventional study involving an exclusion period still ongoing at the time of inclusion and which, in the investigator's opinion, may interfere with the present study."}, 'identificationModule': {'nctId': 'NCT07474532', 'acronym': 'BENZ-AC', 'briefTitle': 'Attitudes and Beliefs Related to Benzodiazepine Deprescribing', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Providing Educational Information Material in Routine Care on Attitudes and Beliefs Related to Benzodiazepine Deprescribing', 'orgStudyIdInfo': {'id': '69HCL26_0218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long term benzodiazepine user', 'description': 'Older patients hospitalized in a geriatric ward, receiving long-term treatment with a benzodiazepine (or related drug) prior to hospital admission and receiving during routine care an educational information material about benzodiazepine deprescribing.', 'interventionNames': ['Other: Geriatrician rPATD Benzo questionnaire']}, {'label': 'Hospital physicians', 'description': 'Hospital physicians responsible for the routine care of patients (=Group 1) included in the study.', 'interventionNames': ['Other: Patient rPATD Benzo questionnaire']}], 'interventions': [{'name': 'Patient rPATD Benzo questionnaire', 'type': 'OTHER', 'description': "A member of the pharmaceutical team administered the rPATD questionnaire to the patient at T0 (within three days of admission) and at T1 (between the third and ninth day of hospitalization).\n\nThe rPATD (Revised Patients' Attitudes Towards Deprescribing) questionnaire was developed to evaluate patients' attitudes and beliefs about discontinuing or reducing medication. The tool explores several dimensions, including perception of the need for treatment, attachment to medication, concerns about discontinuation, and confidence in medical decisions.\n\nThe tool was initially validated in elderly patients, demonstrating good psychometric properties and satisfactory internal consistency. This study uses a specific validated adaptation of the rPATD to the context of benzodiazepines (rPATD Benzo) to target representations related to these molecules.", 'armGroupLabels': ['Hospital physicians']}, {'name': 'Geriatrician rPATD Benzo questionnaire', 'type': 'OTHER', 'description': 'A member of the pharmaceutical team administered the last 2 items of the rPATD questionnaire to the geriatrician at T0 (within three days of patient\'s admission) with the following pre-question: "In your opinion, what was the patient\'s response to the question?"', 'armGroupLabels': ['Long term benzodiazepine user']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Elsa REALLON', 'role': 'CONTACT', 'email': 'elsa.reallon@chu-lyon.fr', 'phone': '+33 4 72 11 06 31'}], 'facility': 'Hôpital des Charpennes', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Elsa REALLON', 'role': 'CONTACT', 'email': 'elsa.reallon@chu-lyon.fr', 'phone': '+33 4 72 11 06 31'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}