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Not yet recruiting NCT07474532

Attitudes and Beliefs Related to Benzodiazepine Deprescribing

Observational Geriatric Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient rPATD Benzo questionnaire, Geriatrician rPATD Benzo questionnaire.
Who it may be relevant to
Registry conditions: Geriatric Patients. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Providing Educational Information Material in Routine Care on Attitudes and Beliefs Related to Benzodiazepine Deprescribing

Overview

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. Benzodiazepines 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. Chronic 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. Benzodiazepines 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. Chronic 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. Health 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. In 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. These 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. In 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.

Interventions

  • Other Patient rPATD Benzo questionnaire
    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). The 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 dis
  • Other Geriatrician rPATD Benzo questionnaire
    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?"

Primary outcome measures

  • 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) [Time frame: at 0day and 9 days]
Secondary outcome measures (12)
  • Analysis of patients' open-ended responses to additional questions at the end of last 2 items of the rPATD Benzo at T1. [Time frame: during 9 days]
  • Comparative responses from patients and physicians to the last two items of the rPATD Benzo. [Time frame: during 3 days]
  • Association between the rPTAD Benzo score at T0 and the patient's sociodemographic, medical, and medication factors [Time frame: during 3days]
  • Contents of the patient's discharge order compared to their responses to the last two items of the rPATD Benzo at T0 [Time frame: Patient's discharge (more than 9 days)]
  • Contents of the patient's discharge order compared to their responses to the last two items of the rPATD Benzo at T1 [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - duration [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - medication [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - person initiating deprescribing [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - dose [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - reassessment [Time frame: during 9 days]
  • Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - lack of indication [Time frame: during 9 days]

Eligibility criteria

Inclusion criteria

  • Patients hospitalized in a geriatric hospital;
  • Receiving long-term treatment with benzodiazepines or related drugs;
  • 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);
  • Able to communicate and participate in the questionnaires provided for in the protocol;
  • Able to indicate their non-opposition to participating in the study.

Exclusion criteria

  • Opposition to participation in the study;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital des Charpennes — Lyon

Identifiers

NCT: NCT07474532 · 69HCL26_0218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗