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NCT Number: NCT07474532

Attitudes and Beliefs Related to Benzodiazepine Deprescribing

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient rPATD Benzo questionnaire

Other

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 discontinuation, and confidence in medical decisions.

The 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.

Geriatrician rPATD Benzo questionnaire

Other

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 outcomes

  1. 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

    As part of the primary endpoint, each item is studied individually as an ordinal variable matched between T0 and T1.

    To facilitate clinical interpretation and limit instability related to minor variations in response, the responses are grouped into three levels of agreement:

    • Somewhat disagree (responses: "strongly disagree" and "disagree")
    • Neutral (response: "Neither agree nor disagree")
    • Somewhat agree (responses: "agree" and "strongly agree")

    The variation is defined for each item as follows:

    • Change to a higher level of agreement;
    • Change to a lower level of agreement;
    • Stability (maintaining the level of agreement).

Secondary outcomes

  1. 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

    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.

    • Additional question: "What made you change your mind since the first assessment?" "
    • Definition of a significantly different response: A response is considered significantly different if it differs by at least two levels on the Likert scale.

    This threshold differentiates between minor fluctuations in positioning and a significant change in the patient's attitudes or beliefs.

  2. Comparative responses from patients and physicians to the last two items of the rPATD Benzo.

    Time frame: during 3 days

    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.

  3. Association between the rPTAD Benzo score at T0 and the patient's sociodemographic, medical, and medication factors

    Time frame: during 3days

    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.

  4. 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)

    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.

  5. 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

    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.

  6. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction

    Time frame: during 9 days

    dose reduction

  7. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - duration

    Time frame: during 9 days

    duration

  8. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - medication

    Time frame: during 9 days

    potentially inappropriate medication

  9. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - person initiating deprescribing

    Time frame: during 9 days

    patient, physician, pharmacist

  10. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - dose

    Time frame: during 9 days

    dose step

  11. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - reassessment

    Time frame: during 9 days

    reassessment

  12. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - lack of indication

    Time frame: during 9 days

  13. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - adverse effects

    Time frame: during 9 days

    adverse effects

  14. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction

    Time frame: during 9 days

    discontinuation

  15. Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - switch

    Time frame: during 9 days

    switch

Study contacts

Contact information is provided by the study sponsor or research team.

Elsa REALLON

CONTACT

[email protected]

+33 4 72 11 06 31

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: BENZ-AC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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