Geriatric PatientsBENZ-ACNCT07474532
Attitudes and Beliefs Related to Benzodiazepine Deprescribing
An observational study of Geriatric Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Patients
- What is being tested?
- Patient rPATD Benzo questionnaire and Geriatrician rPATD Benzo questionnaire
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital des Charpennes
Lyon, 69000
Elsa REALLON, +33 4 72 11 06 31, elsa.reallon@chu-lyon.fr
About this study
Official title: Impact of Providing Educational Information Material in Routine Care on 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.
Read more
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.
- Conditions
- Geriatric Patients
- Being tested
- Patient rPATD Benzo questionnaire, Geriatrician rPATD Benzo questionnaire
- Keywords
- Benzodiazepine, Z-drugs, deprescribing, rPATD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient rPATD Benzo questionnaireOther
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 questionnaireOther
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?"
| Study group | Role | What they receive |
|---|---|---|
| Long term benzodiazepine user | 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. Receives: Other: Geriatrician rPATD Benzo questionnaire | |
| Hospital physicians | Hospital physicians responsible for the routine care of patients (=Group 1) included in the study. Receives: Other: Patient rPATD Benzo questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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).
Measured: at 0day and 9 days
Secondary outcomes (15)
Analysis of patients' open-ended responses to additional questions at the end of last 2 items of the rPATD Benzo at T1.
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.
Measured: during 9 days
Comparative responses from patients and physicians to the last two items of the rPATD Benzo.
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.
Measured: during 3 days
Association between the rPTAD Benzo score at T0 and the patient's sociodemographic, medical, and medication factors
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.
Measured: during 3days
Contents of the patient's discharge order compared to their responses to the last two items of the rPATD Benzo at T0
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.
Measured: 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
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.
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction
dose reduction
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - duration
duration
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - medication
potentially inappropriate medication
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - person initiating deprescribing
patient, physician, pharmacist
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - dose
dose step
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - reassessment
reassessment
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - lack of indication
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - adverse effects
adverse effects
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction
discontinuation
Measured: during 9 days
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - switch
switch
Measured: during 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start4 May 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474532
- Sponsor's protocol ID
- 69HCL26_0218
- Acronym
- BENZ-AC
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Providing Educational Information Material in Routine Care on Attitudes and Beliefs Related to Benzodiazepine Deprescribing
- ClinicalTrials.gov ID
- NCT07474532
- Acronym / sponsor ID
- BENZ-AC / 69HCL26_0218
- Conditions
- Geriatric Patients
- Keywords
- Benzodiazepine, Z-drugs, deprescribing, rPATD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long term benzodiazepine user | – | Other: Geriatrician rPATD Benzo questionnaireOlder 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. |
| Hospital physicians | – | Other: Patient rPATD Benzo questionnaireHospital physicians responsible for the routine care of patients (=Group 1) included in the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient rPATD Benzo questionnaireA 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. | Other | Hospital physicians |
| Geriatrician rPATD Benzo questionnaireA 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?" | Other | Long term benzodiazepine user |
Primary outcome
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).
15 secondary outcomes
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
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - adverse effects
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 - Type of deprescribing - switch
Time frame: during 9 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Patients, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsa REALLON (+33 4 72 11 06 31, elsa.reallon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: at 0day and 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.