- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474532
Attitudes and Beliefs Related to Benzodiazepine Deprescribing (BENZ-AC)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Elsa REALLON
- Phone Number: +33 4 72 11 06 31
- Email: elsa.reallon@chu-lyon.fr
Study Locations
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Lyon, France, 69000
- Hopital des Charpennes
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Contact:
- Elsa REALLON
- Phone Number: +33 4 72 11 06 31
- Email: elsa.reallon@chu-lyon.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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?"
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Hospital physicians
Hospital physicians responsible for the routine care of patients (=Group 1) included in the study.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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:
The variation is defined for each item as follows:
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at 0day and 9 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
This threshold differentiates between minor fluctuations in positioning and a significant change in the patient's attitudes or beliefs. |
during 9 days
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Comparative responses from patients and physicians to the last two items of the rPATD Benzo.
Time Frame: during 3 days
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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.
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during 3 days
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Association between the rPTAD Benzo score at T0 and the patient's sociodemographic, medical, and medication factors
Time Frame: during 3days
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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.
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during 3days
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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)
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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.
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Patient's discharge (more than 9 days)
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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
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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.
|
during 9 days
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction
Time Frame: during 9 days
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dose reduction
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during 9 days
|
|
Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - duration
Time Frame: during 9 days
|
duration
|
during 9 days
|
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - medication
Time Frame: during 9 days
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potentially inappropriate medication
|
during 9 days
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - person initiating deprescribing
Time Frame: during 9 days
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patient, physician, pharmacist
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during 9 days
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - dose
Time Frame: during 9 days
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dose step
|
during 9 days
|
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - reassessment
Time Frame: during 9 days
|
reassessment
|
during 9 days
|
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - lack of indication
Time Frame: during 9 days
|
during 9 days
|
|
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - adverse effects
Time Frame: during 9 days
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adverse effects
|
during 9 days
|
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction
Time Frame: during 9 days
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discontinuation
|
during 9 days
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Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - switch
Time Frame: during 9 days
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switch
|
during 9 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL26_0218
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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