Hôpital des Charpennes
Lyon, 69000, France
NCT Number: NCT07474532
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
Lyon, 69000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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?"
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:
The variation is defined for each item as follows:
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.
This threshold differentiates between minor fluctuations in positioning and a significant change in the patient's attitudes or beliefs.
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.
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.
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.
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.
Time frame: during 9 days
dose reduction
Time frame: during 9 days
duration
Time frame: during 9 days
potentially inappropriate medication
Time frame: during 9 days
patient, physician, pharmacist
Time frame: during 9 days
dose step
Time frame: during 9 days
reassessment
Time frame: during 9 days
Time frame: during 9 days
adverse effects
Time frame: during 9 days
discontinuation
Time frame: during 9 days
switch
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
Impact of Providing Educational Information Material in Routine Care on Attitudes and Beliefs Related to Benzodiazepine Deprescribing
Acronym: BENZ-AC
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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