Attitudes and Beliefs Related to Benzodiazepine Deprescribing

NCT07474532 | Not Yet Recruiting

• 1 other identifier: 69HCL26_0218
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Geriatric Patients

Keywords

Benzodiazepine; Z-drugs; deprescribing; rPATD

Outcome Measures

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)

  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).

  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.

  during 9 days

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

  during 3 days

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

  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 (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

  during 9 days

Study Arms (2)

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.

Other: Geriatrician rPATD Benzo questionnaire

Hospital physicians

Hospital physicians responsible for the routine care of patients (=Group 1) included in the study.

Other: Patient rPATD Benzo questionnaire

Interventions

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.

Hospital physicians

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?"

Long term benzodiazepine user

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Opposition to participation in the study;

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital des Charpennes

Lyon, 69000, France

Location

Central Study Contacts

Elsa REALLON

CONTACT

+33 4 72 11 06 31; elsa.reallon@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 16, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (1)