Impact of Providing Educational Information Material in Routine Care on Attitudes and Beliefs Related to Benzodiazepine Deprescribing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Geriatrician rPATD Benzo questionnaire (Other)
Hospital physicians
Hospital physicians responsible for the routine care of patients (=Group 1) included in the study.
干预措施: Patient rPATD Benzo questionnaire (Other)
结局指标
主要结局
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)
时间窗: 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).
次要结局
- 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)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - dose reduction(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - duration(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - medication(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - person initiating deprescribing(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - dose(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - deprescribing modality - reassessment(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - lack of indication(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - reason for deprescribing - adverse effects(during 9 days)
- Description of Routine Care Prescription Data Concerning Benzodiazepines Prescribed to Patients - Type of deprescribing - switch(during 9 days)
