Feasibility of a Theory-based Benzodiazepines Deprescribing Intervention in Belgian Nursing Homes: the END-IT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility of the data collection process
研究概览
简要总结
The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting.
The main questions it aims to answer are:
- Is the intervention we developped feasible
- To what extent will the intervention be implemented in nursing homes
- To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants
Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work.
Researchers will compare this intervention to usual care, to see if the intervention is feasible, and to gather first data on intervention effectiveness in benzodiazepines deprescriping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •65 years old and older
- •Taking at least one benzodiazepine or Z-drug for 4 weeks or more
排除标准
- •Unability to communicate in French
- •Palliative care
- •Ongoing benzodiazepine withdrawal
- •Ongoing alcohol withdrawal
- •Severe anxiety
- •Severe depression
结局指标
主要结局
Feasibility of the data collection process
时间窗: At 6 months
Data collection process will be assessed through the quality of collected data (rate of missing data)
Nursing homes' adherence to the intervention
时间窗: Assessed at 6 months
has the intervention been implemented as intended, e.g. global number of implemented intervention components
nursing home residents' responsiveness to the intervention
时间窗: Assessed at 6 months
has far did they respond to the intervention, and how far have them been engaged by the intervention
Feasibility of the recruitment process
时间窗: At 6 months
The feasibility of the recruitment will be assessed through the ratio between included residents and residents contacted for participation.
Healthcare providers responsiveness to the intervention
时间窗: Assessed at 6 months
has far did they respond to the intervention, and how far have them been engaged by the intervention, e.g level of attendance to education session for healthcare providers
次要结局
- Intervention mechanisms of impact(At 6 months)
- Contextual factors at the level of of the nursing home(Baseline)
- Contextual factors at the level of the nursing home resident(Baseline)
- Exploratory benzodiazepine deprescribing rate analysis(At 6 months)