Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months
研究概览
简要总结
This study is a cluster randomized control trial aimed to measure the effectiveness of an educational knowledge transfer intervention to prescribers on the discontinuation of two targeted classes: Benzodiazepines andNon-benzodiazepine hypnotics.
详细描述
The investigators intend to develop an electronic decision support tool based on the best evidence available. This electronic deprescribing tool provides the rationale on the indications of prescribing or deprescribing Benzodiazepines or/and Non-benzodiazepine hypnotics and also provides interactive tapering suggestion integrated on a calendar. It is designed to help family doctors with the goal of improving health outcomes for the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Randomization
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 ≥65 years who have been taking Benzodiazepines or/and Non-benzodiazepine hypnotics for at least 3 months and who do not meet any exclusion criterion
排除标准
- •incapacity or unwillingness to provide written informed consent. Patient with dementia, psychotic disorder, a severe personality disorder; institutionalization; terminal illness, seizure disorders, rapid eye movement sleep disorders, benzodiazepine withdrawal, ethanol withdrawal, severe generalized anxiety disorder, epilepsy and periprocedural anesthesia
结局指标
主要结局
Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months
时间窗: 3 months
The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation
Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 6 months
时间窗: 6 months
The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation
Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 12 months
时间窗: 12 Months
The effectiveness of a new deprescribing electronic knowledge transfer tool for GP´s (rate of benzodiazepine and Non-benzodiazepine hypnotics discontinuation
次要结局
- Adverse drug withdrawal effects(At baseline, 3 months, 6 months, 12 months)
- GPs level satisfaction regarding deprescribing(At baseline, 12 months)
- Health-related quality of life of patients(At baseline, 3 months, 6 months, 12 months)
- number of falls of patients(At baseline, 3 months, 6 months, 12 months)
- motor vehicle crashes of patients(At baseline, 3 months, 6 months, 12 months)
- Patients Beliefs about Medicines(At baseline, 3 months, 6 months, 12 months)
研究者
Luís Miguel André Monteiro
PhD Candidate at University of Beira Interior; Family Doctor
University of Beira Interior