The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 924
- 试验地点
- 110
- 主要终点
- Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
研究概览
简要总结
This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and older capable of giving informed consent,
- •Having his/her Global Medical File managed by one of the participating general practitioners
- •Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis
- •Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems
排除标准
- •Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal
- •Presence of terminal illness
- •Any cases where stopping of (z-)BZDs might be harmful
- •Unwillingness or inability to provide informed consent
- •Not having e-literacy (being familiar with email and internet use)
- •Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.
研究组 & 干预措施
Usual care
Patients will receive 'usual care' left at the discretion of the treating general practitioner (GP). They are expected to follow the Belgian guidelines, which propose education of the patient about the harmful effects of chronic benzodiazepines and z-drugs ((z-)BZD) use, the alternatives, and the advice to discontinue (z-)BZD use. A stepped approach is recommended. First, a minimal intervention strategy such as a discontinuation letter or a short advice is applied. If unsuccessful, a brief intervention, which may span one or more consults, is recommended. During such an intervention, the GP will - based on the principles of motivational interviewing- assess the patient's readiness for change and match the appropriate intervention. A tapering scheme will be developed which typically consists of a 10-20% reduction in the daily dose of the (z-)BZD every 2-4 weeks.
干预措施: Usual care (Behavioral)
Blended care
Usual care is supported by the use of an interactive e-tool. The e-tool provides psycho-education about sleep and sleep medication, and exercises featuring cognitive behavioural techniques to enhance the self-management of the patient. It's purpose is to motivate patients to discontinue the use of (z-)BZD, to adapt alternative remedies and to support them in this process. The patient can grant the participating GP access to all his answers in the e-tool, making it possible to discuss their findings and experiences face-to-face. During consultations, the GP will also assess the patients' readiness for change and match the appropriate intervention. A tailored gradual taper of the (z-)BZD will be agreed upon, which typically consists of a 10-20% reduction in the daily dose every 2-4 weeks. Follow-up appointments are scheduled depending on the needs of the patient until the end of dose reduction.
干预措施: Blended care (Behavioral)
结局指标
主要结局
Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
时间窗: 12 months
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
次要结局
- Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening(6 months)
- EQ-5D-3L assessed at week 6, 12, 26 and 52(12 months)
- Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52(12 months)
- The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52(12 months)
研究者
Kristien Coteur
Project manager - p.p. Chief investigator prof. dr. Catharina Matheï
KU Leuven
