Murphy Andrea L, Turner Justin P, Rajda Malgorzata, Magalhaes Sandra, Allen Kathleen G, Gardner David M
Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
College of Pharmacy, Dalhousie University, Halifax, Nova Scotia, Canada.
Explor Res Clin Soc Pharm. 2022 Aug 3;7:100164. doi: 10.1016/j.rcsop.2022.100164. eCollection 2022 Sep.
Chronic benzodiazepine receptor agonist (BZRA) use among older adults is a public health concern given cognitive and physical risks. One in four older adults in New Brunswick, Canada, is a long-term user of BZRAs. Previous studies using a direct-to-patient approach as the primary intervention target have shown promise in reducing BZRA use. The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study aims to reduce the long-term use of BZRAs in older adults and increase the use of cognitive behavioural therapy for insomnia (CBTi), which is the recommended first line treatment.
The trial (ClinicalTrials.gov registration NCT04406103) is a three arm, open-label, parallel randomized controlled trial in NB, Canada. Eligible participants 65 years and older using BZRAs long-term will be randomly allocated to: the Eliminating Medications through Patient Ownership of End Results (EMPOWER) information package group; the Sleepwell information package group; or treatment-as-usual (TAU). Information packages will be mailed via Canada Post. The primary outcome of BZRA discontinuation at 6 months will be compared across groups. Secondary outcomes include participants with ≥25% BZRA dose reduction, and switching to newly prescribed alternate sedative-hypnotics. Several exploratory outcomes will also be examined.
Targeting participants with information packages informing them of appropriate use, dangers, and approaches to reducing BZRA use and increasing CBTi use may be beneficial in a region of Canada with the highest rate of chronic BZRA use in older adults. Comparing information packages and TAU will provide insights into the effectiveness of direct-to-patient interventions for BZRA reduction.
鉴于认知和身体风险，老年人长期使用苯二氮䓬受体激动剂（BZRA）是一个公共卫生问题。在加拿大新不伦瑞克省，四分之一的老年人是BZRA的长期使用者。以往以直接面向患者的方法作为主要干预目标的研究在减少BZRA使用方面显示出了前景。新不伦瑞克省的“睡眠时你的答案”（YAWNS NB）研究旨在减少老年人对BZRA的长期使用，并增加失眠认知行为疗法（CBTi）的使用，CBTi是推荐的一线治疗方法。
该试验（ClinicalTrials.gov注册号NCT04406103）是在加拿大新不伦瑞克省进行的一项三臂、开放标签、平行随机对照试验。符合条件的65岁及以上长期使用BZRA的参与者将被随机分配到：通过患者对最终结果的掌控来消除药物（EMPOWER）信息包组；Sleepwell信息包组；或常规治疗（TAU）组。信息包将通过加拿大邮政邮寄。将比较各组在6个月时停用BZRA的主要结局。次要结局包括BZRA剂量减少≥25%的参与者，以及改用新处方的替代镇静催眠药的情况。还将检查几个探索性结局。
在加拿大老年人慢性BZRA使用率最高的地区，针对参与者提供信息包，告知他们BZRA的正确使用方法、危险以及减少使用和增加CBTi使用的方法可能是有益的。比较信息包和常规治疗将深入了解直接面向患者的干预措施在减少BZRA使用方面的有效性。
