Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
BMJ Open. 2020 Feb 18;10(2):e033688. doi: 10.1136/bmjopen-2019-033688.
Problematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process.
This study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study.
This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations.
NCT03937180.
苯二氮䓬类药物的使用问题是一个全球性的健康问题。尽管长期使用苯二氮䓬类药物的不良反应众所周知，但在初级保健中实施停药干预仍然很困难。考虑到混合保健在治疗睡眠障碍和支持物质使用障碍方面的成功，有证据表明，结合全科医生面对面咨询和患者基于网络的自学的混合保健方法，有利于在初级保健中停止慢性苯二氮䓬类药物治疗原发性失眠。因此，本研究旨在评估这种方法对长期停止苯二氮䓬类药物和佐匹克隆、扎来普隆药物（（z-）BZD）使用的有效性，并评估实施过程。
这是一项多中心、实用、集群随机对照试验，纳入了 1200 名患者，由 120 名全科医生参与。通过使用分层按语言分组的块随机系统，以 1:1 的比例在全科医生层面上进行常规护理或混合护理的分配。研究人群包括长期每日使用（z-）BZD 治疗原发性失眠至少 6 个月的成年初级保健患者。主要结局测量指标是通过尿液中（z-）BZD 的毒理学筛查评估的 12 个月时停药（z-）BZD 的患者比例。次要结局包括 6 个月时停药（z-）BZD、生活质量和（z-）BZD 规定的每日定义剂量数。数据将通过一个特定的研究在线平台收集，并使用意向治疗分析进行分析。嵌套研究将评估混合保健实施过程。
该试验已获得 UZ/KU 鲁汶伦理委员会的研究批准（参考号：S61194）。研究结果将通过开放获取、同行评审的出版物和会议演讲进行传播。
NCT03937180。
