OBJECTIVE: Our objective was to design and test the feasibility and acceptability of a BI intervention adapted to address individual, inappropriate use of z-hypnotics among older adults. This preparatory study aimed to optimize the intervention in advance of a quantitative randomized controlled trial investigating the treatment effect in a larger population.
METHODS: This feasibility case series was conducted at Akershus University Hospital, Norway, in autumn 2021. We included 5 adults aged ≥65 years with long-term (≥4 weeks) use of z-hypnotics and 2 intervening physicians. Additionally, 2 study investigators contributed with process evaluation notes. The BI consists of information on the risk of inappropriate use and individualized advice on how to reduce use. The focus of the intervention is behavioral and aims, in cooperation with the patient and based on shared decision-making, to change patient behavior regarding sleep medication rather than physician-based detoxification and termination of z-hypnotic prescriptions. Qualitative and descriptive quantitative data were collected from intervening physicians, study investigators, and participants at baseline, immediately after the intervention, and at the 6-week follow-up.
RESULTS: Data were obtained from 2 physicians, 2 study investigators, and 5 participants (4 women) with a median age of 84 years. The average time spent on the BI consultation was 15 minutes. All 5 participants completed the intervention without problems. The participants and 2 intervening physicians reported the intervention as acceptable and were satisfied with the delivery of the intervention. After the intervention, 2 participants stopped their use of z-hypnotics completely and participated in the follow-up interview. Study investigators identified logistical challenges regarding location and time requirements. Identified aspects that may improve the intervention and reduce dropouts included revising the intervention content, focusing on rebound insomnia, adding an information leaflet, and supporting the patient in the period between the intervention and follow-up. The notion that the intervention should best be located and conducted by the patient\'s own general practitioner was supported by the participants.
CONCLUSIONS: We identified important aspects to improve the designed intervention and found that the BI is feasible and acceptable for incorporation into a larger randomized trial investigating the treatment effect of BI for reducing z-hypnotic use by older adults.
BACKGROUND: ClinicalTrials.gov NCT03162081; http://tinyurl.com/rmzx6brn.
目的:我们的目的是设计和测试BI干预措施的可行性和可接受性,老年人不适当使用z-催眠药。这项准备研究旨在在定量随机对照试验研究更大人群的治疗效果之前优化干预措施。
方法:这个可行性案例系列在Akershus大学医院进行,挪威,2021年秋天我们纳入了5名年龄≥65岁,长期(≥4周)使用z-催眠药的成年人和2名干预医生。此外,2名研究调查人员提供了过程评估笔记。BI包括有关不当使用风险的信息以及有关如何减少使用的个性化建议。干预的重点是行为和目标,与患者合作,基于共同决策,改变患者关于睡眠药物的行为,而不是基于医生的排毒和终止z催眠处方。定性和描述性定量数据是从干预医生那里收集的,研究调查人员,和基线的参与者,干预后立即,在6周的随访中。
结果:数据来自2名医生,2名研究人员,5名参与者(4名女性),中位年龄为84岁。BI咨询的平均时间为15分钟。所有5名参与者都没有问题地完成了干预。参与者和2名干预医生报告干预措施为可接受的,并对干预措施的实施感到满意。干预之后,2名参与者完全停止使用z-催眠药,并参加了后续访谈。研究调查人员确定了有关位置和时间要求的后勤挑战。确定了可以改善干预和减少辍学的方面,包括修改干预内容,专注于反弹失眠,添加信息传单,并在干预和随访期间支持患者。参与者支持干预措施最好由患者自己的全科医生定位和实施。
结论:我们确定了改善设计干预措施的重要方面,并发现BI是可行和可接受的,可以纳入一项更大的随机试验,研究BI对减少老年人使用z-催眠药的治疗效果。
背景:ClinicalTrials.govNCT03162081;http://tinyurl.com/rmzx6brn.