Pilot studies of complementary and integrative health approaches to support benzodiazepine deprescribing in older adults with the US Deprescribing Research Network

摘要 本申请是针对被确认为NOT-AT-22-012的特殊利益通知而提交的。 苯二氮卓类受体激动剂(BZRAs)，包括苯二氮卓类药物以及较新的非 苯二氮，苯二氮卓类受体激动剂，如唑吡坦，是问题的主要来源 给老年人开处方。这非常令人担忧，因为苯二氮卓类药物和其他苯二氮卓类药物 受体激动剂具有实质性的危害，包括增加跌倒、骨折、认知障碍和 机动车事故。然而，考虑到这些药物的高使用率，持续的高使用率并不令人惊讶。 老年人失眠和焦虑的患病率及其生理和心理依赖 这通常会使这些药物一旦开始服用就很难停止。虽然有一些人 干预措施已经显示出支持停用BZRA的前景，这些药物未能获得吸引力 在改变人口层面对BZRA的使用方面，呼吁采取新的方法来解决这个令人头疼的问题。前景看好的焦点 因为这样的努力是在互补和综合健康(CIH)方面。让老年人积极参与 在改变他们的药物和在这些努力中具有自我效能是战略的重要组成部分 减少对BZRA的过度使用。许多CIH模式涉及这些心理过程和/或非常适合于 对它们进行补充。此外，老年人对CIH的广泛兴趣为 广泛采用已被证明有效的CIH模式。因此，这项提案的目标是选择， 资助和支持前景看好的先导性研究，这些研究具有导致大型临床试验的巨大潜力 调查促进老年人停用BZRA的CIH干预措施。为了实现这一目标，我们将 调整美国非处方药研究网络的现有基础设施。此基础设施和相关 流程不仅包括选择和资助奖项，还包括提供持续的支持和指导， 研究设计、实施和吸引利益相关者参与，为试点获奖者提供最佳机会 在他们的工作中取得成功，并将其作为更大范围、更明确的研究的跳板。我们有两个目标。目标1是 确定并为非常有价值的提案提供试点资金，为未来的临床工作奠定基础 使用补充和综合健康策略支持停用苯二氮类药物的试验 老年人中的受体激动剂。目标2是向飞行员获奖者提供技能和支持，以提高他们的 有能力在这一领域成功申请并进行未来的大型临床试验。这些目标是非常重要的 补充父母资助的目标，旨在提高研究的质量和数量 正在对老年人进行停药。这项行政补充提案提供了一个令人兴奋的 有机会扩大美国非处方药研究网络的现有工作，以促进下一步 在这一重要领域产生了非处方药研究。

Abstract This application is being submitted in response to the Notice of Special Interest identified as NOT-AT-22-012. Benzodiazepine receptor agonists (BZRAs), which include benzodiazepines as well as newer non- benzodiazepine, benzodiazepine receptor agonists such as zolpidem, are a major source of problematic prescribing for older adults. This is highly concerning, as both benzodiazepines and other benzodiazepine receptor agonists confer substantial harms including increased risk of falls, fractures, cognitive impairment, and motor vehicle accidents. Yet, the continued high rate of use of these medications is not surprising given the high prevalence of insomnia and anxiety among older adults and the physiological and psychological dependence which often makes stopping these medications difficult once they have been started. While a number of interventions have demonstrated promise to support deprescribing of BZRAs, the failure of these to gain traction in changing population-level use of BZRAs calls for new approaches to this vexing problem. A promising focus for such efforts is in complementary and integrative health (CIH). Engaging older adults to be active participants in changing their medications and to have self-efficacy in these efforts are vital components of strategies to reduce overuse of BZRAs. Many CIH modalities engage these psychological processes and/or are well-suited to complement them. Moreover, widespread interest in CIH among older adults creates fertile ground for widespread adoption of CIH modalities that are proven to be effective. The goal of this proposal is thus to select, fund, and support highly promising pilot studies that hold major potential to lead to large clinical trials investigating CIH interventions that promote deprescribing of BZRAs in older adults. To achieve this goal, we will adapt existing infrastructure of the US Deprescribing Research Network. This infrastructure and related processes involve not only selecting and funding awards, but providing ongoing support and guidance about research design, implementation, and engaging stakeholders to give pilot awardees the best chance of succeeding in their work and using it as a springboard for larger, definitive studies. We have 2 aims. Aim 1 is to identify and provide pilot funding for highly meritorious proposals that provide the groundwork for future clinical trials that use complementary and integrative health strategies to support deprescribing of benzodiazepine receptor agonists in older adults. Aim 2 is to provide skills and supports to pilot awardees that will enhance their ability to successfully apply for and conduct future large clinical trials in this area. These aims are highly complementary to the goals of the parent grant, which seeks to enhance the quality and quantity of research being conducted on deprescribing for older adults. This administrative supplement proposal offers an exciting opportunity to expand on the existing work of the US Deprescribing Research Network to promote the next generation of deprescribing research in this important area.