Study in Outpatient Medicine using Nudges to improve Sleep: The SOMNUS Trial

摘要 镇静剂-催眠药是与跌倒、骨折、高风险有关的依赖形成物质。 失眠(梦游、梦游)和认知障碍。然而，这些药物很受欢迎，而且 通常是用于治疗失眠的长期处方，尽管指南建议限制其使用并 支持认知行为疗法治疗失眠。电子健康带来的行为经济学推动 录音是一种很有前途的方式，可以鼓励认知行为阅读疗法和手机应用程序的使用 失眠和减少高风险的Z-药物处方。轻推是来自行为科学的见解，适合于 现有的临床工作流程，旨在保留选择，但影响对所需行为的决策。 我们建议在门诊医学中使用轻推改善睡眠(睡眠)来回应 NHLBI的特殊利益通知(非-HL-21-010)。Somnus试验将模拟长期结果 使用我们的Roybal老龄化行为干预中心的微观模拟对我们的轻推策略进行评估 未来美国人模式(目标1)，将电子健康记录中的工作流和推动绩效调整为 开发最佳选择架构(目标2)，并对以下方面进行最小破坏性更改的随机试验 电子健康记录鼓励在日常临床中使用循证治疗失眠 在美国的60家诊所执业(AIM 3)。 该试验将采用以下两个轻推概念：1)询问临床医生的社会责任轻推 寻求开出一种Z-药物，以在简短的自由文本回复中证明 指导方针-采取不协调的行动或取消订单，并预先承诺一项简短的停药计划 开Z-药；2)将药单中预先填写的默认供应天数设置为少量 成片的药片。在一项涉及60家诊所(449名临床医生)的为期18个月的试验中，诊所群将随机接受) 社会责任推动，b)违约，c)社会责任和违约，或d)不干预 (教育控制)。主要的结果衡量标准是每个患者订购的Z-药物供应天数的变化。 次要结果包括开始使用Z-药物治疗新患者的可能性，停止使用Z-药物的可能性 在长期使用者中使用，以及医生感知调查。为了帮助停用Z-药物，我们还将 提供阅读治疗、获得失眠机会、转诊以筛查相关问题和访问评估。 样本量计算表明，检测药片减少6.7%的能力为88.5%(95%CI：83.3，92.6 订好了。该提案将把行为经济学方法整合到实施研究中，以 鼓励涉及失眠治疗的循证决策。它将提高安全性和有效性。 为睡眠有问题的人去看医生的日常临床实践。它还将提供估计 治疗对未来美国人的好处。

ABSTRACT Sedative-hypnotic "z-drugs" are dependence-forming substances associated with falls, fractures, high-risk parasomnias (sleepwalking, sleep-driving), and cognitive impairment. However, these drugs are popular and are usually prescribed long-term for insomnia, despite guideline recommendations to limit their use and to favor cognitive-behavior therapy for insomnia. Behavioral economic nudges delivered in the electronic health record are a promising way to encourage the use of cognitive-behavioral bibliotherapy and phone apps for insomnia and to reduce high-risk Z-drug prescribing. Nudges are insights from behavioral science that fit into existing clinical workflows, intended to preserve choice but influence decision-making toward desired behavior. We propose the Study in Outpatient Medicine using NUdges to improve Sleep (SOMNUS) in response to NHLBI's Notice of Special Interest (NOT-HL-21-010). The SOMNUS trial will simulate the long-term outcomes of our nudging strategy using microsimulation from our Roybal Center for Behavioral Interventions in Aging's Future Americans Model (Aim 1), align workflow and nudge performance in the electronic health record to develop the best choice architecture (Aim 2), and conduct a randomized trial of minimally disruptive changes to the electronic health record to encourage the use of evidence-based therapies for insomnia in everyday clinical practice at 60 clinics in the U.S. (Aim 3). The trial will employ the following two nudge concepts: 1) Social Accountability Nudges that ask a clinician seeking to prescribe a Z-drug to either justify, in a brief free-text response, the reason for a guideline-discordant action or to cancel the order, and to precommit to a brief deprescribing plan whenever prescribing a Z-drug; 2) setting default days supply, pre-populated in the medication order, to a small number of pills. In an 18-month trial involving 60 clinics (449 clinicians), clinic-clusters will be randomized to receive a) social accountability nudges, b) defaults, c) both social accountability and defaults, or d) no intervention (education control). The primary outcome measure is the change in Z-drug days supply ordered per patient. Secondary outcomes include probability of starting a new patient on a Z-drug, probability of discontinuation among long-term users, and a physician perceptions survey. To aid in deprescribing Z-drugs, we will also provide bibliotherapy, access to insomnia, referrals for screening for related problems and visit assessments. Sample size calculations indicate an 88.5% (95% CI: 83.3, 92.6) power to detect a 6.7% decrease in pills ordered. This proposal will integrate behavioral economic approaches into implementation research to encourage evidence-based decisions involving the treatment of insomnia. It will improve the safety and efficacy of everyday clinical practice for people visiting their physician with sleep problems. It will also provide estimates of the benefits of treatment to future Americans.