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

摘要 镇静催眠“z-药物”是与福尔斯、骨折、高危 睡眠异常（梦游、睡眠驾驶）和认知障碍。然而，这些药物很受欢迎， 尽管指南建议限制其使用， 支持认知行为疗法治疗失眠电子健康中的行为经济学推动 记录是鼓励使用认知行为阅读疗法和手机应用程序的一种有前途的方式， 失眠和减少高风险Z药物处方。助推是行为科学的见解， 现有的临床工作流程，旨在保留选择，但影响决策对所需的行为。 我们建议在门诊医学中使用NUdges来改善睡眠（SOMNUS），以应对 NHLBI的特别关注通知（NOT-HL-21-010）。SOMNUS试验将模拟长期结果 我们的轻推策略使用微观模拟从我们的罗伊巴尔中心的行为干预老龄化的 未来美国人模型（目标1），调整工作流程，并推动电子健康记录的性能， 开发最佳选择架构（目标2），并进行最小破坏性变化的随机试验， 电子健康记录，以鼓励在日常临床中使用循证疗法治疗失眠 在美国的60家诊所执业（目标3）。 该试验将采用以下两个推动概念：1）社会责任推动，要求临床医生 寻求处方Z药物，以证明，在简短的自由文本回应中， 指导方针不一致的行动或取消订单，并预先承诺一个简短的取消处方计划，每当 处方Z药物; 2）将预先填充在药物订单中的默认天数供应设置为较小的数字 药丸。在一项为期18个月的试验中，涉及60家诊所（449名临床医生），诊所群将随机接受a） 社会问责轻推，B）违约，c）社会问责和违约，或d）不干预 （教育控制）。主要结局指标是每位患者订购的Z药物日供应量的变化。 次要结局包括新患者开始使用Z药物的概率、停药概率 在长期使用者中，以及医生的看法调查。为了帮助取消Z药物处方，我们还将 提供阅读疗法、失眠症治疗、相关问题筛查转诊和访问评估。 样本量计算表明，88.5%（95% CI：83.3，92.6）的把握度可检测到药丸减少6.7% 命令。该提案将把行为经济学方法纳入实施研究， 鼓励基于证据的决策涉及失眠的治疗。它将提高安全性和有效性 为有睡眠问题的人提供日常临床实践。它还将提供估计数 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.