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

使用助推改善睡眠的门诊医学研究：SOMNUS 试验

• 批准号: 10737562
• 负责人: JASON N. DOCTOR
• 金额: $ 77.11万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10737562
• 关键词: Aging; American; Architecture; Automobile Driving; Behavior; Behavior Therapy; Behavioral; Behavioral Sciences; Bibliotherapy; Caring; Chronic; Clinic; Clinical; Cognitive; Cognitive Therapy; Cost Savings; Data; Decision Making; Dependence; Drug Addiction; Drug Prescriptions; Drug usage; Education; Educational Materials; Elderly; Electronic Health Record; Eszopiclone; Evidence based practice; Fracture; Future; Guidelines; Health; Impaired cognition; Intervention; Link; Literature; Medicine; Midwestern United States; Modeling; National Heart, Lung, and Blood Institute; Outcome; Outcome Measure; Outpatients; Parasomnias; Patients; Perception; Performance; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Physicians; Polypharmacy; Population; Probability; Process Measure; Quality of life; Randomized; Recommendation; Resources; Safety; Sample Size; Sedation procedure; Sleep; Sleep Disorders; Sleeplessness; Social Accountability; Somnambulism; Surveys; Telephone; Text; Update; Visit; Work; Zaleplon; age related; behavior test; behavioral economics; clinical practice; design; drug metabolism; evidence base; falls; high risk; hypnotic; implementation research; implementation strategy; improved; improvement on sleep; insight; interest; models and simulation; multiple chronic conditions; pill; population health; prescription opioid; preservation; primary care clinic; primary outcome; provider behavior; randomized trial; response; screening; secondary outcome; sedative; simulation; sleep health; sleeping pill; vehicular accident; zolpidem

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.

抽象的 镇静催眠“z 药物”是与跌倒、骨折、高风险相关的形成依赖性的物质 异态睡眠（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并限制其使用，但通常会长期开具治疗失眠的药物 支持失眠的认知行为疗法。电子健康领域的行为经济推动 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法 失眠和减少高风险Z药物处方。助推是来自行为科学的见解，适合 现有的临床工作流程，旨在保留选择，但影响决策以实现所需的行为。 我们提出了使用 NUdges 改善睡眠的门诊医学研究 (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 使用皇家衰老行为干预中心的微观模拟来了解我们的助推策略 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中的性能 开发最佳选择架构（目标 2），并进行随机试验以最小程度地破坏性改变 电子健康记录鼓励在日常临床中使用循证失眠疗法 在美国 60 家诊所执业（目标 3）。 该试验将采用以下两个助推概念：1）询问临床医生的社会责任助推 寻求开出一种 Z 药物，以在简短的自由文本回复中证明治疗的原因 采取与指南不一致的行动或取消订单，并在任何时候预先承诺一项简短的取消处方计划 开Z-药物处方； 2) 将默认供应天数设置为较小的数字，在药物订单中预先填充 的药丸。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，诊所集群将被随机分配接受 a) 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）。主要结果指标是每个患者订购的 Z 药物天数的变化。 次要结局包括新患者开始使用 Z 药物的概率、停药的概率 长期用户的调查以及医生的看法调查。为了帮助停用 Z 药物，我们还将 提供阅读疗法、失眠治疗、相关问题筛查转诊和就诊评估。 样本量计算表明，检测药片数量减少 6.7% 的功效为 88.5%（95% CI：83.3，92.6） 订购了。该提案将行为经济学方法纳入实施研究，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 患有睡眠问题的患者的日常临床实践。它还将提供估计 治疗对未来美国人的好处。