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 镇静催眠的“ Z-Crugs”是与跌倒，裂缝，高风险相关的依赖性物质 寄生虫（梦游，睡眠驾驶）和认知障碍。但是，这些药物很受欢迎， 尽管有指南建议限制其使用和 有利于认知行为治疗失眠。在电子健康中提供的行为经济轻推 记录是鼓励使用认知行为的书目和电话应用程序的一种有希望的方法 失眠并减少高风险的Z-grug处方。轻推是行为科学的见解，适合 现有的临床工作流程，旨在保留选择，但会影响对所需行为的决策。 我们建议使用午睡来改善睡眠（somnus）的门诊医学研究 NHLBI特别关注的通知（NOT-HL-21-010）。 SOMNUS试验将模拟长期结果 我们使用皇家衰老行为干预中心的微观仿真的able策略 未来的美国人模型（AIM 1），电子健康记录中的工作流程和轻推性能 开发最佳选择体系结构（AIM 2），并对最小破坏性更改进行随机试验 电子健康记录鼓励在日常临床中使用基于证据的疗法用于失眠 在美国60个诊所进行练习（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问责制 寻求开处方Z-grug以简短的自由文本回复的正当理由，这是a的原因 指南诉讼或取消命令，并在任何时候进行简短的分类计划 开处方Z-Crug； 2）设置默认天供应，以药物订单预先填充，为少数数字 药丸。在涉及60个诊所（449名临床医生）的18个月试验中，将随机分配诊所群体以接收a） 社会问责制，b）违约，c）社会问责制和违约，或d）不干预 （教育控制）。主要结果指标是每位患者订购Z-Crug天供应的变化。 次要结果包括在Z-grug上启动新患者的概率，中断的概率 在长期用户和医师看法调查中。为了帮助划分Z-Strugs，我们也将 提供书目疗法，失眠症，转介筛查相关问题和访问评估。 样本量计算表明88.5％（95％CI：83.3，92.6）检测药丸降低6.7％的功率 订购。该建议将将行为经济方法纳入实施研究 鼓励涉及治疗失眠的基于证据的决策。它将提高安全性和功效 拜访患有睡眠问题的医生的日常临床实践。它还将提供估计 对未来美国人的治疗的好处。