Enhancing Hypnotic Medication Discontinuation in Primary Care through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy

项目摘要/摘要 寻求治疗的失眠症患者最常出现在初级保健中，他们的第一次也通常是唯一的 治疗是一种处方催眠药物。超过65%的处方催眠药用于 一年多，超过30%的人继续使用它们超过五年。这些代理可能对以下方面有用 急性失眠和某些慢性睡眠困难的病例，但长期使用催眠药可导致 依赖和发病率增加(例如，跌倒、认知/驾驶障碍)。减少或停产 长期使用催眠药对开处方的医生和使用催眠药的患者来说都是一项具有挑战性的任务 他们。尽管基于证据的医生监督用药逐渐减少(SMT)方案已经显示 这种干预措施虽然有效，但尚未在初级保健中广泛传播。大多数初级保健提供者 (PCP)愿意将他们的失眠患者转介到基于证据的替代非药物治疗，例如 认知行为失眠疗法(CBTI)，但这种疗法通常很难在专业之外获得 睡眠中心。鉴于研究和临床实践之间的差距，迫切需要开发和 验证成本效益干预措施，以促进小学失眠和催眠逐渐减少的管理 关心。为响应PAR-20-183，本应用程序经过精心设计以解决这些问题。我们 将进行一项大型随机试验，比较数字CBT(DCBTI)/SMT干预与 SMT干预单独用于催眠停药和改善失眠症状。 一项基于实践的研究中来自8-10家初级保健诊所的430名催眠依赖患者的样本 科罗拉多州奥罗拉市科罗拉多大学医学院附属网络将作为研究 参与者。该项目的主要目标是比较dCBTI+SMT和使用SMT的性能 单独用于实现催眠减少/停药和失眠症状的改善。此外，我们 将在随机对照试验中纳入有效性实施评估，以确定患者-提供者-以及 可能影响采用、实施和维持这类干预措施的系统一级因素 测试过。有效性/实施的结果应有助于设计未来的实施试验 在此确定的促进将dCBTI和SMT干预措施传播到初级保健中的战略应 这些治疗方法在目前的试验中被证明是有效的。我们还将收集探索性数据以确定 对dCBTI/SMT反应最好。这项研究将提供有关可行性、临床应用的新的有用信息。 这些干预措施的实用性以及患者、提供者和系统级别的可接受性，以管理失眠和 减少/消除初级保健中催眠药物的使用。这个项目应该是迈向 最终传播可获得的、具有成本效益的战略，以管理重大公共卫生问题和 改善数百万长期使用受控物质睡眠辅助剂的人的生活质量。

PROJECT SUMMARY/ABSTRACT Treatment-seeking insomnia sufferers most often present in primary care where their first and usually only treatment is a prescription hypnotic medication. More than 65% of individuals prescribed hypnotics use them for more than a year, and more than 30% remain on them for more than five years. Such agents may be useful for acute insomnia and certain cases with chronic sleep difficulties, but prolonged hypnotic use can lead to dependency and increased morbidity (e.g., falls, cognitive/driving impairments). Reducing or discontinuing hypnotics after prolonged use is a challenging task for both prescribing physicians and the patients who use them. Although evidenced-based physician-supervised medication tapering (SMT) protocols have shown efficacy, such interventions have yet to be disseminated widely in primary care. Most primary care providers (PCPs) are willing to refer their insomnia patients to alternative evidence-based non-drug treatments such as cognitive behavioral insomnia therapy (CBTI), but such treatment is often difficult to access outside of specialty sleep centers. Given this gap between research and clinical practice, there is a pressing need to develop and validate cost-effective interventions to facilitate the management of insomnia and hypnotic tapering in primary care. In response to PAR-20-183, This application has been carefully designed to address these issues. We will conduct a large randomized trial to compare the combined digital CBT (dCBTI)/SMT intervention, to the SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement. A sample of 430 hypnotic-reliant patients drawn from 8-10 primary care clinics within a practice-based research network affiliated with the University of Colorado Medical School in Aurora, Colorado will serve as study participants. The main objective of the project is to compare the performance of dCBTI+SMT with SMT used alone for achieving hypnotic reduction/discontinuation and insomnia symptom improvement. In addition, we will incorporate an Effectiveness-Implementation assessment into the RCT to identify patient- provider- and system-level factors that may impact adoption, implementation and maintenance of the types of interventions tested. Findings from the effectiveness/implementation should help design future trials of implementation strategies identified herein to promote dissemination of dCBTI and SMT interventions into primary care should these treatments prove effective in the current trial. We also will gather exploratory data to determine who responds best to dCBTI/SMT. This study will provide new and useful information about the feasibility, clinical utility, and patient-, provider-, and system-level acceptability of these interventions to manage insomnia and reduce/eliminate hypnotic use in primary care. This project should serve as a necessary first step toward the eventual dissemination of accessible, cost-effective strategies to manage a significant public health problem and improve the quality of life of millions of chronic users of controlled-substance sleep aids.