Path To Better Sleep + Virtual Coaching: The Effectiveness and Implementation of Internet-Based Self-Management Program for Insomnia in a Regional Healthcare System

更好的睡眠虚拟辅导之路：区域医疗系统中基于互联网的失眠自我管理计划的有效性和实施

• 批准号: 10316372
• 负责人: ERIC HERMES
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10316372
• 关键词: Address; Adherence; Adoption; Affect; Caring; Clinic; Clinical; Clinical Practice Guideline; Clinical Trials Network; Clinical effectiveness; Cognitive Therapy; Consolidated Framework for Implementation Research; Data; Data Security; Effectiveness; Elements; Evaluation; Exposure to; Fatigue; Gold; Guidelines; Health; Health Promotion; Healthcare Systems; Hybrids; Individual; Internet; Intervention; Interview; K-Series Research Career Programs; Literature; Maintenance; Measures; Medical; Mental Health; Mental disorders; Methodology; Methods; Modality; Modeling; Mood Disorders; Moods; Morbidity - disease rate; Outcome; Outpatients; Patients; Pharmaceutical Preparations; Post-Traumatic Stress Disorders; Prevalence; Principal Investigator; Process; Provider; Publishing; Qualitative Methods; Quality of life; Randomized; Reach Effectiveness Adoption Implementation and Maintenance; Replicating Effective Programs; Reporting; Research; Resource-limited setting; Resources; Risk; Rural; Schedule; Self Care; Self Management; Services; Severities; Site; Sleep; Sleeplessness; Stimulus; Suicide; Symptoms; System; Testing; Time; Training; Travel; Veterans; Visit; Work; base; connected care; design; diaries; digital; digital intervention; disorder prevention; effectiveness evaluation; effectiveness trial; evidence base; formative assessment; functional disability; gaps in access; hypnotic; implementation evaluation; implementation intervention; implementation outcomes; implementation strategy; improved; innovation; military veteran; online version; pandemic disease; patient engagement; programs; rural area; rural healthcare; rural setting; sedative; self-management program; service organization; social stigma; standard care; treatment as usual; virtual coach

Background: As many as 1.8 million individuals using VA services meet criteria for insomnia disorder, a condition associated with suicide, poor functioning, and medical and mental health disorders. Cognitive Behavioral Therapy for insomnia (CBTi) is the gold-standard treatment. However, only a small fraction of Veterans receive CBTi due to a host of barriers. A digital intervention delivering CBTi, Path to Better Sleep (PTBS), has been developed by VA specifically for Veterans. PTBS, enhanced by personal coaching, may mitigate barriers to CBTi by enabling self-management beyond clinic walls. Significance: Current PTBS dissemination practices consist of inadequate messaging, poor integration into clinical workflow, and no personal support. Preliminary data indicate that while PTBS has increased access to CBTi, only an estimated 0.8% of Veterans with insomnia disorder have visited the PTBS site. To address these gaps, (1) coaching must be integrated with PTBS (Coached PTBS) to increase engagement/adherence and (2) Coached PTBS must be embedded in current VA care practices using a scalable implementation strategy. The prevalence of insomnia far outweighs VA’s capacity to deliver gold-standard treatment through any single modality. An array of treatment options is needed. Moreover, PTBS coaching delivered through a hub-and- spoke model is a scalable approach to MISSION Act directives mandating evidence-based care in rural areas. Innovation and Impact: PTBS is the first digital CBTi designed for Veterans. PTBS is open access and meets stringent VA information security requirements. Coaching integrated into PTBS will increase engagement and adherence. A hub-and-spoke model of coaching limits reliance on local facility resources. A scalable implementation strategy for digital interventions, optimized in prior research, will be used. The VISN 1 clinical trials network allows access to a rural Veteran population and provides research coordination resources. Specific Aims: 1. [Establish effectiveness of Coached PTBS when implemented in rural-facing VISN 1 facilities] H1: Veterans randomized to Coached PTBS will report greater improvement in insomnia severity (primary) and sleep parameters (secondary) compared to [PTBS + Contact (enhanced treatment as usual control)] 2. Evaluate the quantitative outcomes of REP-DI, the strategy used to embed Coached PTBS in VA care. H2: REP-DI will result in adequate Reach among Veterans, Adoption among providers, and Maintenance. 3. Conduct a 3-part formative evaluation of implementation. Interviews with Veterans, providers, and staff will be informed by constructs from the Consolidated Framework for Implementation Research (CFIR). Data will optimize implementation in real time by tailoring implementation strategy elements to specific contexts. Methodology: A pragmatic hybrid type-2 effectiveness/implementation mixed-methods trial will be used. Outpatients with insomnia disorder will be referred by providers and randomized to Coached PTBS or PTBS + Contact. The implementation strategy will be REP-DI, a scalable and resource efficient strategy for implementing digital interventions. REP-DI will include provider training and augmentation of site referral processes to support PTBS implementation. Outcomes will be evaluated according to the RE-AIM framework. Outcomes include insomnia severity (primary), sleep parameters, fatigue, mood, sedative-hypnotic use, and other measures collected at baseline, 8 weeks, and 6 months. REP-DI quantitative implementation outcomes include Reach, Adoption, and Maintenance evaluated at patient and provider/staff levels. A 3-part formative evaluation employing qualitative methods will identify patient and provider/staff determinants. Next Steps/Implementation: Coached PTBS can be implemented across VA using REP-DI by the National Center for Health Promotion and Disease Prevention and secondary VA partners such as the Offices of Rural Health and Connected Care.

背景：多达 180 万名使用 VA 服务的人符合失眠症标准，这是一项 与自杀、功能不良以及医疗和精神健康障碍相关的状况。认知的 失眠行为疗法（CBTi）是金标准治疗方法。然而，只有一小部分 退伍军人由于一系列障碍而获得 CBTi。提供 CBTi 的数字干预，更好的睡眠之路 (PTBS) 是由 VA 专门为退伍军人开发的。通过个人辅导增强的 PTBS 可能 通过实现诊所之外的自我管理来消除 CBTi 的障碍。 意义：当前的 PTBS 传播实践包括信息传递不充分、融入不充分等。 临床工作流程，无需个人支持。初步数据表明，虽然 PTBS 增加了获得 CBTi，估计只有 0.8% 患有失眠症的退伍军人访问过 PTBS 网站。为了解决这些 差距，(1) 辅导必须与 PTBS（辅导 PTBS）相结合，以提高参与度/依从性，以及 (2) 辅导的 PTBS 必须使用可扩展的实施策略嵌入到当前的 VA 护理实践中。这 失眠的患病率远远超过了 VA 通过任何单一手段提供黄金标准治疗的能力 情态。需要一系列的治疗方案。此外，PTBS 辅导通过中心和- 辐条模型是一种可扩展的方法，旨在执行任务法案指令，要求在农村地区提供基于证据的护理。 创新和影响：PTBS 是第一个为退伍军人设计的数字 CBTi。 PTBS 是开放获取并满足 严格的 VA 信息安全要求。融入 PTBS 的辅导将提高参与度和 坚持。中心辐射型教练模式限制了对当地设施资源的依赖。可扩展的 将使用在先前研究中优化的数字干预实施策略。 VISN 1 临床 试验网络允许接触农村退伍军人群体并提供研究协调资源。 具体目标： 1. [确定在面向农村的 VISN 1 设施中实施辅导 PTBS 的有效性] H1：随机接受辅导 PTBS 的退伍军人将报告失眠严重程度有更大改善（主要） 和睡眠参数（次要）与 [PTBS + 接触（按照常规控制加强治疗）] 相比 2. 评估 REP-DI 的定量结果，该策略用于将辅导 PTBS 嵌入 VA 护理中。 H2：REP-DI 将在退伍军人中产生足够的覆盖面、提供者的采用和维护。 3. 对实施情况进行三部分形成性评估。对退伍军人、提供者和工作人员的采访将 通过实施研究综合框架 (CFIR) 的构建了解情况。数据 将通过根据具体情况定制实施策略要素来实时优化实施。 方法：将使用实用的混合 2 型有效性/实施混合方法试验。 患有失眠症的门诊患者将由提供者转介并随机分配至辅导 PTBS 或 PTBS + 接触。实施策略将是 REP-DI，这是一项可扩展且资源高效的策略 实施数字干预。 REP-DI 将包括提供商培训和站点推荐的增强 支持 PTBS 实施的流程。结果将根据 RE-AIM 框架进行评估。 结果包括失眠严重程度（主要）、睡眠参数、疲劳、情绪、镇静催眠药物的使用以及 在基线、8 周和 6 个月收集的其他指标。 REP-DI量化实施成果 包括在患者和提供者/员工层面评估的覆盖范围、采用和维护。形成性三部分 采用定性方法的评估将确定患者和提供者/工作人员的决定因素。 后续步骤/实施： 可以使用国家健康促进中心的 REP-DI 在 VA 范围内实施辅导 PTBS 疾病预防和退伍军人事务部的二级合作伙伴，例如农村卫生和互联护理办公室。