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180万使用VA服务的人符合失眠症的标准， 与自杀、功能障碍以及医疗和心理健康障碍相关的疾病。认知 失眠行为疗法（CBTi）是金标准治疗。然而，只有一小部分 退伍军人接受CBTi由于一系列的障碍。数字干预提供CBTi，更好的睡眠之路 （PTBS），是由VA专门为退伍军人开发的。PTBS，通过个人教练增强，可以 通过实现超越诊所围墙的自我管理，减轻CBTi的障碍。 意义：目前的PTBS传播实践包括信息传递不足， 临床工作流程没有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%的失眠症退伍军人访问了PTBS网站。解决这些 差距，（1）辅导必须与PTBS（辅导PTBS）集成，以提高参与度/依从性，以及（2） 教练PTBS必须嵌入到当前的VA护理实践中使用可扩展的实施策略。的 失眠的患病率远远超过了VA通过任何单一的治疗提供金标准治疗的能力。 模态。需要一系列治疗方案。此外，PTBS辅导通过一个中心和- 辐条模式是一种可扩展的方法，以使命法案指令授权在农村地区的循证护理。 创新和影响：PTBS是第一个为退伍军人设计的数字CBTi。PTBS是开放获取的， 严格的信息安全要求。整合到PTBS中的辅导将增加参与度， 坚持。中心辐射式的教练模式限制了对当地设施资源的依赖。一个可扩展 将使用在先前研究中优化的数字干预措施实施战略。VISN 1临床 试验网络允许访问农村退伍军人人口，并提供研究协调资源。 具体目标： 1. [在面向农村的VISN 1设施中实施时，确定指导式PTBS的有效性] H1：随机分配至指导PTBS组的退伍军人将报告失眠严重程度的改善更大（主要） 和睡眠参数（次要）与[PTBS +接触（增强治疗与常规对照）]相比 2.评价REP-DI的定量结局，该策略用于将教练PTBS嵌入VA护理。 H2：REP-DI将在退伍军人中产生足够的覆盖率，在供应商中采用，并维持。 3.对实施情况进行三部分的形成性评价。与退伍军人，供应商和工作人员的访谈将 从实施研究的综合框架（CFIR）的结构通知。数据 将根据具体情况调整执行战略要素，从而优化真实的执行工作。 方法学：将使用务实的混合2型有效性/实施混合方法试验。 失眠症门诊患者将由提供者转诊，并随机分配至指导PTBS或PTBS +组 Contact.实施战略将是REP-DI，这是一个可扩展和资源高效的战略， 实施数字干预。REP-DI将包括提供者培训和增加研究中心转诊 支持PTBS实施的流程。将根据RE-AIM框架评价结局。 结果包括失眠严重程度（主要）、睡眠参数、疲劳、情绪、镇静催眠药的使用， 在基线、8周和6个月时收集的其他测量值。REP-DI量化执行成果 包括在患者和提供者/工作人员层面评估覆盖率、采用率和维护率。三部分形成 采用定性方法的评价将确定患者和提供者/工作人员的决定因素。 后续步骤/实施： 国家健康促进中心可以使用REP-DI在VA中实施指导性PTBS， 疾病预防和二级VA合作伙伴，如农村卫生和连接护理办公室。