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服务的人符合失眠障碍的标准