SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)

技术驱动的失眠干预辅助镇静催眠处方（SEDATIVE）

• 批准号: 10623177
• 负责人: ADAM DANIEL BRAMOWETH
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10623177
• 关键词: Accidents; Address; Aftercare; Air; Artificial Intelligence; Behavior Therapy; Behavioral; Biological Process; COVID-19 pandemic; Caring; Chronic; Chronic Insomnia; Clinic; Clinical; Clinical Pharmacists; Clinical Psychology; Clinical Trials; Cognitive; Cognitive Therapy; Communication; Communities; Consultations; Dependence; Development; Diagnosis; Disease; Dreams; Effectiveness; Enrollment; Ensure; Evidence based intervention; Fatigue; Foundations; Funding; Health; Health Services; Health Services Accessibility; Home; Impairment; Injury; Intervention; Link; Medical; Medical Societies; Medicine; Mental Health; Mental disorders; Methodology; Military Personnel; Outcome; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy (field); Pharmacy facility; Pilot Projects; Provider; Psychologist; Psychotherapy; Quality of life; Recommendation; Research; Risk; Schedule; Scientific Societies; Secure; Self Management; Services; Sleep; Sleep Disorders; Sleeplessness; Stimulus; Suicide prevention; Symptoms; Technology; Testing; Therapeutic; Time; Training; Translating; Transportation; Veterans; arm; barrier to care; care delivery; clinical practice; cloud based; common treatment; coronavirus disease; digital; digital health; digital intervention; digital platform; digital technology; effective intervention; effectiveness testing; evidence base; flexibility; functional disability; functional independence; functional outcomes; hypnotic; improved; improvement on sleep; innovation; mobile application; new technology; novel strategies; operation; patient home care; personalized care; pilot test; post intervention; recruit; rehabilitation research; research and development; sedative; sleep quality; success; symptom treatment; technology platform; telehealth; usability; user-friendly

Background: Chronic insomnia, one of the most common health problems among Veterans increases risk for medical and psychiatric disorders, higher rates of accidents and injuries, and functional impairment. The most common forms of treatment are prescription sedative-hypnotic medications and cognitive behavioral therapy for insomnia (CBT-I), a multi-component psychotherapy. Despite strong evidence in support for CBT-I as the first line treatment, sedative-hypnotics remain the most common. Sedative-hypnotic use is linked to potential tolerance, dependence, and abuse as well as risk for daytime fatigue and cognitive and physical impairment. Furthermore, sedative-hypnotics treat symptoms while CBT-I focuses on the cognitive/behavioral causal factors. Notably, deprescribing sedative-hypnotics, which may help to reduce associated risk and improve Veteran function and quality of life, is often accompanied by the return or worsening of insomnia symptoms. Thus, to improve Veteran sleep outcomes, deprescribing and CBT-I should occur simultaneously. Furthermore, a telehealth-based intervention that combines CBT-I with deprescribing could result in improved Veteran sleep, function, and quality of life while also increasing access to care in an efficient and scalable manner. Significance/Impact: Both deprescribing and CBT-I are evidence-based interventions regularly delivered within VA; however, a combined intervention that can streamline care and optimize Veteran outcomes is not readily available. The Clinician Operated Assistive Sleep Technology (COAST) is an evidence-based, digital sleep platform that combines aspects of in-person CBT-I (personalized care) with the benefits of telehealth (in home care, flexible scheduling). COAST’s unique approach utilizes artificial intelligence to develop tailored recommendations and integrates provider expertise and personalized deprescribing in an easy to use, efficient, and scalable package. The proposed intervention has potential to significantly impact, and improve, Veteran health and the delivery of sedative-hypnotic deprescribing and CBT-I in VA. This proposal is consistent with VA RR&D’s scope to translate research into clinical practice in order to maximize Veterans’ functional independence, quality of life, and participation in their lives and community. Innovativeness: This pilot study is pragmatic and unique. There are currently no funded studies that combine deprescribing and CBT-I, delivered by a scalable and efficient digital platform like COAST. Focusing on sleep and functional outcomes will also ensure that this intervention can improve Veterans’ functional capabilities and quality of life in addition to the reduction of clinical symptoms and improvement of care delivery. Specific Aims: Aim 1 will assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use and their participation in a dual deprescribing and insomnia intervention, delivered through a digital health platform. Aim 2 will assess Veterans’ acceptability and usability of the COAST platform. Aim 3 will assess change in Veteran insomnia, sedative-hypnotic use, and clinical and functional outcomes pre- to post-intervention. Methodology: This single-arm, 12-week intervention will recruit and enroll 50 Veterans with chronic sedative- hypnotic medication use, a desire to reduce these medications, and ability to participate in a digital health intervention. Feasibility will be based on recruitment and participation. Assessments of acceptability/usability, and clinical and functional outcomes will occur at baseline, post-treatment, and 3-months post-treatment. Next Steps: Findings will be used to inform the development of a larger, appropriately powered clinical trial to test the effectiveness of COAST to deliver CBT-I and integrated pharmacist-led deprescribing to improve Veteran sleep and function and reduced use of sedative-hypnotic medications. Also, next steps will include efforts to better understand the factors that help or hinder Veterans’ use of digital interventions. Future research efforts will involve VA operations partners (e.g., Office of Mental Health and Suicide Prevention, Telehealth Services) and Veteran advisory groups to ensure the needs of Veterans and VA are met.

背景：慢性失眠是退伍军人中最常见的健康问题之一，增加了患病风险 医疗和精神疾病、事故和伤害发生率较高以及功能障碍。 常见的治疗形式是处方镇静催眠药物和认知行为疗法 尽管有强有力的证据支持 CBT-I 作为治疗失眠的方法，但 CBT-I 是一种多成分心理治疗。 作为一线治疗，镇静催眠药仍然是最常见的，与潜在的使用有关。 耐受、依赖和滥用，以及日间疲劳、认知和身体损伤的风险。 此外，镇静催眠药治疗症状，而 CBT-I 侧重于认知/行为因果关系 值得注意的是，停用镇静催眠药可能有助于降低相关风险并改善症状。 老兵的功能和生活质量下降，往往伴随着失眠症状的复发或恶化。 因此，为了改善退伍军人的睡眠结果，取消处方和 CBT-I 应同时进行。 基于远程医疗的干预措施将 CBT-I 与取消处方相结合，可以改善退伍军人的睡眠， 功能和生活质量，同时还以高效和可扩展的方式增加获得护理的机会。 意义/影响：取消处方和 CBT-I 都是定期提供的循证干预措施 然而，在 VA 内，可以简化护理和优化退伍军人治疗结果的综合干预措施并不可行 临床医生操作的辅助睡眠技术 (COAST) 是一种基于证据的数字化技术。 睡眠平台将面对面 CBT-I（个性化护理）的各个方面与远程医疗（在 COAST 的独特方法利用人工智能来开发量身定制的服务。 推荐并以易于使用、高效、 拟议的干预措施有可能显着影响和改善退伍军人。 该提案与 VA 一致。 RR&D 的范围是将研究转化为临床实践，以最大限度地提高退伍军人的功能 独立性、生活质量以及对生活和社区的参与。 创新性：这项试点研究务实且独特，目前尚无资助研究将其结合起来。 取消处方和 CBT-I，由 COAST 等可扩展且高效的数字平台提供。 功能结果还将确保这种干预能够提高退伍军人的功能能力 除了减少临床症状和改善护理服务之外，还可以提高生活质量。 具体目标：目标 1 将评估招募长期使用镇静催眠药的退伍军人的可行性，以及 他们参与通过数字健康平台提供的双重处方和失眠干预措施。 目标 2 将评估退伍军人对 COAST 平台的可接受性和可用性，目标 3 将评估退伍军人的变化。 退伍军人失眠、镇静催眠的使用以及干预前后的临床和功能结果。 方法：这项为期 12 周的单组干预措施将招募和招募 50 名患有慢性镇静剂的退伍军人 使用催眠药物、减少这些药物的愿望以及参与数字健康的能力 可行性将基于对可接受性/可用性的评估。 临床和功能结果将在基线、治疗后和治疗后 3 个月时发生。 后续步骤：研究结果将用于为更大规模、适当动力的临床试验的开发提供信息，以 测试 COAST 提供 CBT-I 和综合药剂师主导的取消处方的有效性，以改善 退伍军人的睡眠和功能以及减少镇静催眠药物的使用此外，下一步将包括。 更好地了解有助于或阻碍退伍军人使用未来数字干预措施的因素。 研究将涉及 VA 运营合作伙伴（例如心理健康和自杀预防办公室、 远程医疗服务）和退伍军人咨询小组，以确保退伍军人和退伍军人事务部的需求得到满足。