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

背景：慢性失眠是退伍军人中最常见的健康问题之一，它增加了患上 医疗和精神障碍、更高的事故和伤害率以及功能障碍。最多的 常见的治疗形式是处方镇静催眠药物和认知行为疗法。 失眠(CBT-I)，一种多组份的心理疗法。尽管有强有力的证据支持CBT-I作为 一线治疗，镇静催眠药仍然是最常见的。镇静剂-催眠药的使用与潜在的 耐受性、依赖性和虐待，以及白天疲劳、认知和身体损害的风险。 此外，镇静剂-催眠药治疗症状，而CBT-I侧重于认知/行为原因 各种因素。值得注意的是，停用镇静催眠药，这可能有助于降低相关风险并改善 退伍军人的功能和生活质量，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，停药和CBT-I应该同时进行。此外， 将CBT-I与停药相结合的远程健康干预可能会改善退伍军人的睡眠， 在提高功能和生活质量的同时，以高效和可扩展的方式增加获得护理的机会。 意义/影响：停药和CBT-I都是定期提供的循证干预措施 然而，在退伍军人中，可以简化护理并优化退伍军人结局的综合干预措施 现成的。临床医生操作的辅助睡眠技术(COSTAR)是一种基于证据的数字化技术 结合了面对面CBT-I(个性化护理)和远程医疗优势的睡眠平台(In 居家护理、灵活的日程安排)。Coaste的独特方法利用人工智能开发定制的 以易于使用、高效、 和可扩展的包。拟议的干预措施有可能显著影响和改善退伍军人 退伍军人健康与镇静催眠药停药和CBT-I的使用。这项建议与退伍军人事务部的意见一致 RR&D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，生活质量，参与他们的生活和社区。 创新性：这项先导研究是务实和独特的。目前还没有资助的研究结合在一起 取消处方和CBT-I，由可扩展且高效的数字平台(如Coast)提供。专注于睡眠 而功能结果也将确保这种干预可以改善退伍军人的功能能力 除了减少临床症状和改善护理提供之外，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剂和催眠药的退伍军人的可行性 他们参与了通过数字健康平台提供的停药和失眠双重干预。 目标2将评估退伍军人对海岸平台的可接受性和可用性。目标3将评估 老兵失眠，镇静催眠药的使用，以及干预前后的临床和功能结果。 方法：这项为期12周的单臂干预将招募50名患有慢性镇静剂的退伍军人。 催眠药物的使用，减少这些药物的欲望，以及参与数字健康的能力 干预。可行性将取决于招募和参与情况。可接受性/可用性评估， 临床和功能结果将在基线、治疗后和治疗后3个月发生。 下一步：研究结果将被用于开发一项规模更大、动力适当的临床试验，以 测试COSTAR提供CBT-I和综合药剂师指导的停药以改善疗效的有效性 老兵的睡眠和功能，以及镇静催眠药物的减少使用。此外，下一步将包括 努力更好地了解帮助或阻碍退伍军人使用数字干预的因素。未来 研究工作将涉及退伍军人管理局业务合作伙伴(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，以确保满足退伍军人和退伍军人的需求。

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.