NOCTEM, LLC, 218 Oakland Avenue, Pittsburgh, PA, 15213, USA.
Warfighter Performance Department, Naval Health Research Center, 140 Sylvester Rd, San Diego, CA, 92106, USA.
Trials. 2021 Jan 11;22(1):46. doi: 10.1186/s13063-020-04974-z.
Insomnia affects almost one in four military service members and veterans. The first-line recommended treatment for insomnia is cognitive-behavioral therapy for insomnia (CBTI). CBTI is typically delivered in-person or online over one-to-four sessions (brief versions) or five-to-eight sessions (standard versions) by a licensed doctoral or masters-level clinician with extensive training in behavioral sleep medicine. Despite its effectiveness, CBTI has limited scalability. Three main factors inhibit access to and delivery of CBTI including restricted availability of clinical expertise; rigid, resource-intensive treatment formats; and limited capacities for just-in-time monitoring and treatment personalization. Digital technologies offer a unique opportunity to overcome these challenges by providing scalable, personalized, resource-sensitive, adaptive, and cost-effective approaches for evidence-based insomnia treatment.
This is a hybrid type 3 implementation-effectiveness randomized trial using a scalable evidence-based digital health software platform, NOCTEM™'s Clinician-Operated Assistive Sleep Technology (COAST™). COAST includes a clinician portal and a patient app, and it utilizes algorithms that facilitate detection of sleep disordered patterns, support clinical decision-making, and personalize sleep interventions. The first aim is to compare three clinician- and system-centered implementation strategies on the reach, adoption, and sustainability of the COAST digital platform by offering (1) COAST only, (2) COAST plus external facilitation (EF: assistance and consultation to providers by NOCTEM's sleep experts), or (3) COAST plus EF and internal facilitation (EF/IF: assistance/consultation to providers by NOCTEM's sleep experts and local champions). The second aim is to quantify improvements in insomnia among patients who receive behavioral sleep care via the COAST platform. We hypothesize that reach, adoption, and sustainability and the magnitude of improvements in insomnia will be superior in the EF and EF/IF groups relative to the COAST-only group.
Digital health technologies and machine learning-assisted clinical decision support tools have substantial potential for scaling access to insomnia treatment. This can augment the scalability and cost-effectiveness of CBTI without compromising patient outcomes. Engaging providers, stakeholders, patients, and decision-makers is key in identifying strategies to support the deployment of digital health technologies that can promote quality care and result in clinically meaningful sleep improvements, positive systemic change, and enhanced readiness and health among service members.
ClinicalTrials.gov NCT04366284 . Registered on 28 April 2020.
失眠影响近四分之一的现役军人和退伍军人。失眠的一线推荐治疗方法是认知行为疗法失眠（CBTI）。CBTI 通常由经过广泛行为睡眠医学培训的持照博士或硕士级临床医生通过一到四次（简短版本）或五到八次（标准版本）的会议亲自或在线提供。尽管 CBTI 有效，但它的扩展性有限。限制获得和提供 CBTI 的三个主要因素包括临床专业知识的限制可用性；僵化的、资源密集型的治疗模式；以及即时监测和治疗个性化的有限能力。数字技术通过提供可扩展的、个性化的、资源敏感的、自适应的和具有成本效益的基于证据的失眠治疗方法，为克服这些挑战提供了独特的机会。
这是一项混合类型 3 实施效果随机试验，使用可扩展的基于证据的数字健康软件平台，即 NOCTEM 的临床医生操作辅助睡眠技术（COAST）。COAST 包括一个临床医生门户和一个患者应用程序，它利用算法来促进检测睡眠障碍模式、支持临床决策和个性化睡眠干预。第一个目标是通过提供（1）仅 COAST、（2）COAST 加外部促进（EF：NOCTEM 的睡眠专家为提供者提供协助和咨询）或（3）COAST 加 EF 和内部促进（EF/IF：NOCTEM 的睡眠专家和当地冠军为提供者提供协助/咨询），比较三种临床医生和系统为中心的实施策略对 COAST 数字平台的可达性、采用和可持续性的影响。第二个目标是量化通过 COAST 平台接受行为睡眠护理的患者中失眠的改善情况。我们假设，在 EF 和 EF/IF 组中，与仅 COAST 组相比，失眠的可达性、采用率和可持续性以及失眠改善的幅度都将更高。
数字健康技术和机器学习辅助的临床决策支持工具具有扩大失眠治疗机会的巨大潜力。这可以增强 CBTI 的可扩展性和成本效益，而不会影响患者的治疗效果。让提供者、利益相关者、患者和决策者参与进来，是确定支持部署数字健康技术战略的关键，这些技术可以促进高质量的护理，并导致有临床意义的睡眠改善、积极的系统变化以及现役军人的健康和战备状态的提高。
ClinicalTrials.gov NCT04366284。注册于 2020 年 4 月 28 日。
