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

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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.