Real World Adoption of an OUD Digital Health Therapeutic

项目总结/摘要 阿片类药物危机是一种流行病，对美国的健康，社会和经济造成了毁灭性的后果。 States. 2020年，据报告有270万12岁以上的人患有阿片类药物使用障碍（OUD）。 最近估计，美国阿片类药物危机的总经济负担接近1.5万亿美元。 OUD的治疗包括药物治疗（MOUD）结合咨询或行为治疗， 控制疾病，实现和保持更好的健康，提高生活质量。经常吸毒率 很高，获得咨询的机会有限且昂贵。虽然MOUD是标准的护理和高效 在降低急性发病率和死亡率方面， 个别病人的药物使用模式和与药物有关的医疗、精神和社会问题。当移动的 现有工具支持OUD治疗，这些产品仅提供一般信息，而非个性化信息 对每个人的当前状态做出响应的反馈，以支持他/她的个人康复。 在目前资助的NIDA第二阶段STTR赠款中，我们正在临床评估KIOS，一种创新软件 平台使用非线性控制理论，以满足FDA 510（k）器械许可的要求。KIOS是一个 跟踪多个相互作用的症状的数字健康治疗（例如，渴望、情绪、疼痛）映射患者 轨迹，并提供及时的循证干预策略，直接响应患者报告的 需求通过移动的设备，KIOS可为患者提供个性化的建议， 加强生活方式干预，以改善与MOUD同时进行的自我管理。这一拟议 快速通道项目是KIOS开发的下一步，旨在展示其真实世界 采用包括端点，以支持付款人的积极覆盖决定。这一创新工具有助于 患者管理OUD有可能对公共卫生产生深远的影响， 商业成功。 该应用程序的第一阶段检查付款人和其他非患者利益相关者的障碍和促进因素 采用，并将结果相应地纳入软件和试验设计中。它有三个具体目标： 目标1.执行快速定性分析以确定利益相关者的需求 目标2.实施适用的软件变更 目标3。完成II期临床试验设计 II期采用混合2型设计评价KIOS在临床研究中的有效性。II期 这项工作包括三个具体目标： 目标1。优化实施方案 目标2.在随机临床试验中证明有效性 目标3。在真实的世界环境中检查KIOS的实现

PROJECT SUMMARY / ABSTRACT The opioid crisis is an epidemic with devastating health, social, and economic consequences for the United States. In 2020, 2.7 million people over the age of 12 were reported to suffer from opioid use disorder (OUD). The total economic burden of the opioid crisis in the US was recently estimated to be nearly $1.5 trillion. Treatment for OUD involves medication (MOUD) combined with counseling or behavioral therapy to manage the illness, achieve and sustain better health, and improve quality of life. Rates of recurrent drug use are high, and access to counseling is limited and costly. While MOUD is standard of care and highly effective at reducing acute morbidity and mortality, there are advantages to treatment approaches tailored to address an individual patient’s drug use patterns and drug-related medical, psychiatric, and social problems. While mobile tools exist to support OUD treatment, these products offer only generalized information and not personalized feedback that is responsive to each person’s current status to support his/her individual recovery. In a currently funded NIDA Phase II STTR grant, we are clinically evaluating KIOS, an innovative software platform using nonlinear control theory, to satisfy requirements for FDA 510(k) device clearance. KIOS is a digital health therapeutic that tracks multiple interacting symptoms (e.g., craving, mood, pain) to map patient trajectories and deliver timely evidence-based intervention strategies, responding directly to patient-reported needs. Accessible via mobile devices, KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management concomitant to MOUD. This proposed Fast-Track project is the next step in the development of KIOS, designed to demonstrate its real-world adoption including endpoints to support positive coverage decisions from payors. This innovative tool to help patients manage OUD has the potential to have a profound impact on public health and achieve significant commercial success. Phase I of this application examines barriers and facilitators to payor and other non-patient stakeholder adoption, and incorporates the results into the software and trial design accordingly. It has three Specific Aims: Aim 1. Perform Rapid Qualitative Analysis to Define Stakeholder Needs Aim 2. Implement Applicable Software Changes Aim 3. Finalize Clinical Trial Design for Phase II Phase II evaluates the effectiveness of KIOS in clinical studies using a hybrid type 2 design. The Phase II effort is comprised of three Specific Aims: Aim 1. Optimize Implementation Program Aim 2. Demonstrate Effectiveness in a Randomized Clinical Trial Aim 3. Examine Implementation of KIOS in a Real World Context