Real World Adoption of an OUD Digital Health Therapeutic

OUD 数字健康疗法在现实世界中的采用

基本信息

批准号：
10741217
负责人：
Gregg Siegel
金额：
$ 31.95万
依托单位：
BIOMEDICAL DEVELOPMENT CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10741217
关键词：
Absenteeism Acute Address Adoption Age Anxiety Behavior Behavior Therapy Behavioral Clinic Clinical Clinical Research Clinical Trials Clinical Trials Design Code Combination Medication Complex Computer software Counseling Data Development Devices Documentation Drug usage Economic Burden Economics Education Effectiveness Elements Epidemic Evidence based intervention Feedback Foundations Funding Goals Grant Health Health Care Costs Healthcare Systems Individual Institutional Review Boards Intervention Interview Maps Marketing Measurement Measures Medical Medical Device Moods Morbidity - disease rate National Institute of Drug Abuse Opioid Overdose Pain Patient Self-Report Patients Pattern Persons Pharmaceutical Preparations Phase Principal Investigator Privatization Process Product Packaging Protocols documentation Psychological reinforcement Public Health Quality of life Randomized, Controlled Trials Reach, Effectiveness, Adoption, Implementation, and Maintenance Recovery Recurrence Reporting Research Research Design Research Personnel Resource Development Self Management Site Small Business Innovation Research Grant Small Business Technology Transfer Research Social Problems Software Design Specific qualifier value Structure Supportive care Symptoms Testing Therapeutic Time United States Work addiction clinical trial protocol commercialization control theory cost craving dashboard depressive symptoms design digital health digital treatment effectiveness clinical trial effectiveness evaluation effectiveness trial experience handheld mobile device hybrid type 2 design implementation evaluation implementation facilitation implementation outcomes implementation strategy improved improved outcome individual patient innovation lifestyle intervention medication for opioid use disorder medication-assisted treatment mobile application mortality novel opioid epidemic opioid misuse opioid use disorder patient oriented personalized approach phase 1 study phase 2 designs programs provider portal public health emergency randomized, clinical trials response satisfaction social standard of care success therapeutic opioid tool trial design uptake usability

项目摘要

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

项目概要/摘要阿片类药物危机是一种流行病，给美国带来了毁灭性的健康、社会和经济后果据报道，2020 年有 270 万名 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造成的总经济负担接近 1.5 万亿美元。 OUD 的治疗包括药物治疗 (MOUD) 结合咨询或行为疗法控制疾病，实现并维持更好的健康，并提高反复吸毒率。率很高，获得咨询的机会有限且成本高昂，而 MOUD 是标准护理且非常有效。在降低急性发病率和死亡率方面，针对特定问题量身定制的治疗方法具有优势。个体患者的药物使用模式以及与药物相关的医疗、精神和社会问题。存在支持 OUD 处理的工具，这些产品仅提供通用信息，不提供个性化信息针对每个人当前状态的反馈，以支持他/她的个人康复。在目前资助的 NIDA II 期 STTR 拨款中，我们正在临床评估 KIOS，一种创新软件平台采用非线性控制理论，满足 FDA 510(k) 设备许可要求。数字健康治疗可跟踪多种相互作用的症状（例如渴望、情绪、疼痛）以绘制患者图轨迹并提供及时的基于证据的干预策略，直接响应患者报告 KIOS 可通过移动设备访问，按需为患者提供个性化建议和服务。加强生活方式干预，以改善 MOUD 的自我管理。 Fast-Track 项目是 KIOS 开发的下一步，旨在展示其真实世界采用决策包括支持付款人积极承保的端点，这种创新工具可以提供帮助。患者管理 OUD 有可能对公共健康产生深远影响并取得重大成果商业上的成功。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。它具有三个具体目标：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 期使用混合 2 型设计评估 KIOS 在临床研究中的有效性。努力由三个具体目标组成：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. 检查 KIOS 在现实世界中的实施情况