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

项目摘要 /摘要阿片类药物危机是一种流行病，对联合的健康，社会和经济后果造成了毁灭性的流行国家。据报道，在2020年，有270万人患有阿片类药物使用障碍（OUD）。最近，美国阿片类药物危机的总经济燃烧量估计近1.5万亿美元。 OUD治疗涉及用药（MOUD）与咨询或行为疗法相结合管理疾病，实现和维持更好的健康，并改善生活质量。复发毒品使用率很高，获得咨询的机会有限且昂贵。穆德是护理标准和高效在降低急性发病率和死亡率方面，量身定制的治疗方法有优势患者的药物使用模式以及与药物有关的医学，精神病和社会问题。手机存在用于支持Oud处理的工具，这些产品仅提供通用信息，而不是个性化的信息对每个人的当前状态有反应的反馈，以支持他/她的个人康复。在当前资助的NIDA II期STTR赠款中，我们正在临床评估KIO，这是一种创新的软件使用非线性控制理论的平台，以满足FDA 510（k）设备清除率的要求。库是一个跟踪多种相互作用症状（例如，渴望，情绪，痛苦）的数字健康疗法轨迹并提供及时基于证据的干预策略，直接响应患者报告需要。可通过移动设备访问，信息库为患者提供按需个性化建议和加强生活方式干预措施，以改善与穆德同时进行的自我管理。这提出了 Fast-Track Project是售货亭开发的下一步，旨在展示其现实世界采用包括终点，以支持付款人的积极覆盖决定。这种创新的工具来帮助患者管理Oud有可能对公共卫生产生深远的影响并获得重大影响商业成功。该申请检查障碍和付款人和其他非患者利益相关者的I阶段检查障碍和促进者采用，并将结果纳入软件和试验设计中。它具有三个特定的目标：目标1。执行快速定性分析以定义利益相关者需求目标2。实施适用的软件更改目标3。确定第二阶段的临床试验设计第二阶段使用杂交2型设计评估了渠道在临床研究中的有效性。 II期努力完成了三个具体目标：目标1。优化实施程序 AIM 2。在随机临床试验中证明有效性目标3。在现实世界中检查千差志的实施