Remotely Observed Methadone Evaluation (ROME)

远程观察美沙酮评估 (ROME)

• 批准号: 10483876
• 负责人: Steffani R Bailey
• 金额: $ 26.79万
• 依托单位: SONARA HEALTH INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483876
• 关键词: Accountability; Address; Adherence; Affect; American; Bar Codes; Buprenorphine; Caring; Centers for Disease Control and Prevention (U.S.); Certification; Clinic; Clinic Visits; Communicable Diseases; Complex; Computer software; Consumption; Data; Detection; Dose; Ecological momentary assessment; Educational Background; Emergency department visit; Evaluation; Event; FDA approved; Face; Feedback; Future; Geography; Greek; HIV/HCV; Harm Reduction; Health Care Sector; Health Sciences; Health Services Accessibility; Healthcare; Home; Hospitalization; Hospitals; Hour; Image; Incidence; Individual; Interview; Label; Licensing; Location; Machine Learning; Measures; Methadone; Methods; Naltrexone; Needle Sharing; Neonatal Abstinence Syndrome; Opiate Addiction; Opioid; Oregon; Overdose; Patient Care; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Physicians; Positioning Attribute; Prevention; Privacy; Productivity; Provider; Quality of Care; Regimen; Regulation; Relapse; Research; Resources; Rural; Rural Community; Safety; Savings; Small Business Innovation Research Grant; Societies; Testing; Time; Training; Travel; United States; Universities; Vial device; Video Recording; Visit; authority; automated algorithm; barrier to care; chronic pain patient; clinical decision-making; commercial application; commercialization; cost; design; effective therapy; efficacy evaluation; feasibility testing; illicit drug use; improved; indicated prevention; insight; machine learning algorithm; methadone treatment; mortality; opioid treatment program; opioid use disorder; opioid user; overdose death; overdose risk; prescription opioid; product development; rural area; sensor; social; socioeconomics; telehealth; usability; web app; webinar; willingness

Abstract – Three million Americans and 16 million individuals worldwide have had or currently suffer from opioid use disorder (OUD). OUD afflicts individuals from all socioeconomic and educational backgrounds with devastating consequences, including a rising incidence of neonatal abstinence syndrome and the spread of infectious diseases, i.e., HIV and hepatitis C, associated with syringe sharing. The most recent provisional data from the Centers for Disease Control and Prevention (CDC) indicate that approximately 81,230 drug overdose deaths occurred in the United States in the 12 months leading up to May 2020—the largest annual number of drug overdoses ever recorded. In 2019, hospitals estimated an annual cost of OUD of $787B to society, $93B to taxpayers, and $89B to the healthcare sector. Medications for opioid use disorder (e.g., methadone, buprenorphine, or naltrexone) are central to the treatment of OUD. Methadone, a proven and effective opioid medication for treating OUD, extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements for certification. The regulations require new patients to take their dose in person six days per week and limit the locations where patients may receive methadone. Finding an OTP can be challenging, especially for those in rural areas as only 3% of OTPs are rurally located. The greatest barriers that keep individuals with OUD from receiving treatment include 1) Availability; 2) Accessibility (i.e., daily visits for directly observed dosing); 3) Acceptability (i.e., need for detox for other non-methadone treatment options); and 4) Privacy. To address these barriers, Elpidatec has developed Elpida, an OTP-specific, mobile- and desktop-friendly web-application that combines video, tamper-evident barcode labels, facial recognition, and machine learning (ML) to enable accelerated take-home methadone regimens while maintaining safety and diversion prevention. Elpida enhances patient access to treatment, aligns with OTP workflow, and improves physician assessment and management of OUD patients, providing previously inaccessible patient information via real-time, ecological momentary assessments (EMAs). In this project, Elpidatec will complete feasibility testing, iterative product development, and market fit testing of Elpida in partnership with Adapt Oregon, a rural OTP, and Oregon Health and Science University. The Phase I SBIR application has three aims: 1) Conduct feasibility testing of the minimum viable product (MVP) with patient- and clinician-facing web- applications and evaluate tracking performance; 2) Develop and integrate key ML-enhanced features such as facial recognition and methadone vial position tracking for automated dosing event interpretation; and 3) Assess the demand and acceptability of Elpida among providers and patients. Insights gathered in Phase I will inform actionable improvements and the design of EMA constructs to be executed in Phase II. In Phase II, Elpidatec will also examine efficacy measures (e.g., treatment retention, relapse rates) via larger scale testing.

抽象的 - 全世界有300万美国人和1600万个人已经或目前患有阿片类药物 障碍（OUD）。 Oud会员从各个社会经济和教育背景中具有毁灭性的个人 后果，包括新生儿禁欲综合征的不断增长和感染性的传播 疾病，即HIV和丙型肝炎，与注射器共享有关。来自 疾病控制与预防中心（CDC）表明大约81,230例药物过量死亡 截至2020年5月的12个月中，发生在美国，这是年度最大的毒品数量 过量的记录。 2019年，医院估计，社会的年度费用为787B美元，$ 93B至 纳税人，医疗保健部门的$ 89B。阿片类药物使用障碍的药物（例如Metagadone， 丁丙诺啡或纳曲酮）是对OUD治疗的核心。美沙酮，一种经过验证有效的阿片类药物 用于治疗OUD，扩大护理保留率，降低死亡率并抑制非法药物使用的药物。然而， Meadadone治疗仅限于联邦认证的阿片类药物治疗计划（OTP），必须满足 认证的复杂监管要求。法规要求新患者服用剂量 每周六天的人，限制患者可能会收到Metagadone的位置。找到一个OTP可以 要具有挑战性，尤其是对于农村地区的人来说，只有3％的OTP位置。最大的障碍 使OUD接受治疗的个人包括1）可用性； 2）可访问性（即每日访问 直接观察到给药）； 3）可接受性（即，对于其他非甲二酮治疗选择，需要排毒）； 4）隐私。为了解决这些障碍，Elpidatec开发了Elpida，这是一个特异性OTP，移动和 结合视频，篡改条形码标签，面部识别的桌面友好的网络应用程序， 和机器学习（ML），以在维护的同时启用加速的带室的替代方案 安全与转移预防。 ELPIDA可增强患者的治疗机会，与OTP工作流程保持一致以及 改善OUD患者的身体评估和管理，提供以前无法访问的患者 通过实时的生态瞬时评估（EMA）信息。在这个项目中，Elpidatec将完成 可行性测试，迭代产品开发以及Elpida的市场拟合测试与适应 俄勒冈州，粗糙的OTP和俄勒冈州健康与科学大学。 I阶段SBIR应用程序具有三个目标： 1）通过患者和面向临床的网络对最低可行产品（MVP）进行可行性测试 - 应用和评估跟踪性能； 2）开发和整合关键ML增强功能，例如 自动给药事件解释的面部识别和Meadadone瓶位位置跟踪； 3）评估 提供者和患者的elpida的需求和可接受性。一阶段收集的洞察力将告知 可在II阶段执行的EMA构建体的可行改进和设计。在第二阶段，elpidatec 还将通过大规模测试检查有效性措施（例如，治疗保留率，继电器率）。