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 - 300 万美国人和全世界 1600 万人曾经或目前正在使用阿片类药物 紊乱（OUD）。 OUD 对所有社会经济和教育背景的个人造成毁灭性的影响 后果，包括新生儿戒断综合症发病率上升和传染病传播 与共用注射器相关的疾病，即艾滋病毒和丙型肝炎。最新临时数据来自 美国疾病控制与预防中心 (CDC) 表示，大约 81,230 人因药物过量死亡 截至 2020 年 5 月的 12 个月内，美国发生了最多的年度毒品事件 曾经记录过的服药过量。 2019 年，医院估计每年 OUD 给社会带来的成本为 $787B，为 $93B 纳税人，以及 $89B 给医疗保健部门。治疗阿片类药物使用障碍的药物（例如美沙酮、 丁丙诺啡或纳曲酮）是 OUD 治疗的核心。美沙酮，一种经过验证且有效的阿片类药物 治疗 OUD 的药物，延长护理时间，降低死亡率，并抑制非法药物的使用。然而， 美沙酮治疗仅限于联邦认证的阿片类药物治疗计划 (OTP)，该计划必须符合 复杂的认证监管要求。该规定要求新患者按时服药 每周六天，并限制患者可以接受美沙酮的地点。查找 OTP 可以 具有挑战性，特别是对于农村地区的人来说，因为只有 3% 的 OTP 位于农村。最大的障碍 阻碍 OUD 患者接受治疗的因素包括 1) 可用性； 2）可访问性（即每日访问 用于直接观察剂量）； 3) 可接受性（即需要戒毒以接受其他非美沙酮治疗方案）； 4) 隐私。为了解决这些障碍，Elpidatec 开发了 Elpida，一种 OTP 特定的、移动和 桌面友好的网络应用程序，结合了视频、防篡改条形码标签、面部识别、 和机器学习 (ML)，以加速带回家的美沙酮治疗方案，同时保持 安全和防止转移。 Elpida 增强患者获得治疗的机会，与 OTP 工作流程保持一致，并且 改善医生对 OUD 患者的评估和管理，为以前无法​​接触到的患者提供帮助 通过实时生态​​瞬时评估（EMA）获取信息。在这个项目中，Elpidatec将完成 Elpida 与 Adapt 合作进行可行性测试、迭代产品开发和市场适应性测试 俄勒冈州、乡村 OTP 和俄勒冈健康与科学大学。第一阶段 SBIR 申请有三个目标： 1) 通过面向患者和临床医生的网络对最小可行产品 (MVP) 进行可行性测试 应用程序并评估跟踪性能； 2) 开发和集成关键的 ML 增强功能，例如 面部识别和美沙酮药瓶位置跟踪，用于自动解释给药事件； 3) 评估 医疗服务提供者和患者对尔必达的需求和接受程度。第一阶段收集的见解将提供信息 可行的改进和 EMA 结构的设计将在第二阶段执行。在第二阶段，Elpidatec 还将通过更大规模的测试来检查疗效指标（例如治疗保留率、复发率）。