Remotely Observed Methadone Evaluation (ROME)

远程观察美沙酮评估 (ROME)

• 批准号: 10774067
• 负责人: Steffani R Bailey
• 金额: $ 5.5万
• 依托单位: SONARA HEALTH INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-08 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10774067
• 关键词: Accountability; Achievement; Adherence; Administrator; Adverse event; Authorization documentation; Automobile Driving; Award; Awareness; Behavior; Benefits and Risks; Businesses; Caring; Cellular Phone; Climate; Clinical; Clinical Trials; Collaborations; Communities; Complex; Cornea; Cost Measures; Cost Savings; Country; Development; Directly Observed Therapy; Doctor of Medicine; Doctor of Philosophy; Dose; Drops; Education; Electronics; Emergency department visit; Employment; Ensure; Entrepreneurship; Environment; Equity; Evaluation; Face; Feedback; Fees; Fentanyl; Fingerprint; Friction; Funding; Future; Goals; Government Programs; Grant; Growth; Health; Health Care Costs; Health Services Accessibility; Healthcare; Home; Hospitalization; Human; Individual; Industry; Innovation Corps; Institution; Insurance; Interview; Investments; Knowledge; Label; Left; Legal patent; Life; Local Government; Location; Love; Manuscripts; Marketing; Measurement; Measures; Mediation; Medicaid; Medical; Methadone; Mind; Mission; Modeling; Names; Nurses; Oregon; Outcome; Overdose; Participant; Patient Recruitments; Patient-Focused Outcomes; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Play; Positioning Attribute; Price; Privatization; Prognosis; Program Evaluation; Protocols documentation; Provider; Public Health; Qualifying; Quality of Care; Quality of life; Randomized, Controlled Trials; Recommendation; Records; Recovery; Regimen; Regulation; Reporting; Research; Research Personnel; Role; Running; Science; Secure; Security; Services; Side; Small Business Innovation Research Grant; Social status; State Government; Technology; Testing; Time; Training; Transportation; Treatment Protocols; Trust; United States; United States Substance Abuse and Mental Health Services Administration; Universities; Vision; Visit; Work; Writing; acceptability and feasibility; alcohol use disorder; authority; care costs; case-by-case basis; commercialization; compliance behavior; cost; design; diagnostic tool; digital; digital platform; effective therapy; experience; falls; feasibility testing; health related quality of life; improved; infancy; innovation; insight; medication compliance; meetings; member; methadone treatment; mobile application; new technology; novel diagnostics; novel strategies; novel therapeutics; opioid epidemic; opioid treatment program; opioid use disorder; patient engagement; patient population; patient retention; payment; pill; prevent; product development; programs; rural counties; social; social stigma; standard of care; success; timeline; treatment center; treatment duration; treatment program; usability; virtual; web app; web platform

1. Executive Summary of Sonara Health SBIR Phase I and Team Methadone is an effective treatment for patients with opioid use disorder (OUD), however its use is highly regulated at the federal and state level due to concerns of overdose and diversion. As a result, methadone can only be administered in OTPs, and it can take patients months of care before an OTP will authorize take-home methadone. These barriers can reduce patient engagement and retention, which severely impacts health outcomes. They can also prevent OTPs from fully being able to serve their communities. Sonara is an innovative solution that reduces friction for OTPs providing life-saving methadone treatment for opioid use disorder. It works by combining a secure web platform with low-cost, tamper-evident, single-use packaging to track per-patient, per-dose adherence to take home methadone. Clinicians have the ability to view each dosing session on-demand (i.e. asynchronously) to ensure patient adherence to treatment regimens and intervene in the case of concerning patient behavior. Through Sonara's remote observation platform, clinicians are able to increase access to take-home methadone, while preventing opportunities for diversion or misuse. It will also improve accountability and transparency for patients and providers alike by actively reporting key indicators of recovery success. These goals serve to advance patient engagement and retention, which in turn improves clinician engagement, and ultimately the health outcomes of patients. The objective of Sonara Health's SBIR Phase I grant awarded and initiated in October 2022 was to conduct feasibility testing of the minimum viable product (MVP of Sonara's web application and evaluate its performance for opioid treatment programs (OTPs) in dispensing take-home methadone in a safe and responsible way. The specific aims of the proposed study are: 1) Conduct feasibility testing of Sonara's minimum viable product with patient- and clinician-facing web application and evaluate tracking performance 2) Research, develop, and integrate a measurement-based care framework that measures frequent, personalized improvement to a patient's OUD outcomes and delivers them to their care team 3) Assess the demand and acceptability of Sonara among providers and target patients The proposed I-Corps team will include the following three members. Member Name Role Justin Geller Industry Expert Michael Giles, M.D. C-Level Corporate Officer (CEO) Kim Hoffman, PhD PD/PI All three members are committed to the time required by the I-Corps program.

1. Sonara Health SBIR第一阶段和团队的执行摘要 美沙酮是阿片类药物使用障碍（OUD）患者的有效治疗方法， 由于担心过量和转移，在联邦和州一级受到高度管制。作为 因此，美沙酮只能在一次性治疗中使用，而且需要数月的护理 在检察官办公室批准带回家的美沙酮之前这些障碍可以减少患者 参与和保留，这严重影响健康成果。它们还可以防止OTP 完全有能力为他们的社区服务 Sonara是一种创新的解决方案，可减少OTP提供救生美沙酮的摩擦 阿片类药物使用障碍的治疗。它的工作原理是将一个安全的网络平台与低成本， 防篡改、一次性使用包装，可跟踪每个患者、每个剂量的依从性，以便带回家 美沙酮临床医生能够按需查看每个给药阶段（即 异步），以确保患者遵守治疗方案，并在出现以下情况时进行干预： 关于病人的行为 通过Sonara的远程观察平台，临床医生能够增加对 将美沙酮带回家，同时防止转移或滥用的机会。它还将 通过积极报告，改善患者和提供者的问责制和透明度 复苏成功的关键指标。这些目标有助于提高患者参与度， 保留，这反过来又提高了临床医生的参与度，并最终改善了 患者 Sonara Health的SBIR第一阶段赠款于2022年10月授予并启动，其目标是 对最小可行产品（Sonara Web应用程序的MVP）进行可行性测试 并评估其在阿片类药物治疗计划（OTP）中的性能， 以安全和负责任的方式使用美沙酮。 拟议研究的具体目标是： 1)对Sonara的最小可行产品进行可行性测试， 面向临床医生的Web应用程序并评估跟踪性能 2)研究、开发和整合基于测量的护理框架， 对患者的OUD结果进行频繁的个性化改善，并将其交付给 他们的护理团队 3)评估供应商和目标患者对Sonara的需求和可接受性 拟议的第一军团小组将包括以下三名成员。 成员名称角色 Justin Geller行业专家 迈克尔·贾尔斯，医学博士C-Level Corporate Officer（CEO） Kim霍夫曼，PD/PI博士 所有三名成员都致力于I军团计划所需的时间。