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，但其用途 由于担心过量和转移，该药物在联邦和州一级受到严格监管。作为一个 结果，美沙酮只能在 OTP 中使用，并且可能需要患者数月的护理时间 在 OTP 批准带回家的美沙酮之前。这些障碍会减少患者 参与度和保留度，这严重影响健康结果。它们还可以防止 OTP 充分能够为社区服务。 Sonara 是一种创新解决方案，可减少 OTP 的摩擦，提供挽救生命的美沙酮 治疗阿片类药物使用障碍。它的工作原理是将安全的网络平台与低成本、 防篡改的一次性包装可跟踪每位患者、每剂剂量的依从性并带回家 美沙酮。临床医生能够按需查看每次给药过程（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 关于患者的行为。 通过 Sonara 的远程观察平台，临床医生能够增加获得 带回家的美沙酮，同时防止转移或滥用的机会。它还将 通过积极报告，提高患者和提供者的责任感和透明度 恢复成功的关键指标。这些目标有助于提高患者的参与度和 保留率，进而提高临床医生的参与度，并最终提高患者的健康结果 患者。 Sonara Health 于 2022 年 10 月授予并启动的 SBIR 第一阶段拨款的目标是 对最小可行产品（Sonara 的 Web 应用程序的 MVP）进行可行性测试 并评估其在配药回家中阿片类药物治疗计划 (OTP) 的表现 以安全和负责任的方式美沙酮。 拟议研究的具体目标是： 1) 与患者和患者一起对 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 频繁、个性化地改善患者的 OUD 结果，并将其交付给 他们的护理团队 3) 评估提供者和目标患者对 Sonara 的需求和接受程度 拟议的 I-Corps 团队将包括以下三名成员。 会员姓名 角色 贾斯汀·盖勒行业专家 Michael Giles，医学博士 C 级公司官员（首席执行官） Kim Hoffman，博士 PD/PI 所有三名成员都承诺遵守 I-Corps 计划所需的时间。