Remotely Observed Methadone Evaluation (ROME)

1.Sonara Health SBIR第一阶段和团队执行摘要 美沙酮是治疗阿片类药物使用障碍(OUD)的有效药物，但其使用 由于担心服药过量和转移，在联邦和州一级受到严格监管。作为一名 结果，美沙酮只能在口服避孕药中使用，患者需要数月的护理 在OTP批准带回家的美沙酮之前。这些障碍可能会减少患者 参与和保留，这严重影响健康结果。它们还可以防止OTP 不能完全服务于他们的社区。 Sonara是一种创新的解决方案，可以减少OTP提供救命美沙酮的摩擦 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，用于跟踪每个患者、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次给药过程(即 以确保患者遵守治疗方案，并在以下情况下进行干预 关于病人的行为。 通过Sonara的远程观察平台，临床医生能够增加访问 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，提高对患者和提供者的责任感和透明度 复苏成功的关键指标。这些目标有助于提高患者参与度和 保留，这反过来又提高了临床医生的敬业度，并最终改善了 病人。 Sonara Health于2022年10月授予并启动的SBIR第一阶段赠款的目标是 对最低可行产品(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)与患者一起对Sonara的最低可行产品进行可行性测试-以及 面向临床医生的Web应用程序和评估跟踪性能 2)研究、开发和集成基于测量的护理框架 经常、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的需求和可接受性 拟议的i-Corps团队将包括以下三名成员。 成员名称角色 贾斯汀·盖勒行业专家 迈克尔·贾尔斯，医学博士，C级公司官(CEO) Kim Hoffman，博士，PD/PI 所有三名成员都致力于i-Corps计划所要求的时间。

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.