GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain

摘要 慢性疼痛与巨大的痛苦和其他共病相关，如抑郁、失眠、 疲劳，行动不便，生活质量变差。大多数慢性疼痛患者的护理发生在 尽管混合了药物治疗(如阿片类药物和药物)，但仍匆忙进行初级保健就诊 疗效和潜在危险副作用风险增加的证据，包括成瘾和死亡。 即使这些治疗方法在减轻疼痛方面有效，它们也可能不会改善精神和功能状态 实际上可能会加重抑郁症。需要方便地获取循证非药理学信息 包括患者信息和技能培养在内的治疗选择将对慢性疼痛患者有所帮助。 为了解决非药理学方法治疗慢性疼痛的需要，我们建议开发 Gemini平台，促进通过视频提供在线综合医疗小组访问(IMGV) 会议，消除了有身体和/或实际限制的患者的主要访问障碍 禁止参加每周的面对面会议。在在线小组会议期间，患者使用Gemini进行 心身家庭实践，能够根据他们的情况选择循证的自我护理实践选项 自己的喜好和症状，并从基于小组的活动中获得同伴的支持。家庭实践和 自我管理工具，包括正念、身心练习、慢性疾病的自我管理 疼痛、减压、睡眠和营养。对于患者来说，双子座是一个独特而安全的群体 干预，使用游戏化来奖励参与度，并允许用户个性化自我管理 工具。对于临床医生和研究人员，双子座也有一个提供者门户，它使用每日测量跟踪 并能够监控患者的症状、坚持家庭实践和社会互动。 目标1：在第一阶段反馈的基础上增强/改进第一阶段原型，并增加大部分实现 用于管理/安排小组访问、更新干预内容以及FHIR/SMART的管理功能 基于EHR的集成。在AIM 2开始试验之前，将进行一次小规模试验。与试验有关 功能将首先实现，然后用于试验的软件将被“锁定”。附加功能 审判开始后将继续执行，但对S单独代码库。 目的2：进行一项随机的双臂对照试验(N=212)，以检验我们的假设：双子座的使用 干预将导致减少疼痛影响，更好的疼痛相关结果，提高疼痛自我效能 管理，并减少止痛药的使用，与对照组相比，最高可达6 从干预参与开始算起几个月。

Abstract Chronic pain is associated with substantial suffering and other co-morbidities such as depression, insomnia, fatigue, lowered mobility, and worse quality-of-life. Most of the care of chronic pain patients occurs during hurried primary care visits with pharmacological treatments (e.g. opioids and medications) despite mixed evidence of efficacy and increased risk of potentially dangerous side effects, including addiction and death. Even when these treatments are effective in reducing pain, they may not improve mental and functional status and may actually increase depression. The need for easy access to evidence-based non-pharmacological treatment options that include patient information and skill building would be helpful to chronic pain patients. To address the need for non-pharmacological approaches to treating chronic pain, we proposed developing the GEMINI platform to facilitate the delivery of online Integrative Medical Group Visits (IMGV) via video conferencing, eliminating a major access barrier for patients with physical and/or practical limitations that prohibit attending weekly in-person sessions. Between the online group sessions, patients use GEMINI for mind-body home practice with the ability to select evidence-based self-care practice options based on their own preferences and symptoms, and to gain peer support from group-based activities. The home practice and self-management tools covering such topics as mindfulness, mind-body practices, self-management of chronic pain, stress reduction, sleep, and nutrition. For patients, GEMINI is a unique and secure group-based intervention, uses gamification to reward engagement, and allows users to individualize self-management tools. For clinicians and researchers, GEMINI also has a Provider Portal, which uses daily measure tracking and enables monitoring of patients’ symptoms, adherence to home practice, and social interactions. Aim 1: Enhance/refine Phase I prototype based on Phase I feedback and add implementation of mostly administrative features for managing/scheduling group visits, updating intervention content, and FHIR/SMART- based EHR integration. A small pilot test will be conducted before starting the trial in Aim 2. Trial-related features will be implemented first and then the software used for the trial will be “locked.” Additional feature implementation will continue after the start of the trial, but on s separate codebase. Aim 2: Conduct a randomized 2-arm controlled trial (N=212) to test our hypotheses that the use of the GEMINI intervention would result in reduced pain impact, better pain-related outcomes, improved self-efficacy in pain management, and reduced pain medication use, as compared to the comparator control group, for up to 6 months from the start of the intervention participation.