GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain

摘要 慢性疼痛与大量的痛苦和其他共病如抑郁症，失眠， 疲劳、活动性降低和生活质量下降。大多数慢性疼痛患者的护理发生在 尽管药物治疗（例如阿片类药物和药物）混合， 有效性的证据和潜在危险副作用的风险增加，包括成瘾和死亡。 即使这些治疗方法能有效地减轻疼痛，它们也可能无法改善精神和功能状态 实际上可能会增加抑郁症。需要方便地获得基于证据的非药理学 包括患者信息和技能培养的治疗选择将有助于慢性疼痛患者。 为了解决对非药物方法治疗慢性疼痛的需求，我们建议开发 GEMINI平台，通过视频促进在线整合医疗组访视（IMGV）的交付 会议，消除了身体和/或实际限制的患者的主要访问障碍， 禁止参加每周一次的面对面会议。在在线小组会议之间，患者使用GEMINI 身心家庭实践与选择基于证据的自我护理实践选项的能力，根据他们的 自己的喜好和症状，并获得同伴的支持，以小组为基础的活动。家庭实践和 自我管理工具，涵盖正念，身心实践，慢性自我管理等主题 疼痛、减压、睡眠和营养。对于患者来说，GEMINI是一个独特而安全的基于组的 干预，使用游戏化来奖励参与，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，GEMINI还提供了一个提供商门户，该门户使用日常测量跟踪 并且能够监测患者的症状、对家庭实践的坚持以及社会互动。 目标1：根据第一阶段的反馈，增强/完善第一阶段的原型，并增加主要 用于管理/安排小组访视、更新干预内容和FHIR/SMART的管理功能- 基于EHR的整合在目标2的试验开始之前，将进行一次小规模的试点测试。试验相关 功能将首先实现，然后用于试用的软件将被“锁定”。附加特征 在试验开始后，将继续实施，但使用的是单独的代码库。 目的2：进行随机2组对照试验（N=212），以检验我们的假设，即使用GEMINI 干预将减少疼痛的影响，改善疼痛相关的结果，提高疼痛的自我效能 管理，并减少止痛药的使用，与比较对照组相比，最多6 从参与干预开始的几个月内。

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.