GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain

GEMINI：管理慢性疼痛的虚拟综合医疗小组访问

• 批准号: 10699898
• 负责人: Paula Marie Gardiner
• 金额: $ 74.72万
• 依托单位: BRIGHTOUTCOME INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699898
• 关键词: 2 arm randomized control trial; Address; Adherence; Adult; Affect; Analgesics; Anxiety; COVID-19 pandemic; Caring; Cessation of life; Chronic Care; Clinical Research; Code; Communities; Complementary Health; Computer software; Control Groups; Dangerousness; Development; Fast Healthcare Interoperability Resources; Fatigue; Feedback; Fees; Health Services; High Prevalence; Home; Integrative Medicine; Internet; Intervention; Low income; Marketing; Measures; Medical; Medicare; Mental Depression; Mind; Modeling; Monitor; Office Visits; Opioid; Outcome; Pain; Pain management; Patient Monitoring; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Practice Management; Preparation; Privatization; Provider; Qualitative Methods; Quality of life; Randomized; Randomized, Controlled Trials; Research; Research Design; Research Personnel; Rewards; Risk; Role; Schedule; Secure; Self Care; Self Efficacy; Self Management; Sleep; Sleeplessness; Social Interaction; Support Groups; Symptoms; System; Telephone; Testing; Training; Update; Videoconferencing; Visit; addiction; arm; base; chronic pain; chronic pain management; chronic pain patient; cohort; commercialization; comorbidity; design; digital health; evidence base; functional status; improved; innovation; low health literacy; mental state; mind/body; mindfulness; negative affect; nutrition; online delivery; pain reduction; pain self-management; pandemic disease; patient-level barriers; peer; peer support; pharmacologic; pilot test; preference; prescription pain reliever; primary care visit; product development; prototype; provider portal; racial diversity; response; secondary analysis; side effect; skills; stress reduction; symptom self management; telehealth; tool; treatment arm; usability; virtual; web platform

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.

抽象的 慢性疼痛与严重的痛苦和其他并发症有关，例如抑郁、失眠、 慢性疼痛患者的大部分护理都发生在疲劳、活动能力下降和生活质量较差的时期。 尽管混合药物治疗（例如阿片类药物和药物），仍匆忙进行初级保健就诊 疗效证据和潜在危险副作用（包括成瘾和死亡）风险增加的证据。 即使这些治疗可以有效减轻疼痛，但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，需要轻松获得基于证据的非药物治疗。 包括患者信息和技能培养的治疗方案将对慢性疼痛患者有所帮助。 为了满足治疗慢性疼痛的非药物方法的需求，我们建议开发 GEMINI 平台促进通过视频提供在线综合医疗团体就诊 (IMGV) 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 进行活动。 身心家庭实践，能够根据自己的情况选择基于证据的自我护理实践选项 自己的喜好和症状，并通过小组活动获得同伴支持。 自我管理工具涵盖正念、身心练习、慢性病自我管理等主题 对于患者来说，GEMINI 是一个独特且安全的团体。 干预，使用游戏化来奖励参与度，并允许用户进行个性化的自我管理 对于新手和研究人员，GEMINI 还提供了一个提供者门户，该门户使用日常测量跟踪。 并能够监测患者的症状、家庭实践的遵守情况和社交互动。 目标 1：根据第一阶段反馈增强/完善第一阶段原型，并添加主要实施 用于管理/安排团体访问、更新干预内容和 FHIR/SMART 的管理功能 在开始目标 2 中的试验之前，将进行基于 EHR 集成的小型试点测试。 功能将首先实现，然后用于试用的软件将被“锁定”。 试用开始后将继续实施，但在单独的代码库上。 目标 2：进行随机 2 组对照试验 (N=212) 来检验我们的假设，即使用 GEMINI 干预将减少疼痛影响、改善疼痛相关结果、提高疼痛自我效能 与对照组相比，管理和减少止痛药使用最多 6 干预参与开始后的几个月。