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 慢性疼痛与抑郁症，失眠，诸如抑郁症，失眠等其他合并症有关 疲劳，降低流动性和较差的生活质量。慢性疼痛患者的大部分护理发生在 匆忙进行药物治疗（例如阿片类药物和药物）的初级保健访问所需的混合 有效性和潜在危险副作用的风险增加的证据，包括加法和死亡。 即使这些治疗方法有效减轻疼痛，它们也可能无法改善心理和功能状态 并且实际上可能会增加抑郁症。需要轻松访问基于证据的非药理学 包括患者信息和技能建设在内的治疗方案对慢性疼痛患者有帮助。 为了满足对治疗慢性疼痛的非药理方法的需求，我们提出了发展 双子座平台，旨在通过视频促进在线综合医疗小组访问（IMGV） 会议，消除具有身体和/或实际限制患者的主要访问障碍 禁止参加每周面对面会议。在在线小组会议之间，患者使用双子座 心身家庭练习，能够根据他们的能力选择基于证据的自我护理实践选择 自己的偏好和符号，并从基于小组的活动中获得同伴支持。家庭练习和 自我管理工具涵盖了正念，思维体实践，慢性自我管理等主题 疼痛，减轻压力，睡眠和营养。对于患者，双子座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还拥有一个提供商门户，该门户使用每日测量跟踪 并可以监测患者的症状，遵守家庭练习以及社交互动。 AIM 1：根据I期反馈增强/完善I期原型，并添加主要的实现 管理/调度组访问，更新干预内容的管理功能以及FHIR/SMART- 基于EHR集成。在AIM 2开始试验之前，将进行小型试点测试。与试验有关 功能将首先实现，然后将用于试用的软件“锁定”。附加功能 试验开始后，实施将继续，但在S单独的代码库中。 目标2：进行随机的2臂对照试验（n = 212），以测试我们的假设使用双子座 干预会导致疼痛影响减轻，更好的疼痛相关结果，提高疼痛的自我效能感 与比较器对照组相比，管理和减少止痛药物的使用，最多6 从干预开始开始的几个月。