Transcending COVID-19 barriers to pain care in rural America: Pragmatic comparative effectiveness trial of evidence-based, on-demand, digital behavioral treatments for chronic pain

超越美国农村地区疼痛护理的 COVID-19 障碍：针对慢性疼痛的循证、按需、数字行为治疗的实用比较有效性试验

• 批准号: 10425444
• 负责人: Brennan Spiegel
• 金额: $ 96.67万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-10 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10425444
• 关键词: 3-Dimensional; 3D virtual reality; 3D world; Address; Affect; Alabama; Algorithms; American; Anxiety; Authorization documentation; Behavior Therapy; COVID-19; COVID-19 impact; COVID-19 pandemic; California; Caring; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Characteristics; Chronic Disease; Clinical; Cognitive Therapy; Computers; Consensus; Coronavirus; Coupled; Data; Development; Distress; Educational Curriculum; Electronic Health Record; Epidemic; Esthesia; Fright; Future; Geography; Goals; Goggles; Head; Health; Health Services Accessibility; Health system; Healthcare; Home; International; Internet; Intervention; Learning; Louisiana; Measures; Medical; Medicare; Mental Depression; Mental Health; Mental Health Services; Meta-Analysis; Mobile Health Application; Opioid; Pain; Pain intensity; Pain interference; Pain management; Patient Care; Patient Rights; Patients; Persons; Pharmaceutical Preparations; Prediction of Response to Therapy; Privacy; Provider; Psyche structure; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Risk; Running; Rural; Rural Community; Schedule; Self Administration; Services; Sleep; Sleeplessness; Social isolation; Stress; Support Groups; Surveys; Techniques; Technology; Telemedicine; Telephone; Testing; Time; Training; Transcend; Visit; Vulnerable Populations; Work; adverse outcome; base; beneficiary; biopsychosocial; care delivery; care seeking; care systems; chronic pain; chronic pain management; chronic pain patient; clinical care; comparative effectiveness trial; computer program; digital; digital health; digital treatment; emotional distress; evidence base; experience; health care availability; health care quality; health management; high risk; indexing; mHealth; non-opioid analgesic; opioid epidemic; opioid use; pain reduction; pandemic disease; primary outcome; programs; psychological distress; psychosocial; rapid growth; recruit; rural America; rural Americans; rural residence; satisfaction; self-management program; skills; social; social vulnerability; sociodemographics; substance use; treatment program; treatment response; two-dimensional; video visit; virtual; virtual reality; virtual world

PROJECT SUMMARY The COVID-19 pandemic has affected everyone in different ways. For people from the rural America with chronic diseases, particularly those who experience pain, the pandemic can not only worsen pain, but also it can trigger anxiety, depression, trouble sleeping, and substance use. This psychological distress is exacerbated by physical and social isolation, fear of seeking in-person visits, and diminished ability to access clinical care during the pandemic. One way doctors and health systems are reaching out is by video visits, where patients and their providers communicate online via the Internet. However, video visits still have limits. Therefore, we can help support them with other techniques. Beyond video visits, there are home-based programs that patients can administer themselves to help manage their pain. These proven programs can overcome staffing shortfalls, be used across long distance to reach anyone in the world and can be used at the time and place of the patients' choosing. In this study, we will compare two available, evidence-based, digital treatment programs that patients can use at home. The goal is to see if one approach is better than the other, and whether certain patients respond to one more than the other. The first program is an app that can run on any smartphone or computer. The program offers an 8-week, at-home curriculum to learn and practice new skills that can help manage pain. The program runs on a standard screen on your phone or computer. The second program is also a proven, 8-week program, but it uses a technology called virtual reality, or VR. VR involves wearing specialized goggles that create a sensation of being in a 3D world. Evidence shows that virtual worlds can help people learn and retain new skills that help reduce pain. The study will recruit 300 people from rural communities in California, Louisiana, and Alabama and randomize them into either the 2D or 3D programs. We will then follow patients for 8 weeks days and measure their pain levels. We will also measure signs of distress, including Coronavirus-related anxiety, along with measuring medications used for pain, such as opioids, and the impact of pain on overall quality of life. To conduct the study, we will ask patients to periodically complete short surveys online and allow permission for the research team to collect information from the electronic health record. We developed this study working with patient partners from the American Chronic Pain Association (ACPA), and they will be part of the research team throughout the conduct, analysis, and reporting of the study. The results will help patients, doctors, and health system decide how best to administer home-based, patient-administered, digital treatment programs for pain, and will offer recommendation on how to select the right treatment for the right patient.

项目概要 COVID-19 大流行以不同的方式影响着每个人。对于来自美国农村的人们 慢性疾病，特别是那些经历疼痛的人，大流行不仅会加剧疼痛，而且还会 引发焦虑、抑郁、睡眠困难和药物滥用。这种心理困扰进一步加剧 身体和社会隔离、害怕寻求亲自就诊以及在治疗期间获得临床护理的能力下降 大流行。医生和卫生系统伸出援手的一种方式是通过视频访问，患者及其家人 提供商通过互联网进行在线交流。然而，视频访问仍然存在局限性。因此，我们可以帮助 用其他技术支持他们。除了视频就诊之外，患者还可以通过家庭计划 自我管理以帮助控制他们的疼痛。这些经过验证的计划可以克服人员短缺问题， 可以远距离覆盖世界上任何人，并且可以在患者所在的时间和地点使用 选择。 在这项研究中，我们将比较患者可以使用的两种可用的、基于证据的数字治疗方案 在家里。目标是看看一种方法是否比另一种更好，以及某些患者是否对其中一种方法有反应 比另一个多。第一个程序是一个可以在任何智能手机或计算机上运行的应用程序。该计划 提供为期 8 周的家庭课程，学习和练习有助于控制疼痛的新技能。该计划 在手机或计算机的标准屏幕上运行。第二个项目也是经过验证的、为期 8 周的项目， 但它使用了一种称为虚拟现实（VR）的技术。 VR 需要佩戴专门的护目镜来创建 置身于 3D 世界的感觉。有证据表明虚拟世界可以帮助人们学习和保留新技能 有助于减轻疼痛。 该研究将从加利福尼亚州、路易斯安那州和阿拉巴马州的农村社区招募 300 人，并随机分组 将它们放入 2D 或 3D 程序中。然后我们将跟踪患者 8 周并测量他们的疼痛 水平。我们还将测量痛苦的迹象，包括与冠状病毒相关的焦虑，以及测量 用于止痛的药物，例如阿片类药物，以及疼痛对整体生活质量的影响。为了进行这项研究， 我们将要求患者定期在线完成简短的调查，并允许研究团队进行 从电子健康记录中收集信息。我们与患者合作伙伴合作开展了这项研究 美国慢性疼痛协会 (ACPA)，他们将成为整个研究团队的一部分 研究的进行、分析和报告。结果将帮助患者、医生和卫生系统做出决定 如何最好地实施以家庭为基础、由患者管理的数字化疼痛治疗方案，并将提供 关于如何为正确的患者选择正确的治疗方法的建议。