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: 10242572
• 负责人: Brennan Spiegel
• 金额: $ 106.31万
• 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/10242572
• 关键词: 3-Dimensional; 3D virtual reality; 3D world; Address; Affect; Alabama; Algorithms; American; Anxiety; Authorization documentation; Behavior Therapy; COVID-19; 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.

项目摘要 COVID-19疫情以不同方式影响每个人。对于来自美国农村的人来说， 慢性疾病，特别是那些经历疼痛的人，大流行不仅会加重疼痛，而且还会 引发焦虑抑郁失眠和吸毒这种心理痛苦加剧了 身体和社会隔离，害怕寻求亲自访问，以及在治疗期间获得临床护理的能力下降 大流行病医生和卫生系统接触的一种方式是视频访问，患者和他们的家人可以通过视频访问。 供应商通过互联网在线沟通。然而，视频访问仍然有局限性。因此，我们可以帮助 用其他技术支持他们。除了视频访问，还有一些基于家庭的计划，患者可以 管理自己以帮助管理他们的疼痛。这些经过验证的计划可以克服人员短缺， 可以远距离接触世界上的任何人，并且可以在患者的时间和地点使用。 选择 在这项研究中，我们将比较两个可用的，基于证据的，患者可以使用的数字治疗方案 在家里目的是看看一种方法是否比另一种方法更好，以及某些患者是否对一种方法有反应。 比另一个。第一个程序是一个可以在任何智能手机或电脑上运行的应用程序。程序 提供为期8周的家庭课程，学习和练习有助于管理疼痛的新技能。程序 在手机或电脑的标准屏幕上运行。第二个项目也是一个经过验证的8周项目， 但它使用了一种叫做虚拟现实的技术，简称VR。VR涉及佩戴专门的护目镜， 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。 帮助减轻疼痛。 这项研究将从加州、路易斯安那和亚拉巴马的农村社区招募300人， 将它们转换成2D或3D程序。然后我们将对患者进行为期8周的随访， 程度.我们还将测量痛苦的迹象，包括与冠状病毒有关的焦虑，沿着测量 用于疼痛的药物，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 从电子健康记录中收集信息。我们与患者合作伙伴一起开展了这项研究， 美国慢性疼痛协会（ACPA），他们将在整个研究团队的一部分， 研究的实施、分析和报告。研究结果将帮助患者、医生和卫生系统做出决定。 如何最好地管理家庭、患者管理的数字疼痛治疗计划，并将提供 建议如何为正确的患者选择正确的治疗方法。