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.

项目摘要 COVID-19大流行以不同的方式影响了每个人。适用于美国农村的人们 慢性疾病，尤其是那些经历疼痛的人，大流行不仅会恶化疼痛，而且还可以 触发焦虑，抑郁，睡眠麻烦和使用物质。这种心理困扰因 身体和社会隔离，害怕寻求面对面的访问以及在期间获得临床护理的能力 大流行。医生和卫生系统伸出的一种方式是通过视频访问，患者及其他们的 提供商通过互联网在线沟通。但是，视频访问仍然有限制。因此，我们可以帮助 用其他技术支持他们。除了视频访问之外，还有一些家庭计划 管理自己以帮助控制痛苦。这些经过验证的计划可以克服人员缺口，是 长距离使用以触及世界上的任何人，可以在患者的时间和地点使用 选择。 在这项研究中，我们将比较患者可以使用的两个可用的，循证的数字治疗计划 在家里。目的是查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个做出反应 比另一个更多。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。该程序 提供为期8周的家庭课程，以学习和练习可以帮助控制疼痛的新技能。该程序 在手机或计算机上的标准屏幕上运行。第二个程序也是一个经过验证的8周计划， 但是它使用一种称为虚拟现实或VR的技术。 VR涉及戴着专门的护目镜，创建一个 在3D世界中的感觉。证据表明，虚拟世界可以帮助人们学习和保留新技能 这有助于减轻疼痛。 该研究将招募来自加利福尼亚州，路易斯安那州和阿拉巴马州农村社区的300人，然后随机分组 他们进入2D或3D程序。然后，我们将关注患者8周，并测量他们的疼痛 水平。我们还将测量痛苦的迹象，包括与冠状病毒有关的焦虑，并测量 用于疼痛的药物，例如阿片类药物，以及疼痛对整体生活质量的影响。为了进行研究， 我们将要求患者定期完成在线简短调查，并允许研究团队 从电子健康记录中收集信息。我们开发了这项研究，与患者合作伙伴合作 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，分析和报告。结果将帮助患者，医生和卫生系统决定 如何最好地管理基于家庭的，患者管理的，用于痛苦的数字治疗计划，并将提供 建议如何为合适的患者选择正确的治疗方法。