Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

在美国，每天有近100人死于处方阿片类药物过量。过度依赖 对那些患有慢性疼痛的人使用阿片类药物是导致这场危机的因素之一。疼痛，包括急性和慢性疼痛， 这是如此严重，它需要阿片类药物试图保持在可耐受的水平，是一个不断的伴侣 美国有10万人，其中大部分是非洲或西班牙裔背景，全世界还有数百万人 患有镰状细胞病(SCD)。疼痛是SCD的标志性症状，也是几乎 每年急诊科(ED)入院人数为20万人，是住院的主要原因， 据估计，美国每年的医疗费用为24亿美元。我们将进行混合类型1的有效性 360例SCD患者针刺加导引放松疗效评价实施试验 同时观察和收集三个卫生系统的执行情况：伊利诺伊大学 医院和健康科学系统，佛罗里达大学健康大学和杜克大学健康系统。每个人 为大量患有SCD的人群提供服务，使用EPIC作为他们的电子健康记录，并具有临床和 翻译科学奖(CTSA)，这将有助于加快将发现转化为改善的患者 关心。UG3一年规划阶段：第一年包括里程碑驱动的规划，以准备三个健康 为随后的务实临床试验(UH3)建立系统。在UH3实施阶段，我们的3-ARM，3- 现场随机对照试验将遵循定量智能设计。一场务实的审判，评估 适应性干预，我们的指导放松和针灸干预对患者的 特征和不断演变的疼痛状态。我们依靠综合框架进行实施研究 (CFIR)计划、执行和评估相关的实施流程。补语和补语的用法 SCD患者进行综合(CIH)治疗，以减少疼痛、阿片类药物的使用，并使自己能够更好地 应对他们的疼痛是众所周知的，但很少有研究评估这些疗法的有效性， 也没有一个还评估跨多个医疗保健系统和患者群体的实施 正如这项研究所做的那样。

Nearly 100 people die every day from a prescription opioid overdose in the United States (US). Over-reliance on opioids for these with chronic pain is one of the factors that led to this crisis. Pain, both acute and chronic, that is so severe that it requires opioids to attempt to keep to tolerable levels, is a constant companion to the 100,000 people in the United States, mostly of African or Hispanic background, and millions more worldwide living with sickle cell disease (SCD). Pain is SCD’s hallmark symptom, and the leading cause for almost 200,000 annual emergency department (ED) admissions, and is the leading cause of hospitalization, with estimated annual health care costs in the US of $2.4 billion. We will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with SCD while observing and gathering information on implementation in three health systems: University of Illinois Hospital & Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. UG3 1-year Planning Phase: Year 1 comprises milestone-driven planning to prepare the three health systems for the subsequent pragmatic clinical trial (UH3). During the UH3 Implementation Phase, our 3-arm, 3- site randomized controlled trial will follow a quantitative SMART design. A pragmatic trial that evaluates adaptive interventions where our guided relaxation and acupuncture interventions responds to patients’ characteristics and evolving pain status. We rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative (CIH) therapies by those with SCD to reduce pain, opioid use, and enable themselves to better cope with their pain is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will.