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

引导放松和针灸治疗慢性镰状细胞病疼痛的混合有效性实施试验

基本信息

批准号：
10492748
负责人：
Ardith Z Doorenbos
金额：
$ 157.38万
依托单位：
UNIVERSITY OF ILLINOIS AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-21 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10492748
关键词：
Accident and Emergency department Acupuncture Therapy Acute Address Admission activity African Age Alternative Therapies Anxiety Caring Characteristics Chronic Clinic Clinical Clinical and Translational Science Awards Collaborations Companions Complementary Health Complementary therapies Consolidated Framework for Implementation Research Data Data Collection Effectiveness Electronic Health Record Ensure Evaluation Exposure to Florida Health Health Care Costs Health Sciences Health system Healthcare Systems Hispanic Hospitalization Hospitals Hybrids Illinois Individual Insurance Insurance Coverage Integrative Medicine Integrative Therapy Intervention Medicare/Medicaid Opioid Outcome Pain Pain management Patient Care Patients Persons Pharmaceutical Preparations Phase Policies Population Pragmatic clinical trial Prescription opioid overdose Privatization Procedures Process Protocols documentation Public Health Randomized Randomized Controlled Trials Relaxation Research Safety Sickle Cell Anemia Site Sleep Speed Structure Symptoms System Testing Translations United States United States National Institutes of Health Universities adaptive intervention arm base chronic pain chronic pain management collaboratory depressive symptoms design effective therapy effectiveness evaluation effectiveness implementation study effectiveness implementation trial implementation evaluation implementation facilitators implementation process improved improved outcome information gathering opioid therapy opioid use pain catastrophizing pain reduction patient population pragmatic trial prescription opioid recruit response sex side effect treatment as usual

项目摘要

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.

在美国 (US)，每天有近 100 人死于处方阿片类药物过量。过度依赖对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，无论是急性还是慢性，这种情况非常严重，以至于需要阿片类药物来尝试将其维持在可容忍的水平，它是美国有 100,000 人，其中大部分具有非洲或西班牙裔背景，全球有数百万人患有镰状细胞病 (SCD)。疼痛是 SCD 的标志性症状，也是几乎所有疾病的主要原因每年急诊室 (ED) 入院人数为 200,000 人，是住院的主要原因，其中美国每年的医疗保健费用估计为 24 亿美元。我们将进行混合1型有效性实施试验以评估针灸和引导放松对 360 名 SCD 患者的有效性同时观察和收集三个卫生系统实施情况的信息：伊利诺伊大学医院与健康科学系统、佛罗里达大学健康系统和杜克大学健康系统。每个为大量患有 SCD 的人群提供服务，使用 EPIC 作为他们的电子健康记录，并拥有临床和转化科学奖 (CTSA)，这将有助于加速将发现转化为改善患者的情况关心。 UG3 1 年规划阶段：第 1 年包括里程碑驱动的规划，以准备三个健康后续实用临床试验（UH3）的系统。在 UH3 实施阶段，我们的 3 臂、3- 现场随机对照试验将遵循定量 SMART 设计。评估的务实试验适应性干预，我们的引导放松和针灸干预对患者的反应做出反应特征和不断变化的疼痛状态。我们依靠实施研究综合框架 (CFIR) 计划、执行和评估相关的实施流程。使用互补和 SCD 患者采用综合 (CIH) 疗法来减少疼痛、阿片类药物的使用，并使自己能够更好地应对疼痛是众所周知的，但很少有研究评估这些疗法的有效性，没有一个也评估多个医疗保健系统和患者群体的实施情况正如本研究将要进行的那样。