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

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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.