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.
