Trial Summary

Nearly 100 people die every day in the United States from a prescription opioid overdose. This crisis is caused in part by an overreliance on opioids to treat individuals experiencing chronic pain. Acute or chronic pain is a constant companion to more than 100,000 people living with sickle cell disease in the United States and millions more worldwide. Pain is a hallmark of sickle cell disease and results in almost 200,000 annual emergency department admissions and is a leading cause of hospitalization. It is known that the use of complementary and integrative therapies to reduce pain and opioid use has the potential to enable patients with sickle cell disease to better cope with their pain, yet few studies have evaluated the effectiveness of such therapies, and none have assessed how to implement them across multiple healthcare systems and patient populations.

To address this gap, GRACE is a pragmatic trial conducted across 3 large healthcare systems that will assess the effects of guided relaxation and acupuncture treatments for people with sickle cell disease. GRACE has 3 priorities:

• Evaluate the effectiveness of guided relaxation and acupuncture to improve pain control.
• Determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics.
• Describe the processes and structures required to implement guided relaxation and acupuncture within healthcare systems.

The intervention phase involved 3 arms (guided relaxation, acupuncture, and usual care) and followed a quantitative adaptive design that responded to patients’ characteristics and evolving pain status. GRACE used the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes.

NIH Project Information