Trial Summary

Acute or chronic pain is a constant companion to more than 100,000 people living with sickle cell disease in the U.S. 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 there are few studies that have evaluated the effectiveness of such therapies, and none have assessed how to implement them across multiple health care systems.

To address this gap, the Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) is a pragmatic trial conducted across three large health systems that will assess the effects of guided relaxation and acupuncture treatments for people with sickle cell disease. GRACE has three 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 planning phase was milestone-driven to prepare the participating health systems for implementation. The currently ongoing intervention phase will involve three arms (guided relaxation versus acupuncture versus usual care) and will follow a quantitative adaptive design that responds to patients’ characteristics and evolving pain status. GRACE will use the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes.

NIH Project Information