The GRACE trial, an NIH Collaboratory Trial, is studying real-world implementation of nonpharmacologic pain management strategies for patients with sickle cell disease. Dr. Robert Molokie, a GRACE co–principal investigator, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

One innovation the GRACE trial is bringing to the NIH Collaboratory’s portfolio of pragmatic trials is its use of a sequential, multiple-assignment, randomized trial (SMART) design. In this adaptive approach, patients are randomly assigned to treatment groups, and those who do not respond to the treatment undergo a secondary randomization to either continue with the initial intervention or switch to the other group.

The GRACE trial is studying acupuncture and guided relaxation with the goals of reducing pain and reducing patients’ reliance on opioid medication.

Using a pragmatic, adaptive design, Molokie said, “I think we will get the most realistic findings of how these therapeutic interventions work, whereas in more classic trials they’re going to end up with such a group of selected patients that it may not be as generalizable as a pragmatic clinical trial.” Molokie is a clinical associate professor of medicine at the University of Illinois Chicago.

GRACE is supported by the NIH through the NIH HEAL Initiative under a grant from the National Center for Complementary and Integrative Health and receives logistical and technical support from the PRISM Resource Coordinating Center.