A SMART design to optimize treatment strategies for patient and family caregiver outcomes

Sequential multiple randomization trial (SMART) designs are experimental designs used to identify treatment strategies that maximize targeted health outcomes. SMART designs are receiving greater attention in nursing and other health disciplines to develop multicomponent interventions that are tailored to the patient's (or family caregiver's) needs and preferences. A SMART design resembles a traditional randomized controlled trial (RCT) design in that it scientifically examines intervention effects with randomization. However, the two designs address very different research inquiries. In this article, we compare traditional RCT designs and SMART designs, describe the adaptive treatment framework that underlies SMART designs and key features of SMART designs, and illustrate the application of a SMART design to develop an adaptive palliative care treatment to improve patient and caregiver outcomes.