Defining usual care in clinical trials

Pragmatic trials occur within the complexity of real-world care delivery, and when effective, contribute to more rapid translation into practice because of their greater generalizability. Research with older adults is complex when participants have chronic conditions and multiple comorbidities. Often pragmatic trials introduce a novel intervention and try to determine whether it offers a benefit beyond the usual or routine care provided. Researchers commonly focus attention on describing the intervention, yet the comparator condition of usual or routine care can be anything but standard, reducing the effect size of the intervention and introducing threats to the overall validity of the study. The current article describes clinical trial guidelines, then illustrates the complexity of characterizing usual care for interventions ad-dressing type 2 diabetes. The authors provide recommendations for improving description of usual care and discuss implications for gerontological nursing research.