An important advantage of embedding pragmatic clinical trials within health care systems is the availability of detailed clinical data on potential participants during trial design. These data can be used to determine eligibility criteria, predict changes in participant characteristics over time, and inform sample size calculations and other design features.
Investigators from the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Demonstration Project, recently shared their experiences with using electronic health record data on patients in the participating health systems to inform trial design. The article was published in Clinical Trials.
SPOT was designed to compare the effect of 2 outreach interventions and usual care on the rate of fatal and nonfatal suicide attempts in 3 large health care delivery systems. The investigators used historical data from the electronic health records of the participating health systems to select eligibility requirements, estimate the distribution of patient characteristics during the trial, and calculate statistical power and sample size. Their experiences offer lessons for others who are designing pragmatic trials embedded in health systems with automated data sources.
SPOT was supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and received logistical and technical support from the NIH Collaboratory Coordinating Center. Download a study snapshot of SPOT, and learn more about the NIH Collaboratory Demonstration Projects.