The completed rollout of Epic’s Enterprise electronic medical record (EMR) this past November and the continued implementation of OnCore, Yale’s clinical research management system (CRMS), are paving the way to an integrated information technology environment that fully supports research. Each system on its own plays a critical role in Yale’s success as a leading clinical research organization. Integrating the two platforms holds even more promise; and Yale stands on the leading edge of adopting new industry standards that enable increased integration between a CRMS and an EMR.
“Yale should be very proud of its leadership in this area. The commitment to adopting new industry standards and the willingness to share lessons learned in the process will help shape the future of what such integration can look like,” said Nancy Smider, Ph.D., Research Informatics Implementation Lead for Epic Systems Corporation in Verona, Wisconsin.
The implementation of OnCore by itself has been essential to Yale’s infrastructure. Investigators have been forced in recent years to spend increasing amounts of time administering and reporting on clinical trials, which detracts from their ability to conduct actual research. “During our search for a clinical research management system, I was very mindful of selecting a system that would meet the needs of our entire research enterprise,” said Thomas Lynch, Jr., M.D., director of Yale Cancer Center. “I couldn’t be more pleased at how OnCore is helping to support researchers at the Cancer Center and across the medical campus.” OnCore now supports 90 multicenter clinical trials and almost 1,500 protocols—of which almost five hundred are investigator-initiated studies—and has generated over 17,000 case report forms.
Epic, a strong proponent of the standards defined by the nonprofit Integrating the Healthcare Enterprise (IHE) organization; and Forte Research Systems (the manufacturer of OnCore, which also supports a standards-based approach) agreed to work with Yale to help realize our vision of supporting and expanding clinical and translational research more effectively. The early phases of this integration have resulted in more efficient and effective planning for clinical studies; faster initiation of studies resulting from easier access to potential patient populations and registries; and general improvements to the research experience for study participants. To the best of our knowledge, Yale is the first institution to adopt the Clinical Research Process Content (CRPC) component, which uses IHE standards for interoperability between EMRS and specialized research systems, in an actual live environment. This adoption enables the sharing of more complex study billing definitions between OnCore and Epic.
Today, Epic populates subject demographic information in OnCore with the touch of a button, effectively eliminating duplicate data entries and the associated risk of data entry errors. Almost 6,000 subjects have been enrolled so far without the need to rekey demographic data. Information on all active studies and individual participant enrollment status is communicated from OnCore to Epic automatically and in real time, keeping this information in sync between the two systems. In addition, study billing definitions are created in OnCore and transmitted to Epic, which then uses this information to provide enhanced research billing compliance functions. YCCI has also worked with Epic and Forte to create an interface for laboratory data that eliminates the need to record lab values manually in OnCore.
YCCI’s ongoing focus includes developing opportunities for investigators to access clinical data in new ways to support their research efforts, including enabling researchers to assess more accurately whether they will be able to meet accrual requirements, or with appropriate permissions, to tap into the clinical data of over 150,000 patients currently entered in Yale’s Epic disease registries. All these changes pave the way for better outcomes-based research—an area that is expected to grow over the next few years.
Future opportunities being explored by YCCI include the ability to use Epic’s MyChart patient portal as part of direct-to-patient recruitment efforts; interfaces to improve the regulatory landscape by pushing adverse events information from Epic into OnCore; the ability to complete OnCore case report forms without leaving Epic; and patients’ ability to complete periodic assessments through MyChart for quality-of-life and other research.
Yale is breaking new ground in its initiative to connect OnCore with Epic using industry standards, and is serving as a model for other academic institutions. Although there is still work to be done, there are also many new opportunities to explore. Today, Yale is well on its way to reaching its goal of integrating health care delivery and research functions to improve the understanding of disease; improve the quality of health care; and ultimately move toward personalized medicine.
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