An issue that continues to plague academic medical centers is the lack of interoperability between electronic health record systems and specialized clinical trial management software. Without interoperability, teams running trials often have to double-enter data into the two systems.
“Academic medical centers require both clinical trials management software and EHRs. One system can’t do both things, so the bidirectional flow of data between them is the holy grail,” says Srini Kalluri, founder, president, CEO & chief customer officer of Forte Research Systems, a Madison, Wis., developer of clinical trial management software.
Tesheia Johnson, chief operating officer at the Yale Center for Clinical Investigation (YCCI) at the Yale School of Medicine, has worked with Forte on an interface between its OnCore system and Yale’s implementation of Epic. Launched in 2006, YCCI was created specifically to support and facilitate clinical and translational research and training across the entire medical campus.
“The regulatory and administrative burden of clinical trials management is so great,” Johnson says. “We knew we wanted better integration with limited redundant data entry, and it was at a meeting here at Yale in January 2012 that we sat in a room with Forte and Epic executives and talked about how painful a problem this was for us and how it created extra work. And in academic medical centers, our budgets are tightening, so anywhere we can find synergies we need to pursue them. We are still moving down that path.”
Yale started with billing first because as with most academic medical centers that is a big compliance concern. “We did have a dedicated research billing system previously that wasn’t integrated with anything. That was like doing triple data entry,” Johnson says.
Since the interface went live in February 2013, procedure billing designations are indicated at the protocol level within OnCore, which then provides this information to the EHR for use in determining how to route charges. (OnCore interfaces with Epic via the industry standard Integrating the Healthcare Enterprise (IHE) Retrieve Process for Execution (RPE) profile.)
OnCore also sends protocol and subject information to Epic. The subject status is communicated from OnCore to the EMR, so a patient can be flagged within the EHR to indicate that he or she is a research participant. (The interface uses the IHE Clinical Research Process Content (CRPC) profile, a supplement to the RPE profile, providing study definition content using the HL7 Study Design Structured Document.)
“The potential value is incredible,” Johnson says. “Clinicians can now identify in the EHR which patients are in a study and they study’s parameters, so that is a huge leap forward. We can also alert clinicians to new trial opportunities.”
Kallurisays interest is widespread in more tightly integrating clinical trial management systems and the EHR. “In the last two to three years there has been important work by CDISC (Clinical Data Interchange Standards Consortium) and other groups on standards development in this area, although they started from ground zero and those standards are just beginning to evolve.,” he says. There is also interest from EHR vendors, and not just Epic, on these types of interfaces, he adds. “There is a real groundswell. We are in discussions with several customers who use Epic, and some customers using other systems are reaching out to their vendors to express their interest in this type of interface.”
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