EHRs open opportunities for clinical trials, research participation

Mark G. Weiner, MD, FACP, FACMI, needed patients to participate in a clinical study exploring whether 81 milligrams of aspirin would be a better dosage than 325 milligrams to prevent a second heart attack.

So Weiner, a primary care physician at Temple General Internal Medicine Associates in Philadelphia, turned to his electronic health record (EHR) system and wrote a computer query to identify the patients who met the specific criteria for the aspirin study, called “Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness” (ADAPTABLE).

EHRs are making it easier for physicians to identify patients for clinical trials and share data that could be used by researchers in large-scale population health studies.

“There increasingly have been more and more opportunities to use [EHRs] for clinical trials, and those opportunities have increasingly gotten more and more sophisticated,” said Peter J. Embi, MD, MS, president and CEO of the Regenstrief Institute, an informatics and healthcare research organization based in Indianapolis.

Researchers can use and analyze data contained in EHRs to conduct wide-scale population health-type studies, with computer programs segregating data based on study criteria, such as patient gender, age, health conditions, current medications and the like, Embi said.

That’s a passive use of the data, Embi said, noting that HIPAA as well as other regulatory and institutional privacy regulations restrict the extent to which de-identified data can be used.

But EHRs also allow doctors to actively engage and recruit patients to participate in research, Embi said, pointing to computer functions that can be added to EHRs alerting physicians about research opportunities.

Next: Overcoming challenges

Identifying, overcoming challenges

Embi explained that clinical trial alerts can be added to most EHR systems just as any other customized functions would be: with computing coding. The EHR also needs to be integrated with systems containing information on open research projects, which he acknowledged is more likely to happen when physicians are part of a larger medical institution.

“It’s a type of decision support but instead of clinical decision support, it’s research decision support,” he said.

Challenges remain, however.

“The issue is not necessarily the technology but the workflow issues within clinical care,” Weiner said.

He pointed out that doctors working on research projects must find the time or staff to analyze EHR data – a requirement some will find difficult to meet. Similarly, doctors who want to let individual patients know about trials might not have the additional time during office visits or, indeed, in the course of a routine day that would be needed to present and discuss such topics.

But Embi noted the growing opportunities of integrating a clinical trial alert with a doctor’s EHR and his or her patient portal, allowing notices about research to go directly to patients via the portal.

“That kind of thing happens more and more,” Embi said. He added that such direct notices informing patients of opportunities and how they can learn more means that doctors aren’t using precious time during medical visits to discuss the topic with those who might not be interested. “I expect we’ll see more of that; it will be more common in time.”