Practices can use EMRs to join more clinical trials
■ A column about keeping your practice in good health
By Victoria Stagg Elliott — is a longtime staff member. She covered practice management issues and wrote the "Practice Management" column from 2009 to 2013. She also covered public health and science from 2000 to 2009. Posted March 12, 2012.
During the past year, the Midwest Center for Women’s HealthCare signed up patients for research into birth control, abnormal Pap smears and treatment of overactive bladder. The single-specialty practice, which has 16 offices in the Chicago suburbs, was able to do this in part because of its electronic medical record system.
“[Research] is a revenue source,” said Michael Benson, MD, an obstetrician-gynecologist who leads these projects at Midwest. “It’s good for the patients. It’s good for society. And it’s the only way that you can move forward in terms of finding better treatments for patients.”
Nonacademic practices have long taken part in scientific study in some way, although this frequently has been awkward and time-intensive. Extracting the necessary data from paper charts has never been speedy. Digital technology and health system reform have made participation in clinical trials easier and more appealing.
The Midwest Center for Women’s Health Care, a practice of 39 physicians, five mid-level health professionals and 225 employees, earns a modest amount of extra income from these efforts, and those who run the practice hope that the work will better position it to participate in accountable care organizations and other aspects of reform.
“It’s not a huge amount of money for our organization,” said Eric Brodsky, Midwest’s director of billing and operations. “But when it comes to clinical integration and accountable care organizations, all of this data needs to be collected and analyzed. This will help us be prepared to be able to do that.”
Several EMR vendors, like Midwest’s, help practices participate in clinical trials and other types of research, sometimes at no extra charge.
But the system helps Midwest beyond linking the practice to possible research opportunities. Having an EMR aids participation itself. The EMR system helps the practice tackle several key questions that need to be answered as part of the analysis to decide whether to move forward with a project.
“We don’t think that [clinical trials] are a losing proposition for a clinician, but they have to think very carefully what the operational aspects of the trial are,” said Kevin Renahan, executive director for investigator relations with Covance, a contract research organization based in Princeton, N.J.
For example, the system can identify the number of potential research subjects and who they are in minutes. Clerks thumbing through paper charts for similar information could take hours.
The system also helps identify the most common medical issues in the practice, which suggests what research it is most likely to participate in. This is another analysis that can be carried out quickly electronically rather than manually, with many staff hours devoted to poring over paper charts.
When a research project is under way, the relevant data can be entered once and then transmitted to the appropriate parties rather than having to be written and then entered in different databases, increasing the risk of error. Compliance issues with the Health Insurance Portability and Accountability Act are handled as part of usual care and the informed consent process when patients decide whether to participate.
This means that at Midwest, work associated with research projects can be handled primarily by Dr. Benson and a nurse practitioner, who still perform their usual clinical duties. Some practices have dedicated personnel, but so far, Midwest has been able to do this without that additional expense of staff.
Although having an EMR has made participation in clinical research easier, it has not become easy.
These projects can add revenue to a practice, but they require some technical expertise and the ability to obtain patient consent ethically and avoid sampling bias.
“It can be a pretty involved process,” Dr. Benson said. “I think a healthy dose of skepticism is the first thing a practice needs. There’s a fair amount of work involved.”
Another caveat is that although a practice may want to participate in research, there may not be an appropriate project. For instance, Midwest is taking part in a small number of projects but wants to do far more.
“It’s not an overnight thing,” Benson said. “But I expect that over time we will participate in more.”
Relevant training is widely available through government agencies and other organizations. Study sponsors generally provide significant guidance to ensure that projects comply with necessary regulations.
Victoria Stagg Elliott is a longtime staff member. She covered practice management issues and wrote the "Practice Management" column from 2009 to 2013. She also covered public health and science from 2000 to 2009.