Researchers increasingly turn to electronic medical records (EMR) to encourage participation in clinical trials. Few studies have methodically and systematically compared the use of EMR with more traditional patient recruitment strategies to measure impact and effectiveness. Some researchers fret that over-dependence on technology could adversely impact diverse participation. Now a group of researchers, led by Stephen Juraschek, MD, PhD, Assistant Professor at Beth Israel Deaconess Medical Center (BIDMC), and Hailey Miller, RN, PhD, Postdoctoral Associate at Duke University School of Nursing, compared four electronic-based recruitment methods and four traditional patient recruitment approaches to investigate how differing strategies can possibly impact enrollment of groups deemed “under-represented in the medical literature.” Their research findings validated their hypothesis that over-dependence on EMRs can lead to less diverse trials, not more.
With the results recently published in the journal Clinical Trials, a major premise underlying this study, that Black Americans are underrepresented in clinical trials and that by identifying such patients with relevant conditions in EMRs, and by pairing them with appropriate research, trials can become more diversified. The investigators discovered that EMRs have valuable information but their previous research was validated that whites more commonly interface with health systems via electronic patient portals while a majority of Black participants engage via traditional mail.
The study team employed a number of direct recruitment approaches, both digital and traditional to identify adults with gout for a clinical trial investigating the links between diet and the condition. By using EMR records to identify possible enrollees, the team messaged them via secure patient portals. The team also used more traditional approaches, such as community mailings and advertisements both in newspapers and on social media.
The researchers not only calculated response but also cost efficacy and the demographic attributes of the ultimate study enrollees. Interestingly, they uncovered differences in how the different demographics—in this case white and Black adults—enroll in a study.
First, they found that although they could identify two-thirds of the Blacks participants via the electronic medical record, it turned out they didn’t have an active patient portal. That means the health system made such a portal available to the health consumer but they found no interest in taking the time to register online and actually use the online tool. Rather, these Black enrollees actually learned of the study via a brochure sent in the mail. Black participants otherwise wouldn’t have even known of the trial: one that was relevant to their specific health condition.
The authors of this study had conducted previous research which found that whites disproportionately use patient portals.
Premise Moving Forward
Although the use of electronic medical records can boost enrollment generally in a clinical trial it can also perpetuate predominantly white participation. The overdependence on electronic recruitment can perpetuate the underrepresentation of Black patients in clinical research.
A hybrid strategy is required, using EMRs with follow up via postal mailings to possible enrollees, to actually yield the best results based on this research. The researchers suggest this hybrid approach is cost effective and serves to increase participation of underrepresented groups, such as Blacks and women.
TrialSite News commissioned an “African American Clinical Research Disparity Survey,” which involved responses from about 100 African Americans from southeast Texas. The findings were informative. There is a general tendency with underrepresented groups, whether African Americans, Latinos, Native Americans, women or certain white demographic cohorts, to not trust pharmaceutical companies, various government agencies and even large health systems. To encourage and in fact realize more engagement with research necessitates trust.
Stephen Juraschek, MD, PhD, Assistant Professor at Beth Israel Deaconess Medical Center (BIDMC)
Hailey Miller, RN, PhD, Postdoctoral Associate at Duke University School of Nursing
Call to Action: For other study authors, see link to source.