NEW YORK – Four academic medical centers have joined forces to attract more participants in the Midwest, particularly from rural communities, to the US National Institutes of Health's All of Us Research Program.
The All of Us program formally began recruiting participants in 2018, after a short beta phase, as an effort to collect genetic, medical, and environmental health data from more than 1 million people in the US. The program's goal is to create a massive database of diverse and anonymized information for precision medicine research, though there are also plans to share research-grade results from genomic tests as well. In December, for example, All of Us began offering disease risk and pharmacogenetic test results to more than 155,000 participants who had shared blood samples with the program.
The latest Midwestern effort, dubbed the Heartland Consortium, is a collaboration among medical centers at the University of Kansas, University of Iowa, University of Missouri, and University of Nebraska and is the first All of Us consortium dedicated to engaging patients in these regions. The four organizations submitted a recruitment proposal to All of Us, and the NIH approved the Heartland Consortium last month. All four of the institutes are new participants in the All of Us program.
Before these four institutes joined, there were a few All of Us enrollment sites already in the Midwest, such as Rush University Medical Center in Chicago and Henry Ford Health System in Detroit. But the Heartland Consortium will specifically focus on enrolling patients in the Midwest's rural regions, a historically underrepresented population in clinical trials.
Rural patients, when compared to those in urban areas, are more likely to die from heart disease, cancer, and unintentional injuries, such as from motor vehicle crashes, according to the Centers for Disease Control and Prevention. That's in part due to distance from healthcare facilities and higher rates of obesity and cigarette smoking, among other lifestyle factors.
The four states "really filled in a geographic gap that we had identified," said Holly Garriock, chief cohort development officer at All of Us. "Rural populations come with a unique set of environmental exposures and different health challenges. … Data from participants who live in rural areas will help elucidate the impact of those environmental exposures."
The All of Us program initially kicked off with enrollment sites at many large academic medical centers, which tend to be in urban regions. All of Us has already launched some programs to address its limited presence outside of big cities, such as its mobile asset program, in which vehicles travel across the country to recruit participants.
However, while useful, mobile units are not the same as a standing program that establishes the presence of All of Us in a region long term, Garriock said.
"That's one of the reasons we're so excited about it," she said of the Heartland Consortium. "It's going to be easier for [patients in these areas] to participate in the program."
Racial and ethnic minorities in rural areas are especially underrepresented in research, Garriock added. Having a physical presence in these communities through the Heartland Consortium, she said, "helps increase the diversity of the data [and] helps round out and provide a more robust picture of the participants … reflecting the diversity of those who live in the US."
The Heartland Consortium, which is being led by the University of Kansas Medical Center, was awarded $6.3 million in initial funding for the research effort, with an opportunity to renew the award annually for four years. The consortium's principal investigator is Akinlolu Ojo, executive dean of the University of Kansas School of Medicine.
KUMC did not make an executive available for interview.
The consortium's goal is to enroll at least 6,000 participants in the Midwest in its first year. Half of that cohort, researchers hope, will include racial and ethnic groups historically underrepresented in biomedical research.
"We're still in the process of planning," said Alejandro Comellas, principal investigator at the University of Iowa and director of the clinical research unit at the university's Institute for Clinical and Translational Science. As a pulmonologist, he said he's especially interested in seeing what data from All of Us can illuminate about lung health.
As a first step, Comellas and colleagues will recruit patients from rural areas who travel to receive care at UI Hospitals & Clinics in Iowa City. From there, the team is building strategies to connect with participants in their own communities, such as by partnering with local primary-care clinics, other healthcare providers, and community organizations.
Investigators also plan to host informational events in various locations across the state, build awareness about All of Us, and answer questions from potential participants.
Those forums could take place in schools, churches, and other community gathering places, Comellas noted. He added that he and another program coordinator speak Spanish, a skill they expect will be useful when recruiting participants of Hispanic and Latino heritage, who might feel more comfortable asking questions or raising concerns in Spanish.
"Instead of waiting for participants to come to us, we want to get to them," he said.