May 12, 2023

Goodland native runs UKSM-Wichita research clinic for rural residents

Posted May 12, 2023 10:45 AM
Goodland native Tiffany Schwasinger-Schmidt, M.D. with a patient. Photo by University of Kansas Medical School-Wichita
Goodland native Tiffany Schwasinger-Schmidt, M.D. with a patient. Photo by University of Kansas Medical School-Wichita

KU Medical Center

WICHITA - Rural Kansans who thought they were just too far away from where medical research happens might be pleasantly surprised with the changes taking place at the Center for Clinical Research at the University of Kansas School of Medicine-Wichita (CCR).

Using telehealth, telephone and even the United States Postal Service, researchers at CCR are devising new ways to include more rural residents in their clinical trials.

“We’re really excited about our rural outreach, about breaking down barriers for people that live in rural regions,” said Tiffany Schwasinger-Schmidt, M.D., associate professor of internal medicine at the University of Kansas School of Medicine-Wichita and director of the CCR.

The CCR is a research facility on KU Medical Center’s Wichita campus, and it is one of the KU Medical Center Clinical and Translational Science Units (CTSUs) that provides services to researchers. Although it shares the same address as the Wichita campus, its separate entrance, dedicated parking and proximity to Interstate 135 allows rural residents easy access to its facility.

“Clinical trials open up potential opportunities,” Schwasinger-Schmidt said. “In a lot of the clinical trials that we do, people have tried other treatments and they haven’t been successful, or there just haven’t been a lot of treatments available. Just having the opportunity to try something — that’s a significant opportunity for patients.”

Inside the CCR are a laboratory, pharmacy and two exam rooms as well as researchers and study coordinators.  These scientists are tackling some of medicine’s toughest challenges, including Alzheimer’s disease, treatment-resistant depression and COVID-19 prevention and treatment.

Rural representation

People who live in rural areas have different environmental factors than those who live in urban or suburban areas, and those factors need to be studied in clinical trials, Schwasinger-Schmidt said.

“We have different socio-economic areas that we live in, and we have different exposures to environmental components,” she said. “We have different stressors — so many different things that interplay into our health, that define the social determinants of health.”

K. James Kallail, Ph.D., associate dean for research for KU School of Medicine-Wichita, said rural Kansans no doubt have barriers to participating in clinical trials. “These individuals usually live distant to academic hospitals and clinical researchers, yet they need representation, “ Kallail said. “Especially in new drug development, their participation is needed to provide robust data on drug effectiveness and efficacy.”

There’s a myth that rural residents don’t want to participate in scientific research, which Schwasinger-Schmidt hasn’t found to be true.

“I think there’s a misconception that people who move to rural areas are looking for more solitude,” she said. “And while there is some peacefulness and solitude out in the country, that doesn’t mean you shouldn’t have access to cutting-edge therapies. And just because you don’t choose the hustle and bustle of the city doesn’t mean that you don’t want to do your part for advancing science.”

Schwasinger-Schmidt understands those motives because she’s lived them. As a girl growing up in Goodland, Kansas, the future doctor had to spend hours in the car to access medical care.

“I’m a western Kansas girl, born and raised. And I know the challenges that people face living in those rural areas with access to health care, and especially access to clinical trials and research,” she said.

She’s also aware of the potential for perception problems when rural-centered research isn’t conducted in a rural area. “Wichita is the biggest city within Kansas, so sometimes when I talk about rural outreach, people say, ‘But you’re in the largest city in Kansas.’ But it’s the connections to rural communities that matter, and really focusing on how we can help others.”

Kent and Jo Dove, Sedgewick, have both participated in clinical trials at the Center for Clinical Research in Wichita. Photo courtesy Jo and Kent Dove. 
Kent and Jo Dove, Sedgewick, have both participated in clinical trials at the Center for Clinical Research in Wichita. Photo courtesy Jo and Kent Dove. 

Clinical trial participant Jo Dove and her husband, Kent, make bimonthly visits to the CCR from their home in rural Sedgewick, Kansas, population 1,603. The route is around one hour round-trip, but the retired couple said they don’t mind the drive.

“When you see each other every two weeks, you sit down and have conversations with (CCR personnel),” Jo Dove said. “They ask, ‘How has your week been?’ It feels like a family conversing.”

Jo has been part of multiple clinical trials studying Alzheimer’s disease, and Kent participated in a COVID-19 study in 2021. Their visits to the CCR have easily reached the triple digits. Jo said she’s on her 84th visit for this particular clinical trial involving infusions of an investigational product.

“When you live in the country, you get used to going somewhere for services, whether it be for groceries or other places to shop,” Kent explained. “To travel down here is just a reason to go out to eat afterward.”

Different strategies for outreach

The CCR has a variety of different strategies for clinical trial participants, including in-person, telehealth, and even via U.S. mail.

“We have analyzed just how many visits are needed in a face-to-face environment,” Schwasinger-Schmidt said. “And we’re considering the financial burden placed on rural participants who have to drive to Wichita, pay for transportation costs, and then maybe pay for lodging if an overnight stay is needed.”

Instead of traveling to Wichita, rural residents can participate in some clinical trials via a secure video platform. “Before the pandemic, using telehealth in clinical trials was unheard of,” Schwasinger-Schmidt said. “The participants came to our center to be seen for study visits. But the pandemic opened things up, and now we consider what we can do safely over a telemedicine platform.”

For telehealth to be an equitable solution, however, all of Kansas needs affordable, high-speed internet access, she said. “In some areas of Kansas, internet signals and cell phone signals are not always the most reliable. Solving this problem addresses the social issue of getting people better connected, not just for clinical trials but for other important opportunities.”

Tina Peck, APRN, confers with CCR site manager Trish Steele and Schwasinger-Schmidt. Courtesy photo
Tina Peck, APRN, confers with CCR site manager Trish Steele and Schwasinger-Schmidt. Courtesy photo

One recent COVID-19 study named ACTIV-6 introduced Schwasinger-Schmidt (and clinical trial participants all over the state) to the concept of “virtual” clinical trials using online forms and medication sent through the mail. Schwasinger-Schmidt led a statewide effort that mailed medications such as ivermectin to participants who met specific criteria. Follow-up was also conducted remotely.

Study coordinators tracked the participants’ daily diaries, which included when they took the medication, how they felt while taking it and how long it took COVID-19 symptoms to resolve.

“It’s a great way to be able to reach out to everyone who wants to participate and to eliminate distance barriers,” Schwasinger-Schmidt said.

Clinical trials such as the ACTIV-6 platform set the stage for future trials to use delivery via mail or courier, Schwasinger-Schmidt said. “I think there are going to be more and more opportunities to do remote work and break down barriers. These remote opportunities allow us to still take great care of people and advance medicine regardless of their physical location.”

Rural outreach for Alzheimer’s clinical trials

The Center for Clinical Research (CCR) in Wichita is currently running four different studies on Alzheimer’s disease and regularly focuses 20-25% of its clinical trials on dementia research.

Tiffany Schwasinger-Schmidt, M.D., director of the CCR, said the current studies use a mixture of in-person visits and phone calls or telehealth videoconferencing. “Participants will need to be seen in person for at least 50% of the time for our current trials,” she said.

About half (46%) of all Alzheimer’s disease clinical trial participants have identified themselves as living in rural areas.

“I have made it a priority to engage with rural communities to promote access to clinical trials research. This is especially important in the field of neurocognitive disorders, given the limited number of neurologists in the state of Kansas,” Schwasinger-Schmidt said.

Eric Vidoni, Ph.D., associate professor of neurology at the University of Kansas Alzheimer’s Disease Research Center, said that for new treatments to help as many people as possible, “our friends and family in rural and frontier Kansas need to be included.”

He explained why that diversity was important. “If a drug or treatment is difficult to produce, transport or administer, that drug may not work in a county that recently lost a trusted clinic or pharmacy” even if the drug is approved. “Making sure people in rural and frontier counties are included in trials gives us an opportunity to identify those problems early.”

Learn more about joining a clinical trial in Wichita.