An integrated health care organization serving both Virginia and West Virginia teamed with the Virginia Department of Health to conduct an important COVID-19 surveillance study. Roanoke’s Carilion Clinic, a non-profit health care organization serves nearly one million Virginians and West Virginians recently accepted to offer to conduct the region’s first-of-its-kind COVID-19 Seroprevalence study, conducted to help researchers and physicians better understand how many people residing in Southwest Virginia area may be actually infected with SARS-CoV-2, the virus behind COVID-19. Thus far at the midway point of the study about 4,000 people have responded to the study’s 10-minute enrollment survey. But in regards to study completion—requiring that participants come into the clinic have blood draw– only 43% of participants have completed their commitment. At a cost of $566,309, the study is subsidized by the CARES Act funds and ends Dec. 31, 2020. The study’s lead investigator, Dr. Paul Skolnik, recently issued a request to the public to come and participate in (and complete) this important study. Carilion officials also urged that participants that haven’t completed their blood tests to please do so to help the health organization meet its commitment. This important data will offer greater insight into the prevalence of COVID-19 in this region. Importantly, that data will help direct a more efficient rollout of vaccinations targeting COVID-19.
Carilion researchers recently announced via local online news SmithMountainLake announce the need for more participants for the study. Tiffany Holland wrote that “With 22 localities in the Carilion service area eligible for participation, the health provider issued a request for more participants a the following cities and counties:”
· Allegheny County
· Bland County
· Bedford County
· Buena County
· Craig County
· Floyd County
· Henry County
· Rockbridge County
· Russell County
Participation from more rural areas within Virginia and West Virginia are lagging as is participation among Blacks and Hispanics.
In addition to the need to serve the rural communities, Dr. Skolnik commented, “Participation is critical among our minority and ethnic groups because COVID-19 has disproportionately affected them throughout the pandemic.” The physician/investigator continued, “There is personal benefit to finding out if you had the COVID-19 infection. There is no risk to our participants. All the personal information we gather is confidential and protected. The results are shared with our participants in confidence too.”
Patient/Participant Recruitment Challenges
Research teams frequently find the process of identifying sufficient numbers of study participants as a continuously challenging affair. Although in this case the study team benefited by the use of electronic health record (Epic) technology as a way to more expeditiously identify prospective participants, e.g. such as those patients that came in for COVID-19 tests, the study team also collected samples from pediatric patient visits for COVID-19 tests (only with parent or legal guardian and consent). The study team then followed up with calls to the public for participation for the study that commenced in November.
However, challenges involving patient identification and recruitment represents a frequent and ongoing theme with clinical research.
Importance of this Study
Not only will this study help health officials in southwestern Virginia identify COVID-19 infection trends and hotspots, it also supports the rollout of COVID-19 vaccines from Pfizer and Moderna. Dr. Skolnik commented, “The vaccine rollout may be helped by the information about the prevalence of previous COVID-19 infections around Virginia.” He continued, “But we need complete information from our participants. Their answers to the questions and the results of their blood tests help us to determine antibody production and prevalence. They are going to help us make decisions about how we continue to prevent COVID-19 and how we deliver the vaccines.”
The Trial Site Organization
Carilion Clinic is a not-for-profit healthcare organization based in Roanoke, VA.Through their comprehensive network of hospitals, primary and specialty physician practices and other complementary services as well as an associated medical school, the health organization collaborates to drive effective quality care to nearly 1 million people.
Carilion Clinic, according to a study authored by both Carilion and the University of Virginia Weldon Cooper Center for Public Service’s Center for Economy and Policy Studies, contributes over $3.2 billion and nearly 24,000 jobs to Virginia’s economy as recently as two years ago.
With 954,500 primary care visits per annum, the regional health system manages nearly 175,000 emergency department visits annually. They employ 732 primary physicians and over 80 specialists at over 273 practice sites. Leveraging electronic health record technology from Epic, Carilion can identify patients based on condition for specific research studies. With seven (7) hospitals in the regional network, the service area covers a large section of southwestern Virginia.
Paul Skolnik, MD, Chair of Medicine
Call to Action: If you are based in this part of Virginia or West Virginia, consider contributing to the cause against COVID-19. Reach out to the site location at [email protected].