Grand Rounds June 7, 2024: The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet For A Novel Cohort Study (Russell Rothman, MD, MPP; Jason Block, MD)

Posted on by Elizabeth Mccamic

Speakers

Russell Rothman, MD, MPP
Professor, Internal Medicine, Pediatrics, & Health Policy
Senior Vice President, Population and Public Health
Director, Institute for Medicine and Public Health

Jason Block, MD
Assistant Professor, Harvard Medical School
Faculty Member, Harvard Center for Population and Development Studies
Physician, Brigham and Women’s Hospital

Keywords

CODA, PCORnet, diabetes, COVID-19, pragmatic research

Key Points

  • PCORnet has been around for 10 years and was designed to bring together health systems, clinicians and researchers as well as harnessing medical electronic data and other partners to focus on patient-centered research. The network can support real-world evidence studies, population health research, comparative effectiveness research, pragmatic research, health systems research, and more.
  • PCORnet includes 8 clinical research networks at more than 75 large health systems health systems, including academic health centers and community clinics, which gives a diverse population to recruit into clinical trials with reach across the U.S. The PCORnet sites have a common data model so it is standardized across systems.
  • The COVID-19 Diabetes Assessment (CODA) Study worked with PCORnet Front Door to rapidly identify diverse sites for the study. PCORnet Front Door is the access point for PCORnet resources and services and can support study design, connections to network collaborators, and PCORnet study designation.
  • CODA will recruit and follow a cohort of 1,600 adult and pediatric participants with recent diagnosis of Type 1 (T1D) and Type 2 (T2D) diabetes to examine the relationship between SARS-CoV-2 exposure and glycemic control, metabolic function, inflammation, cardiovascular risk, and patient-reported outcomes.
  • CODA will explore the role of genomic/social/environmental factors on glycemic control, inflammation, and metabolic function, and it will also leverage EHR data from 38 PCORnet health systems participating in the NIH RECOVER program to explore the role of COVID-19 infection on diabetes development and progression.
  • There is epidemiologic evidence that suggests increases in the incidence of T1 and T2 diabetes in both adults and children plus possible worsening of preexisting disease after COVID-19 infection. Mechanisms may include direct effects on pancreatic beta cells that produce insulin, increase in inflammation, immune dysregulation, and other metabolic changes caused by infection with SARS-CoV-2. Other factors may contribute to increased rates of diabetes and worsening of disease including social factors, environmental stressors, health disparities, and other issues.
  • The study will take place at 15 PCORnet sites across the U.S. Five sites are from PEDSnet with large children’s hospitals to help recruit pediatric participants. Participants with a new diagnosis of T1D and T2D, English and Spanish speakers, age 11 and older are eligible for the study, with an enrollment goal of 1,000 adults and 600 children at 3 levels (surveys, mixed meal tolerance test (MMTT), and SphygmoCor to assess arterial stiffness) over 24 months.
  • CODA also will integrate and leverage supplement EHR data to explore the role of COVID on diabetes development and potential remission in T2D.

 

Discussion Themes

-What are your expectations about the folks who will participate and if there are differences between the pops who will participate at the different levels. We do provide additional compensation to engage participants at different levels. Particularly with participants with T1D who are younger, families are very interested in understanding more about the diabetes. Our plans are to recruit 400 total patients (25% of total) for MMTTs and 200 total patients (12.5%) for the vascular stiffness study.

–How did you develop your patient recruitment materials? The infographic that we developed to explain the different levels of participation was created by someone on our team with experience in health literacy. We tried designing materials at a sixth grade reading level, with white space on the page to help with the recruitment and consent process and increase participant understanding.

 

Tags

#pctGR, @Collaboratory1