PCORnet® Resources to Power Study Exploring the Relationship Between COVID-19 and Diabetes

Posted on August 3, 2023November 14, 2023 by Jodi Snare

A large new study will use PCORnet® to explore the relationship between COVID-19 and diabetes with the goal of guiding future treatment interventions and public health approaches. Vanderbilt University Medical Center (VUMC) received a four-year, $28 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, this week to support this research.

The COVID-19 and Diabetes Assessment (CODA) Study will use PCORnet and the TID Exchange, a research network of diabetes centers, to identify and recruit 1,600 participants who either have a known COVID-19 infection within the past 90 days and have also been diagnosed with diabetes during that period, or have a recent diabetes diagnosis and no known COVID-19 infection in the past year. The study will compare and follow the two groups for two years.

With the ability to engage with hundreds of healthcare sites and access to electronic health record data from more than 30 million patients annually, PCORnet resources are critical to ensuring the CODA Study captures a broad and diverse representation of patients. In alignment with the patient-centered focus of PCORnet® Network Partners, the study will also answer important questions patients are asking about the link between diabetes and COVID-19. Namely, to what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes? The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

“This study will greatly expand our knowledge about the relationship between COVID-19 and diabetes and will also provide us novel information about what factors influence the early course of diabetes in children and adults with type 1 or type 2 diabetes,” said principal investigator and project leader Russell Rothman, MD, MPP, of VUMC and Principal Investigator of the STAR Clinical Research Network.

Rothman will co-lead the CODA Study alongside Alvin C. Powers, MD, of Vanderbilt University; Jonathan Schildcrout, PhD, of Vanderbilt University; and Jason Block, MD, MPH, of the Harvard Pilgrim Health Care Institute. Recruitment will begin soon.

Which of the Two Newer Classes of Diabetes Drugs is Better? Patients and PCORnet® Will Guide Answers

Posted on August 29, 2022November 14, 2023 by Jodi Snare

Two newer classes of type 2 diabetes medications have the potential to transform the way people manage the condition that currently impacts more than 32 million Americans. Recent studies have shown that sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) not only control blood sugar, but may also reduce risk of heart attack, stroke, hospitalization for heart failure, and death due to cardiovascular causes in those with established cardiovascular disease and those at high risk. These events are the most common cause of disability and death in patients with type 2 diabetes. The development of SGLT2i and GLP-1 RA medications represent a tremendous breakthrough. But questions remain. Which is better? And, perhaps even more intriguing, might these medicines work even better in combination?

PRECIDENTD (PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes) is a study combining the power of PCORnet, the National Patient-Centered Clinical Research Network, and patient insights to find out. The study, which is funded by the Patient-Centered Outcomes Research Institute, plans to recruit 9,000 adults with type 2 diabetes and with or at high risk for heart disease via eight PCORnet sites to be randomly assigned treatment with an SGLT2i, a GLP-1 RA, or both. These patients will be followed by the study team for an average of nearly four years to determine which medication approach is most effective at reducing major health events, such as heart attack, stroke, kidney problems, and death.

“Of the 32 million Americans living with type 2 diabetes, more than 20 million also have, or are at high risk for, heart disease,” said Brendan Everett, principal investigator for PRECIDENTD. “Two newer classes of drugs that effectively treat both conditions concurrently represent a huge advance in diabetes care that’s no less significant than the introduction of statins for heart health in 1991. But no study has compared the classes head-to-head to guide patients on which one is better, and in what circumstances. Those are the questions PRECIDENTD hopes to answer.”

Breaking the ‘curse of knowledge’ is key, says patient partner

The research team knows it can’t deliver answers on its own. Encouraging patients to participate in a randomized trial is always a challenge. To understand and overcome potential obstacles to participation, PRECIDENTD established a patient-centered advisory board comprised of people with diabetes to share their experience and serve as influencers for patients participating in the study.

One of those patient influencers, Ed Simeone, says reaching diabetes patients effectively comes down to breaking the “curse of knowledge,” or the assumption that everyone in the room shares your knowledge and perspective.

“When study materials are packed with technical jargon, they aren’t educational or motivating to the layperson,” said Ed. “We need to transcend that jargon and help patients understand that what sits before them is an opportunity to have a remarkable impact on diabetes care. No diabetes patient should suffer a stroke simply because the potential benefits of the new treatments available weren’t clear.”

Ed sits in regular Zoom calls along with five other patients, the study principal investigator, and medical professionals spanning endocrinology, cardiology and more, to explain what goals and health outcomes are important to the diabetes community. Together, the advisory board develops tactics to ensure the study team works with all stakeholders and enrolls participants from racial and ethnic groups with high diabetes prevalence, many of which have also historically been excluded from diabetes research. Patient partners were pivotal in designing PRECIDENTD’s endpoints and engagement materials; when the study concludes, they will play an important role in sharing results, too, ensuring that the findings are integrated into usual care and make sense to frontline providers and their patients.

“Other studies I’ve participated in took blood and moved on,” said Ed. “As an advisory board member, I see my advice come to life. They are thirsty for our perspective and bring a humility that, frankly, could serve all future research.”

The PRECIDENTD study is currently setting up contracts with enrolling sites through PCORnet. Results are expected in 2028, which will help patients, their families, and their healthcare providers decide which type of diabetes medication is best for their specific combination of medical conditions, preferences, and goals.

PCORnet is Delivering Important COVID-19 Answers

Posted on February 11, 2021November 14, 2023 by Jodi Snare

With access to coordinated heath data from more than 70 million people across the United States, PCORnet®, the National Patient-Centered Clinical Research Network, is a key resource in the fight against COVID-19. To maximize its utility, the Patient-Centered Outcomes Research Institute (PCORI) offered enhancement funding for nine existing PCORnet-enabled research studies. The idea behind these enhancement awards is to leverage existing infrastructure from PCORI-funded research to more efficiently expand understanding of COVID-19 and address this public health crisis.

One of many lessons learned from the COVID-19 pandemic is that good public health decisions in times of crisis require fast analysis of diverse patient data. While many healthcare organizations across the U.S. have the capacity to use their electronic health records (EHRs) and claims data as tools for horizon-scanning and disease surveillance, few offer the infrastructure to support the large-scale integration needed in the pandemic. The coordinated, interoperable infrastructure of PCORnet supports that needed speed and efficiency.

Following are a few snapshots of how PCORI-funded enhancement awards are supporting the use of PCORnet to combat the pandemic:

The Identifying and Predicting Patients with Preventable High Utilization project initially set out to use PCORnet to better understand and support people who frequently visit health care systems. With a COVID-19 enhancement award from PCORI, the research team will use the project’s existing infrastructure to develop prediction models to plan for resource needs and improve outcomes for patients hospitalized with COVID-19.
Variation in Case Management Programs and Their Effectiveness in Managing High-Risk Patients for Medicare ACOs, a project using PCORnet resources to improve case management programs in health systems, is expanding its scope to understand how the pandemic-driven shift to telehealth is affecting care and health outcomes for older patients with multiple chronic health problems.
Comparing Ways for Patients and Clinics to Improve Blood Pressure Control seeks to monitor how well clinics and patients are controlling blood pressure. With its enhancement award, it will use the same PCORnet-enabled cohort of patients to examine how taking different types of blood pressure medicines affects patients’ risk for contracting COVID-19 and severity of infection.
As patients with type 2 diabetes may have a higher risk of severe COVID-19 infections, the project team for Comparing Medicines for Treating Type 2 Diabetes among Patients with Chronic Kidney Disease is using its established data resources enabled by PCORnet to look at whether people with type 2 diabetes have a higher risk of COVID-19-related hospital stays. The team is also comparing rates of COVID-19 hospital stays for people who take different diabetes medicines.
Improving Methods for Extracting Data from Clinicians’ Notes in Electronic Health Records is working to create better methods for obtaining data from PCORnet-accessible EHR notes using natural language processing, or NLP. With NLP, computer programs interpret written language and make it easier to sort and study. With its enhancement award, the project team will use that same NLP technology to examine unstructured clinician notes for COVID-19 patients in an effort to glean new insights that may not be captured in a structured EHR record.
Understanding How Health Policy Affects Weight Loss Counseling and Diabetes Care set out to use PCORnet data resources to understand how the Affordable Care Act’s policy for insurance companies to pay for obesity screening and counseling affects the health of people with, or at risk for, diabetes. Now, it has expanded its scope to better understand outcomes related to the transition to virtual visits for patients with, or at high risk of, diabetes before, during, and after COVID-19.
An established PCORnet-enabled study was working to answer the question: Does Paying Doctors to Virtually Provide Chronic Care Management Improve Health for People with Diabetes Who Have Medicare Coverage? PCORI’s enhancement award is now allowing the team to also look at COVID-19 outcomes for people with type 2 diabetes who have at least one additional chronic disease and are covered by Medicare.
The scope of the Comparing Two Ways to Promote Healthy Weight Gain and Prevent Obesity in Early Childhood project expanded with a COVID-19 enhancement award. Now, the team is also using PCORnet to look at the impact of COVID-19 on families in the study who are participating in the Greenlight and Greenlight Plus programs, two interventions to support parents with low health literacy.

For more information about PCORI’s enhancement awards for COVID-19 research, check out the PCORI funding website.

PaTH: How EHR Data is Collected and Protected via a Chocolate-Making Analogy

Posted on June 2, 2017November 9, 2023 by Jodi Snare

The PaTH Clinical Research Network (CRN) developed this guide to explain how electronic health record (EHR) data is captured, protected, and utilized for research purposes via a chocolate-making analogy.

Access the resource here.

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