PCORnet®, the National Patient-Centered Clinical Research Network, is helping a research team to better understand how gaps in care impact the experience of adults with congenital heart disease, or CHD. The CHI-RON study, which stands for Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult-Centered Care, is combining clinical and claims data insights from PCORnet with patient-reported data to help guide health care providers in how best to care for this population, not only at the point of diagnosis, but also throughout their lives.
“Many patients with CHD are diagnosed and treated as children, but it is important to remember that treatment isn’t a cure,” said Anitha John, co-principal investigator of the study. “CHD patients should continue care throughout adulthood to catch any serious cardiac issues early enough to support a positive prognosis.”
But achieving ongoing CHD care can be tricky. Because these are rare diseases, many patients fall out of care simply because there are a very small subset of providers—less than 500 across the country—who are board certified to care for these patients in adulthood. There’s also little data on the outcomes of patients who lapse in care, leaving adult CHD patients unsure of how their journey might unfold.
A holistic look at the CHD journey across three data sources
The CHI-RON study is the first of its kind to fill in these knowledge gaps by exploring three distinct types of data at once: patient-reported outcomes, claims, and electronic health records, or EHRs.
For patient-reported insights, the project is leveraging the first patient-powered registry for adults with CHD—the Congenital Heart Initiative. Patients who are recruited for this research participate via enrollment in the registry, which allows researchers to ask patients directly about health, wellness and any specific barriers to care. The effort is led by Children’s National Hospital and Louisiana Public Health Institute.
But patient-reported outcomes alone aren’t enough to fully understand the big picture of the CHD journey. That’s why the researchers are using PCORnet resources to add insights from EHR data spanning 14 participating research sites and 3,000 demographically diverse individuals. With health records for 66 million patients available for observational studies, PCORnet provides vast scale to power research on rare conditions affecting even small numbers of people.
In partnership with two claims data partners, HealthCore and CVS Health, researchers are using PCORnet to add a third layer of insights from administrative claims, which provide information on doctors’ visits, bills, insurance information and more. Existing relationships were leveraged to connect with the claims partners directly.
“PCORnet is a fantastic resource to help us fully understand the impact of gaps in CHD care,” said Tom Carton, co-principal investigator of CHI-RON. “It is essentially turbo-charging our patient-reported data with two additional layers of insights from claims and EHRs, unlocking answers that would be impossible to achieve in isolation.”
Patient-centered study design
Like all research designated as PCORnet Studies, CHI-RON is designed to put patient needs front and center. Patients sit on the study’s multi-stakeholder advisory board, adding vocal input to its metrics, endpoints and design. The partnership with the Adult Congenital Heart Association (ACHA) has also allowed the team to provide participants with much-needed resources on their underlying cardiac condition. More importantly, the ACHA collaboration has provided participants with the opportunity to interact with other patients—a key request by many of the CHI participants.
Patients also provided input into the study’s recruitment materials, sharing insights on what strategies would and wouldn’t work across the CHD community. Even the study’s name was chosen by patients, who thought the reference to Homer’s The Iliad was fitting given the character Chiron’s ability to turn wounds into healing.
“While other CHD registries exist, they are provider-based and not patient-powered,” said John. “CHI-RON’s registry is driving thousands of organic patient responses to support our research, while also giving patients living with CHD a community in which they no longer feel alone.”
The study team hopes this three-year study will empower CHD patients by establishing a system to study different care protocols and interventions aimed at reducing gaps in care.