CHI-RON

National Studies Show How the PCORnet® Infrastructure Supports Meaningful Engagement

Posted on by Jodi Snare

Meaningful engagement is central to patient-centered health research but implementing it at a national scale can pose challenges—from recruiting participants and sustaining involvement, to ensuring patient perspectives shape research questions and outcomes. Research teams can use resources available through PCORnet®, a national patient-centered health research network, to enable large-scale research. A recent supplement in the journal Medical Care highlights how two PCORnet® Study teams leveraged the PCORnet infrastructure to improve recruitment and retention efforts, and to embed engagement throughout the research lifecycle.

 

The CHI-RON Study: Improving Representation Through Data-Driven Recruitment

Working with 12 sites across four PCORnet® Clinical Research Networks, the CHI-RON Study examined the effects of gaps in recommended care for individuals with adult congenital heart disease (ACHD).

CHI-RON, or Congenital Heart Initiative–Redefining Outcomes and Navigation to adult-centered care, is one of more than 60 PCORnet® Studies answering critical patient-centered questions on heart disease, metabolic conditions, obesity and more.

 

CHI-RON patient partners and researchers work alongside the community

 

Repurposed from article, available here online.

CHI-RON included two patients as co-investigators, a role that allows embedded patient input at every stage.  Additional patient partners also provided input on the study design, advised on challenges, designed recruitment videos, facilitated community connections, and created social media content.

When asked how they felt about their contributions to the research, the patient partners reported strong feelings of meaningfulness and contribution (measured using the validated Patient Engagement in Research Scale; PEIRS22).

“Building a truly patient-centered research team in which patient partners were included at every step enabled us to create a study that drew people in,” said Ruth Phillippi, MS, patient co-investigator and program lead at the Washington Adult Congenital Heart Program. “Not just to the registry but to a distinct and engaged research coalition that values our opinions and lived experiences.”

The CHI-RON study team also used the PCORnet® Common Data Model to help increase diversity in the trial.

Recruiting participants that reflect real-world populations has been a persistent challenge in ACHD research. Individuals who are younger, male or not actively engaged in clinical care have historically been underrepresented, limiting generalizability.

To address this, the CHI-RON study team developed a systematic recruitment approach. Patient, clinician, and researcher partners worked with the data science teams within PCORnet to design an algorithm to identify individuals traditionally not reflected in ACHD research and generated site-specific recruitment lists to support tailored outreach efforts. This tailored approach, embedded in the study design, successfully expanded demographic reach.

“I really do think it was the combination of the recruitment algorithm in addition to our engagement strategy that helped successfully increase the number of patients that we had previously underrepresented,” Anitha John, MD, PhD, CHI-RON investigator, reflected during a recent PCORnet® Best Practice Sharing Session.

“We were able to increase the numbers of younger, male patients, and also achieved better representation across race, ethnicity, and educational background.”

Read the full publication here.

 

PRECIDENTD: Sustaining Engagement in a National Pragmatic Trial

The PCORnet® Study PRECIDENTD (PRevention of CardIovascular and DiabEtic KidNey Disease in Type 2 Diabetes) is a national trial comparing two classes of diabetes medications, SGLT-2and GLP-1 (sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists).

Large pragmatic trials often struggle with retention and adherence, particularly when resources are limited and study teams are distributed across many sites.

“Drugs in these classes can be expensive and insurance coverage varies,” said PRECIDENTD investigator Lindsay Mayberry, MS, PhD. “That means that patients often needed additional support in order to actually adhere to trial requirements and complete study assessments. Patient input helped us understand the challenges patients face and how we might get ahead of them.”

PRECIDENTD engaged patients to co-design an automated text message-based tool designed to identify participants who need support to adhere to study medications, as well as to remind participants of study timelines and follow-ups, and express appreciation for their role in research. This included holding a community engagement studio to receive input on the study design and to shape the text messaging program’s goals and structure. Researchers then collaborated with a patient advisory council to codesign message content and tone and ensure the texting intervention reflected the real-world needs and experiences of people living with type 2 diabetes. In addition to helping to test the system, two patient partners served in decision-making roles on the executive committee alongside study investigators and helped to publish and disseminate results.

“Pragmatic trials place real demands on participants and study staff alike,” said patient partner Ed Simeone. “As a patient partner, being part of the co-design process from the start — including the development of the text messaging program — helped ensure that communication was clear, burden was manageable, and participants felt genuinely supported. That kind of collaborative approach builds trust and turns a research study into a shared endeavor.”

The program achieved an 80% response rate to text messages, with 25% of these interactions identifying barriers to taking the study medication that required coordinator support. By targeting outreach to those most in need, the approach helped study teams use limited resources more effectively while keeping participants engaged.

Through targeted outreach and other engagement strategies, PRECIDENTD reflects the comprehensive approach to engagement that all PCORnet® Studies should follow.

Read the full publication here.

These two PCORnet® Studies demonstrate some of the ways researchers can leverage the research-ready community and expertise within PCORnet to deepen engagement efforts.

 

Explore the Medical Care Supplement

The publications highlighted here are part of the recent Medical Care supplement, “PCORnet®: Accelerating Patient-Centered Comparative Clinical Effectiveness Research.” The supplement includes 19 peer-reviewed, open-access articles showcasing how investigators are using PCORnet to reshape patient-centered health research. Learn more and explore the full supplement here.

Contact the PCORnet® Front Door to learn how the PCORnet infrastructure can support your patient-centered health research.

PCORnet® Resources Are Being Used to Reduce Gaps in Congenital Heart Disease Care

Posted on by Jodi Snare

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 widespread 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.

Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease

Posted on by Jodi Snare

Page last updated February 4, 2026

ClinicalTrials.gov#: NCT05185232
Study Design: Retrospective Observational
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator:Thomas Carton and Anitha John
Institution: Louisiana Public Health Institute (LPHI)
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (project webpage)
Funding Date: 2021
Study Duration: 2021 – 2024
Participating PCORnet® Clinical Research Networks: INSIGHT, OneFlorida+, PEDSnet, REACHnet
Therapeutic Area: Cardiovascular, Rare Diseases
Condition: Congenital Heart Disease; Comorbidities and Coexisting Conditions
Age Range: 18 Years and older (Adult,  Older Adult)
Status: Completed

Research Question(s):

  1. How does receiving current recommended care affect long-term outcomes and healthcare needs amongst the numerous rare disease subtypes of congenital heart defects?
  2. What factors are associated with gaps in recommended care?
  3. Do patients report feeling better when they remain in specialty care?