PRECIDENTD

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.

PRECIDENTD – PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Posted on by Jodi Snare

Page last updated November 07, 2025

Study Website: PRECIDENTD
ClinicalTrials.gov#: NCT05390892
Study Design: Intervention Trial
Principal Investigator: Brendan Everett
Institution: Brigham and Women's Hospital
Funder: Patient-Centered Outcomes Research Institute (PCORI); (project webpage)
Participating PCORnet® Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, STAR
Therapeutic Area: Cardiovascular, Endocrinology
Condition: Type2Diabetes; Atherosclerotic Cardiovascular Disease (ASCVD)
Age Range: 40 Years to 80 Years (Adult, Older Adult)
Status: Recruiting

Research Question(s):

  1. In patients with type 2 diabetes, are SGLT2 inhibitors or GLP-1 recent agonists better for preventing heart attack, stroke, blood vessel disease, heart failure, kidney disease, and death?
  2. Is combination therapy with both medication classes better than one therapy alone?

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

Posted on 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.