The CHI-RON Study

BACKGROUND: The Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult-Centered Care (CHI-RON) study is a unique collaboration between the PCORnet and Congenital Heart Initiative (CHI), the first patient powered registry for adult congenital heart disease (ACHD) patients. The CHI-RON study examines the effects of gaps in recommended care in ACHD. OBJECTIVE: Recruitment of racially diverse, younger, out-of-care, and male participants has been challenging in ACHD studies. Our goal was to design patient engagement and recruitment strategies to improve representation. RESEARCH DESIGN: Launched in December 2020, patients from any location can self-enroll in the CHI registry, while the CHI-RON study (5/2022 - 10/2023) recruited ACHD patients at 12 sites participating in PCORnet. CHI-RON Recruitment methodology included a patient partner engagement toolkit and a recruitment algorithm using the PCORnet® Common Data Model designed specifically to improve diversity and reduce self-enrollment biases in comparison to the CHI registry. SUBJECTS: ACHD patients, age 18 years or older, with the ability to complete PROs independently. MEASURES: Demographic/Recruitment Statistics for study participants and Patient Engagement in Research Scale (PEIRS-22) for the study team partners. RESULTS: As of October 2023, a total of 2652 participants were recruited through CHI-RON recruitment methodology while 1326 were self-enrolled in the CHI. CHI-RON recruitment methodologies have increased representation when compared with self-enrolled CHI participants in terms of ethnicity (10.9% vs. 7.4% Hispanic, P<0.001), race (5.4% vs. 2.6%, Black/African American, P<0.001), sex (41% vs. 28% male, P<0.001), younger age (35.5 +/-12.8 y vs. 43.5±14.5 y, P<0.001), and education (33.4% vs. 24% high school equivalent or less, P<0.001).Most study team patient partners (n=12, 86%) reported a very to extremely high degree of engagement (PEIRS-22 average score 101.6), especially in the subdomains of contributions, support, feeling valued, and benefits. CONCLUSIONS: Patient engagement and novel recruitment strategies are critical to improving the inclusion of under-represented populations in clinical research and ensuring alignment with the needs of ACHD patients.