Abstract 15763: Increasing Diversity Among Research Participants Through Patient Engagement in the Congenital Heart Initiative

Abstract

Background: The Congenital Heart Initiative (CHI) is the first patient-powered digital registry for adults with congenital heart disease (ACHD). The CHI-Redefining Outcomes and Navigation to Adult-Centered Care (CHI-RON) study is built upon the CHI as a unique collaboration with PCORnet. Goal: Recruitment of populations that are racially diverse, younger, out-of-care, and male has been challenging in ACHD studies. Our goal was to design patient engagement and recruitment strategies to increase these underrepresented populations. Methods: Launched in December 2020, patients across the globe can self-enroll in the CHI registry. The CHI-RON study, initiated in May 2022, recruits ACHD patients at 12 PCORnet centers. Patients are involved in all aspects of the study including recruitment (see Figure 1). Results: As of May 2023, a total of 2,520 participants were recruited by CHI-RON centers while 1,494 self-enrolled in the CHI. Most participants report complex CHD anatomy (n=1,660, 49%). A total of 762 (36%) participants are considered out of care. CHI-RON recruitment methodologies increased representation when compared to self-enrolled CHI participants in terms of ethnicity (10.3 % vs 7.4% Hispanic, p=0.005), race (5.4% vs 2.6%, African American, p<0.001), sex (41% vs 28% male, p<0.001), age (34.8 +/-12.5 years vs 44.5 +/- 14.3 years, p<0.001), and education (33% vs 22% high school equivalent or less, p<0.001). Most patients involved in the study team (n=11, 83%) reported a very to extremely high degree of meaningfulness (average score 85.2) per the Patient Engagement in Research Scale (PEIRS-22). The mean scores of each of the seven subdomains demonstrated significant meaningfulness, especially in the subdomains of convenience, contributions, and benefits. Conclusions: Patient engagement is critical to improving the inclusion of underrepresented populations in clinical research and ensuring alignment with the needs of ACHD patients.