The CHI-RON Study: Using PCORnet® and Patient Engagement Strategies to Improve Diversity Among Research Participants in the Congenital Heart Initiative.

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.