Direct-to-participant Recruitment Through Electronic Health Records (EHR) for a Virtual Pediatric Early Allergen Feeding Study

Background: Consistent early food allergen exposure may decrease the risk of developing food allergies but specific products and strategies require rigorous studies, preferably in a real-world setting. We developed and launched a direct-to-family, virtual study, following 1500 infants (30% with eczema) at age 4-6 months, randomized 1:1 to a 16-food protein product or control. Here, we report early data on the utilization of EHR to reach participants and insights on both the challenges and opportunities with direct-to-participant studies in children.

Methods: Through an IRB-approved study protocol and partnership with the institution’s informatics team, study information was initially distributed to all EHR accounts for infants currently 4-6 months of age, identified with an Epic Clarity Query. The messages are then applied daily to accounts that have aged into the study. The message includes a short summary of why we’re doing this study, the inclusion criteria and contact information for the study team, as well as a link to our study website.

Results: The outreach began on 26-March-2021. As of 07-July-2021, 1624 EHR Messages were distributed, with 266 families viewing the message, 88 indicating interest, and 101 declining the notification. This early data represents a 16% open rate and a 5% click-through rate.

Conclusion: A global pandemic required clinical research to innovate to adapt to an increasingly digital world. Decentralized studies open new opportunities for clinical research, with the ability to reach broad and diverse populations. Novel direct-to-participant recruitment tactics, such as those through EHR, will be needed as decentralized studies continue to gain traction.