REAL-WORLD FEASIBILITY AND IMPACT OF DECENTRALIZED TRIAL RECRUITMENT FOR PATIENTS WITH INFLAMMATORY BOWEL DISEASE AT THREE ACADEMIC CENTERS

• DOI: 10.1093/ibd/izae282.027
• Publication Date: 2025-03-04T21:37:47Z
• Authors: Connie Chan; Stavros Stefanopo...; Morish Shah; Jacqueline Bird; Prabhu Shankar; Xinzhou Wang; Drew Helmus; Catherine Mcleod; Pamela Reyes-Merc...; Trisha Persaud; Kevin Hricik; Lindsey Kaydo; Mounir Ibrahim; Priya Patel; Sravya Kurra; Gaurav Narang; Shashank Garg; Sarthak Kakkar; Daniel Stein; Tim Sobol; Ben Cohen; Bruce Sands; Maged Rizk; Maneesh Dave; Ashish Atreja

Abstract

BACKGROUND Patient recruitment for clinical trials has traditionally been conducted through in-person visits, limiting overall enrollment. Alternatively, decentralized trial recruitment allows potential subjects to be identified via the electronic health record (EHR) and approached through digital outreach channels. Our investigation evaluates the effectiveness of decentralized recruitment methods and digital communication channels to enhance patient engagement within Inflammatory Bowel Disease (IBD) patients.

METHODS We designed an EHR-integrated decentralized trial for an NIH-funded multi-site IBD study at three centers. Using the Commure/Engage/Rx.health platform, we sent educational content and enrollment links via text and email. For bulk prescriptions, we identified potential participants by IBD diagnosis and upcoming appointments and conducted follow-up calls to address questions. One-to-one prescriptions targeted patients missed in bulk outreach, while self-enrollment was available through text codes on clinic fliers.

RESULTS We approached 7027 patients over 12 months and successfully enrolled 543 patients across three IBD centers (mean age 42.1 ± 15.6 years, 63.3% females, 75% White, 6.3% current smokers, 39.0% ulcerative colitis, 60.6% Crohn’s disease, 46.4% partnered) (Figure 1). 81.2% were recruited from bulk outreach methods. 0.3% of patients reported having a need for additional resources to successfully engage digitally. Age (P=0.02), gender (P< 0.01), and race (P< 0.01) were statistically significant in determining digital clinical trial enrollment and engagement. At UC Davis, 549 patients were approached, and 70 patients were enrolled with mean age 45.2± 17.2, 61.4% female, 89.7% White (p=0.04), 64.3% Crohn’s disease, 4.3% smoker, 51.4% partnered, and 60.0% recruited via bulk prescription. At Cleveland Clinic, 1746 patients were approached, and 133 patients were enrolled with mean age 44.0 ± 14.2 (p< 0.001), 74.4 female (p< 0.001), 85.5% White, 62.9% Crohn’s disease, 7.52% smoker, 52.6% partnered, and 82.0% recruited via bulk prescription. At Mount Sinai, 4052 patients were approached, and 340 patients were enrolled with mean age 41.3 ± 16.9, 59.4% female (p=0.001), 71.8% White, 59.1% Crohn’s disease, 1.76% smoker, 42.9% partnered, and 95.6% recruited via bulk prescription (p< 0.001).

DISCUSSION/CONCLUSION Recruitment of IBD patients using automated digital outreach is feasible. Bulk outreach of IBD cohorts proved to be the most effective recruitment method across all three sites, with the majority of patients recruited from home. These findings illustrate improvement in patient enrollment by incorporating decentralized digital recruitment, demonstrating its potential for application in future clinical trials involving IBD and other chronic diseases.

Figure 1.