Automated Digital Outreach with Human in the Loop is an Effective strategy for Recruitment and Electronic Patient Reported Outcomes: Results from All4IBD Multi-Centric Pragmatic Trial

ObjectivesPatient recruitment is a critical factor for successful completion of a clinical trial. Decentralized trial recruitment allows potential subjects to be identified via the electronic health record (EHR) and approached through digital channels. We sought to understand the real-world effectiveness of decentralized trial recruitment leveraging electronic patient reported outcomes (ePROs) in patients with inflammatory bowel disease (IBD). MethodsAs part of a National Institutes of Health (NIH) funded multi-site clinical trial, we designed an EHR-integrated decentralized trial recruitment process to contact eligible patients at three tertiary IBD centers. We leveraged the Commure Engage/Rx.health (Mountain View, California) digital health formulary and automation engine integrated with Epic Systems (Epic Systems, Verona, WI) to digitally approach patients in an automated manner (with human-in-the loop) to complete the online enrollment process and monitor adherence with ePROs. ResultsUsing digital outreach complemented by in-person engagement, we approached 6,687 eligible patients over 12 months and successfully enrolled 543 patients (mean age 40.7 {+/-} 15.7 years, 63.3% females, 39.4% ulcerative colitis, 60.6% Crohns disease). 81.2% were recruited from bulk outreach methods. Gender (P<0.01), and race (P<0.01) were significantly associated with digital clinical trial enrollment. Patients were continually monitored with ePROs throughout the duration of the study. ConclusionsThis is one of the first studies to show the feasibility and successful recruitment of patients with IBD using automated digital outreach. We found a combination of outreach methods with human in the loop an effective strategy for clinical trial accrual. These findings suggest that ePROs can be successfully used in IBD centers to support treat-to-target strategy. Study HighlightsO_LIWhat is Known: O_LIThe most common reason for clinical trial failure is lack of accrual. C_LIO_LIClinical trial recruitment strategies have remained largely unchanged despite technological advances. C_LIO_LIThere is limited real world data around the use of electronic patient reported outcomes on a digital platform for patients with inflammatory bowel disease C_LI C_LIO_LIWhat is New Here O_LIne of the first studies to employ a prospective decentralized recruitment approach for a multicenter clinical trial in inflammatory bowel disease. C_LIO_LIfeasibility of an automated digital outreach for enrollment and continued monitoring using electronic patient reported outcomes C_LI C_LI