Abstract
Background
Issues with patient recruitment and enrolment are the primary barriers for missed clinical trial timelines; 8 out of 10 clinical trials are delayed or unable to be completed because of the lack of timely patient recruitment. Current patient recruitment efforts are inefficient as they are typically dependent on the manual screening of patients during face-to-face visits. With the rapid development of digital communication platforms within healthcare and the broad consumer adoption of smartphones, there are increasing opportunities to overcome some of these barriers. Digital platforms have great potential for research and clinical care of chronic conditions, such as inflammatory bowel disease (IBD), an often debilitating disease that currently affects over three million adults in the United States. In this paper, we utilized a digital medicine platform (Trialengage, Rx.Health, New York, NY) to improve patient recruitment for an ongoing mindfulness trial which had limited success in face-face enrolment (16 patients over 6 months).
Methods
Patients enrolled in the Mount Sinai Crohn’s and Colitis Registry (MSCCR) were remotely outreached about enrolling in a mindfulness study for IBD patients. A text-based clinical rules engine was used to inform registry patients about the trial and to allow patients to indicate interest in participating via text message. Eligible IBD patients were bulk “prescribed” a notification through RxHealth’s digital medicine platform, RxUniverse. Characteristics of the enrolled population, characteristics of patients who responded, and timeliness of responses were analyzed.
Results
Of the 1364 patients in the MSCCR with available phone numbers, 270 patients affirmatively replied they wanted to participate in the study. Patients who opted-in to receiving more information about the study were more likely to have inadequate control of their IBD (25.64% vs 18.97%; P<.05) and more likely to have a recent history of depression based on a validated patient health questionnaire (15.38% vs 8.4%; P<.05) than those who opted-out. There were no significant differences in terms of race, gender, and age between the two groups. In terms of timeliness of response among those enrolled, the majority of patients responded within 2 hours of notification.
Conclusion
Digital medicine software platforms can facilitate large-scale, lower-effort recruitment of eligible patients for clinical trials. Future research should be done to explore their expanded use for recruitment, patient education, and study data collection. Additional technologies such as patient-powered networks, social media, e-recruiting bots, and other remote engagement platforms can aid clinical trials by saving time and reducing costs of patient recruitment.
Su1784 – Reinventing Inflammatory Bowel Disease (IBD) Clinical Trial Recruitment Using Novel Digital Medicine Tools
