Reinventing Inflammatory Bowel Disease (IBD) Clinical Trial Recruitment Using Novel Digital Medicine Tools

Abstract

Background: Issues with patient recruitment and enrollment are the primary barriers for missed clinical trial timelines; 8 out of 10 clinical trials are delayed or unable to be completed because of lack of timely patient recruitment. Current patient recruitment efforts are inefficient and time-consuming, since they are typically dependent on manually screening patients during face-to-face visits to the clinic or hospital. With the rapid development of digital communication platforms within health care and the broad consumer adoption of smartphones, there are increasing opportunities to overcome some of these barriers. These platforms have particularly great potential for research and clinical care of chronic conditions, such as inflammatory bowel disease (IBD), an often debilitating disease which currently affects over three million adults in the United States. Objective: To integrate and utilize a digital medicine platform to improve patient recruitment and enrollment processes in clinical trials. Methods: Patients enrolled in the Mount Sinai Crohn's and Colitis Registry (MSCCR) were remotely approached 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 to the study. Patients who opted into receiving more information about the study were more likely to have inadequate control of their IBD (25.64% vs 18.97%; P