Implementing Digital Technology to Transitioning a Clinical Trial to a Registry – TAILOR-PCI Digital Study: Methods/Study Design (Preprint)

BACKGROUND TAILOR-PCI was the largest cardiovascular genotype-based randomized clinical trial (RCT) investigating whether CYP2C19 genotype-guided selection of oral P2Y12 inhibitor therapy improved ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Registry was a novel proof-of-concept study that evaluated the feasibility of extending the main RCT follow-up period using a remote digital platform. OBJECTIVE To describe patients onboarding, engagement and results of a digital registry after enrollment in a RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letters containing a URL to the TAILOR-PCI Digital Registry website (http://tailorpci.eurekaplatform.org), instructing them to download the study app. Patients previously enrolled in the TAILOR-PCI study, with a smartphone, were eligible to join the Digital Registry. Those who did not respond to the letter were contacted by phone to survey reasons for non-participation and were invited again to join the study. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard, consent and enrol patients in the Digital Registry. Patients were asked to complete health-related surveys and provide follow-up data digitally. Consent rate to the Digital Registry, duration of participation in the Digital Registry and monthly activity completion rate. The hypothesis being tested was formulated before data collection began. RESULTS After the parent trial was completed, letters were mailed to 907 eligible patients (representing 19% of total enrolled in the RCT) across 24 sites, who were within 15.6 ± 5.2 months after randomization leading to 290 unique individuals visits to the Digital Registry website. Among those invited, 110 patients (12%) consented: 45 (41%) after the letter, 37 (34%) after the 1st phone call and 28 (25%) after a 2nd call. Of the 862 who didn’t consent after the letter, 453 patients (53%) did not respond to repeated phone calls and among the 409 patients who responded, 171 (41%) declined participation stating lack of time, 128 (31%), due to lack of smartphone and 47 (11%) due to difficulty understanding what was expected of them in the study. Patients who consented were older, had less diabetes or tobacco use; a greater proportion had bachelor's degrees or higher and were more computer literate than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9±7.6% without a decrease in this rate throughout the study duration. There were no differences between randomization arms in any patient reported outcomes using the digital platform. CONCLUSIONS Extended follow-up after enrollment in a RCT using a digital registry is technically feasible but was limited due to inability to contact most eligible patients, lack of time or access to a smartphone. Among those enrolled, most patients completed required electronic visits. Enhanced recruitment methods, such as introduction of the digital study at the time of RCT consent, provision of smartphone and robust study support for onboarding, should be explored further. CLINICALTRIAL TAILOR-PCI (Clinicaltrials.gov: NCT01742117)