JMIR Publications

ABSTRACT

Background:

Accurate and timely ascertainment of clinical endpoints, particularly hospitalizations, is crucial for clinical trials. The TAILOR-PCI Digital Study extended the main TAILOR-PCI trial's follow-up period (NCT#01742117) to two years, utilizing a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations.

Objective:

The primary objectives were to evaluate the geofencing-triggered notifications and routine monthly mobile surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site.

Methods:

Participants in the United States and Canada from the TAILOR-PCI Digital Follow-up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants also received monthly CV hospitalization survey notifications.

Results:

Of the 85 participants who consented for the Digital Study, downloaded the mobile app and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators in 5 patients, whereas 8/9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization was missed by the survey since it occurred within 2 weeks of the previous hospitalization and the participant could only report a single hospitalization. Three of these were also detected by the geofencing algorithm, but 6/9 (66.7%) were missed by geofencing: one occurred in a participant that never consented to geofencing, while five hospitalizations occurred in participants which had subsequently (after consent) turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (Q1, Q3:1-3) days, monthly surveys within 11 (IQR: 6.5–25) days, and site coordinator methods within 38 (Q1, Q3: 9-105) days. The geofencing algorithm triggered 245 notifications in 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from non-hospital healthcare facility visits. Algorithm refinement increased the accuracy of true hospital visit alerts from 35.4% to 93.3%.

Conclusions:

The monthly survey detected 8/9 CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value. Digital tools could potentially reduce the burden on site study coordinators in ascertaining CV hospitalizations. The benefits of more timely reporting with geofencing must be balanced against false notifications which can be overcome with algorithm refinements. Clinical Trial: NCT#01742117