Patient Onboarding and Engagement to Build a Digital Study After Enrollment in a Clinical Trial (TAILOR-PCI Digital Study): Intervention Study

• Published in: JMIR formative research 2022-06, Vol.6 (6), p.e34080-e34080
• Main Authors: Avram, Robert, So, Derek, Iturriaga, Erin, Byrne, Julia, Lennon, Ryan, Murthy, Vishakantha, Geller, Nancy, Goodman, Shaun, Rihal, Charanjit, Rosenberg, Yves, Bailey, Kent, Farkouh, Michael, Bell, Malcolm, Cagin, Charles, Chavez, Ivan, El-Hajjar, Mohammad, Ginete, Wilson, Lerman, Amir, Levisay, Justin, Marzo, Kevin, Nazif, Tamim, Olgin, Jeffrey, Pereira, Naveen
• Format: Article
• Language: English
• Subjects: Angina pectoris; Angioplasty; Clinical trials; Consent; COVID-19; Data collection; Dyspnea; Enrollments; Medical research; Multimedia; Original Paper; Participation; Patients; Questionnaires; Smartphones; Text messaging
• ISSN: 2561-326X; 2561-326X
• DOI: 10.2196/34080

The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. The aim of this study is to describe patients' onboarding, engagement, and results in a digital study after enrollment in an RCT. In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began. After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented-40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P