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

Robert Avram, Derek So, Erin Iturriaga, Julia Byrne, Ryan Lennon, Vishakantha Murthy, Nancy Geller, Shaun Goodman, Charanjit Rihal, Yves Rosenberg, Kent Bailey, Michael Farkouh, Malcolm Bell, Charles Cagin, Ivan Chavez, Mohammad El-Hajjar, Wilson Ginete, Amir Lerman, Justin Levisay, Kevin Marzo, Tamim Nazif, Jeffrey Olgin, Naveen Pereira, Robert Avram, Derek So, Erin Iturriaga, Julia Byrne, Ryan Lennon, Vishakantha Murthy, Nancy Geller, Shaun Goodman, Charanjit Rihal, Yves Rosenberg, Kent Bailey, Michael Farkouh, Malcolm Bell, Charles Cagin, Ivan Chavez, Mohammad El-Hajjar, Wilson Ginete, Amir Lerman, Justin Levisay, Kevin Marzo, Tamim Nazif, Jeffrey Olgin, Naveen Pereira

Abstract

Background: 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.

Objective: The aim of this study is to describe patients' onboarding, engagement, and results in a digital study after enrollment in an 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 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.

Results: 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<.001). A greater proportion had bachelor's degrees (47.2% vs 25.7%; P<.001) and were more computer literate (90.5% vs 62.3% of daily internet use; P<.001) than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9% (SD 7.6%); there was no decrease in this rate throughout the study duration.

Conclusions: Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further.

Trial registration: Clinicaltrails.gov NCT01742117; https://ichgcp.net/clinical-trials-registry/NCT01742117.

Keywords: cardiology; clinical trial; digital health; digital study; mobile health; mobile phone; smartphone.

Conflict of interest statement

Conflicts of Interest: SG has received research grant support and honoraria from: Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Novo Nordisk A/C, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, Servier, Valeo Pharma; and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Centre for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, PERFUSE Research Institute, and TIMI Study Group (Brigham Health). MF has received research grant support from Amgen, Astra Zeneca, Novartis, and Novo Nordisk. .

©Robert Avram, Derek So, Erin Iturriaga, Julia Byrne, Ryan Lennon, Vishakantha Murthy, Nancy Geller, Shaun Goodman, Charanjit Rihal, Yves Rosenberg, Kent Bailey, Michael Farkouh, Malcolm Bell, Charles Cagin, Ivan Chavez, Mohammad El-Hajjar, Wilson Ginete, Amir Lerman, Justin Levisay, Kevin Marzo, Tamim Nazif, Jeffrey Olgin, Naveen Pereira. Originally published in JMIR Formative Research (https://formative.jmir.org), 13.06.2022.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) diagram. PCI: percutaneous coronary intervention; RCT: randomized controlled trial; TAILOR-PCI: Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention.
Figure 2
Figure 2
Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention e-visit completion rate.
Figure 3
Figure 3
Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention activities completion rates.

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