The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

Early in the COVID-19 pandemic, cardiology clinics rapidly implemented telemedicine to maintain access to care. Little is known about subsequent trends in telemedicine use and visit volumes across cardiology subspecialties. We conducted a retrospective cohort study including all patients with ambulatory visits at a multispecialty cardiovascular center in Northern California from March 2019 to February 2020 (pre-COVID) and March 2020 to February 2021 (COVID). Telemedicine use increased from 3.5% of visits (1200/33,976) during the pre-COVID period to 63.0% (21,251/33,706) during the COVID period. Visit volumes were below pre-COVID levels from March to May 2020 but exceeded pre-COVID levels after June 2020, including when local COVID-19 cases peaked. Telemedicine use was above 75% of visits in all cardiology subspecialties in April 2020 and stabilized at rates ranging from over 95% in electrophysiology to under 25% in heart transplant and vascular medicine. From June 2020 to February 2021, subspecialties delivering a greater percentage of visits through telemedicine experienced larger increases in new patient visits (r = 0.81, p = 0.029). Telemedicine can be used to deliver a significant proportion of outpatient cardiovascular care though utilization varies across subspecialties. Higher rates of telemedicine adoption may increase access to care in cardiology clinics.

Background Telehealth use has increased in specialty clinics, but there is limited evidence on the outcomes of telehealth in primary cardiovascular disease (CVD) prevention. Objective The objective of this study was to evaluate the initial outcomes of CardioClick, a telehealth primary CVD prevention program. Methods In 2017, the Stanford South Asian Translational Heart Initiative (a preventive cardiology clinic focused on high-risk South Asian patients) introduced CardioClick, which is a clinical pathway replacing in-person follow-up visits with video visits. We assessed patient engagement and changes in CVD risk factors in CardioClick patients and in a historical in-person cohort from the same clinic. Results In this study, 118 CardioClick patients and 441 patients who received in-person care were included. CardioClick patients were more likely to complete the clinic’s CVD prevention program (76/118, 64.4% vs 173/441, 39.2%, respectively; P<.001) and they did so in lesser time (mean, 250 days vs 307 days, respectively; P<.001) than the patients in the historical in-person cohort. Patients who completed the CardioClick program achieved reductions in CVD risk factors, including blood pressure, lipid concentrations, and BMI, which matched or exceeded those observed in the historical in-person cohort. Conclusions Telehealth can be used to deliver care effectively in a preventive cardiology clinic setting and may result in increased patient engagement. Further studies on telehealth outcomes are needed to determine the optimal role of virtual care models across diverse preventive medicine clinics.