The past year challenged patients, health care providers, and health systems alike to adapt and recalibrate to meet healthcare needs within pandemic constraints. The coronavirus 2019 (COVID-19) pandemic has radically interfered with the accessibility and delivery of cardiovascular care in the United States. With an emphasis on social distancing and stay-at-home orders in effect, many Americans delayed seeking routine medical care and treatment for acute cardiac symptoms due to fear of contracting the coronavirus. The COVID-19 pandemic compelled a rapid shift toward virtual care solutions across cardiovascular domains. The U.S Department of Veterans Affairs (VA) expanded virtual modalities, notably in specialty care and rehabilitation, which offered secure solutions to maintain treatment continuity. Within the VA and other health systems, virtual cardiac rehabilitation (CR) was embraced as an efficacious alternative to on-site cardiac rehabilitation that enabled patients to receive cardiac care remotely. Leveraging the infrastructure and lessons learned from the pandemic-induced expansion of virtual care carries enormous potential to refine virtual CR and revitalize future treatment paradigms for cardiovascular disease patients.
Background: Participation in cardiac rehabilitation (CR) is recommended for all patients with coronary artery disease (CAD) following hospitalization for acute coronary syndrome or stenting. Yet, few patients participate due to the inconvenience and high cost of attending a facility-based program, factors which have been magnified during the ongoing COVID pandemic. Based on a retrospective analysis of CR utilization and cost in a third-party payer environment, we forecasted the potential clinical and economic benefits of delivering a home-based, virtual CR program, with the goal of guiding future implementation efforts to expand CR access. Methods: We performed a retrospective cohort study using insurance claims data from a large, third-party payer in the state of Pennsylvania. Primary diagnostic and procedural codes were used to identify patients admitted for CAD between October 1, 2016, and September 30, 2018. Rates of enrollment in facility-based CR, as well as all-cause and cardiovascular hospital readmission and associated costs, were calculated during the 12-months following discharge. Results: Only 37% of the 7,264 identified eligible insured patients enrolled in a facility-based CR program within 12 months, incurring a mean delivery cost of $2,922 per participating patient. The 12-month all-cause readmission rate among these patients was 24%, compared to 31% among patients who did not participate in CR. Furthermore, among those readmitted, CR patients were readmitted less frequently than non-CR patients within this time period. The average per-patient cost from hospital readmissions was $30,814 per annum. Based on these trends, we forecasted that adoption of virtual CR among patients who previously declined CR would result in an annual cost savings between $1 and $9 million in the third-party healthcare system from a combination of increased overall CR enrollment and fewer hospital readmissions among new HBCR participants. Conclusions: Among insured patients eligible for CR in a third-party payer environment, implementation of a home-based virtual CR program is forecasted to yield significant cost savings through a combination of increased CR participation and a consequent reduction in downstream healthcare utilization.
Background: Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. Methods: We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. Conclusion: GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.
Cardiac rehabilitation (CR) is recommended for patients with coronary heart disease, however, participation among veterans remains poor. Smartphones may facilitate data transfer and communication between patients and providers, among other benefits. We evaluated the feasibility of a smartphone-enabled CR program in a population of veterans. Qualifying veterans were prospectively enrolled in a single-arm, nonrandomized feasibility study of a smartphone-enabled, home-based CR program, featuring an app with daily reminders to exercise, log vitals, and review educational materials. A coach remotely monitored patients through an online dashboard and scheduled telephone visits. Clinical end points were assessed as an exploratory aim. After 21 veterans provided informed consent, 18 were enrolled and successfully completed at least 30 days of the program; 13 completed the entire 12-week intervention. Mean (standard deviation) age was 62 (7) years and 96% were male. Program completers logged a mean (standard deviation) of 3.5 (1.4) exercise sessions and 150 (86) exercise minutes per week. The majority (84%) of program completers reported being satisfied overall with the program. Mean functional capacity improved by 1.0 metabolic equivalents (5.3 to 6.3, 95% confidence interval 0.3 to 1.7; p = 0.008) and mean systolic blood pressure at rest improved by 9.6 mm Hg (mean difference 9.6, 95% confidence interval −19.0 to −0.7; p = 0.049) among completers. Smartphone-enabled, home-based CR is feasible in veterans with heart disease and is associated with moderate to high levels of engagement and patient satisfaction.
Background
Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first‐line therapy, although patient adoption remains low. Home‐based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low‐resource settings, remains unknown.
Methods
Smart Step is a pilot randomized trial of smartphone‐enabled HBET vs walking advice in patients with symptomatic PAD in an inner‐city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone‐based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6‐minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year.
Results
A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants.
Conclusions
The potential significance of this trial will be to provide preliminary evidence of a home‐based, “mobile‐first” approach for delivering a structured exercise rehabilitation program. Smartphone‐enabled HBET can be potentially more accessible than center‐based programs, and if proven effective, may have a potential widespread public health benefit.