Leveraging Telemedicine to Improve guideline-directed Medical Therapy Use and Outcomes Among Rural Patients with Heart Failure- the RURAL-HF Trial
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Modified Project Summary/Abstract Section Patients with heart failure (HF) in rural communities face approximately 20% higher mortality risk compared to urban counterparts, driven largely by poor access to cardiology specialty care and underutilization of guideline-directed medical therapy (GDMT). While evidence-based HF therapies can reduce mortality by more than 50%, only 4-6% of patients achieve optimal GDMT dosing within six months of diagnosis. Underutilization of GDMT accounts for an estimated 16% of the excess mortality risk experienced by rural versus urban HF patients. Telehealth and remote patient monitoring represent promising strategies to overcome geographic challenges and improve GDMT utilization. However, while small pilot studies have demonstrated feasibility, no adequately powered randomized trial has evaluated telehealth-enabled GDMT optimization specifically designed for patients with HF in rural areas. To address this knowledge gap, we propose a type 1 hybrid effectiveness-implementation, multi-center, randomized controlled trial enrolling 600 patients hospitalized with acute HF at rural hospitals across two health systems. The intervention leverages provider-to-provider telehealth collaboration, where cardiovascular specialists from the study team provide evidence-based, protocol-driven GDMT initiation and uptitration recommendations to participants' outpatient care teams (primary care providers or cardiologists). This approach is supported by continuous remote monitoring of patient vital signs through cellular-enabled devices (blood pressure, heart rate, weight) that transmit data without requiring home internet access. The study team will review physiologic data weekly and provide specific medication recommendations at weekly intervals during the first six weeks post-discharge. The intervention targets achievement of maximally tolerated GDMT within 90 days, with continued safety monitoring through this period. The primary, win-ratio based composite hierarchical outcome includes all-cause mortality, heart transplant or ventricular assist device, HF hospitalization (first and recurrent), and change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire over six months of follow-up. Implementation outcomes will be evaluated using the RE-AIM framework to assess reach, effectiveness, adoption, implementation fidelity, and maintenance. A mixed-methods approach combining quantitative metrics with qualitative interviews of clinicians and patients will examine acceptability, implementation costs, and challenges and facilitators across various rural settings to inform future scalability. This trial addresses the critical need for scalable, evidence-based strategies to reduce cardiovascular health disparities in rural America. Successful completion will provide the first rigorous evidence for telehealth-enabled GDMT optimization for patients with HF in rural areas and generate essential implementation data to guide broader dissemination of this approach.
