ACC 2024: Hózhó (Heart Failure Optimization at Home to Improve Outcomes): A Pragmatic Clinical Trial of Telephone-based Guideline-directed Medical Therapy Optimization in Navajo Nation

There is underutilization of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction in the United States, particularly among American Indian populations like the Navajo Nation. Access to care, especially for heart-related issues, is limited in rural areas served by the Indian Health Service. To address this, a telehealth model called Hózhó (Heart Failure Optimization at Home to Improve Outcomes) was designed. It involves initiating and adjusting GDMT over the phone with remote monitoring using a home blood pressure cuff. The model aims to improve GDMT uptake rates compared to usual care in rural Navajo Nation, with input from the community and stakeholders.

The trial was conducted within the Navajo Nation, and it enrolled heart failure (HF) patients with a left ventricular ejection fraction (LVEF) ≤ 40% who had seen a primary care physician within the last 12 months and were not on hospice care. It aimed to compare a phone-based optimization model to usual clinic-based care. The study used a stepped wedge cluster randomized trial design, patients were divided into clusters and received the intervention at different time points, gradually transitioning all patients to the intervention arm. Data were collected from electronic health records, focusing on a primary outcome of increased GDMT prescriptions filled within 30 days. Success was defined by any new GDMT addition or transitioning from an Angiotensin Receptor Blocker (ARB)/Angiotensin-Converting Enzyme inhibitor (ACEi) to an Angiotensin Receptor-Neprilysin inhibitor (ARNi). Secondary outcomes included individual GDMT class additions, prescribed doses, and HF hospitalizations. 

The patients in the intervention arm received a home blood pressure cuff and were trained on how to use it. A telehealth team, consisting of primary care physicians and cardiology telementoring, guided patients through assessing missing GDMT, eligibility for therapy, and initiating low doses of missing medications. The recommendations were discussed over the phone, and if agreed upon, medicines were prescribed. Follow-up calls assessed tolerability and collected vital signs, with ongoing education provided. Lab work was required after medication alteration, and patients were called regularly for dose adjustments until optimized. The protocols were designed to align with professional guidelines and aimed to start patients on low doses of all eligible therapies upfront. The trial was conducted at two Indian Health Service sites (Gallup Indian Medical Center and Tohatchi Health Care Center) serving the Navajo Nation, where cardiology care is limited.

The study demonstrated significant and rapid adoption of therapies, particularly in the intervention arm, where patients crossed over into the intervention from usual care. At 30 days, there was a substantial increase in the proportion of patients receiving additional GDMT, with the intervention arm showing a significantly higher rate compared to usual care (66% vs. 13%). The intervention arm also saw higher rates of dosage increases (79% vs. 23%) and lower HF hospitalizations. Adverse events were minimal and not significantly different between the two arms. The intervention resulted in the addition of a GDMT class for every two patients treated. However, beta-blockers did not show a statistically significant increase in the intervention arm.

The limitations of the study included a small sample size and being conducted within a single healthcare system, specifically the IHS. The results may not be fully applicable to other healthcare systems. The study involved input from various stakeholders and was designed to meet the needs of the community. There were challenges with follow-up visits, reflecting real-world conditions with limited access to care. Future research will focus on long-term adherence and durability of the intervention. Overall, the telehealth model used led to significant increases in the uptake of GDMT, suggesting it could be a cost-effective strategy for improving care in rural settings.

American College of Cardiology (ACC) Congress 2024, 6th April – 8th April 2024, Atlanta, Georgia, USA