Key Points:
- GDMT utilization is suboptimal among American Indian patients with HFrEF in Navajo Nation.
- In this pragmatic, stepped-wedge, randomized clinical trial, a telehealth intervention using telephone calls and remote BP monitoring was significantly more effective than usual care in rapid GDMT optimization.
Guideline directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) improves outcomes and survival. However, many American Indian patients have limited access to care and cardiovascular specialists, leading to GDMT underutilization.
On April 7, 2024, the principal results of the “Hózhó (Heart Failure Optimization At Home To Improve Outcomes): A Pragmatic Clinical Trial Of Telephone-based Guideline-directed Medical Therapy Optimization In Navajo Nation” were presented at ACC Scientific Sessions 2024. The purpose of this study was to evaluate a telehealth model for GDMT initiation and uptitration in rural Navajo Nation using phone calls and a home blood pressure cuff, with a goal to establish quadruple therapy by 30 days.
This pragmatic trial randomized patients with HFrEF (LVEF <= 40%) to the telehealth model or usual care in a stepped-wedge fashion over 5 time-points, 30 days apart, until all patients crossed over to the telehealth arm by day 150. Patients were included if they received care at one of two participating Indian Health Service (IHS) facilities, had an LVEF <= 40%, and were seen in the clinic in the prior 12 months. The primary outcome was the increase in number of GDMT classes filled at a pharmacy at 30 days post-randomization.
Of the 103 enrolled patients, the median age was 65 years, 71% were female, 100% were American Indian, 61% had diabetes, 48% had coronary artery disease. The median LVEF was 32%. At baseline, 94% of patients were on beta blocker, 87% were on an ACE/ARB or ARNI, 40% were on an MRA, and 44% were on an SGLT2i. Patients in the intervention arm were significantly more likely to undergo the addition of a GDMT class at 30 days compared to usual care (OR 12.99 [95% CI 6.87-24.53], P <0.001), with a number needed to treat of only 2. Heart failure hospitalizations were also significantly lower in the intervention arm (1.3% vs 4.3%, OR 0.30 [95% CI 0.11-0.85], p=0.024), and there was no difference in total adverse events (6.6% vs. 5.0%, p=0.506).
Limitations include a small sample size from a single health care system with no-cost medications, which limits generalizability. Longer term adherence and outcomes were not assessed in the present study.
Lauren A. Eberly MD, MPH, from the University of Pennsylvania, concluded: “A telehealth model leveraging phone-based GDMT optimization with remote telemonitoring led to significant and rapid increases in the uptake of GDMT. This low cost-strategy could be expanded to other rural settings where access to care is limited.”