Gallup Indian Medical Center, Indian Health Service, Gallup, New Mexico.
Division of Cardiovascular Medicine, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia.
JAMA Intern Med. 2024 Jun 1;184(6):681-690. doi: 10.1001/jamainternmed.2024.1523.
Underutilization of guideline-directed medical therapy for heart failure with reduced ejection fraction is a major cause of poor outcomes. For many American Indian patients receiving care through the Indian Health Service, access to care, especially cardiology care, is limited, contributing to poor uptake of recommended therapy.
To examine whether a telehealth model in which guideline-directed medical therapy is initiated and titrated over the phone with remote telemonitoring using a home blood pressure cuff improves guideline-directed medical therapy use (eg, drug classes and dosage) in patients with heart failure with reduced ejection fraction in Navajo Nation.
DESIGN, SETTING, AND PARTICIPANTS: The Heart Failure Optimization at Home to Improve Outcomes (Hózhó) randomized clinical trial was a stepped-wedge, pragmatic comparative effectiveness trial conducted from February to August 2023. Patients 18 years and older with a diagnosis of heart failure with reduced ejection fraction receiving care at 2 Indian Health Service facilities in rural Navajo Nation (defined as having primary care physician with 1 clinical visit and 1 prescription filled in the last 12 months) were enrolled. Patients were randomized to the telehealth care model or usual care in a stepped-wedge fashion, with 5 time points (30-day intervals) until all patients crossed over into the intervention. Data analyses were completed in January 2024.
A phone-based telehealth model in which guideline-directed medical therapy is initiated and titrated at home, using remote telemonitoring with a home blood pressure cuff.
The primary outcome was an increase in the number of guideline-directed classes of drugs filled from the pharmacy at 30 days postrandomization.
Of 103 enrolled American Indian patients, 42 (40.8%) were female, and the median (IQR) age was 65 (53-77) years. The median (IQR) left ventricular ejection fraction was 32% (24%-36%). The primary outcome occurred significantly more in the intervention group (66.2% vs 13.1%), thus increasing uptake of guideline-directed classes of drugs by 53% (odds ratio, 12.99; 95% CI, 6.87-24.53; P < .001). The number of patients needed to receive the telehealth intervention to result in an increase of guideline-directed drug classes was 1.88.
In this heart failure trial in Navajo Nation, a telephone-based strategy of remote initiation and titration for outpatients with heart failure with reduced ejection fraction led to improved rates of guideline-directed medical therapy at 30 days compared with usual care. This low-cost strategy could be expanded to other rural settings where access to care is limited.
ClinicalTrials.gov Identifier: NCT05792085.
射血分数降低的心力衰竭患者指南指导的药物治疗使用率低是预后不良的一个主要原因。对于许多通过印度卫生服务机构接受治疗的美国印第安患者来说，获得医疗服务的机会，特别是心脏病学方面的服务，是有限的，这导致他们接受推荐的治疗的比例较低。
研究通过电话启动和调整指南指导的药物治疗，并使用远程血压袖带进行远程监测的远程医疗模式是否能改善接受治疗的射血分数降低的心力衰竭患者（例如，药物种类和剂量）在纳瓦霍族的使用情况。
设计、地点和参与者：心力衰竭优化居家改善结局（Hózhó）随机临床试验是一项从 2023 年 2 月到 8 月进行的分步楔形、实用比较有效性试验。参与者为 2 家农村纳瓦霍族印第安卫生服务机构接受治疗的年龄在 18 岁及以上的射血分数降低的心力衰竭诊断患者（定义为在过去 12 个月内有接受过 1 次临床就诊和 1 次处方的初级保健医生）。患者以分步楔形的方式随机分配到远程医疗护理模式或常规护理，共 5 个时间点（30 天间隔），直到所有患者都进入干预组。数据分析于 2024 年 1 月完成。
一种基于电话的远程医疗模式，在家中启动并调整指南指导的药物治疗，使用远程血压袖带进行远程监测。
主要结局是在随机分组后 30 天内从药房配药的指南指导药物种类的增加。
在 103 名入组的美国印第安患者中，42 名（40.8%）为女性，中位（IQR）年龄为 65（53-77）岁。中位（IQR）左心室射血分数为 32%（24%-36%）。干预组的主要结局发生的比例显著更高（66.2% vs 13.1%），因此指南指导药物种类的使用率增加了 53%（优势比，12.99；95%置信区间，6.87-24.53；P < .001）。需要接受远程医疗干预的患者人数为 1.88。
在纳瓦霍族的这项心力衰竭试验中，对于射血分数降低的心力衰竭的门诊患者，通过电话进行远程启动和调整治疗的策略在 30 天内导致了指南指导的药物治疗率的提高，与常规护理相比。这种低成本的策略可以扩展到其他医疗服务有限的农村地区。
ClinicalTrials.gov 标识符：NCT05792085。
