Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Percentage That Had Increase in Classes of Guideline Directed Medical Therapy
研究概览
简要总结
Heart failure causes significant morbidity and mortality, particularly in Navajo Nation. There are well-established evidence of improved mortality and lower heart failure hospitalizations with certain pharmacotherapies for heart failure with reduced ejection fraction (HFrEF). However, these medications are underutilized nationally, including in the Indian Health Service which is one important driver of poor heart failure outcomes. Therefore, as part of an EHR-based pragmatic clinic trial, we are implementing and testing a model that identifies American Indian HFrEF patients receiving care at one large Indian Health Service Site who meet clinical criteria for, but are not on appropriate therapy, and implements a model in patients are initiated and titrated on appropriate therapy over the phone with remote tele monitoring using home blood pressure cuff. We will evaluate the impact of this model to improve uptake of GDMT among HFrEF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart failure with reduced ejection fraction with last ejection fraction equal to or less than 40%
- •Have a primary care physician at Gallup Indian Medical Center or Tohatchi Health Center
- •Have been seen in the last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
排除标准
- •On hospice
- •LVAD/translant
- •Home inotropes
- •No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
研究组 & 干预措施
Control
Usual care, control group
Telehealth Model
Patient enrolled in the GDMT Telehealth HF improvement program in which hone BP cuff is provided and medication is initiated and titrated over the phone
干预措施: EHR-based GDMT Optimization (Behavioral)
结局指标
主要结局
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy
时间窗: 30 days
% of Patients that had Increase in the number of classes of Guideline Directed Medical Therapy (Beta-blocker, ACEi/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, SGLT2i)
次要结局
- Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor(30 days)
- Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy(30 days)
- Rates of Increase/Addition of Aldosterone Receptor Antagonists(30 days)
- Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors(30 days)
- Rates of Increase/Addition of Beta-blockers(30 days)
- Addition of or Increase in Dose for ACEi/ARB/ARNI(30 days)
- Addition of or Increase in Dose of Beta-blocker(30 days)
- Addition of or Increase in Dose of Aldosterone Receptor Antagonists(30 days)