Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

On hospice
LVAD/translant
Home inotropes
No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center

Arm && Interventions

Group	Intervention	Description
Telehealth Model	EHR-based GDMT Optimization	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

Primary Outcome Measures

Name	Time	Method
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy	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)

Secondary Outcome Measures

Name	Time	Method
Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor	30 days	Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)
Rates of Increase/Addition of Aldosterone Receptor Antagonists	30 days	Rates of Rx for Aldosterone receptor antagonists
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy	30 days	Proportion of patients that had an increase in the number of classes or dose of Guideline Directed Medical Therapy (Beta-blocker, Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, Sodium-glucose co-transporter 2 inhibitors)
Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors	30 days	Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
Rates of Increase/Addition of Beta-blockers	30 days	Rates of Rx for Beta-blockers
Addition of or Increase in Dose for ACEi/ARB/ARNI	30 days	Increase in Dose for ACEi/ARB/ARNI
Addition of or Increase in Dose of Beta-blocker	30 days	Addition of or Increase in Dose for Beta-blocker
Addition of or Increase in Dose of Aldosterone Receptor Antagonists	30 days	Dose increase or addition of Aldosterone receptor antagonists