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

Study Overview
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Brief Summary
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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.

Official Title
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Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: EHR-based GDMT Optimization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped Wedge Design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telehealth Model<br>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 | Behavioral: EHR-based GDMT Optimization<br>* Patients will be prescribed appropriate GDMT for HFrEF if they meet clinical criteria by the study team, appropriate lab work and follow up testing will be sent and followed up by the team. All recommendations and plans will be copied to primary care providers who can opt out if disagree, but also to improve telementoring to build clinical comfort.<br>|
| No Intervention: Control<br>Usual care, control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage that had Increase in Classes of Guideline Directed Medical Therapy | % 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) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage that had Increase in Classes of Guideline Directed Medical Therapy | % of Patients that had Increase in the number of classes 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) | 60 days | 
| Percentage that had Increase in Classes of Guideline Directed Medical Therapy | % of Patients that had Increase in the number of classes 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) | 6 months | 
| Percentage that had Increase in Classes of Guideline Directed Medical Therapy | % of Patients that had Increase in the number of classes of Guideline Directed Medical Therapy (B-blocker, Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, Sodium-glucose co-transporter 2 inhibitors) | 12 months | 
| Rates of Angiotensin Receptor-Neprilysin Inhibitor | Rates of Rx for Entresto (Sacubritril-Valsartan) | 30 days, 60 days, 6 months, 12 months | 
| Rates of Sodium-glucose co-transporter 2 inhibitors | Rates of Rx for Sodium-glucose co-transporter 2 inhibitors | 30 days, 60 days, 6 months, 12 months | 
| Rates of Aldosterone receptor antagonists | Rates of Rx for Aldosterone receptor antagonists | 30 days, 60 days, 6 months, 12 months | 
| Rates of Angiotensin-converting enzyme inhibitors | Rates of Rx for Angiotensin-converting enzyme inhibitors | 30 days, 60 days, 6 months, 12 months | 
| Rates of Angiotensin receptor blockers | Rates of Rx for Angiotensin receptor blockers | 30 days, 60 days, 6 months, 12 months | 
| Dose change of Angiotensin receptor blockers | Dose change of Rx for Angiotensin receptor blockers | 30 days, 60 days, 6 months, 12 months | 
| Dose change of Angiotensin Receptor-Neprilysin Inhibitor | Dose change of Rx for Angiotensin Receptor-Neprilysin Inhibitor | 30 days, 60 days, 6 months, 12 months | 
| Dose change of Angiotensin-converting enzyme inhibitors | Dose change of Rx for Angiotensin-converting enzyme inhibitors | 30 days, 60 days, 6 months, 12 months | 
| Dose change of Beta-blocker | Dose change of Rx for Beta-blocker | 30 days, 60 days, 6 months, 12 months | 
| Dose change of Aldosterone receptor antagonists | Dose change of Rx for Aldosterone receptor antagonists | 30 days, 60 days, 6 months, 12 months |