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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: EHR-based GDMT Optimization

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Gallup, New Mexico, United States, 87301
      • Gallup Indian Medical Center
    • Tohatchi, New Mexico, United States, 87325
      • Tohatchi Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care, control group
Active Comparator: 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	Behavioral: EHR-based GDMT Optimization; 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.

What is the study measuring?

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 or Dose of Guideline Directed Medical Therapy	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)	30 days
Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor	Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)	30 days
Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors	Rates of Rx for Sodium-glucose co-transporter 2 inhibitors	30 days
Rates of Increase/Addition of Aldosterone Receptor Antagonists	Rates of Rx for Aldosterone receptor antagonists	30 days
Rates of Increase/Addition of Beta-blockers	Rates of Rx for Beta-blockers	30 days
Addition of or Increase in Dose for ACEi/ARB/ARNI	Increase in Dose for ACEi/ARB/ARNI	30 days
Addition of or Increase in Dose of Beta-blocker	Addition of or Increase in Dose for Beta-blocker	30 days
Addition of or Increase in Dose of Aldosterone Receptor Antagonists	Dose increase or addition of Aldosterone receptor antagonists	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months	Baseline and follow up comfort prescribing therapy: Through survey we will assess at baseline and on follow-up how comfortable (from 1-5) providers feel with prescribing each of the following medications: Beta-blocker, Aldosterone receptor antagonist, Angiotensin-converting enzyme inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, Sodium-glucose co-transporter 2 inhibitors. This measure is a score on a scale from 1-5, with 1 indicating low comfort level and 5 indicating high comfort level.	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Indian Health Service (IHS)
• Investigators: Principal Investigator: Lauren Eberly, MD, MPH, Indian Health Service, Upenn; Study Director: Maricruz Merino, MD, Indian Health Service (IHS)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 02141989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data is protected by the Navajo Nation Human Research Board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No