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

NCT05792085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-01-30

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Maricruz Merino, MD · Indian Health Service (IHS)

  • Lauren Eberly, MD, MPH · Indian Health Service, Upenn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05792085 on ClinicalTrials.gov