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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-08-01

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped Wedge Design

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

EHR-based GDMT Optimization

Intervention Type BEHAVIORAL

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.

Control

Usual care, control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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