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

University of Pennsylvania

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: EHR-based GDMT Optimization

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05792085

02141989

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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103 participants in 2 patient groups

Telehealth Model

Active Comparator group

Description:

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

Treatment:

Behavioral: EHR-based GDMT Optimization

Control

No Intervention group

Description:

Usual care, control group