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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byLauren Eberly, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Maricruz Merino, MD

Principal Investigator

Indian Health Service (IHS)

Lauren Eberly, MD, MPH

Principal Investigator

Indian Health Service, Upenn

Eligibility Criteria

Inclusion Criteria

Patients with heart failure and an ejection fraction of 40% or less.

You possess a primary care provider affiliated with the Gallup Indian Medical Center or Tohatchi Health Center.

You have had a visit to either Gallup Indian Medical Center or Tohatchi Health Center within the past 12 months.

Exclusion Criteria

You are using inotropes (medications to strengthen your heart) at home.

No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center

You are currently in hospice care.

See 1 more

Treatment Details

Interventions

EHR-based GDMT Optimization (Behavioral Intervention)

Participant Groups

2Treatment groups

Active Control

Group I: Telehealth ModelActive Control1 Intervention

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 II: ControlActive Control1 Intervention

Usual care, control group