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

NCT05792085 | Completed Results DMC

• 1 other identifier: 02141989
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief 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

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy

  30 days

• Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor

  30 days

• Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors

  30 days

• Rates of Increase/Addition of Aldosterone Receptor Antagonists

  30 days

• Rates of Increase/Addition of Beta-blockers

  30 days

Other Outcomes (1)

• Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months

  6 months

Study Arms (2)

Telehealth Model

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Usual care, control group

Interventions

EHR-based GDMT Optimization 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.

Telehealth Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• On hospice
• LVAD/translant
• Home inotropes
• No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center

Sponsors & Collaborators

• University of Pennsylvania: lead
• Indian Health Service (IHS): collaborator

Study Sites (2)

Gallup Indian Medical Center

Gallup, New Mexico, 87301, United States

Location

Tohatchi Health Center

Tohatchi, New Mexico, 87325, United States

Location

Related Publications (1)

• Eberly LA, Tennison A, Mays D, Hsu CY, Yang CT, Benally E, Beyuka H, Feliciano B, Norman CJ, Brueckner MY, Bowannie C, Schwartz DR, Lindsey E, Friedman S, Ketner E, Detsoi-Smiley P, Shyr Y, Shin S, Merino M. Telephone-Based Guideline-Directed Medical Therapy Optimization in Navajo Nation: The Hozho Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 1;184(6):681-690. doi: 10.1001/jamainternmed.2024.1523.

  PMID: 38583185 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Lauren Eberly
• Organization: University of Pennsylvania

Lauren.Eberly@pennmedicine.upenn.edu

2676244449

Study Officials

• Maricruz Merino, MD

  Indian Health Service (IHS)

  STUDY DIRECTOR

• Lauren Eberly, MD, MPH

  Indian Health Service, Upenn

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped Wedge Design

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 30, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)