Clinical trial NCT05792085: Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation
Official title: Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Indian Health Service (IHS)
First posted: 2023-03-30
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage That Had Increase in Classes of Guideline Directed Medical Therapy
timeFrame: 30 days
Secondary outcomes:
measure: Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy
timeFrame: 30 days
measure: Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor
timeFrame: 30 days
measure: Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors
timeFrame: 30 days
measure: Rates of Increase/Addition of Aldosterone Receptor Antagonists
timeFrame: 30 days
measure: Rates of Increase/Addition of Beta-blockers
timeFrame: 30 days
measure: Addition of or Increase in Dose for ACEi/ARB/ARNI
timeFrame: 30 days
measure: Addition of or Increase in Dose of Beta-blocker
timeFrame: 30 days
measure: Addition of or Increase in Dose of Aldosterone Receptor Antagonists
timeFrame: 30 days
Other outcomes:
measure: Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months
timeFrame: 6 months
Locations:
city: Gallup
country: United States
facility: Gallup Indian Medical Center
state: New Mexico
city: Tohatchi
country: United States
facility: Tohatchi Health Center
state: New Mexico
Study officials:
affiliation: Indian Health Service (IHS)
name: Maricruz Merino, MD
role: STUDY_DIRECTOR
affiliation: Indian Health Service, Upenn
name: Lauren Eberly, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: