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

Heart Failure Clinical Trial

— Hozho  

Official title:

Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792085
• Other study ID #: 00000000000
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Gallup Indian Medical Center	Gallup	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Indian Health Service

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient and Provider Satisfaction	Through a provider survey, we will assess how satisfied (1-10) patients and (separately) providers are with the implementation of this model.	1, 6 months
Other	Provider Comfort with Guideline Directed Medical Therapy prescribing	Baseline and follow up comfort prescribing therapy: Through survey we will assess at baseline and on follow-up how comfortable (from 1-10) providers feel with prescribing each of the following medications: Beta-blocker, Aldosterone receptor antagonist, Angiotensin-converting enzyme inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, Sodium-glucose co-transporter 2 inhibitors.	Baseline, 1, 6 months
Primary	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	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, Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, Sodium-glucose co-transporter 2 inhibitors)	60 days
Secondary	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, Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, Sodium-glucose co-transporter 2 inhibitors)	6 months
Secondary	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 (B-blocker, Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, Sodium-glucose co-transporter 2 inhibitors)	12 months
Secondary	Rates of Angiotensin Receptor-Neprilysin Inhibitor	Rates of Rx for Entresto (Sacubritril-Valsartan)	30 days, 60 days, 6 months, 12 months
Secondary	Rates of Sodium-glucose co-transporter 2 inhibitors	Rates of Rx for Sodium-glucose co-transporter 2 inhibitors	30 days, 60 days, 6 months, 12 months
Secondary	Rates of Aldosterone receptor antagonists	Rates of Rx for Aldosterone receptor antagonists	30 days, 60 days, 6 months, 12 months
Secondary	Rates of Angiotensin-converting enzyme inhibitors	Rates of Rx for Angiotensin-converting enzyme inhibitors	30 days, 60 days, 6 months, 12 months
Secondary	Rates of Angiotensin receptor blockers	Rates of Rx for Angiotensin receptor blockers	30 days, 60 days, 6 months, 12 months
Secondary	Dose change of Angiotensin receptor blockers	Dose change of Rx for Angiotensin receptor blockers	30 days, 60 days, 6 months, 12 months
Secondary	Dose change of Angiotensin Receptor-Neprilysin Inhibitor	Dose change of Rx for Angiotensin Receptor-Neprilysin Inhibitor	30 days, 60 days, 6 months, 12 months
Secondary	Dose change of Angiotensin-converting enzyme inhibitors	Dose change of Rx for Angiotensin-converting enzyme inhibitors	30 days, 60 days, 6 months, 12 months
Secondary	Dose change of Beta-blocker	Dose change of Rx for Beta-blocker	30 days, 60 days, 6 months, 12 months
Secondary	Dose change of Aldosterone receptor antagonists	Dose change of Rx for Aldosterone receptor antagonists	30 days, 60 days, 6 months, 12 months