- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792085
Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic in Navajo Nation (Hozho)
December 19, 2023 updated by: University of Pennsylvania
Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Eberly, MD, MPH
- Phone Number: 267-624-4449
- Email: Lauren.Eberly@pennmedicine.upenn.edu
Study Locations
-
-
New Mexico
-
Gallup, New Mexico, United States, 87301
- Gallup Indian Medical Center
-
Contact:
- Lauren Eberly, MD, MPH
- Phone Number: 267-624-4449
- Email: Lauren.Eberly@pennmedicine.upenn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Usual care, control group
|
|
Active Comparator: Telehealth Model
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Time Frame: 30 days
|
% 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Time Frame: 60 days
|
% 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
|
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Time Frame: 6 months
|
% 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
|
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Time Frame: 12 months
|
% 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
|
Rates of Angiotensin Receptor-Neprilysin Inhibitor
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Rates of Rx for Entresto (Sacubritril-Valsartan)
|
30 days, 60 days, 6 months, 12 months
|
Rates of Sodium-glucose co-transporter 2 inhibitors
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
|
30 days, 60 days, 6 months, 12 months
|
Rates of Aldosterone receptor antagonists
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Rates of Rx for Aldosterone receptor antagonists
|
30 days, 60 days, 6 months, 12 months
|
Rates of Angiotensin-converting enzyme inhibitors
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Rates of Rx for Angiotensin-converting enzyme inhibitors
|
30 days, 60 days, 6 months, 12 months
|
Rates of Angiotensin receptor blockers
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Rates of Rx for Angiotensin receptor blockers
|
30 days, 60 days, 6 months, 12 months
|
Dose change of Angiotensin receptor blockers
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Dose change of Rx for Angiotensin receptor blockers
|
30 days, 60 days, 6 months, 12 months
|
Dose change of Angiotensin Receptor-Neprilysin Inhibitor
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Dose change of Rx for Angiotensin Receptor-Neprilysin Inhibitor
|
30 days, 60 days, 6 months, 12 months
|
Dose change of Angiotensin-converting enzyme inhibitors
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Dose change of Rx for Angiotensin-converting enzyme inhibitors
|
30 days, 60 days, 6 months, 12 months
|
Dose change of Beta-blocker
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Dose change of Rx for Beta-blocker
|
30 days, 60 days, 6 months, 12 months
|
Dose change of Aldosterone receptor antagonists
Time Frame: 30 days, 60 days, 6 months, 12 months
|
Dose change of Rx for Aldosterone receptor antagonists
|
30 days, 60 days, 6 months, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient and Provider Satisfaction
Time Frame: 1, 6 months
|
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
|
Provider Comfort with Guideline Directed Medical Therapy prescribing
Time Frame: Baseline, 1, 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Maricruz Merino, MD, Indian Health Service
- Principal Investigator: Lauren Eberly, MD, MPH, Indian Health Service, Upenn
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
January 26, 2023
First Submitted That Met QC Criteria
March 17, 2023
First Posted (Actual)
March 30, 2023
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000000000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Patient data is protected by the Navajo Nation Human Research Board
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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