Trial Outcomes & Findings for Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation (NCT NCT05792085)

Results Overview

% 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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

30 days

Results posted on

2025-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 Patient enrolled in the GDMT Telehealth HF improvement program at t=0. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 2 Remain in control group (usual care) from t=0 to t=30 days. At t=30 days, patients cross over into intervention arm and are enrolled in the GDMT Telehealth HF improvement program at t=30 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 3 Remain in usual care from t=0 to t=60 days. At t=6- days, patients cross over into intervention arm and enrolled in the GDMT Telehealth HF improvement program at t=60 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 4 Remain in usual care from t=0 to t=90 days. At t=90 days, patients cross over into intervention arm and enrolled in the GDMT Telehealth HF improvement program at t=90 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 5 Remain in usual care from t=0 to t=120 days. At t=120 days, patients cross over into intervention arm and enrolled in the GDMT Telehealth HF improvement program at t=120 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.
Overall Study STARTED	21	21	20	20	21
Overall Study COMPLETED	21	21	20	20	20
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Patient enrolled in the GDMT Telehealth HF improvement program at t=0. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 2 Remain in control group (usual care) from t=0 to t=30 days. At t=30 days, patients cross over into intervention arm and are enrolled in the GDMT Telehealth HF improvement program at t=30 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 3 Remain in usual care from t=0 to t=60 days. At t=6- days, patients cross over into intervention arm and enrolled in the GDMT Telehealth HF improvement program at t=60 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 4 Remain in usual care from t=0 to t=90 days. At t=90 days, patients cross over into intervention arm and enrolled in the GDMT Telehealth HF improvement program at t=90 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.	Cohort 5 Remain in usual care from t=0 to t=120 days. At t=120 days, patients cross over into intervention arm and enrolled in the GDMT Telehealth HF improvement program at t=120 days. in which home BP cuff is provided and medication is initiated and titrated over the phone with remote telemonitoring using a home BP cuff. Phone-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 to build capacity and clinical comfort.
Overall Study Death	0	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telehealth Model n=103 Participants 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 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.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	103 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	103 Participants n=5 Participants
LVEF	32 Percentage n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=82 Participants Usual care, control group
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy	66.2 percentage of patients	13.1 percentage of patients

SECONDARY outcome

Timeframe: 30 days

Proportion of patients that had an increase in the number of classes or dose 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)

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy	79 percentage of patients	22.6 percentage of patients

SECONDARY outcome

Timeframe: 30 days

Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor	39.7 Percentage of patients	6.3 Percentage of patients

SECONDARY outcome

Timeframe: 30 days

Rates of Rx for Sodium-glucose co-transporter 2 inhibitors

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors	37.2 Percentage of patients	4.6 Percentage of patients

SECONDARY outcome

Timeframe: 30 days

Rates of Rx for Aldosterone receptor antagonists

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Rates of Increase/Addition of Aldosterone Receptor Antagonists	30.6 Percentage of patients	0.9 Percentage of patients

SECONDARY outcome

Timeframe: 30 days

Rates of Rx for Beta-blockers

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Rates of Increase/Addition of Beta-blockers	3.5 Percentage of patients	2.1 Percentage of patients

SECONDARY outcome

Timeframe: 30 days

Increase in Dose for ACEi/ARB/ARNI

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Addition of or Increase in Dose for ACEi/ARB/ARNI	46.7 Percentage of patients	8.8 Percentage of patients

SECONDARY outcome

Timeframe: 30 days

Addition of or Increase in Dose for Beta-blocker

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Addition of or Increase in Dose of Beta-blocker	17.4 Percentage of patients	8 Percentage of patients

SECONDARY outcome

Timeframe: 30 days

Dose increase or addition of Aldosterone receptor antagonists

Outcome measures

Outcome measures
Measure	Telehealth Model n=102 Participants 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 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.	Control n=81 Participants Usual care, control group
Addition of or Increase in Dose of Aldosterone Receptor Antagonists	38.4 Percentage of patients	6.5 Percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Baseline and follow up comfort prescribing therapy: Through survey we will assess at baseline and on follow-up how comfortable (from 1-5) 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. This measure is a score on a scale from 1-5, with 1 indicating low comfort level and 5 indicating high comfort level.