Heart Failure
Conditions
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.
Interventions
BEHAVIORALEHR-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.
Sponsors
Indian Health Service (IHS)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped Wedge Design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage That Had Increase in Classes of Guideline Directed Medical Therapy | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy | 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) |
| Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor | 30 days | Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan) |
| Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors | 30 days | Rates of Rx for Sodium-glucose co-transporter 2 inhibitors |
| Rates of Increase/Addition of Aldosterone Receptor Antagonists | 30 days | Rates of Rx for Aldosterone receptor antagonists |
| Addition of or Increase in Dose for ACEi/ARB/ARNI | 30 days | Increase in Dose for ACEi/ARB/ARNI |
| Addition of or Increase in Dose of Beta-blocker | 30 days | Addition of or Increase in Dose for Beta-blocker |
| Addition of or Increase in Dose of Aldosterone Receptor Antagonists | 30 days | Dose increase or addition of Aldosterone receptor antagonists |
| Rates of Increase/Addition of Beta-blockers | 30 days | Rates of Rx for Beta-blockers |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Telehealth Model |
|---|---|
| Age, Continuous | 65 years |
| LVEF | 32 Percentage |
| Race (NIH/OMB) American Indian or Alaska Native | 103 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 103 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 | 0 / 20 | 1 / 20 | 0 / 21 |
| other Total, other adverse events | 2 / 21 | 3 / 21 | 2 / 20 | 4 / 20 | 8 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 20 | 0 / 20 | 0 / 21 |
Outcome results
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)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Percentage That Had Increase in Classes of Guideline Directed Medical Therapy | 66.2 percentage of patients |
| Control | Percentage That Had Increase in Classes of Guideline Directed Medical Therapy | 13.1 percentage of patients |
Secondary
Addition of or Increase in Dose for ACEi/ARB/ARNI
Increase in Dose for ACEi/ARB/ARNI
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Addition of or Increase in Dose for ACEi/ARB/ARNI | 46.7 Percentage of patients |
| Control | Addition of or Increase in Dose for ACEi/ARB/ARNI | 8.8 Percentage of patients |
Secondary
Addition of or Increase in Dose of Aldosterone Receptor Antagonists
Dose increase or addition of Aldosterone receptor antagonists
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Addition of or Increase in Dose of Aldosterone Receptor Antagonists | 38.4 Percentage of patients |
| Control | Addition of or Increase in Dose of Aldosterone Receptor Antagonists | 6.5 Percentage of patients |
Secondary
Addition of or Increase in Dose of Beta-blocker
Addition of or Increase in Dose for Beta-blocker
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Addition of or Increase in Dose of Beta-blocker | 17.4 Percentage of patients |
| Control | Addition of or Increase in Dose of Beta-blocker | 8 Percentage of patients |
Secondary
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy
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)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy | 79 percentage of patients |
| Control | Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy | 22.6 percentage of patients |
Secondary
Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors
Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors | 37.2 Percentage of patients |
| Control | Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors | 4.6 Percentage of patients |
Secondary
Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor
Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor | 39.7 Percentage of patients |
| Control | Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor | 6.3 Percentage of patients |
Secondary
Rates of Increase/Addition of Aldosterone Receptor Antagonists
Rates of Rx for Aldosterone receptor antagonists
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Rates of Increase/Addition of Aldosterone Receptor Antagonists | 30.6 Percentage of patients |
| Control | Rates of Increase/Addition of Aldosterone Receptor Antagonists | 0.9 Percentage of patients |
Secondary
Rates of Increase/Addition of Beta-blockers
Rates of Rx for Beta-blockers
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Model | Rates of Increase/Addition of Beta-blockers | 3.5 Percentage of patients |
| Control | Rates of Increase/Addition of Beta-blockers | 2.1 Percentage of patients |
Other Pre-specified
Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Model | Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months | 1.86 score on a scale | Standard Deviation 0.86 |
| Control | Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months | 4.36 score on a scale | Standard Deviation 0.63 |