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| Name | Class |
|---|---|
| Indian Health Service (IHS) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Model | Active Comparator | 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 |
|
| Control | No Intervention | Usual care, control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHR-based GDMT Optimization | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maricruz Merino, MD | Indian Health Service (IHS) | Study Director |
| Lauren Eberly, MD, MPH | Indian Health Service, Upenn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gallup Indian Medical Center | Gallup | New Mexico | 87301 | United States | ||
| Tohatchi Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38583185 | Derived | Eberly LA, Tennison A, Mays D, Hsu CY, Yang CT, Benally E, Beyuka H, Feliciano B, Norman CJ, Brueckner MY, Bowannie C, Schwartz DR, Lindsey E, Friedman S, Ketner E, Detsoi-Smiley P, Shyr Y, Shin S, Merino M. Telephone-Based Guideline-Directed Medical Therapy Optimization in Navajo Nation: The Hozho Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 1;184(6):681-690. doi: 10.1001/jamainternmed.2024.1523. |
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Patient data is protected by the Navajo Nation Human Research Board
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | percentage of patients | 30 days |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Patients in cohort 1 receive the intervention (telehealth model) immediately (t=0 days) while the other cohorts (1-4) remain in usual care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any other minor adverse event | Cardiac disorders | Systematic Assessment | Minor adverse events including hyperkalemia, hypokalemia, hyponatremia, acute kidney injury (creatinine increase >0.3) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Eberly | University of Pennsylvania | 2676244449 | Lauren.Eberly@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2022 | Aug 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Stepped Wedge Design
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|
| 30 days |
| Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor | Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan) | 30 days |
| Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors | Rates of Rx for Sodium-glucose co-transporter 2 inhibitors | 30 days |
| Rates of Increase/Addition of Aldosterone Receptor Antagonists | Rates of Rx for Aldosterone receptor antagonists | 30 days |
| Rates of Increase/Addition of Beta-blockers | Rates of Rx for Beta-blockers | 30 days |
| Addition of or Increase in Dose for ACEi/ARB/ARNI | Increase in Dose for ACEi/ARB/ARNI | 30 days |
| Addition of or Increase in Dose of Beta-blocker | Addition of or Increase in Dose for Beta-blocker | 30 days |
| Addition of or Increase in Dose of Aldosterone Receptor Antagonists | Dose increase or addition of Aldosterone receptor antagonists | 30 days |
| 6 months |
| Tohatchi |
| New Mexico |
| 87325 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| LVEF | Median | Inter-Quartile Range | Percentage |
|
| OG001 | Control | Usual care, control group |
|
|
| 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) | Posted | Number | percentage of patients | 30 days |
|
|
|
| Secondary | Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor | Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan) | Posted | Number | Percentage of patients | 30 days |
|
|
|
| Secondary | Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors | Rates of Rx for Sodium-glucose co-transporter 2 inhibitors | Posted | Number | Percentage of patients | 30 days |
|
|
|
| Secondary | Rates of Increase/Addition of Aldosterone Receptor Antagonists | Rates of Rx for Aldosterone receptor antagonists | Posted | Number | Percentage of patients | 30 days |
|
|
|
| Secondary | Rates of Increase/Addition of Beta-blockers | Rates of Rx for Beta-blockers | Posted | Number | Percentage of patients | 30 days |
|
|
|
| Secondary | Addition of or Increase in Dose for ACEi/ARB/ARNI | Increase in Dose for ACEi/ARB/ARNI | Posted | Number | Percentage of patients | 30 days |
|
|
|
| Secondary | Addition of or Increase in Dose of Beta-blocker | Addition of or Increase in Dose for Beta-blocker | Posted | Number | Percentage of patients | 30 days |
|
|
|
| Secondary | Addition of or Increase in Dose of Aldosterone Receptor Antagonists | Dose increase or addition of Aldosterone receptor antagonists | Posted | Number | Percentage of patients | 30 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | Cohort 2 | Patients in cohort 2 are randomized to receive the intervention at t=30 days. Patients in cohort 2 receive usual care until t=30 days when they cross over to receive the intervention (telehealth model) (t=30 days) while the other cohorts (3-5) remain in usual care. | 0 | 21 | 0 | 21 | 3 | 21 |
| EG002 | Cohort 3 | Patients in cohort 3 are randomized to receive the intervention at t=60 days. Patients in cohort 3 receive usual care until t=60 days when they cross over to receive the intervention (telehealth model) (t=60 days) while the other cohorts (4-5) remain in usual care. | 0 | 20 | 0 | 20 | 2 | 20 |
| EG003 | Cohort 4 | Patients in cohort 4 are randomized to receive the intervention at t=90 days. Patients in cohort 4 receive usual care until t=90 days when they cross over to receive the intervention (telehealth model) (t=90 days) while cohort 5 remains in usual care. | 1 | 20 | 0 | 20 | 4 | 20 |
| EG004 | Cohort 5 | Patients in cohort 5 are randomized to receive the intervention at t=120 days. Patients in cohort 5 receive usual care until t=120 days when they cross over to receive the intervention (telehealth model) (t=120days). | 0 | 21 | 0 | 21 | 8 | 21 |
|
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