Improving HF Treatment and GDMT in IHS
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR-based GDMT Optimization
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Gallup Indian Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
GDMT EHR-Model
Control
Arm Description
Patient enrolled in the GDMT EHR-based HF improvement program
Usual care, control group
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
Rates of Angiotensin Receptor-Neprilysin Inhibitor
Rates of Rx for Entresto (Sacubritril-Valsartan)
Rates of Sodium-glucose co-transporter 2 inhibitors
Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
Rates of Aldosterone receptor antagonists
Rates of Rx for Aldosterone receptor antagonists
Rates of Angiotensin-converting enzyme inhibitors
Rates of Rx for Angiotensin-converting enzyme inhibitors
Rates of Angiotensin receptor blockers
Rates of Rx for Angiotensin receptor blockers
Dose change of Angiotensin receptor blockers
Dose change of Rx for Angiotensin receptor blockers
Dose change of Angiotensin Receptor-Neprilysin Inhibitor
Dose change of Rx for Angiotensin Receptor-Neprilysin Inhibitor
Dose change of Angiotensin-converting enzyme inhibitors
Dose change of Rx for Angiotensin-converting enzyme inhibitors
Dose change of Beta-blocker
Dose change of Rx for Beta-blocker
Dose change of Aldosterone receptor antagonists
Dose change of Rx for Aldosterone receptor antagonists
Full Information
NCT ID
NCT05792085
First Posted
January 26, 2023
Last Updated
August 24, 2023
Sponsor
University of Pennsylvania
Collaborators
Indian Health Service
1. Study Identification
Unique Protocol Identification Number
NCT05792085
Brief Title
Improving HF Treatment and GDMT in IHS
Official Title
Improving the Quality of Heart Failure Care Among American Indian Patients in the Indian Health Service: A Pragmatic Clinic Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Indian Health Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 implement a model in which our study team will get patients on appropriate therapy through tele monitoring. We will evaluate the impact of this model to improve uptake of GDMT among HFrEF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped Wedge Design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDMT EHR-Model
Arm Type
Active Comparator
Arm Description
Patient enrolled in the GDMT EHR-based HF improvement program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care, control group
Intervention Type
Behavioral
Intervention Name(s)
EHR-based GDMT Optimization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Description
% 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
Secondary Outcome Measure Information:
Title
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Description
% 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)
Time Frame
60 days
Title
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Description
% 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)
Time Frame
6 months
Title
Percentage that had Increase in Classes of Guideline Directed Medical Therapy
Description
% 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)
Time Frame
12 months
Title
Rates of Angiotensin Receptor-Neprilysin Inhibitor
Description
Rates of Rx for Entresto (Sacubritril-Valsartan)
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Rates of Sodium-glucose co-transporter 2 inhibitors
Description
Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Rates of Aldosterone receptor antagonists
Description
Rates of Rx for Aldosterone receptor antagonists
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Rates of Angiotensin-converting enzyme inhibitors
Description
Rates of Rx for Angiotensin-converting enzyme inhibitors
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Rates of Angiotensin receptor blockers
Description
Rates of Rx for Angiotensin receptor blockers
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Dose change of Angiotensin receptor blockers
Description
Dose change of Rx for Angiotensin receptor blockers
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Dose change of Angiotensin Receptor-Neprilysin Inhibitor
Description
Dose change of Rx for Angiotensin Receptor-Neprilysin Inhibitor
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Dose change of Angiotensin-converting enzyme inhibitors
Description
Dose change of Rx for Angiotensin-converting enzyme inhibitors
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Dose change of Beta-blocker
Description
Dose change of Rx for Beta-blocker
Time Frame
30 days, 60 days, 6 months, 12 months
Title
Dose change of Aldosterone receptor antagonists
Description
Dose change of Rx for Aldosterone receptor antagonists
Time Frame
30 days, 60 days, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Patient and Provider Satisfaction
Description
Through a provider survey, we will assess how satisfied (1-10) patients and (separately) providers are with the implementation of this model.
Time Frame
1, 6 months
Title
Provider Comfort with Guideline Directed Medical Therapy prescribing
Description
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.
Time Frame
Baseline, 1, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maricruz Merino, MD
Organizational Affiliation
Indian Health Service
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lauren Eberly, MD, MPH
Organizational Affiliation
Indian Health Service, Upenn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gallup Indian Medical Center
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patient data is protected by the Navajo Nation Human Research Board
Learn more about this trial
Improving HF Treatment and GDMT in IHS
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