Status:

COMPLETED

Cost and Shared Decision-Making for Heart Failure

Lead Sponsor:

Emory University

Collaborating Sponsors:

Agency for Healthcare Research and Quality (AHRQ)

Conditions:

Chronic Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study is designed to understand the impact of providing patient-specific cost at the time of the clinical encounter on decision-making for heart failure medications. The researchers will provide ...

Detailed Description

For many years, medical treatment of heart failure with reduced ejection fraction (HFrEF) was defined by a combination of low-cost, generic medications. Recently, new medications have demonstrated red...

Eligibility Criteria

Inclusion

  • Diagnosis of HFrEF (ejection fraction \< 40%)
  • Outpatient clinical encounter with cardiologist (virtual or in-person)

Exclusion

  • Advanced HF therapy (LVAD or transplant or undergoing active workup or listing for these therapies; home inotrope usage)
  • Patient currently in hospice care or with known life expectancy under 1 year
  • Dialysis-dependence or glomerular filtration rate (GFR) \< 30 (due to medication contraindications)
  • Pregnancy (because many guideline-recommended drugs, including those with associated high costs, are not approved for use in pregnancy)
  • Non-English speaking (because of the absence of non-English speaking research staff to communicate with non-English speaking patients and to qualitatively analyze/code audio-recorded data)

Key Trial Info

Start Date :

June 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 15 2023

Estimated Enrollment :

247 Patients enrolled

Trial Details

Trial ID

NCT04793880

Start Date

June 1 2021

End Date

November 15 2023

Last Update

December 15 2023

Active Locations (4)

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Page 1 of 1 (4 locations)

1

UCHealth Heart and Vascular Center Clinics

Aurora, Colorado, United States, 80045

2

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

3

Emory Clinic, Emory University Hospital

Atlanta, Georgia, United States, 30322

4

Emory St. Joseph's Hospital

Atlanta, Georgia, United States, 30342