Heart Failure Clinical Trial

Cost and Shared Decision-Making for Heart Failure

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 patients with heart failure with patient-specific cost information for non-generic heart failure medications. This cost information will be populated onto a checklist of recommended HF medications so that patients and their clinicians will have this information available during their clinical encounter. Patients in the control arm will receive the same checklist but without the cost information.

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Full 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 reductions in mortality and hospitalization. These include the angiotensin receptor blocker and neprilysin inhibitor (ARNI) sacubitril-valsartan, sodium-glucose cotransporter-2 inhibitors (SGLT2I), and ivabradine. These medications all carry important clinical benefits but also are more expensive, with co-payments varying significantly but often in the range of $50-$100 per month. These costs are highly relevant for patients' decisions, especially for patients who have Medicare Part D drug coverage and are not eligible for co-pay assistance programs.

Prior research has demonstrated that patients are sensitive to costs regarding HFrEF medications and receptive to cost discussions with clinicians. Some broad efforts at price transparency have been promoted, but generic price information is of little value to patients and clinicians when out-of-pocket costs vary significantly from patient to patient based on insurance coverage. At present, neither clinicians nor patients have out-of-pocket costs available at the time of clinical encounters in order to facilitate integration of this information into decisions.

The objective of this trial is to examine the impact of integrating patient-specific out-of-pocket cost into shared decision-making regarding heart failure medications in patients with HFrEF. This will be performed by integrating patient-specific cost into an existing, evidence-based checklist for HFrEF medications. The study will utilize a simple cluster-randomized design. All patients in the study will receive, at the time of a clinical encounter, an evidence-based heart failure medication checklist that describes guideline-recommended medications for HFrEF. Patients in the intervention group will receive a version of the checklist that also includes their estimated co-payment for non-generic heart failure medications based upon their insurance status at the time of the encounter.

This study is designed as a preliminary trial to understand the real impact of providing patient-specific cost at the time of the clinical encounter. The researchers will audio record clinical encounters, conduct a follow-up survey with participants, and collect follow-up data regarding each patient's medications.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study is for people with:

Heart Failure

Estimated Enrollment:

247

Study ID:

NCT04793880

Recruitment Status:

Completed

Sponsor:

Emory University

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There are 4 Locations for this study

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UCHealth Heart and Vascular Center Clinics
Aurora Colorado, 80045, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory Clinic, Emory University Hospital
Atlanta Georgia, 30322, United States
Emory St. Joseph's Hospital
Atlanta Georgia, 30342, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

247

Study ID:

NCT04793880

Recruitment Status:

Completed

Sponsor:


Emory University

How clear is this clinincal trial information?

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