CompletedNot Applicable

Cost and Shared Decision-Making for Heart Failure

United States247 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants who Discussed Medication Cost

Timeframe: Day 1 (during clinic encounter)

Trial details

NCT IDNCT04793880

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-08

View on ClinicalTrials.gov More Chronic Heart Failure trials