CLINICAL TRIAL

Medication Cost Information for Heart Failure

Recruiting · 18+ · All Sexes · Atlanta, GA

This study is evaluating whether providing patients with information about the cost of medications may help them make better decisions about their medications.

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About the trial for Heart Failure

Eligible Conditions
Heart Failure · Chronic Heart Failure (CHF)

Treatment Groups

This trial involves 2 different treatments. Medication Cost Information is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Medication Cost Information
BEHAVIORAL
Heart Failure Medicines Checklist
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Heart Failure Medicines Checklist
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosis of HFrEF (ejection fraction < 40%)
An outpatient clinical encounter with a cardiologist can be either a virtual visit or an in-person visit show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: End of study (up to 26 months)
Screening: ~3 weeks
Treatment: Varies
Reporting: End of study (up to 26 months)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: End of study (up to 26 months).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Medication Cost Information will improve 1 primary outcome and 9 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of Day 1 (during clinic encounter).

Length of discussion
DAY 1 (DURING CLINIC ENCOUNTER)
The length of medication cost discussion will be measured in minutes, using the audio recording of the clinic encounter.
DAY 1 (DURING CLINIC ENCOUNTER)
Prescription of non-generic medications
DAY 1 (DURING CLINIC ENCOUNTER)
The number of participants prescribed non-generic medications at the clinic encounter will be obtained from electronic medical records.
DAY 1 (DURING CLINIC ENCOUNTER)
Physician Recommendation Coding System (PhyReCS) Score
DAY 1 (DURING CLINIC ENCOUNTER)
The strength of the clinical recommendation for a medication will be assessed with the Physician Recommendation Coding System (PhyReCS) scale, using the audio recording of the clinic encounter. The PhyReCS is a 5-point scale indicating how strongly the physician recommended a particular treatment. A strong recommendation is coded as +2, a mild recommendation is +1, recommendations neither for nor against treatment are coded as 0, a mild recommendation against treatment is -1, and a strong recommendation against treatment is coded as -2.
DAY 1 (DURING CLINIC ENCOUNTER)
Percentage of Participants who Discussed Medication Cost
DAY 1 (DURING CLINIC ENCOUNTER)
The percentage of patients whose clinic encounters involved a discussion of medication cost will be compared between study arms. The discussion of medication cost is a binary outcome of whether or not the cost of medication was discussed during the recorded clinical encounter. Any mention of medication cost will be counted as a cost discussion.
DAY 1 (DURING CLINIC ENCOUNTER)
Medication persistence
3 MONTHS AFTER CLINIC ENCOUNTER
The number of participants continuing to take their prescribed medication three months after the clinic encounter will be obtained from electronic medical records.
3 MONTHS AFTER CLINIC ENCOUNTER
Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician & Group Survey score
2 TO 3 WEEKS AFTER CLINIC ENCOUNTER
To assess participant perceptions of their doctor, questions 14-18 of the CAHPS Clinician & Group Survey - Adult Visit 4.0 (beta) instrument will be used. Responses are given on a 3-point scale where 1 = yes, definitely, 2 = yes, somewhat, and 3 = no. The total score of these 4 items range from 4 to 12 with lower scores indicating a more positive experience with their healthcare provider.
2 TO 3 WEEKS AFTER CLINIC ENCOUNTER
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Who is running the study

Principal Investigator
N. D.
Prof. Neal Dickert,, MD PhD
Emory University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes heart failure?

The heart muscle is harmed in many conditions. The body naturally tries to compensate for this damage. When the compensation fails, heart failure can develop.

Anonymous Patient Answer

What are the signs of heart failure?

Many symptoms of HF are non-specific. A clinical assessment of symptoms, risk factors for HF, comorbidities and underlying health are required. Physical symptoms are usually moderate or mild in patients with heart failure, however, exercise is common.

Anonymous Patient Answer

What are common treatments for heart failure?

The usual treatment for heart failure are medications, such as vasodilators, ACE inhibitors and beta blockers. Moreover, the medical record should show the treatment history of the patient and their family for at least a month, even if they are treated only for 24 h in an acute hospital ward. The usual treatment for acute decompensated heart failure (ADHF) is inotropic agents, such as (digoxin, hydralazine etc.), vasodilators, inotropes, or drugs like nitroprusside or furosemide.

Anonymous Patient Answer

Can heart failure be cured?

Current treatment options for heart failure are not curative. Future research and new treatment options are needed that reduce the impact of heart failure by improving patient well-being or curing the disease.

Anonymous Patient Answer

What is heart failure?

Heart failure is a heart condition that describes a group of disorders that substantially impair heart function. Its symptoms are fatigue, shortness of breath, and palpitations. It is estimated that it affects 2–3% of the US population; however, heart failure presents differently for different people, depending on the presence of risk factors.

Anonymous Patient Answer

How many people get heart failure a year in the United States?

The number of people who suffer heart failure in each year in the United States is estimated to be about 461,200. The mean annual incidence rate of heart failure in this survey should be the approximate rate of new cases annually, as some may be hospitalized and others may be asymptomatic and undetected. Our estimate for the number of new cases of heart failure annually in the US is similar to estimates made by the American Heart Association.

Anonymous Patient Answer

Is medication cost information typically used in combination with any other treatments?

Recent findings, medication was one of the most expensive out of all prescription medication purchases. Medications and prescription drugs were the largest purchases from the Medicare prescription out of pocket, however, there was a general distrust of medical insurance, and people seemed willing to pay out-of-pocket for prescription drugs, but not out-of-pocket for medications (especially if medications are considered 'non-medication' like blood thinners, etc.

Anonymous Patient Answer

Does heart failure run in families?

Findings from a recent study indicated that at least some forms of heart failure, at least in familial forms, seem to run in families. Thus, genetic predisposition could contribute to the occurrence of this entity.

Anonymous Patient Answer

Is medication cost information safe for people?

A minority of health services payers require detailed, comprehensive (in terms of the costs to patients) medication cost information. The majority do not. These payers should not restrict free information provided by the medical practice, and inpatient pharmacies that provide this information on the prescription should be recognized as an essential aspect of the medical delivery service to patients who would be willing to pay more for that service.

Anonymous Patient Answer

Have there been any new discoveries for treating heart failure?

There are a lot of advances that have happened in treatment of heart failure, but only a few recent developments have been of significant long-term benefit to patients.

Anonymous Patient Answer

What is the primary cause of heart failure?

Results from a recent clinical trial, the primary cause of heart failure was hypertension (40%) and ischemic heart disease (25%). It was associated with coronary heart Disease (5/10). The majority of patients were older (72%) and male (56%) and ischemic heart disease was the cause of heart failure in the male population (p=0.005).

Anonymous Patient Answer

Have there been other clinical trials involving medication cost information?

The patients who participated in the study, all of varying levels of disability, were mostly middle aged to elderly male patients at the end of their life. The patients' disease process was typically classified as either congestive heart failure, or coronary heart disease. They were all receiving medication including ACE inhibitor. A majority of the patients were taking beta blockers; however, use of ACE inhibitor or diuretic was not specified in all of the clinical studies nor in the data collected. All patients were being managed under a clinical pathway and provided with an opportunity to participate in a trial. The only data collected from these studies was the data related to medication costs. Many of the patients mentioned in the studies were using more than one medication.

Anonymous Patient Answer
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