NCT04793880

Cost and Shared Decision-Making for Heart Failure

Integrating Cost Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Medication Cost Information	This version of the HFrEF medication checklist includes patient-specific estimated monthly out-of-pocket cost for each medication. TailorMed, a company designed to provide financial counseling and planning for patients, will generate the patients' out-of-pocket cost based on insurance status. The costs for non-generic HFrEF medications will then be populated onto a checklist of recommended heart failure medications so that patients and their clinicians will have this information available during their clinical encounter.
BEHAVIORAL	Heart Failure Medicines Checklist	The Heart Failure Medicines Checklist is an evidence-based medication checklist that describes guideline-recommended medications for HFrEF. This tool is used during the clinical encounter to facilitate a discussion about medications that may be most appropriate for the patient.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-08-08
• Completion: 2023-11-15
• First posted: 2021-03-11
• Last updated: 2023-12-15

Locations

4 sites across 1 country: United States