Cost and Shared Decision-Making for Heart Failure

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.

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.

This study utilizes a stepped wedge cluster-randomized design where study sites are assigned to transition to the intervention as recruitment milestone are met.

Participants with chronic heart failure with reduced ejection fraction (HFrEF) having a clinic visit at a site randomized to the medication checklist with cost information intervention.

Participants with chronic heart failure with reduced ejection fraction (HFrEF) having a clinic visit at a site randomized to the medication checklist without 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.

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.

The number of patients whose clinic encounters involved a discussion of heart failure medication cost will be compared between study arms. The discussion of heart failure medication cost is a binary outcome of whether or not the cost of heart failure medication was discussed during the recorded clinical encounter. Any mention of heart failure medication cost will be counted as a cost discussion. The primary outcome will be analyzed using a generalized linear mixed model, with covariates including clinic site, time, age, race, sex, insurance status, and income. Potentially different intervention effects by site and patient characteristics will be examined.

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.

The length of medication cost discussion will be measured in minutes, using the audio recording of the clinic encounter.

Participants will rate how helpful they found the medication checklist to be on a 5-point scale where 1 = extremely helpful and 5 = not helpful at all.

Participants in the intervention arm will rate how helpful they found the price information included on the medication checklist to be on a 5-point scale where 1 = extremely helpful and 5 = not helpful at all.

Participant perception of the visit with their doctor will be assessed with the Low Literacy Decisional Conflict Scale (DCS). The DCS includes 10 questions which are responded to as yes (scored as 0), no (scored as 4), or unsure (scored as 2). Total scores range from 0 to 40 with low scores indicating less difficulty in understanding treatment options.

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.

The number of participants prescribed non-generic medications at the clinic encounter will be obtained from electronic medical records.

The number of participants continuing to take their prescribed medication three months after the clinic encounter will be obtained from electronic medical records.

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)

Deidentified data will be made available for sharing upon request, including survey data, electronic health record data, and transcribed interviews.

Data will be available for sharing with investigators seeking to verify analyses or to conduct additional analyses that are appropriate to the nature of these data. Data will be made available for sharing upon request, after execution of a data sharing agreement.