Cost and Shared Decision-Making for Heart Failure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Behavioral: Medication Cost Information
* Behavioral: Heart Failure Medicines Checklist


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study utilizes a stepped wedge cluster-randomized design where study sites are assigned to transition to the intervention as recruitment milestone are met.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication checklist with cost information<br>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. | Behavioral: Medication Cost Information<br>* 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.<br>Behavioral: Heart Failure Medicines Checklist<br>* 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.<br>|
| Active Comparator: Medication checklist<br>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. | Behavioral: Heart Failure Medicines Checklist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Discussed Medication Cost | 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. | Day 1 (during clinic encounter) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Recommendation Coding System (PhyReCS) Score | 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) | 
| Length of discussion | The length of medication cost discussion will be measured in minutes, using the audio recording of the clinic encounter. | Day 1 (during clinic encounter) | 
| Helpfulness of medication checklist score | 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. | 2 to 3 weeks after clinic encounter | 
| Helpfulness of medication checklist with price information score | 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. | 2 to 3 weeks after clinic encounter | 
| Low Literacy Decisional Conflict Scale score | 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. | 2 to 3 weeks after clinic encounter | 
| Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician & Group Survey score | 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 | 
| Prescription of non-generic medications | The number of participants prescribed non-generic medications at the clinic encounter will be obtained from electronic medical records. | Day 1 (during clinic encounter) | 
| Medication persistence | 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 | 
| Clinician perceptions | Clinician perceptions will be assessed qualitatively through focus group interviews. | End of study (up to 26 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Out-of-pocket cost, Shared decision-making, Heart failure with reduced ejection fraction (HFrEF)