Cost and Shared Decision-Making for Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793880
• Other study ID #: STUDY00002215
• Secondary ID: 1R01HS026081-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: December 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: November 15, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory Clinic, Emory University Hospital	Atlanta	Georgia
United States	Emory St. Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	UCHealth Heart and Vascular Center Clinics	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	Clinician perceptions	Clinician perceptions will be assessed qualitatively through focus group interviews.	End of study (up to 26 months)