Clinical trial NCT04793880: Cost and Shared Decision-Making for Heart Failure
Official title: Integrating Cost Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Out-of-pocket cost
Shared decision-making
Heart failure with reduced ejection fraction (HFrEF)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-03-11
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants who Discussed Medication Cost
timeFrame: Day 1 (during clinic encounter)
Secondary outcomes:
measure: Physician Recommendation Coding System (PhyReCS) Score
timeFrame: Day 1 (during clinic encounter)
measure: Length of discussion
timeFrame: Day 1 (during clinic encounter)
measure: Helpfulness of medication checklist score
timeFrame: 2 to 3 weeks after clinic encounter
measure: Helpfulness of medication checklist with price information score
timeFrame: 2 to 3 weeks after clinic encounter
measure: Low Literacy Decisional Conflict Scale score
timeFrame: 2 to 3 weeks after clinic encounter
measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician & Group Survey score
timeFrame: 2 to 3 weeks after clinic encounter
measure: Prescription of non-generic medications
timeFrame: Day 1 (during clinic encounter)
measure: Medication persistence
timeFrame: 3 months after clinic encounter
measure: Clinician perceptions
timeFrame: End of study (up to 26 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth Heart and Vascular Center Clinics
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic, Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Neal W Dickert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: