Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
247 participants
INTERVENTIONAL
2021-06-01
2023-11-15
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Medication checklist with cost information
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.
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.
Medication checklist
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Outpatient clinical encounter with cardiologist (virtual or in-person)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Emory University
OTHER
Responsible Party
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Neal Dickert
Associate Professor
Principal Investigators
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Neal W Dickert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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UCHealth Heart and Vascular Center Clinics
Aurora, Colorado, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory Clinic, Emory University Hospital
Atlanta, Georgia, United States
Emory St. Joseph's Hospital
Atlanta, Georgia, United States
Countries
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References
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Dickert NW, Speight CD, Balser M, Biermann H, Davis JK, Halpern SD, Ko YA, Krishnan A, Matlock DD, Mitchell AR, Moore MA, Montembeau SC, Morris AA, Noonan K, Rao BR, Scherer LD, Sloan CE, Ubel PA, Allen LA. Integrating Out-of-Pocket Costs Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction: A Stepped-Wedge Trial (POCKET-COST-HF). Circ Cardiovasc Qual Outcomes. 2025 Jan;18(1):e011273. doi: 10.1161/CIRCOUTCOMES.124.011273. Epub 2024 Dec 3.
Montembeau SC, Rao BR, Mitchell AR, Speight CD, Allen LA, Halpern SD, Ko YA, Matlock DD, Moore MA, Morris AA, Scherer LD, Ubel P, Dickert NW. Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF): A Trial Providing Out-of-Pocket Costs for Heart Failure Medications during Clinical Encounters. Am Heart J. 2024 Mar;269:84-93. doi: 10.1016/j.ahj.2023.11.013. Epub 2023 Dec 12.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY00002215
Identifier Type: -
Identifier Source: org_study_id