Cost and Shared Decision-Making for Heart Failure

NCT04793880 | Completed

• 2 other identifiers: STUDY000022151R01HS026081-01
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Heart Failure

Keywords

Out-of-pocket cost; Shared decision-making; Heart failure with reduced ejection fraction (HFrEF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Physician Recommendation Coding System (PhyReCS) Score

  Day 1 (during clinic encounter)

• Length of discussion

  Day 1 (during clinic encounter)

• Helpfulness of medication checklist score

  2 to 3 weeks after clinic encounter

• Helpfulness of medication checklist with price information score

  2 to 3 weeks after clinic encounter

• Low Literacy Decisional Conflict Scale score

  2 to 3 weeks after clinic encounter

Study Arms (2)

Medication checklist with cost information

EXPERIMENTAL

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; Behavioral: Heart Failure Medicines Checklist

Medication checklist

ACTIVE COMPARATOR

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

Interventions

Medication Cost Information BEHAVIORAL

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.

Medication checklist with cost information

Heart Failure Medicines Checklist BEHAVIORAL

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; Medication checklist with cost information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HFrEF (ejection fraction \< 40%)
• Outpatient clinical encounter with cardiologist (virtual or in-person)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (4)

UCHealth Heart and Vascular Center Clinics

Aurora, Colorado, 80045, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic, Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Related Publications (2)

• 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.

  PMID: 39624892 DERIVED

• 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.

  PMID: 38096946 DERIVED

Study Officials

• Neal W Dickert, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 11, 2021
• Study Start: June 1, 2021
• Primary Completion: August 8, 2023
• Study Completion: November 15, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available one year after publication of the main results.
• Access Criteria: 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.

Locations

US (4)