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NCT04793880Completed

Cost and Shared Decision-Making for Heart Failure

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

Source: ClinicalTrials.gov · Last updated 15 Dec 2023

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
247 (actual)
First submitted
23 Feb 2021
Start date
1 Jun 2021
Primary completion date
8 Aug 2023
Lead sponsor
Emory University
NCT number
NCT04793880

What you commit to

  • Study type: Interventional
  • Participants enrolled: 247
  • From 1 Jun 2021 to the primary completion date, 8 Aug 2023
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Advanced HF therapy (LVAD or transplant or undergoing active workup or listing for these therapies; home inotrope usage)
  • Pregnancy (because many guideline-recommended drugs, including those with associated high costs, are not approved for use in pregnancy)

Lab values

  • Dialysis-dependence or glomerular filtration rate (GFR) \< 30 (due to medication contraindications)

Other

  • Patient currently in hospice care or with known life expectancy under 1 year
  • 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)

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University Hospital Midtown
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory Clinic, Emory University Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory St. Joseph's Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
UCHealth Heart and Vascular Center Clinics
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.