Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure

Prior treatment

• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study

Other illness

• Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial
• Other conditions that in the opinion of the Principal Investigator may compromise the quality of the clinical trial
• Patients without heart failure

Other

• Provider Focus Group:
• The provider is not interested or is unable to participate in the focus group
• The Principal Investigator determines that the provider is not eligible for this research study
  • Patient Interview Group:
• The patient is not willing to be interviewed
• The Principal Investigator determines that the proposed patient is not eligible for this research study
  • PROs/Clinical Data Integration Group:
• The Principal Investigator determines that the proposed patient is not eligible for this research study
  • A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be invited to provide a blood sample for the purpose of examining the biological determinants of patient health status in HF, except the following:
• Patients who are not interested in providing blood samples
• Patients with contraindications to blood draws

• Eligible participants in the Provider Focus Group and Patient Interview Group:
• Male or female \> 18 years of age
• Ability to understand and provide agreement to participation, which must be obtained prior to initiation of any study procedures
• Willing and able to comply with the protocol requirements and schedule of evaluations
  • The Provider Focus Group must meet the following additional criteria:
• Heart failure providers, including cardiologists, cardiothoracic surgeons, physician assistants, nurse practitioners, nurses, and medical assistants.
• They are members of the University of Utah and/or Intermountain Medical Center Heart Failure Teams.
  • The Patient Interview Group must meet the following additional criteria:
• Documentation of heart failure with reduced ejection fraction (\<50%) or heart failure with preserved ejection fraction (\>50%)
• The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah
• Ability to complete PROs, including the KCCQ12 and PROMIS
• Ability to complete a telephone interview
  • The PROs/Clinical Data Integration Group must meet the following criteria:
• Male or female \> 18 years of age
• Documentation of heart failure with reduced ejection fraction (\<50%) or heart failure with preserved ejection fraction (\>50%)
• The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah
• No other inclusion criteria are required for this group because study-required information will be obtained from electronic medical records and will not require direct patient contact.
  • A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be invited to provide a blood sample for the purpose of examining the biological determinants of patient health status in HF, provided they meet the following criteria:
• Age \> 18
• Documentation of heart failure with reduced ejection fraction (\<50%) or heart failure with preserved ejection fraction (\>50%)
• The patient is followed in heart failure clinic at Intermountain Medical Center or the University of Utah
• The patient has no contraindications for blood draws