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

NCT04264845 | Completed

• 1 other identifier: 1050750
• Study Type: observational
• Target: 1,033
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, open study that will utilize the following tools: survey/questionnaire research, interviews, and focus groups, and secondary/archival data analysis. In addition, a subset of selected subjects will be asked to provide blood samples to examine the biologic determinants of patient health status in heart failure (HF). This will help us understand better the biomarkers or genetic factors that may cause differences in patient quality of life.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Time necessary for PRO completion by patients

  It is believed that data entry requirement below 10 minutes is conducive to patient participation and will not interfere with clinic flow. This will me monitored throughout the trial.

  4 years

• Completion rate among eligible patients

  PRO completion rate will be closely monitored throughout the study. It is anticipated that the completion rate will exceed 80% and will be sustainable over time.

  4 years

Study Arms (3)

Provider Focus Group

All heart failure providers at the participating centers will be screened as potential participants.

Other: Provider Focus

Patient Interview Group

Patients with heart failure who are seen in the heart failure outpatient clinics at the participating centers will be screened for this study. The Principal Investigator will confirm the presence of heart failure based on established and agreed criteria. A real world, diverse population ranging from patients with milder forms of HF to the most advanced disease will be included in this study and allow the researchers to validate the prognostic models in larger, regionally diverse populations to better define the comparative effectiveness of alternative treatments in patients with different risk profiles.

Other: Patient Interview

PROs/Clinical Data Integration Group

Patients with heart failure who are seen in the heart failure outpatient clinics at the participating centers will be screened for this study. The Principal Investigator will confirm the presence of heart failure based on established and agreed criteria. A real world, diverse population ranging from patients with milder forms of HF to the most advanced disease will be included in this study and allow the researchers to validate the prognostic models in larger, regionally diverse populations to better define the comparative effectiveness of alternative treatments in patients with different risk profiles. This group includes a sub-study of patients providing blood samples.

Other: PROs/Clinical Data Integration

Interventions

Provider Focus OTHER

The provider focus groups will be conducted and data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of PROs and acceptability of PRO data in routine clinical care. A formal provider training program will be designed and implemented by a subject matter expert. The focus group session will be repeated at 12 months, with the 12month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care.

Provider Focus Group

Patient Interview OTHER

A trained professional interviewer will conduct a one-time, one-hour, semi-structured telephone interview of each subject to better understand patient experiences with HF, the treatment process and quality of life determinants. Two semistructured interviews will be conducted with the first 30 patients who have had LVAD therapy (of the 100 patients who agreed to be interviewed), before and 12 months after device implantation. The goal of these interviews will be to describe patient experiences with LVAD therapy, examine factors influencing quality of life, and determine whether currently available PRO tools are likely to capture the intended experiences in HF as they relate to LVAD therapy.

Patient Interview Group

PROs/Clinical Data Integration OTHER

A plan has been developed that will integrate PRO scores into patient medical records. Information will be obtained from 2 instruments (KCCQ12 and NIH PROMIS) that are routinely administered as part standard of care. PRO and clinical data will be obtained from electronic medical records of patients seen in the heart failure clinic. All required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study.

PROs/Clinical Data Integration Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All heart failure providers at the Intermountain Medical Center are potential participants in the Provider Focus Group. Patients with heart failure who are seen in the HF outpatient clinics at Intermountain Medical Center are potential participants in the Patient Interview Group or the PROs/Clinical Data Integration Group.

You may qualify if:

• 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%)

You may not qualify if:

• 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
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
• 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
• The Principal Investigator determines that the proposed patient is not eligible for this research study
• PROs/Clinical Data Integration Group:
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
• Other conditions that in the opinion of the Principal Investigator may compromise the quality of the clinical trial
• 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 without heart failure

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Heart Institute

Murray, Utah, 84143, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Abdallah G Kfoury, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: December 1, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 14, 2026

Record last verified: 2025-04

Locations

US (1)