An observational study in Heart Failure, sponsored by Intermountain Health Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Intermountain Health Care, Inc. · Observational
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.
The primary endpoint of this study is the determination of the feasibility and efficiency of integrating routine PRO assessments into the clinical care of patients treated for HF. To reach this, three groups will be involved in the study.
Provider Focus Group (n = 40):
Following obtaining their agreement to participate, the Providers will be given a date, time, and venue for his/her participation in the focus group and will meet for one hour. An agenda and script for the conduct of the focus group session will be developed by a trained moderator. The focus groups will be conducted by a member of the research team. Data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of patient-reported outcomes (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 12 month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care.
Patient Interview Group (n = 100):
Following obtaining agreement to be interviewed, 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 left ventricular assist device (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.
PROs/Clinical Data Integration Group (n = 3500):
The patients' electronic medical records will be reviewed and protocol-required information will be obtained. PRO capture will be expanded in a large population of patients across the continuum of HF patients. A plan has been developed that will integrate PRO scores into their medical records. Information will be obtained from 2 instruments (Kansas City Cardiomyopathy Questionnaire (KCCQ12) and NIH Patient Reported Outcomes Measurement Information System (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 during the study period. Patient information will be stored in a secure research database. The data will be used to build prognostic models of 1-year survival with favorable quality of life in patients with various forms of heart failure.
No follow-up visits will be required for the PROs/Clinical Data Integration Group. All protocol-required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study.
Biologic Determinants of Patient Health Status in HF (n = 1000):
Subjects in the Integration Group that meet the inclusion criteria for this subject subset will be contacted in person by the Principal Investigator or his/her delegate. Subjects will be asked if they are willing to provide their blood samples.
Blood samples will be obtained approximately every six months for the duration of the study (i.e., about 4 years). Approximately 40 ml (or 2.71 tablespoons) of venous blood will be obtained on each scheduled blood draw.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 1,033 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Eligible participants in the Provider Focus Group and Patient Interview Group:
The Provider Focus Group must meet the following additional criteria:
The Patient Interview Group must meet the following additional criteria:
The PROs/Clinical Data Integration Group must meet the following criteria:
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:
Exclusion Criteria:
Provider Focus Group:
Patient Interview Group:
PROs/Clinical Data Integration Group:
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:
All heart failure providers at the participating centers will be screened as potential participants.
Other: Provider Focus
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
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
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.
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.
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.
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.
Time frame: 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.
Time frame: 4 years
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.