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Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure
Sponsor: Intermountain Health Care, Inc.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3640
Start Date
2019-12-01
Completion Date
2026-03
Last Updated
2025-05-06
Healthy Volunteers
Yes
Conditions
Interventions
Provider Focus
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.
Patient Interview
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.
PROs/Clinical Data Integration
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.
Locations (1)
Intermountain Heart Institute
Murray, Utah, United States