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

Heart Failure Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT04264845
• Study type: Observational
• Source: Intermountain Health Care, Inc.
• Status: Enrolling by invitation
• Start date: December 1, 2019
• Completion date: December 2023