Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,033
- 试验地点
- 2
- 主要终点
- Completion rate among eligible patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Patients with contraindications to blood draws
研究组 & 干预措施
Provider Focus Group
All heart failure providers at the participating centers will be screened as potential participants.
干预措施: Provider Focus (Other)
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.
干预措施: Patient Interview (Other)
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.
干预措施: PROs/Clinical Data Integration (Other)
结局指标
主要结局
Completion rate among eligible patients
时间窗: 4 years
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 necessary for PRO completion by patients
时间窗: 4 years
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.
次要结局
未报告次要终点