Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Patient quality of life (QOL) per the KCCQ-12 Questionnaire
研究概览
简要总结
There is evidence for the effectiveness and feasibility of the individual components of TIER-HF-PC, however there is a need to test how these individual components interact to allow the researchers to deliver TIER-HF-PC as a model of care in its totality. In the short term, this study will assess if TIER-HF-PC is beneficial for patients and caregivers.
详细描述
Timely Interventions to Enable and Reach patients with Heart Failure, and their caregivers with Palliative Care, or TIER-HF-PC, is a novel model of palliative care, designed to address gaps of palliative care delivery for patients with advanced heart failure, and their caregivers.
TIER-HF-PC is a service, led by a health coach, with support by a palliative care physician. This health coach will actively screen and monitor patients for problems, and then match the type and intensity of palliative care treatments to the severity of problems reported. The health coach will also facilitate processes for patients to initiate contact with health care providers should problems arise. This decreases the overall burden on palliative care services, enabling a scalable and more cost-effective model of care for a larger number of patients. The service will also utilize a proactive approach to care, increasing self-care skills and understanding of disease and treatment options. Earlier palliative care support will enable problems to be managed actively before they escalate into crises.
Overall aim: To test the effectiveness and implementation of the interacting components of TIER-HF-PC.
Specific aim 1a: To evaluate the impact of TIER-HF-PC on patients. The primary outcome is patient quality-of-life at 24 weeks, measured on the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes include patient anxiety, depression, coping, spirituality, healthcare utilization, survival, and cost-effectiveness of TIER-HF-PC.
Specific aim 1b: To evaluate the impact of TIER-HF-PC on caregivers. Outcomes evaluated include caregiver quality-of-life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients:
- •21 years or older and
- •able to communicate in English/Chinese/Malay and
- •be of stage C or D heart failure, as defined by American College of Cardiology/American Heart Association (ACC/AHA) classification system and
- •have functional limitation of New York Heart Association (NYHA) functional status of at least 2 or more and
- •be deemed by their cardiologist's clinical judgement to have an expected prognosis of at least 6 months survival, and
- •have had a heart failure related hospitalization event (e.g. symptomatic decompensated heart failure) within 6 months prior to recruitment and
- •have a phone that allows telecommunication.
- •Caregivers must meet all the following inclusion criteria to be eligible for the study :
- •direct, unpaid, family caregiver of the patient;
- •self-reported by the patient to be the main person to be either:
- •responsible for up to 4 hours a day of caregiving tasks
- •and/or decision maker/spokesperson with the medical team
- •Caregiver may or may not live in the same residence as the patient.
- •Caregivers must be 21 years and above.
- •Able to communicate in English/Chinese/Malay.
排除标准
- •Patients:
- •have cognitive impairment (e.g., dementia)
- •have severe, untreated, active mental illness (e.g., major depressive disorder)
- •have ventricular assist device implant.
- •have non-reversible hearing or visual loss or
- •are active drug abuser or
- •already known to a palliative care service.
- •Caregivers who meet any of the exclusion criteria at baseline will be ineligible for the study:
- •have cognitive impairment (e.g., dementia) or
- •have severe, untreated, active mental illness (e.g., major depressive disorder)
- •have non-reversible hearing or visual loss.
- •are active drug abuser or
- •are a domestic helper for the patient
研究组 & 干预措施
Regular screening with needs-guided palliative care treatments
The patient continues to receive clinical care from the cardiologist, as well as palliative care treatments that are based upon his/her reported distress and concerns.
干预措施: TIER-HF-PC (Other)
Usual Care
Patient is referred by cardiologist to palliative care.
干预措施: Usual Care (Other)
结局指标
主要结局
Patient quality of life (QOL) per the KCCQ-12 Questionnaire
时间窗: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used: It is a 12-item QOL scale, composed of physical function, symptoms, QOL, social interference and summary score will be used. The KCCQ-12 has similar validity to the 23-item version and is shorter with less respondent burden. The KCCQ-12 can be self-reported by patients or read to patients over the phone by a research coordinator. The total summary score can range from 0 to 100, with higher scores representing better health status. A clinically meaningful change is defined as a change of at least 5 points on the KCCQ. The KCCQ-12 will be measured for all participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. The frequency of our proposed KCCQ tracking is referenced from trials which used KCCQ to track longitudinal changes in QOL.
Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire
时间窗: Baseline, 8 weeks, 16 weeks, and 24 weeks.
The non cardiac specific health-related quality of life (EUROQOL EQ-5D-5L) questionnaire will also be used: This is a global assessment of the patient's quality-of-life in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, that can also be administered over the phone. The results from the 5 dimensions can be combined into a 5-digit number that describes the patient's health state utility. The EQ-5D-5L has been validated in the Singapore cardiac population.
Caregiver Quality of Life (QOL)
时间窗: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
The Singapore Caregiver Quality of Life Scale-15 (SCQOLS-15) will be used: This is a 15-item scale with 5 domains measuring QOL of life caregivers in domains: physical well-being, mental well-being, experience and meaning, impact on daily life, and financial well-being will be used. This will be measured for all caregiver participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. A difference of between 3-5 points in QOL scores could serve as a benchmark to evaluate if the difference between intervention and usual-care group is meaningful.
次要结局
- Healthcare cost analysis(Up to 24 weeks.)
- Patient anxiety and depression(Baseline, 8 weeks, 16 weeks, and 24 weeks.)
- Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)(At Week 25.)
- Acceptability of TIER-HF-PC from patient and caregiver participants - through semi-structured interviews(From Week 25 onwards, up to Week 48.)
- Patient and Caregiver Spirituality(Baseline, 8 weeks, 16 weeks, and 24 weeks.)
- Patient and Caregiver Coping(Baseline, 8 weeks, 16 weeks, and 24 weeks.)
- Assessment of impact of TIER-HF-PC on healthcare utilization(Week 1 to Week 24.)
- Survival analysis(Up to 48 weeks.)