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Transitional Palliative Care in End-stage Heart Failure

2017年8月21日 更新者：Frances Kam Yuet WONG、The Hong Kong Polytechnic University

Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure

Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.

There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.

In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.

Hypothesis

  • there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group

研究概览

地位

完全的

条件

干预/治疗

详细说明

As described

研究类型

介入性

注册 (实际的)

84

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 香港
      • Hong Kong、香港
        • Grantham Hospital
      • Hong Kong、香港
        • Haven of Hope Hospital
      • Hong Kong、香港
        • United Christian Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Ability to speak Cantonese
  • Living within the hospital service area
  • Ability to be contacted by phone

  • Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below:

    (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy

Exclusion Criteria:

  • Discharged to nursing home or other institution
  • Inability to communicate
  • Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Usual Care + Transitional Care Model
Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership
行为的：Transitional Care Model
Symptom assessment and management, care goal setting, post-discharge support
行为的：Usual care
Usual care is the routine practice in the hospital
有源比较器：Usual Care
Usual care
行为的：Usual care
Usual care is the routine practice in the hospital

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Healthcare utilization
大体时间：up to 12 months
The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data
up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Quality of Life
大体时间：baseline, 1 month, 3 months, 6 months, 12 month
Change from baseline in quality of life on the palliative specific McGill Quality of Life Questionnaire Hong Kong version (MQOL-HK) at 1 month; change from baseline in MQOL-HK at 3 months; change from baseline in MQOL-HK at 6 months; change from baseline in MQOL-HK at 12 months
baseline, 1 month, 3 months, 6 months, 12 month
Quality of Life
大体时间：Baseline, 1 month, 3 months, 6 months, 12 months
Change from baseline in quality of life on the heart failure specific Chronic Heart Failure Questionnaire-Chinese version (CHQ) at 1 month; change from baseline in CHQ score at 3 months; change from baseline in CHQ score at 6 months; change from baseline in CHQ score at 12 months
Baseline, 1 month, 3 months, 6 months, 12 months
Functional status
大体时间：Baseline, 1 month, 3 months, 6 months, 12 months
Change from baseline in functional status on the Palliative Performance Scale (PPS) at 1 month; change from baseline in PPS at 3 months; change from baseline in PPS at 6 months; change from baseline in PPS at 12 months
Baseline, 1 month, 3 months, 6 months, 12 months
Symptom intensity
大体时间：Baseline, 1 month, 3 month, 6 month, 12 month
Change from baseline in symptom intensity on the Edmonton Symptom Assessment System (ESAS) at 1 month; change from baseline in ESAS score at 3 month; change from baseline in ESAS score at 6 month; change from baseline in ESAS score at 12 month.
Baseline, 1 month, 3 month, 6 month, 12 month
Satisfaction with care
大体时间：1 month, 3 months, 6 months, 12 months
Change from 1 month in satisfaction with care on the 15-item questionnaire developed by the principal investigator which validity confirmed by an expert panel and reported test-retest reliability of .87 (Sat-care) at 3 month; change from 1 month in Sat-care score at 6 months; change from 1 month in Sat-care score at 12 months
1 month, 3 months, 6 months, 12 months
Caregiver burden
大体时间：Baseline, 1 month, 3 months, 6 months, 12 months
Change from baseline in caregiver burden on the Zarit Caregiver Burden Scale (ZCBS) at 1 month; change from baseline in ZCBS score at 3 months; change from baseline in ZCBS score at 6 months; change from baseline in ZCBS score at 12 months
Baseline, 1 month, 3 months, 6 months, 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Hong Kong Polytechnic University

调查人员

  • 首席研究员：Frances KY Wong、The Hong Kong Polytechnic University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年1月1日

初级完成 (实际的)

2016年2月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2014年3月7日

首先提交符合 QC 标准的

2014年3月12日

首次发布 (估计)

2014年3月13日

研究记录更新

最后更新发布 (实际的)

2017年8月22日

上次提交的符合 QC 标准的更新

2017年8月21日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PolyU5492

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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