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临床试验/NCT02086305
NCT02086305已完成不适用

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

The Hong Kong Polytechnic University3 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
3
主要终点
Healthcare utilization

研究概览

简要总结

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

详细描述

As described

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Usual Care + Transitional Care Model

Experimental

Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership

干预措施: Transitional Care Model (Behavioral)

Usual Care + Transitional Care Model

Experimental

Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership

干预措施: Usual care (Behavioral)

Usual Care

Active Comparator

Usual care

干预措施: Usual care (Behavioral)

结局指标

主要结局

Healthcare utilization

时间窗: up to 12 months

The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data

次要结局

  • Quality of Life(Baseline, 1 month, 3 months, 6 months, 12 months)
  • Functional status(Baseline, 1 month, 3 months, 6 months, 12 months)
  • Symptom intensity(Baseline, 1 month, 3 month, 6 month, 12 month)
  • Satisfaction with care(1 month, 3 months, 6 months, 12 months)
  • Caregiver burden(Baseline, 1 month, 3 months, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frances Kam Yuet WONG

Professor

The Hong Kong Polytechnic University

研究点 (3)

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