跳至主要内容
临床试验/NCT01081899
NCT01081899已完成3 期

The Effectiveness of the Liverpool Care Pathway in Improving End of Life Care for Dying Cancer Patients in Hospital. A Cluster Randomised Trial.

Regional Palliative Care Network2 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
308
试验地点
2
主要终点
Quality of end-of-life care provided to dying cancer patients and their families.

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices.

详细描述

The availability of an effective quality improvement program for the care of dying patients in hospitals is particularly relevant to the healthcare scenario. The LCP-I Program has provided enough evidence to justify a randomized trial to evaluate its effectiveness.

Although the core objective of the LCP-I is improving the quality of end of life care for dying patients, the Program targets the healthcare professionals working on the hospital ward. The only feasible method of assessing the effectiveness of this Program is by performing a cluster trial, where hospital wards are randomized to receive (or not to receive) the implementation of the LCP-I Program.

Pairs of eligible medical wards from different hospitals will be randomized to receive the experimental intervention (the LCP-I Program) or no intervention at all for the duration of the study.

The LCP-I Program will be implemented in the experimental ward by the PCU. The LCP-I Program has a duration of 6 months from the beginning of the intensive training. No intervention will be implemented in the control ward until the end of the evaluation.

Quality of end-of-life care will be evaluated for each pair of randomized wards for all eligible cancer deaths occurring in the six months after the conclusion of the LCP-I Program in the experimental ward.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • "Medical", "General Medical" or "Internal Medical" ward;
  • at least 25 cancer deaths on the ward per year;
  • consent from the Hospital and Ward Management to participate to the trial;
  • consent from an expert and skills-trained PCU to implement the LCP-I Program

排除标准

  • in the hospital another Medical Ward has already been randomised.
  • Individual level
  • Inclusion Criteria:
  • all cancer patients deceased in the ward during the evaluation period;
  • Exclusion Criteria:
  • the deceased was a relative of a professional working in the hospital.

结局指标

主要结局

Quality of end-of-life care provided to dying cancer patients and their families.

时间窗: six months after the implementation of the LCP Program

Measured through the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).

次要结局

  • quality of communication between the healthcare professionals, patients and families(six months after the implementation of the LCP Program)
  • quality of emotional support to family members before and after the patients' death(six months after the implementation of the LCP Program)
  • coordination of care(six months after the implementation of the LCP Program)
  • provision of care focusing on patient's individual needs(six months after the implementation of the LCP Program)
  • patient's physical well-being through a better control of physical symptoms(six months after the implementation of the LCP Program)
  • quality of communication between hospital staff and GPs(six months after the implementation of the LCP Program)
  • appropriateness of therapeutic and diagnostic procedures(six months after the implementation of the LCP Program)

研究者

发起方
Regional Palliative Care Network
申办方类型
Other
责任方
Sponsor

研究点 (2)

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