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

Phase 3
18 Years
Not Enrolling

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Trial Information

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

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.

Ward level

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

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

six months after the implementation of the LCP Program

Safety Issue:


Principal Investigator

Massimo Costantini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Research Institute - Genoa (Italy)


Italy: Ministry of Health

Study ID:




Start Date:

November 2009

Completion Date:

October 2012

Related Keywords:

  • Cancer
  • dying patients
  • cancer
  • hospital
  • Liverpool Care Pathways