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Published in: BMC Health Services Research 1/2011

Open Access 01-12-2011 | Study protocol

The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial

Authors: Massimo Costantini, Simona Ottonelli, Laura Canavacci, Fabio Pellegrini, Monica Beccaro, the LCP Randomised Italian Cluster Trial Study Group

Published in: BMC Health Services Research | Issue 1/2011

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Abstract

Background

Most cancer patients still die in hospital, mainly in medical wards. Many studies in different countries have shown the poor quality of end-of-life care delivery in hospitals. The Program "Liverpool Care Pathway for the dying patient" (LCP), developed in the UK to transfer the hospice model of care into hospitals and other care settings, is a complex intervention to improve the quality of end-of-life care. The results from qualitative and quantitative studies suggest that the LCP Program can improve significantly the quality of end-of-life care delivery in hospitals, but no randomised trial has been conducted till now.

Methods and design

This is a randomized cluster trial, stratified by regions and matched for assessment period. Pairs of eligible medical wards from different hospitals will be randomized to receive the LCP-I Program or no intervention until the end of the trial. The LCP-I Program will be implemented by a Palliative Care Unit.
The assessment of the end-points will be performed for all cancer deaths occurred in the six months after the end of the LCP-I implementation in the experimental wards and, in the same period of time, in the matched control wards. The primary end-point is the overall quality of end-of-life care provided on the ward to dying cancer patients and their families, assessed using the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview".

Discussion

This study can be interpreted as a Phase III trial according to the Medical Research Council Framework. In this study, the effectiveness of a fully defined intervention is assessed by comparing the distribution of the endpoints in the experimental and in the control arm.

Research ID

RFPS-2006-6-341619

Trial registration

ClinicalTrials.gov Identifier: NCT01081899
Appendix
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Metadata
Title
The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial
Authors
Massimo Costantini
Simona Ottonelli
Laura Canavacci
Fabio Pellegrini
Monica Beccaro
the LCP Randomised Italian Cluster Trial Study Group
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2011
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-11-13

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