Abstract
BackgroundMost 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 designThis 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".DiscussionThis 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 IDRFPS-2006-6-341619Trial registrationClinicalTrials.gov Identifier: NCT01081899
Highlights
Most cancer patients still die in hospital, mainly in medical wards
This study can be interpreted as a Phase III trial according to the Medical Research Council Framework
Discussion it is widely shared that clinical practice should be, wherever possible, evidence-based, programs to improve the quality of care are often implemented without an evaluation of their effectiveness [27]
Summary
Many studies in different countries have shown the poor quality of end-of-life care delivery in hospitals. 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. Official Italian statistics on place of death are not available for Italy, but according to ISDOC survey [3], it is estimated that one third (34.6%) of cancer patients die in hospital, with broad geographical differences A number of studies carried out in different countries [5,6,7,8] have shown the poor quality of end-of-life care delivery in hospitals. The results of two Italian studies conducted in patients who died in hospital from cancer (ISDOC) and other conditions (EOLO) confirm what observed for other countries [11,12]
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