The Effectiveness of the LCP in Improving End of Life Care for Dying Cancer Patients in Hospital.

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

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.

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.

The LCP-I Program is a continuous quality Improvement Program of end-of-life care implemented by a Palliative Care Unit (PCU) in a hospital Medical Ward.

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

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

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

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

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

Symptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005)

Tool for recording all diagnostic and therapeutic procedures effectively performed during the last 3 days of life

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.

Costantini M, Romoli V, Leo SD, Beccaro M, Bono L, Pilastri P, Miccinesi G, Valenti D, Peruselli C, Bulli F, Franceschini C, Grubich S, Brunelli C, Martini C, Pellegrini F, Higginson IJ; Liverpool Care Pathway Italian Cluster Trial Study Group. Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial. Lancet. 2014 Jan 18;383(9913):226-37. doi: 10.1016/S0140-6736(13)61725-0. Epub 2013 Oct 16.

Costantini M, Ottonelli S, Canavacci L, Pellegrini F, Beccaro M; LCP Randomised Italian Cluster Trial Study Group. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial. BMC Health Serv Res. 2011 Jan 24;11:13. doi: 10.1186/1472-6963-11-13.