Clinical trial NCT01081899: The Effectiveness of the LCP in Improving End of Life Care for Dying Cancer Patients in Hospital.
Official title: The Effectiveness of the Liverpool Care Pathway in Improving End of Life Care for Dying Cancer Patients in Hospital. A Cluster Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: dying patients
cancer
hospital
Liverpool Care Pathways
Lead sponsor: Regional Palliative Care Network
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of end-of-life care provided to dying cancer patients and their families.
timeFrame: six months after the implementation of the LCP Program
Secondary outcomes:
measure: quality of communication between the healthcare professionals, patients and families
timeFrame: six months after the implementation of the LCP Program
measure: quality of emotional support to family members before and after the patients' death
timeFrame: six months after the implementation of the LCP Program
measure: coordination of care
timeFrame: six months after the implementation of the LCP Program
measure: provision of care focusing on patient's individual needs
timeFrame: six months after the implementation of the LCP Program
measure: patient's physical well-being through a better control of physical symptoms
timeFrame: six months after the implementation of the LCP Program
measure: quality of communication between hospital staff and GPs
timeFrame: six months after the implementation of the LCP Program
measure: appropriateness of therapeutic and diagnostic procedures
timeFrame: six months after the implementation of the LCP Program
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: National Cancer Research Institute
Study officials:
affiliation: National Cancer Research Institute - Genoa (Italy)
name: Massimo Costantini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.