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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01081899
Enrollment
308
Registered
2010-03-05
Start date
2009-11-30
Completion date
2012-10-31
Last updated
2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

dying patients, cancer, hospital, Liverpool Care Pathways

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.

Interventions

OTHERThe LCP-I Program

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.

Sponsors

Regional Palliative Care Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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;

Design outcomes

Primary

MeasureTime frameDescription
Quality of end-of-life care provided to dying cancer patients and their families.six months after the implementation of the LCP ProgramMeasured through the Global Scale of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001).

Secondary

MeasureTime frameDescription
quality of emotional support to family members before and after the patients' deathsix months after the implementation of the LCP ProgramMeasured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001).
coordination of caresix months after the implementation of the LCP ProgramMeasured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001).
provision of care focusing on patient's individual needssix months after the implementation of the LCP ProgramMeasured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001).
quality of communication between the healthcare professionals, patients and familiessix months after the implementation of the LCP ProgramMeasured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001).
quality of communication between hospital staff and GPssix months after the implementation of the LCP Programinterview with GPs
appropriateness of therapeutic and diagnostic proceduressix months after the implementation of the LCP ProgramTool for recording all diagnostic and therapeutic procedures effectively performed during the last 3 days of life
patient's physical well-being through a better control of physical symptomssix months after the implementation of the LCP ProgramSymptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026