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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: The LCP-I Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The LCP-I Program.<br>The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme. | Other: The LCP-I Program<br>* 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.<br>* Other names: continuous quality Improvement Program;|
| No Intervention: standard healthcare practices<br>No specific interventions are planned in the control wards. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of end-of-life care provided to dying cancer patients and their families. | Measured through the Global Scale of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001). | six months after the implementation of the LCP Program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of communication between the healthcare professionals, patients and families | Measured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001). | six months after the implementation of the LCP Program | 
| quality of emotional support to family members before and after the patients' death | Measured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001). | six months after the implementation of the LCP Program | 
| coordination of care | Measured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001). | six months after the implementation of the LCP Program | 
| provision of care focusing on patient's individual needs | Measured through the specific Scales of the Italian version of the Toolkit After-death Bereaved Family Member Interview (Teno J, et al 2001). | six months after the implementation of the LCP Program | 
| patient's physical well-being through a better control of physical symptoms | Symptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005) | six months after the implementation of the LCP Program | 
| quality of communication between hospital staff and GPs | interview with GPs | six months after the implementation of the LCP Program | 
| appropriateness of therapeutic and diagnostic procedures | Tool for recording all diagnostic and therapeutic procedures effectively performed during the last 3 days of life | six months after the implementation of the LCP Program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dying patients, cancer, hospital, Liverpool Care Pathways