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

January 11, 2013 updated by: Regional Palliative Care Network

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • National Cancer Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The LCP-I Program.
The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme.
Other: The 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.
Other Names:
  • continuous quality Improvement Program
NO_INTERVENTION: standard healthcare practices
No specific interventions are planned in the control wards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of end-of-life care provided to dying cancer patients and their families.
Time Frame: six months after the implementation of the LCP Program
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
Time Frame: six months after the implementation of the LCP Program
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
Time Frame: six months after the implementation of the LCP Program
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
Time Frame: six months after the implementation of the LCP Program
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
Time Frame: six months after the implementation of the LCP Program
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
Time Frame: six months after the implementation of the LCP Program
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
Time Frame: six months after the implementation of the LCP Program
interview with GPs
six months after the implementation of the LCP Program
appropriateness of therapeutic and diagnostic procedures
Time Frame: six months after the implementation of the LCP Program
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Palliative Care Network

Investigators

  • Principal Investigator: Massimo Costantini, MD, National Cancer Research Institute - Genoa (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (ESTIMATE)

March 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFPS-2006-6-341619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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