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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regional Palliative Care Network
ClinicalTrials.gov Identifier:
NCT01081899
First received: March 4, 2010
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Other: The LCP-I Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by Regional Palliative Care Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measured through the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).


Secondary Outcome Measures:
  • quality of communication between the healthcare professionals, patients and families [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).

  • quality of emotional support to family members before and after the patients' death [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).

  • coordination of care [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    Measured 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 needs [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).

  • patient's physical well-being through a better control of physical symptoms [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    Symptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005)

  • quality of communication between hospital staff and GPs [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    interview with GPs

  • appropriateness of therapeutic and diagnostic procedures [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]
    Tool for recording all diagnostic and therapeutic procedures effectively performed during the last 3 days of life


Enrollment: 308
Study Start Date: November 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: continuous quality Improvement Program
No Intervention: standard healthcare practices
No specific interventions are planned in the control wards.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081899

Locations
Italy
National Cancer Research Institute
Genoa, Italy, 16132
Sponsors and Collaborators
Regional Palliative Care Network
Investigators
Principal Investigator: Massimo Costantini, MD National Cancer Research Institute - Genoa (Italy)
  More Information

No publications provided by Regional Palliative Care Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regional Palliative Care Network
ClinicalTrials.gov Identifier: NCT01081899     History of Changes
Other Study ID Numbers: RFPS-2006-6-341619
Study First Received: March 4, 2010
Last Updated: January 11, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Regional Palliative Care Network:
dying patients
cancer
hospital
Liverpool Care Pathways

ClinicalTrials.gov processed this record on October 16, 2014