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

March 4, 2010
January 11, 2013
November 2009
October 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01081899 on ClinicalTrials.gov Archive Site
  • 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
  • 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, brethlessness 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
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cancer
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
  • Experimental: The LCP-I Program.
    The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme.
    Intervention: Other: The LCP-I Program
  • No Intervention: standard healthcare practices
    No specific interventions are planned in the control wards.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
October 2012
October 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01081899
RFPS-2006-6-341619
No
Regional Palliative Care Network
Regional Palliative Care Network
Not Provided
Principal Investigator: Massimo Costantini, MD National Cancer Research Institute - Genoa (Italy)
Regional Palliative Care Network
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP