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Completed

NCT Number: NCT01081899

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Research Institute

Genoa, 16132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The LCP-I Program

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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)

  6. quality of communication between hospital staff and GPs

    Time frame: six months after the implementation of the LCP Program

    interview with GPs

  7. 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

Sponsors and collaborators

Lead sponsor

Regional Palliative Care Network

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2010
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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