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

Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081899
• Other study ID #: RFPS-2006-6-341619
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2010
• Last updated: January 11, 2013
• Start date: November 2009
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Regional Palliative Care Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Italy	National Cancer Research Institute	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Regional Palliative Care Network

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	quality of communication between hospital staff and GPs	interview with GPs	six months after the implementation of the LCP Program	No
Secondary	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	No