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

Phase 3

Completed

• Conditions: Cancer
• Interventions: Other: The LCP-I Program

• Registration Number: NCT01081899
• Lead Sponsor: Regional Palliative Care Network

Brief 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The LCP-I Program.	The LCP-I Program	The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme.

Primary Outcome Measures

Name	Time	Method
Quality of end-of-life care provided to dying cancer patients and their families.	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 Outcome Measures

Name	Time	Method
quality of communication between the healthcare professionals, patients and families	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).
quality of emotional support to family members before and after the patients' death	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).
coordination of care	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).
provision of care focusing on patient's individual needs	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).
patient's physical well-being through a better control of physical symptoms	six months after the implementation of the LCP Program	Symptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005)
quality of communication between hospital staff and GPs	six months after the implementation of the LCP Program	interview with GPs
appropriateness of therapeutic and diagnostic procedures	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

Trial Locations

Locations (1)

National Cancer Research Institute; 🇮🇹 Genoa, Italy