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

Regional Palliative Care Network

Status and phase: Completed; Phase 3

Conditions: Cancer

Treatments: Other: The LCP-I Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01081899

RFPS-2006-6-341619

Details and patient eligibility

About

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.

Full 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.

Enrollment: 308 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

The LCP-I Program.

Experimental group

Description:

The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme.

Treatment:

Other: The LCP-I Program

standard healthcare practices

No Intervention group

Description:

No specific interventions are planned in the control wards.