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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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The LCP-I Program.

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

Group Type EXPERIMENTAL

The LCP-I Program

Intervention Type 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.

standard healthcare practices

No specific interventions are planned in the control wards.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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continuous quality Improvement Program

Eligibility Criteria

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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

\- all cancer patients deceased in the ward during the evaluation period;

Exclusion Criteria

\- in the hospital another Medical Ward has already been randomised.

Individual level

\- the deceased was a relative of a professional working in the hospital.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No