The Effectiveness of the LCP in Improving End of Life Care for Dying Cancer Patients in Hospital.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Other: The LCP-I Program |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| 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. |
- 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 ] [ Designated as safety issue: No ]Measured through the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
- quality of communication between the healthcare professionals, patients and families [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]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 [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]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 [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]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 [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]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 [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]Symptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005)
- quality of communication between hospital staff and GPs [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]interview with GPs
- appropriateness of therapeutic and diagnostic procedures [ Time Frame: six months after the implementation of the LCP Program ] [ Designated as safety issue: No ]Tool for recording all diagnostic and therapeutic procedures effectively performed during the last 3 days of life
| Enrollment: | 308 |
| Study Start Date: | November 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: The LCP-I Program.
The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme.
|
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.
Other Name: continuous quality Improvement Program
|
|
No Intervention: standard healthcare practices
No specific interventions are planned in the control wards.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Italy | |
| National Cancer Research Institute | |
| Genoa, Italy, 16132 | |
| Principal Investigator: | Massimo Costantini, MD | National Cancer Research Institute - Genoa (Italy) |
More Information
No publications provided by Regional Palliative Care Network
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Regional Palliative Care Network |
| ClinicalTrials.gov Identifier: | NCT01081899 History of Changes |
| Other Study ID Numbers: | RFPS-2006-6-341619 |
| Study First Received: | March 4, 2010 |
| Last Updated: | January 11, 2013 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Regional Palliative Care Network:
|
dying patients cancer hospital Liverpool Care Pathways |
ClinicalTrials.gov processed this record on May 16, 2013