NCT01081899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P50-P75 for phase_3 cancer

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

March 4, 2010

Last Update Submit

January 11, 2013

Conditions

Cancer

Keywords

dying patientscancerhospitalLiverpool Care Pathways

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • quality of communication between the healthcare professionals, patients and families

    six months after the implementation of the LCP Program

  • quality of emotional support to family members before and after the patients' death

    six months after the implementation of the LCP Program

  • coordination of care

    six months after the implementation of the LCP Program

  • provision of care focusing on patient's individual needs

    six months after the implementation of the LCP Program

  • patient's physical well-being through a better control of physical symptoms

    six months after the implementation of the LCP Program

  • +2 more secondary outcomes

Study Arms (2)

The LCP-I Program.

EXPERIMENTAL

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

Other: The LCP-I Program

standard healthcare practices

NO INTERVENTION

No specific interventions are planned in the control wards.

Interventions

The LCP-I ProgramOTHER

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.

Also known as: continuous quality Improvement Program
The LCP-I Program.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • "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

You may not qualify if:

  • \- in the hospital another Medical Ward has already been randomised.
  • Individual level
  • \- all cancer patients deceased in the ward during the evaluation period;
  • \- the deceased was a relative of a professional working in the hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Research Institute

Genoa, 16132, Italy

Location

Related Publications (2)

  • Costantini M, Romoli V, Leo SD, Beccaro M, Bono L, Pilastri P, Miccinesi G, Valenti D, Peruselli C, Bulli F, Franceschini C, Grubich S, Brunelli C, Martini C, Pellegrini F, Higginson IJ; Liverpool Care Pathway Italian Cluster Trial Study Group. Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial. Lancet. 2014 Jan 18;383(9913):226-37. doi: 10.1016/S0140-6736(13)61725-0. Epub 2013 Oct 16.

    PMID: 24139708DERIVED

  • Costantini M, Ottonelli S, Canavacci L, Pellegrini F, Beccaro M; LCP Randomised Italian Cluster Trial Study Group. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial. BMC Health Serv Res. 2011 Jan 24;11:13. doi: 10.1186/1472-6963-11-13.

    PMID: 21261949DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Massimo Costantini, MD

    National Cancer Research Institute - Genoa (Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

November 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

IT(1)