NCT01470625

Brief Summary

This is a before-after phase II study, according to the Medical Research Council framework, investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient (LCP) in 5 Ligurian hospices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

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

September 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

October 21, 2011

Last Update Submit

January 11, 2013

Conditions

Keywords

DyingPatientsHospiceLiverpool Care Pathways

Outcome Measures

Primary Outcomes (1)

  • feasibility of LCP implementation

    measured as proportion of hospices that complete the experimental phase of introducing the LCP Program and maintain the program in the 6 months subsequent the process of experimental LCP implementation

    6 months after the end of LCP implementation

Secondary Outcomes (9)

  • quality of information provided to patients and to family

    2-4 months after the patient's death

  • Level of advanced care planning among patients

    2 - 4 months after the patient's death

  • Provision of care focusing on patient's individual needs.

    2 - 4 months after the patient's death

  • Quality of emotional support to family members before an after the patient's death

    2 - 4 months after the patient's death

  • Level of care coordination

    2 - 4 months after the patient's death

  • +4 more secondary outcomes

Study Arms (1)

LCP Program

OTHER

The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice

Other: LCP Program

Interventions

The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice

LCP Program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients deceased in the hospice during the evaluation period
  • Approval of ethics committee

You may not qualify if:

  • Prior use of LCP in the hospice
  • Deceased was a relative of a hospice member of staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospice ASL 4

Chiavari, Genova, 16000, Italy

Location

Hospice Gigi Ghirotti "Albaro"

Genova, 16000, Italy

Location

Hospice Gigi Ghirotti "Bolzaneto"

Genova, 16000, Italy

Location

Hospice ASL1 Liguria

Imperia, 18014, Italy

Location

CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia

Savona, 171000, Italy

Location

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Massimo Costantini

    IRCCS AOU San Martino- IST

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

November 11, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations