Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region

January 11, 2013 updated by: Regional Palliative Care Network
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Genova, Italy, 16000
        • Hospice Gigi Ghirotti "Albaro"
      • Genova, Italy, 16000
        • Hospice Gigi Ghirotti "Bolzaneto"
      • Imperia, Italy, 18014
        • Hospice ASL1 Liguria
      • Savona, Italy, 171000
        • CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia
    • Genova
      • Chiavari, Genova, Italy, 16000
        • Hospice ASL 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LCP Program
The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice
The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of LCP implementation
Time Frame: 6 months after the end 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of information provided to patients and to family
Time Frame: 2-4 months after the patient's death
measured with the scale 1 (Informing and promoting shared decision making) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2-4 months after the patient's death
Level of advanced care planning among patients
Time Frame: 2 - 4 months after the patient's death
measured with the scale 2 (Encouraging advance care planning) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Provision of care focusing on patient's individual needs.
Time Frame: 2 - 4 months after the patient's death
measured with the scale 3 (Focus on individual) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Quality of emotional support to family members before an after the patient's death
Time Frame: 2 - 4 months after the patient's death
measured with the scale 4 (Attending to the emotional and spiritual needs of the family) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Level of care coordination
Time Frame: 2 - 4 months after the patient's death
measured with the scale 5 (Providing coordination of care) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the patient's death
Family support levels
Time Frame: 2 - 4 months after the death of the patient
measured with the scale 6 (Supporting the self-efficacy of the family) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the death of the patient
Appropriateness of therapeutic and diagnostic procedures
Time Frame: the last 3 days of life
measured with a specific tool in which all diagnostic and therapeutic procedures and drugs administered to the patient during the last 3 days of life are reported
the last 3 days of life
Overall quality of care experience for patients and family
Time Frame: 2 - 4 months after the death of the patient
measured with the scale 7 (Overall quality of care provided to patients and family) from the Toolkit After-death bereaved family member interview (Teno 2001). The Toolkit will be administered to non-professional caregivers 2-4 months after the patient's death
2 - 4 months after the death of the patient
Quality of communication between General Practitioner and hospice
Time Frame: an expected average of 2 months after the patient's death
measured with a telephonic interview
an expected average of 2 months after the patient's death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Massimo Costantini, IRCCS AOU San Martino- IST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCP-I LIG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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