- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470625
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
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
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Genova, Italy, 16000
- Hospice Gigi Ghirotti "Albaro"
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Genova, Italy, 16000
- Hospice Gigi Ghirotti "Bolzaneto"
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Imperia, Italy, 18014
- Hospice ASL1 Liguria
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Savona, Italy, 171000
- CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia
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Genova
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Chiavari, Genova, Italy, 16000
- Hospice ASL 4
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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
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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
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6 months after the end of LCP implementation
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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
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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
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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
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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
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2 - 4 months after the patient's death
|
|
Family support levels
Time Frame: 2 - 4 months after the death of the patient
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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
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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
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the last 3 days of life
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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
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measured with a telephonic interview
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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.
Sponsor
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
Keywords
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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