End-of-LifePhase 2NCT01470625
Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region
A Phase 2 study testing LCP Program in people with End-of-Life, run by Regional Palliative Care Network at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-of-Life
- What is being tested?
- LCP Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 5 sitesItaly
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients deceased in the hospice during the evaluation period
- Approval of ethics committee
Who cannot join
- Prior use of LCP in the hospice
- Deceased was a relative of a hospice member of staff
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Hospice ASL 4
Chiavari, Genova, 16000
Hospice Gigi Ghirotti "Albaro"
Genova, 16000
Hospice Gigi Ghirotti "Bolzaneto"
Genova, 16000
Hospice ASL1 Liguria
Imperia, 18014
CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia
Savona, 171000
About this study
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.
- Conditions
- End-of-Life
- Being tested
- LCP Program
- Keywords
- Dying, Patients, Hospice, Liverpool Care Pathways
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCP ProgramOther
The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice
| Study group | Role | What they receive |
|---|---|---|
| LCP Program | Other | The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice Receives: Other: LCP Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the end of LCP implementation
Secondary outcomes (9)
quality of information provided to patients and to family
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
Measured: 2-4 months after the patient's death
Level of advanced care planning among patients
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
Measured: 2 - 4 months after the patient's death
Provision of care focusing on patient's individual needs.
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
Measured: 2 - 4 months after the patient's death
Quality of emotional support to family members before an 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
Measured: 2 - 4 months after the patient's death
Level of care coordination
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
Measured: 2 - 4 months after the patient's death
Family support levels
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
Measured: 2 - 4 months after the death of the patient
Appropriateness of therapeutic and diagnostic procedures
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
Measured: the last 3 days of life
Overall quality of care experience for patients and family
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
Measured: 2 - 4 months after the death of the patient
Quality of communication between General Practitioner and hospice
measured with a telephonic interview
Measured: an expected average of 2 months after the patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-of-LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Palliative Care Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Costantini, Study chair, IRCCS AOU San Martino- IST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470625
- Sponsor's protocol ID
- LCP-I LIG
- Status last verified
- Jan 2013
- First submitted
- 21 Oct 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region
- ClinicalTrials.gov ID
- NCT01470625
- Acronym / sponsor ID
- LCP-I LIG
- Conditions
- End-of-Life
- Keywords
- Dying, Patients, Hospice, Liverpool Care Pathways
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Regional Palliative Care NetworkUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCP Program | Other | Other: LCP ProgramThe LCP Program is continuous quality improvement program of end-of-life care implemented in hospice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients deceased in the hospice during the evaluation period
- Approval of ethics committee
Key exclusion criteria (2 listed)
- Prior use of LCP in the hospice
- Deceased was a relative of a hospice member of staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCP ProgramThe LCP Program is continuous quality improvement program of end-of-life care implemented in hospice | Other | LCP Program |
Primary outcome
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
9 secondary outcomes
quality of information provided to patients and to family
Time frame: 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
Provision of care focusing on patient's individual needs.
Time frame: 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
Level of care coordination
Time frame: 2 - 4 months after the patient's death
Family support levels
Time frame: 2 - 4 months after the death of the patient
Appropriateness of therapeutic and diagnostic procedures
Time frame: 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
Quality of communication between General Practitioner and hospice
Time frame: an expected average of 2 months after the patient's death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Costantini study chair
IRCCS AOU San Martino- IST
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCP Program in people with End-of-Life, run by Regional Palliative Care Network at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of LCP implementation (time frame: 6 months after the end of LCP implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.