Terminal IllnessQUALI-PALLINCT02814682
Elaboration of a Multi-dimensional Indicator of Quality in Palliative Care
An observational study of Terminal Illness and End of Life, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to elaborate a multi-dimensional indicator of the quality in palliative care for patients of end-of-life. The study will, as secondary objectives: elaborate in a standard manner one set of indicators of organization and inner working of a palliative care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness, End of Life
- How many people
- 560 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to May 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population: * Patients on palliative care phase, * Family members or other people present beside patients, * Caregivers (physicians, nurses) who care patients.
Who may be able to join
- Aged ≥ 18 years.
- Patient with serious progressive illness and in terminal phase (life expectancy < 3 months): OMS stage is 3 or 4, regardless of etiology.
- Patient informed their diagnosis or not.
- Hospitalized at the moment of inclusion in one of the following care settings: palliative care unit, identified bed or non-identified bed in a care department of short stay.
- No-oppose to participate to the study, by patients, their families or trusted person.
Who cannot join
- Patient has difficulties in reading, writing or understanding french language, also their family.
- Hospitalization in the palliative care setting < 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to elaborate a multi-dimensional indicator of the quality in palliative care for patients of end-of-life.
The study will, as secondary objectives:
- elaborate in a standard manner one set of indicators of organization and inner working of a palliative care setting.
- compare according to these indicators, the qualities of 3 types of palliative care: palliative care unit in hospitals, specified identified bed for palliative care patients and non-specified bed.
- explore the relationship between organizational aspects and results in term of burden.
Read the detailed description
A multicentric study aims on quality of palliative care and will be conducted in three types of 7 palliative care settings: two hospices, two hospital-based palliative care units and three medical units where a mobile palliative care team intervenes.
- Conditions
- Terminal Illness, End of Life
- Keywords
- palliative care, quality, indicator, multi-dimensional
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire for patients
A questionnaire has been elaborated beforehand by the study will be answered by patients in order to evaluate quality such as reliability, dimensionality and validity against criterion.
Measured: From date of enrollment until the date of first documented leaving from hospital or date of death, whichever came first, up to 2 years
Indicator for medical files
The indicators have been defined by the study, in order to evaluate quality of medical files, such as completeness and discriminatory capacity.
Measured: At enrollment
Indicator for caregivers
In order to evaluate quality such as reliability and dimensionality, a questionnaire will be answered by caregivers:
- the Nursing Stress Scale (NSS).
Measured: From date of enrollment until the date of receiving questionnaire returned by caregiver, up to 2 years
Questionnaire for families
A questionnaire has been elaborated, will be answered by patients' families.
Measured: From date of enrollment until the date of receiving questionnaire sent by family, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric GUIRIMAND, MD, Study chair, Maison Médicale Jeanne GarnierPhilippe Aegerter, MD, PhD, Study director, Hôpital Ambroise Paré, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814682
- Sponsor's protocol ID
- NI 10052
- Other IDs
- PHRQ0904
- Acronym
- QUALI-PALLI
- Status last verified
- Nov 2014
- First submitted
- 1 Apr 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guirimand F, Martel-Samb P, Guy-Coichard C, Picard S, Devalois B, Copel L, Abel A, Ghadi V; QUALI-PALLI group and Philippe Aegerter. Development and validation of a French questionnaire concerning patients' perspectives of the quality of palliative care: the QUALI-PALLI-Patient. BMC Palliat Care. 2019 Feb 11;18(1):19. doi: 10.1186/s12904-019-0403-z.
PubMed 30744627
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration of a Multi-dimensional Indicator of Quality in Palliative Care
- ClinicalTrials.gov ID
- NCT02814682
- Acronym / sponsor ID
- QUALI-PALLI / NI 10052
- Conditions
- Terminal Illness, End of Life
- Keywords
- palliative care, quality, indicator, multi-dimensional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jun 2016 (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.
The purpose of this study is to elaborate a multi-dimensional indicator of the quality in palliative care for patients of end-of-life.
The study will, as secondary objectives:
- elaborate in a standard manner one set of indicators of organization and inner working of a palliative care setting.
- compare according to these indicators, the qualities of 3 types of palliative care: palliative care unit in hospitals, specified identified bed for palliative care patients and non-specified bed.
- explore the relationship between organizational aspects and results in term of burden.
Detailed description
A multicentric study aims on quality of palliative care and will be conducted in three types of 7 palliative care settings: two hospices, two hospital-based palliative care units and three medical units where a mobile palliative care team intervenes.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: * Patients on palliative care phase, * Family members or other people present beside patients, * Caregivers (physicians, nurses) who care patients.
Key inclusion criteria (5 listed)
- Aged ≥ 18 years.
- Patient with serious progressive illness and in terminal phase (life expectancy < 3 months): OMS stage is 3 or 4, regardless of etiology.
- Patient informed their diagnosis or not.
- Hospitalized at the moment of inclusion in one of the following care settings: palliative care unit, identified bed or non-identified bed in a care department of short stay.
- No-oppose to participate to the study, by patients, their families or trusted person.
Key exclusion criteria (2 listed)
- Patient has difficulties in reading, writing or understanding french language, also their family.
- Hospitalization in the palliative care setting < 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire for patients
Time frame: From date of enrollment until the date of first documented leaving from hospital or date of death, whichever came first, up to 2 years
A questionnaire has been elaborated beforehand by the study will be answered by patients in order to evaluate quality such as reliability, dimensionality and validity against criterion.
Indicator for medical files
Time frame: At enrollment
The indicators have been defined by the study, in order to evaluate quality of medical files, such as completeness and discriminatory capacity.
Indicator for caregivers
Time frame: From date of enrollment until the date of receiving questionnaire returned by caregiver, up to 2 years
In order to evaluate quality such as reliability and dimensionality, a questionnaire will be answered by caregivers: - the Nursing Stress Scale (NSS).
Questionnaire for families
Time frame: From date of enrollment until the date of receiving questionnaire sent by family, up to 2 years
A questionnaire has been elaborated, will be answered by patients' families.
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 28 Jun 2016.
- Derived from this study: PubMed 30744627Guirimand F, Martel-Samb P, Guy-Coichard C, Picard S, Devalois B, Copel L, Abel A, Ghadi V; QUALI-PALLI group and Philippe Aegerter. Development and validation of a French questionnaire concerning patients' perspectives of the quality of palliative care: the QUALI-PALLI-Patient. BMC Palliat Care. 2019 Feb 11;18(1):19. doi: 10.1186/s12904-019-0403-z.
- Individual participant dataSharing planned: No
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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.
Frédéric GUIRIMAND, MD study chair
Maison Médicale Jeanne Garnier
Philippe Aegerter, MD, PhD study director
Hôpital Ambroise Paré, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Terminal Illness and End of Life, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Questionnaire for patients (time frame: From date of enrollment until the date of first documented leaving from hospital or date of death, whichever came first, up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814682, which also lists 1 linked publication.
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 28 Jun 2016.