Elaboration of a Multi-dimensional Indicator of Quality in Palliative Care

End of Life Clinical Trial

— QUALI-PALLI  

Official title:

Elaboration of a Multi-dimensional Indicator of Quality in Palliative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814682
• Other study ID #: NI 10052
• Secondary ID: PHRQ0904
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: June 23, 2016
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical 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.

• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient has difficulties in reading, writing or understanding french language, also their family.

• Hospitalization in the palliative care setting < 48 hours.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• End of Life
• Terminal Illness

Locations

Country	Name	City	State
France	Maison Médicale Jeanne Garnier	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of enrollment until the date of first documented leaving from hospital or date of death, whichever came first, up to 2 years	No
Primary	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.	At enrollment	No
Primary	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).	From date of enrollment until the date of receiving questionnaire returned by caregiver, up to 2 years	No
Primary	Questionnaire for families	A questionnaire has been elaborated, will be answered by patients' families.	From date of enrollment until the date of receiving questionnaire sent by family, up to 2 years	No