NCT02814682

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

November 1, 2014

Enrollment Period

1.4 years

First QC Date

April 1, 2016

Last Update Submit

June 23, 2016

Conditions

Keywords

palliative carequalityindicatormulti-dimensional

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population: * Patients on palliative care phase, * Family members or other people present beside patients, * Caregivers (physicians, nurses) who care patients.

You may qualify if:

  • 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.
  • No-oppose to participate to the study, by patients, their families or trusted person.

You may not qualify if:

  • Patient has difficulties in reading, writing or understanding french language, also their family.
  • Hospitalization in the palliative care setting \< 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison Médicale Jeanne Garnier

Paris, Île-de-France Region, 75015, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frédéric GUIRIMAND, MD

    Maison Médicale Jeanne Garnier

    STUDY CHAIR
  • Philippe Aegerter, MD, PhD

    Hôpital Ambroise Paré, AP-HP

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

June 28, 2016

Study Start

December 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 28, 2016

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share

Locations