Elaboration of a Multi-dimensional Indicator of Quality in Palliative Care (QUALI-PALLI)

June 23, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

560

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

  • France
    • Ile de France
      • Paris, Ile de France, France, 75015
        • Maison Médicale Jeanne Garnier

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 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

  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
At enrollment
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).
From date of enrollment until the date of receiving questionnaire returned by caregiver, up to 2 years
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.
From date of enrollment until the date of receiving questionnaire sent by family, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Frédéric GUIRIMAND, MD, Maison Médicale Jeanne Garnier
  • Study Director: Philippe AEGERTER, MD, PhD, Hôpital Ambroise Paré, AP-HP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI 10052
  • PHRQ0904 (Other Identifier: The French Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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