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Evaluation of End of Life Quality of Care (EFIQUAVIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775304
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.

The study was approved by the French data protection authority (CNIL) number 611273.


Condition or disease
Neoplasm Malignant Quality of Life End of Life Care

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Study Type : Observational
Actual Enrollment : 997 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : December 15, 2015



Primary Outcome Measures :
  1. Use of emergency services within last 30 days before death [ Time Frame: Through study completion, up to 1 year ]

Secondary Outcome Measures :
  1. Patients received chemotherapy in the last 14 days of life [ Time Frame: Through study completion, up to 1 year ]
  2. Location of death [ Time Frame: Through study completion, up to 1 year ]
  3. Among patients who died in palliative care unit, those who died within 3 days after admission [ Time Frame: Through study completion, up to 1 year ]
  4. Admission in intensive care unit within last 30 days before death [ Time Frame: Through study completion, up to 1 year ]
  5. Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders [ Time Frame: Through study completion, up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

Patients deceased in 2010, among all patients identified in the DRG database of the 5 participating center with a diagnosis of metastatic cancer, during at least one stay between Oct 1st, 2009 and Dec 31, 2010.

200 patients per study center were randomly selected for the study.

Criteria

Inclusion criteria

  • Patients aged ≥ 18,
  • diagnosed with advanced cancer (recruited from hospital activity data, by a stay with a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010)
  • deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from hospital activity data, or from national mortality statistics)

Exclusion Criteria:

  • diagnosis with non solid tumor (haematology)
  • age < 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775304


Locations
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France
Institut Curie
Paris, Ile De France, France, 75005
APHP Hôpital Cochin
Paris, France
APHP Hôpital Européen Georges Pompidou
Paris, France
APHP Hôpital Henri Mondor
Paris, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03775304    
Other Study ID Numbers: NI10031
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms