Clinical trial NCT03775304: Evaluation of End of Life Quality of Care
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Malignant
Quality of Life
End of Life Care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 997
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Use of emergency services within last 30 days before death
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Patients received chemotherapy in the last 14 days of life
timeFrame: Through study completion, up to 1 year
measure: Location of death
timeFrame: Through study completion, up to 1 year
measure: Among patients who died in palliative care unit, those who died within 3 days after admission
timeFrame: Through study completion, up to 1 year
measure: Admission in intensive care unit within last 30 days before death
timeFrame: Through study completion, up to 1 year
measure: Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
state: Ile De France
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Paris
country: France
facility: APHP Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: APHP Hôpital Henri Mondor
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: