Evaluation of End of Life Quality of Care (EFIQUAVIE)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Neoplasm Malignant; End of Life Care

• Study Type: Observational
• Enrollment (Actual): 997

Contacts and Locations

Study Locations

• France
  • Paris, France
    • APHP Hôpital Cochin
  • Paris, France
    • APHP Hôpital Européen Georges Pompidou
  • Paris, France
    • APHP Hôpital Henri Mondor
  • Villejuif, France
    • Institut Gustave Roussy
  • Ile De France
    • Paris, Ile De France, France, 75005
      • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Use of emergency services within last 30 days before death	Through study completion, up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 15, 2015
• Study Completion (Actual): December 15, 2015

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Death
• Other Study ID Numbers: NI10031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No