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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

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 13, 2018
Last Update Posted Date December 13, 2018
Actual Study Start Date January 1, 2011
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2018)
Use of emergency services within last 30 days before death [ Time Frame: Through study completion, up to 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 12, 2018)
  • Patients received chemotherapy in the last 14 days of life [ Time Frame: Through study completion, up to 1 year ]
  • Location of death [ Time Frame: Through study completion, up to 1 year ]
  • 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 ]
  • Admission in intensive care unit within last 30 days before death [ Time Frame: Through study completion, up to 1 year ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Neoplasm Malignant
  • Quality of Life
  • End of Life Care
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2018)
997
Original Actual Enrollment Same as current
Actual Study Completion Date December 15, 2015
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03775304
Other Study ID Numbers NI10031
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2017