Evaluation of End of Life Quality of Care (EFIQUAVIE)

• ClinicalTrials.gov Identifier: NCT03775304
• Recruitment Status: Completed
• First Posted: December 13, 2018
• Last Update Posted: December 13, 2018
• Sponsor: Assistance Publique - Hôpitaux de Paris
• 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

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

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