Evaluation of End of Life Quality of Care

Quality of Life Clinical Trial

— EFIQUAVIE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775304
• Other study ID #: NI10031
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 15, 2015

Study information

• Verified date: March 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: December 15, 2015
• Est. primary completion date: December 15, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End of Life Care
• Neoplasm Malignant
• Neoplasms
• Quality of Life

Locations

Country	Name	City	State
France	APHP Hôpital Cochin	Paris
France	APHP Hôpital Européen Georges Pompidou	Paris
France	APHP Hôpital Henri Mondor	Paris
France	Institut Curie	Paris	Ile De France
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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