EFIQUAVIE: Evaluation of End of Life Quality of Care

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT03775304

Collaborator

(none)

997

Enrollment

Locations

59.4

Actual Duration (Months)

199.4

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Malignant Quality of Life End of Life Care

Study Design

Study Type:

Observational

Actual Enrollment :

997 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 15, 2015

Actual Study Completion Date :

Dec 15, 2015

Outcome Measures

Primary Outcome Measures

Use of emergency services within last 30 days before death [Through study completion, up to 1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Paris	Ile De France	France	75005
2	APHP Hôpital Cochin	Paris		France
3	APHP Hôpital Européen Georges Pompidou	Paris		France
4	APHP Hôpital Henri Mondor	Paris		France
5	Institut Gustave Roussy	Villejuif		France

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT03775304

Other Study ID Numbers:

NI10031

First Posted:

Dec 13, 2018

Last Update Posted:

Dec 13, 2018

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Death

Study Results

No Results Posted as of Dec 13, 2018