Impact of an Early Palliative Approach (LATAREA-IV)

June 19, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Impact of a Computer-assisted Tool to Help Reflection on the Decision to Withhold or to Withdraw Treatments for Surgical Patients in Intensive Care Units

Rationale: Medicalized end of life rose profound society questions and debates. Major Laws and scientific society recommendations emerged from those reflections. These texts help withholding/withdrawing life-sustaining treatments allowing a palliative approach and to favor comfort treatments for end of life patients.

Main Objective: To evaluate the impact of a procedure to support reflection on the level of therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after having identified vulnerability criteria early.

Secondary objectives: To assess the usual care of the control group and the impact of the procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical patients concerned by a palliative strategy; the impact of an incentive approach on length of mechanical ventilation and length of stay in the ICU; To measure the extent of information collected concerning the collegial process; the impact of the procedure on caregivers' satisfaction; To count the number of identified conflicts Study type: Prospective, controlled, cluster randomized study of routine care Purpose: Study the implementation of the Act "Leonetti" released on 22 April 2005 calling for a compassionate approach and palliative care for patients at end of life.

Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period Non-inclusion criteria: Patients hospitalized less than 24h; non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead patients (at the time of admission) Primary endpoint: Rate of deaths with palliative strategy (withholding or withdrawing treatments) Randomization process: each center is randomized adjusting on type of ICU (medical, surgical, mixed) and number of annual hospitalization volume.

  • Control group: ICU usual care
  • Intervention group: vulnerability criteria lead to reflection on level of therapeutic involvement, with the help of a written guide.

Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each time therapeutic strategy will change. Additional data will be collected for the intervention group according to the initial presence or the later apparition of predefined criteria, a standardized reflection procedure will start helped by the implementation of a guide for collegial approach and decision making.

Length: 30 months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92 150
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period
  • No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline

Exclusion Criteria:

  • Patients admitted legally dead or brain-dead

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
the centres applies their usual practices
Other: Group B
strategy promoting early consideration and collegiate vulnerability of patients
Other: strategy promoting early consideration and collegiate vulnerability of patients
One day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants dead with palliative strategy
Time Frame: From ICU hospitalization to 6 months after inclusion
Rate of death with collegial process and withdrawing/withholding treatment
From ICU hospitalization to 6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of the procedure according to ICU type
Time Frame: From ICU hospitalization to 6 months after inclusion
From ICU hospitalization to 6 months after inclusion
Characteristics of surgical patients concerned by a palliative strategy
Time Frame: From ICU hospitalization to 6 months after inclusion
From ICU hospitalization to 6 months after inclusion
Impact of an incentive approach on length of mechanical ventilation and length of stay in the ICU.
Time Frame: From ICU hospitalization to 6 months after inclusion
From ICU hospitalization to 6 months after inclusion
Extent of information collected concerning the collegial process
Time Frame: From ICU hospitalization to 6 months after inclusion
From ICU hospitalization to 6 months after inclusion
Impact of the procedure on caregivers' satisfaction
Time Frame: From ICU hospitalization to 6 months after inclusion
From ICU hospitalization to 6 months after inclusion
Number of identified conflicts
Time Frame: From ICU hospitalization to 6 months after inclusion
From ICU hospitalization to 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Edouard FERRAND, MD, Hôpital FOCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K071203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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