Overview

This trial is active, not recruiting.

Condition criteria of vulnerability
Treatment strategy promoting early consideration and collegiate vulnerability of patients
Sponsor Assistance Publique - Hôpitaux de Paris
Start date October 2012
End date January 2014
Trial size 2750 participants
Trial identifier NCT02471976, K071203

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
the centres applies their usual practices
(Other)
strategy promoting early consideration and collegiate vulnerability of patients
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

Primary Outcomes

Measure
Number of participants dead with palliative strategy
time frame: From ICU hospitalization to 6 months after inclusion

Secondary Outcomes

Measure
Impact of the procedure according to ICU type
time frame: 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
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
Extent of information collected concerning the collegial process
time frame: 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
Number of identified conflicts
time frame: From ICU hospitalization to 6 months after inclusion

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Edouard FERRAND, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.