An interventional study of strategy promoting early consideration and collegiate vulnerability of patients in Criteria of Vulnerability, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care
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.
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
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the centres applies their usual practices
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
Number of participants dead with palliative strategy
Rate of death with collegial process and withdrawing/withholding treatment
Time frame: From ICU hospitalization to 6 months after inclusion
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
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris