Impact of an Early Palliative Approach

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Criteria of Vulnerability

Intervention / Treatment
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* Other: strategy promoting early consideration and collegiate vulnerability of patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>the centres applies their usual practices | |
| Other: Group B<br>strategy promoting early consideration and collegiate vulnerability of patients | Other: strategy promoting early consideration and collegiate vulnerability of patients<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the procedure according to ICU type |  | From ICU hospitalization to 6 months after inclusion | 
| Characteristics of surgical patients concerned by a palliative strategy |  | 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. |  | From ICU hospitalization to 6 months after inclusion | 
| Extent of information collected concerning the collegial process |  | From ICU hospitalization to 6 months after inclusion | 
| Impact of the procedure on caregivers' satisfaction |  | From ICU hospitalization to 6 months after inclusion | 
| Number of identified conflicts |  | From ICU hospitalization to 6 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leonetti law, palliative care