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OpenTrials
Completed

NCT Number: NCT02471976

Impact of an Early Palliative Approach

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital FOCH

Suresnes, 92 150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strategy promoting early consideration and collegiate vulnerability of patients

Other

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

  1. 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

Secondary outcomes

  1. Impact of the procedure according to ICU type

    Time frame: From ICU hospitalization to 6 months after inclusion

  2. Characteristics of surgical patients concerned by a palliative strategy

    Time frame: From ICU hospitalization to 6 months after inclusion

  3. 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

  4. Extent of information collected concerning the collegial process

    Time frame: From ICU hospitalization to 6 months after inclusion

  5. Impact of the procedure on caregivers' satisfaction

    Time frame: From ICU hospitalization to 6 months after inclusion

  6. Number of identified conflicts

    Time frame: From ICU hospitalization to 6 months after inclusion

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: LATAREA-IV

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.