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Impact of an Early Palliative Approach (LATAREA-IV)

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ClinicalTrials.gov Identifier: NCT02471976
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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


Condition or disease Intervention/treatment Phase
Criteria of Vulnerability Other: strategy promoting early consideration and collegiate vulnerability of patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: Group A
the centres applies their usual practices
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471976


Locations
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France
Hôpital FOCH
Suresnes, France, 92 150
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Edouard FERRAND, MD Hôpital FOCH
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02471976    
Other Study ID Numbers: K071203
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Leonetti law
palliative care