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Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives (COSMIC)

Primary Purpose

Patients Died in Intensive Care Unit (ICU)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Improving communication during the end-of-life process
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients Died in Intensive Care Unit (ICU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Relatives of patients who died in the intensive care unit after a decision to withhold or withdraw treatment (adult ICUs only, ICU length of stay > 2 days).
  • Consent to participate in the study
  • Relative who was seen at least once by the physician before the patient's death

Exclusion Criteria:

  • Relative that does not understand, read or speak French
  • Relative who refuses to participate

Sites / Locations

  • Réanimation médicale Bicetre
  • Anesthésie Réanimation Beaujon
  • Réanimation polyvalente Sud Francilien
  • Réanimation Médicale hôpital Cochin
  • Réanimation médicale
  • Réanimation médicale Pitié Salpetriere
  • Réanimation chirurgicale HEGP
  • Réanimation médicale HEGP
  • Réanimation médico chirurgicale Tenon
  • Réanimation polyvalente René Dubos

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard of care

Intervention

Arm Description

All caregivers will receive a leaflet about the importance of end of life (EOL) communication: key elements and recommendations regarding verbal and non-verbal communication. A "local champion" ("opinion leader") will be designated by each team in order to help implement the strategy. These physicians will help colleagues to connect external knowledge and requirements of the study to the local context. Development of a 3-step physician-driven support strategy starting after a decision to withhold or withdraw life-sustaining therapies is implemented: Preparation for the death : Prepare the relative for the patient's imminent death During the dying and death process: The physician enters the patient's room at least once to check on the relatives After the patient's death: the physician and the nurse meet the relative

Outcomes

Primary Outcome Measures

PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief

Secondary Outcome Measures

CAESAR scale that measured quality of dying and death
Quality of dying and death (QODD-1)
Miss-21 - Rapport subscale that describes communication with physician
Hospital Anxiety and Depression Scale (HADS)
Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms

Full Information

First Posted
November 3, 2016
Last Updated
February 10, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02955992
Brief Title
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives
Acronym
COSMIC
Official Title
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a mortality rate of 20%, end-of-life care has become a daily responsibility. Among those deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where physicians, nurses and relatives must work together towards the most consensual decision. In this context, patients' relatives feel vulnerable and, in the months that follow the death, they are most likely to present symptoms that negatively affect their quality of life (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication with caregivers is one of the most highly valued aspects of care that impacts on family members' experience during the patient's stay and after the patient's death. Improving communication during the end-of-life process in the ICU context is a necessity that has been put forward in palliative care and family-centered care guidelines. This study aims to improve both communication skills and behaviour by giving precise recommendations to physicians (3 step strategy) in their direct contact with patients' relatives. A 3-step physician-driven support strategy is used, that consists in 3 meetings with the relative - one before, one during and one after the patient's death. The underlying hypothesis is that this strategy will improve communication in the end-of-life setting and thus should reduce post-ICU burden for family members, specifically the development of prolonged grief 6 months after the death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Died in Intensive Care Unit (ICU)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard of care
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All caregivers will receive a leaflet about the importance of end of life (EOL) communication: key elements and recommendations regarding verbal and non-verbal communication. A "local champion" ("opinion leader") will be designated by each team in order to help implement the strategy. These physicians will help colleagues to connect external knowledge and requirements of the study to the local context. Development of a 3-step physician-driven support strategy starting after a decision to withhold or withdraw life-sustaining therapies is implemented: Preparation for the death : Prepare the relative for the patient's imminent death During the dying and death process: The physician enters the patient's room at least once to check on the relatives After the patient's death: the physician and the nurse meet the relative
Intervention Type
Behavioral
Intervention Name(s)
Improving communication during the end-of-life process
Primary Outcome Measure Information:
Title
PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief
Time Frame
6 months post patient's death
Secondary Outcome Measure Information:
Title
CAESAR scale that measured quality of dying and death
Time Frame
1 month post patient's death
Title
Quality of dying and death (QODD-1)
Time Frame
1 month post patient's ddeath
Title
Miss-21 - Rapport subscale that describes communication with physician
Time Frame
1 month post patient's death
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
1, 3 and 6 months post patient's death
Title
Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms
Time Frame
3 and 6 months post patient's death
Other Pre-specified Outcome Measures:
Title
Questionnaire - lifestyle disruption
Description
Questionnaire developed by the Famiréa Group for relatives about lifestyle disruption
Time Frame
6 months post patient's death
Title
Checklist
Description
Checklist for adherence of investigators to the intervention (intervention groups)
Time Frame
24 hours post patient's death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relatives of patients who died in the intensive care unit after a decision to withhold or withdraw treatment (adult ICUs only, ICU length of stay > 2 days). Consent to participate in the study Relative who was seen at least once by the physician before the patient's death Exclusion Criteria: Relative that does not understand, read or speak French Relative who refuses to participate
Facility Information:
Facility Name
Réanimation médicale Bicetre
City
Le Kremlin-Bicêtre
State/Province
Val-de-marne
ZIP/Postal Code
94276
Country
France
Facility Name
Anesthésie Réanimation Beaujon
City
Clichy
ZIP/Postal Code
92
Country
France
Facility Name
Réanimation polyvalente Sud Francilien
City
Evry
Country
France
Facility Name
Réanimation Médicale hôpital Cochin
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Réanimation médicale
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Réanimation médicale Pitié Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Réanimation chirurgicale HEGP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Réanimation médicale HEGP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Réanimation médico chirurgicale Tenon
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Réanimation polyvalente René Dubos
City
Pontoise
ZIP/Postal Code
95
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35065008
Citation
Kentish-Barnes N, Chevret S, Valade S, Jaber S, Kerhuel L, Guisset O, Martin M, Mazaud A, Papazian L, Argaud L, Demoule A, Schnell D, Lebas E, Ethuin F, Hammad E, Merceron S, Audibert J, Blayau C, Delannoy PY, Lautrette A, Lesieur O, Renault A, Reuter D, Terzi N, Philippon-Jouve B, Fiancette M, Ramakers M, Rigaud JP, Souppart V, Asehnoune K, Champigneulle B, Goldgran-Toledano D, Dubost JL, Bollaert PE, Chouquer R, Pochard F, Cariou A, Azoulay E. A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial. Lancet. 2022 Feb 12;399(10325):656-664. doi: 10.1016/S0140-6736(21)02176-0. Epub 2022 Jan 19.
Results Reference
derived
PubMed Identifier
30577862
Citation
Kentish-Barnes N, Chevret S, Azoulay E. Guiding intensive care physicians' communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL). Trials. 2018 Dec 22;19(1):698. doi: 10.1186/s13063-018-3084-7.
Results Reference
derived

Learn more about this trial

Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives

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