Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives

Study Overview
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Brief Summary
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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.

Official Title
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Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)

Conditions
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Patients Died in Intensive Care Unit (ICU)

Intervention / Treatment
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* Behavioral: Improving communication during the end-of-life process


Participation Criteria
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Eligibility Criteria
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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

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard of care<br> | |
| Experimental: Intervention<br>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 | Behavioral: Improving communication during the end-of-life process<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief |  | 6 months post patient's death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAESAR scale that measured quality of dying and death |  | 1 month post patient's death | 
| Quality of dying and death (QODD-1) |  | 1 month post patient's ddeath | 
| Miss-21 - Rapport subscale that describes communication with physician |  | 1 month post patient's death | 
| Hospital Anxiety and Depression Scale (HADS) |  | 1, 3 and 6 months post patient's death | 
| Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms |  | 3 and 6 months post patient's death |