NCT Number: NCT02955992
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Réanimation médicale Bicetre, Le Kremlin-Bicêtre, Val-de-marne, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief
Time frame: 6 months post patient's death
Secondary outcomes
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CAESAR scale that measured quality of dying and death
Time frame: 1 month post patient's death
-
Quality of dying and death (QODD-1)
Time frame: 1 month post patient's ddeath
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Miss-21 - Rapport subscale that describes communication with physician
Time frame: 1 month post patient's death
-
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1, 3 and 6 months post patient's death
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Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms
Time frame: 3 and 6 months post patient's death
Other outcomes
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Questionnaire - lifestyle disruption
Time frame: 6 months post patient's death
Questionnaire developed by the Famiréa Group for relatives about lifestyle disruption
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Checklist
Time frame: 24 hours post patient's death
Checklist for adherence of investigators to the intervention (intervention groups)
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Official study title
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)
Acronym: COSMIC
Important dates
- Study start
- 2017
- Primary completion
- 2020
- Study completion
- 2021
- First posted
- Nov 4, 2016
- Registry last updated
- Feb 12, 2021
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.