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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | No Intervention | ||
| Intervention | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improving communication during the end-of-life process | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief | 6 months post patient's death |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire - lifestyle disruption | Questionnaire developed by the Famiréa Group for relatives about lifestyle disruption | 6 months post patient's death |
| Checklist | Checklist for adherence of investigators to the intervention (intervention groups) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réanimation médicale Bicetre | Le Kremlin-Bicêtre | Val-de-marne | 94276 | France | ||
| Anesthésie Réanimation Beaujon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35065008 | Derived | 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. | |
| 30577862 |
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| 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 |
| 24 hours post patient's death |
| Clichy |
| 92 |
| France |
| Réanimation polyvalente Sud Francilien | Évry | France |
| Réanimation Médicale hôpital Cochin | Paris | 75006 | France |
| Réanimation médicale | Paris | 75010 | France |
| Réanimation médicale Pitié Salpetriere | Paris | 75013 | France |
| Réanimation chirurgicale HEGP | Paris | 75015 | France |
| Réanimation médicale HEGP | Paris | 75015 | France |
| Réanimation médico chirurgicale Tenon | Paris | 75019 | France |
| Réanimation polyvalente René Dubos | Pontoise | 95 | France |
| Derived |
| 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. |