Clinical trial NCT02955992: Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives
Official title: Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Died in Intensive Care Unit (ICU)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief
timeFrame: 6 months post patient's death
Secondary outcomes:
measure: CAESAR scale that measured quality of dying and death
timeFrame: 1 month post patient's death
measure: Quality of dying and death (QODD-1)
timeFrame: 1 month post patient's ddeath
measure: Miss-21 - Rapport subscale that describes communication with physician
timeFrame: 1 month post patient's death
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1, 3 and 6 months post patient's death
measure: Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms
timeFrame: 3 and 6 months post patient's death
Other outcomes:
measure: Questionnaire - lifestyle disruption
timeFrame: 6 months post patient's death
measure: Checklist
timeFrame: 24 hours post patient's death
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Réanimation médicale Bicetre
state: Val-de-marne
city: Clichy
country: France
facility: Anesthésie Réanimation Beaujon
city: Evry
country: France
facility: Réanimation polyvalente Sud Francilien
city: Paris
country: France
facility: Réanimation Médicale hôpital Cochin
city: Paris
country: France
facility: Réanimation médicale
city: Paris
country: France
facility: Réanimation médicale Pitié Salpetriere
city: Paris
country: France
facility: Réanimation chirurgicale HEGP
city: Paris
country: France
facility: Réanimation médicale HEGP
city: Paris
country: France
facility: Réanimation médico chirurgicale Tenon
city: Pontoise
country: France
facility: Réanimation polyvalente René Dubos
Study officials:
References:
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.
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.