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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Patients Died in Intensive Care Unit (ICU)

Treatments: Behavioral: Improving communication during the end-of-life process

Study type: Interventional

Funder types: Other

Identifiers

NCT02955992

AOM15014

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

standard of care

No Intervention group

Intervention

Experimental group

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: 1. Preparation for the death : Prepare the relative for the patient's imminent death 2. During the dying and death process: The physician enters the patient's room at least once to check on the relatives 3. After the patient's death: the physician and the nurse meet the relative

Treatment:

Behavioral: Improving communication during the end-of-life process