Skip to content

Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02955992
Acronym
COSMIC
Enrollment
900
Registered
2016-11-04
Start date
2017-01-31
Completion date
2021-01-31
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Died in Intensive Care Unit (ICU)

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.

Interventions

BEHAVIORALImproving communication during the end-of-life process

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief6 months post patient's death

Secondary

MeasureTime frame
CAESAR scale that measured quality of dying and death1 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 physician1 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 symptoms3 and 6 months post patient's death

Other

MeasureTime frameDescription
Questionnaire - lifestyle disruption6 months post patient's deathQuestionnaire developed by the Famiréa Group for relatives about lifestyle disruption
Checklist24 hours post patient's deathChecklist for adherence of investigators to the intervention (intervention groups)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026