Patients Died in Intensive Care Unit (ICU) Clinical Trial
— COSMICOfficial title:
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)
| NCT number | NCT02955992 |
| Other study ID # | AOM15014 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2017 |
| Est. completion date | January 2021 |
| Verified date | February 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 900 |
| Est. completion date | January 2021 |
| Est. primary completion date | April 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Anesthésie Réanimation Beaujon | Clichy | |
| France | Réanimation polyvalente Sud Francilien | Evry | |
| France | Réanimation médicale Bicetre | Le Kremlin-Bicêtre | Val-de-marne |
| France | Réanimation chirurgicale HEGP | Paris | |
| France | Réanimation médicale | Paris | |
| France | Réanimation médicale HEGP | Paris | |
| France | Réanimation Médicale hôpital Cochin | Paris | |
| France | Réanimation médicale Pitié Salpetriere | Paris | |
| France | Réanimation médico chirurgicale Tenon | Paris | |
| France | Réanimation polyvalente René Dubos | Pontoise |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Questionnaire - lifestyle disruption | Questionnaire developed by the Famiréa Group for relatives about lifestyle disruption | 6 months post patient's death | |
| Other | Checklist | Checklist for adherence of investigators to the intervention (intervention groups) | 24 hours post patient's death | |
| Primary | PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief | 6 months post patient's death | ||
| Secondary | CAESAR scale that measured quality of dying and death | 1 month post patient's death | ||
| Secondary | Quality of dying and death (QODD-1) | 1 month post patient's ddeath | ||
| Secondary | Miss-21 - Rapport subscale that describes communication with physician | 1 month post patient's death | ||
| Secondary | Hospital Anxiety and Depression Scale (HADS) | 1, 3 and 6 months post patient's death | ||
| Secondary | Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms | 3 and 6 months post patient's death |