Patients Died in Intensive Care Unit (ICU)COSMICNCT02955992
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives
A study testing Improving communication during the end-of-life process in people with Patients Died in Intensive Care Unit (ICU), run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Died in Intensive Care Unit (ICU)
- What is being tested?
- Improving communication during the end-of-life process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2017to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Relative that does not understand, read or speak French
- Relative who refuses to participate
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Anesthésie Réanimation Beaujon
Clichy, 92
Réanimation polyvalente Sud Francilien
Évry
Réanimation médicale Bicetre
Le Kremlin-Bicêtre, Val-de-marne, 94276
Réanimation Médicale hôpital Cochin
Paris, 75006
Réanimation médicale
Paris, 75010
Réanimation médicale Pitié Salpetriere
Paris, 75013
Réanimation chirurgicale HEGP
Paris, 75015
Réanimation médicale HEGP
Paris, 75015
Réanimation médico chirurgicale Tenon
Paris, 75019
Réanimation polyvalente René Dubos
Pontoise, 95
About this study
Official title: Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)
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.
- Being tested
- Improving communication during the end-of-life process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving communication during the end-of-life processBehavioural
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Not described |
| 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:
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 Receives: Behavioral: Improving communication during the end-of-life process |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief
Measured: 6 months post patient's death
Secondary outcomes (5)
CAESAR scale that measured quality of dying and death
Measured: 1 month post patient's death
Quality of dying and death (QODD-1)
Measured: 1 month post patient's ddeath
Miss-21 - Rapport subscale that describes communication with physician
Measured: 1 month post patient's death
Hospital Anxiety and Depression Scale (HADS)
Measured: 1, 3 and 6 months post patient's death
Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms
Measured: 3 and 6 months post patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionApr 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Died in Intensive Care Unit (ICU)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955992
- Sponsor's protocol ID
- AOM15014
- Acronym
- COSMIC
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2016
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35065008Kentish-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.
PubMed 30577862
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)
- ClinicalTrials.gov ID
- NCT02955992
- Acronym / sponsor ID
- COSMIC / AOM15014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | – |
| Intervention | Experimental | Behavioral: Improving communication during the end-of-life processAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Relative that does not understand, read or speak French
- Relative who refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving communication during the end-of-life process | Behavioural | Intervention |
Primary outcome
PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief
Time frame: 6 months post patient's death
5 secondary outcomes
CAESAR scale that measured quality of dying and death
Time frame: 1 month post patient's death
Quality of dying and death (QODD-1)
Time frame: 1 month post patient's ddeath
Miss-21 - Rapport subscale that describes communication with physician
Time frame: 1 month post patient's death
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1, 3 and 6 months post patient's death
Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms
Time frame: 3 and 6 months post patient's death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 35065008Kentish-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.
- Derived from this study: PubMed 30577862Kentish-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving communication during the end-of-life process in people with Patients Died in Intensive Care Unit (ICU), run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief (time frame: 6 months post patient's death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.