Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
Study NCT ID:
NCT02955992
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2016-11-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Questionnaire - lifestyle disruption', 'timeFrame': "6 months post patient's death", 'description': 'Questionnaire developed by the Famiréa Group for relatives about lifestyle disruption'}, {'measure': 'Checklist', 'timeFrame': "24 hours post patient's death", 'description': 'Checklist for adherence of investigators to the intervention (intervention groups)'}], 'primaryOutcomes': [{'measure': 'PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief', 'timeFrame': "6 months post patient's death"}], 'secondaryOutcomes': [{'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"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients Died in Intensive Care Unit (ICU)']}, 'referencesModule': {'references': [{'pmid': '35065008', 'type': 'DERIVED', '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.'}, {'pmid': '30577862', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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).\n* Consent to participate in the study\n* Relative who was seen at least once by the physician before the patient's death\n\nExclusion Criteria:\n\n* Relative that does not understand, read or speak French\n* Relative who refuses to participate"}, 'identificationModule': {'nctId': 'NCT02955992', 'acronym': 'COSMIC', 'briefTitle': "Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)", 'orgStudyIdInfo': {'id': 'AOM15014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', '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.\n\nA "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.\n\nDevelopment of a 3-step physician-driven support strategy starting after a decision to withhold or withdraw life-sustaining therapies is implemented:\n\n1. Preparation for the death : Prepare the relative for the patient\'s imminent death\n2. During the dying and death process: The physician enters the patient\'s room at least once to check on the relatives\n3. After the patient\'s death: the physician and the nurse meet the relative', 'interventionNames': ['Behavioral: Improving communication during the end-of-life process']}], 'interventions': [{'name': 'Improving communication during the end-of-life process', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94276', 'city': 'Le Kremlin-Bicêtre', 'state': 'Val-de-marne', 'country': 'France', 'facility': 'Réanimation médicale Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '92', 'city': 'Clichy', 'country': 'France', 'facility': 'Anesthésie Réanimation Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Évry', 'country': 'France', 'facility': 'Réanimation polyvalente Sud Francilien', 'geoPoint': {'lat': 48.6328, 'lon': 2.44049}}, {'zip': '75006', 'city': 'Paris', 'country': 'France', 'facility': 'Réanimation Médicale hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Réanimation médicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Réanimation médicale Pitié Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Réanimation chirurgicale HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Réanimation médicale HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Réanimation médico chirurgicale Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95', 'city': 'Pontoise', 'country': 'France', 'facility': 'Réanimation polyvalente René Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}