Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-28 @ 9:35 PM
Study NCT ID:
NCT02329418
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2014-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-26', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2014-12-29', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of PTSD', 'timeFrame': '3 months', 'description': 'PTSD is assessed with Impact Event Scale (IES) on the family representative'}], 'secondaryOutcomes': [{'measure': 'Rate of depression', 'timeFrame': '3 months', 'description': 'Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative'}, {'measure': 'Rate of anxiety', 'timeFrame': '3 months', 'description': 'Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative'}, {'measure': 'Mean level of HADS (anxiety and depression subscales)', 'timeFrame': '3 months'}, {'measure': 'Mean level of IES', 'timeFrame': '3 months'}, {'measure': 'Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge', 'timeFrame': 'An average of 6 days'}, {'measure': 'Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies', 'timeFrame': 'An average of 6 days'}, {'measure': 'Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital', 'timeFrame': 'ICU discharge (an average of 3 weeks)'}, {'measure': 'Medical Doctor satisfaction with the processus', 'timeFrame': 'ICU discharge (an average of 3 weeks)'}, {'measure': 'Description of the processus', 'timeFrame': 'ICU discharge (an average of 3 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '15665319', 'type': 'BACKGROUND', 'citation': 'Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.'}, {'pmid': '22914431', 'type': 'BACKGROUND', 'citation': 'Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141.'}, {'pmid': '33549600', 'type': 'DERIVED', 'citation': 'Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)\\[1\\]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.\n\nThere are several ways to assist families of patients in intensive care units \\[2\\], amongst them the use of a written document to explain the environment, therapies and possible outcomes.\n\nHere the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The study will enroll patient representant (family member or close friends designed by the family or pre-admission legal representant).\n\nInclusion Criteria:\n\n* Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge\n* verbal consent to participate\n* Able to communicate in French\n\nExclusion Criteria:\n\n* representant of a patient \\< 18 years old\n* representant of a patient whose stay in ICU lasted less than 48 hours\n* representant of a patient without social security'}, 'identificationModule': {'nctId': 'NCT02329418', 'acronym': 'LATA', 'briefTitle': 'Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '2014-A00758-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Written document', 'description': 'Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.', 'interventionNames': ['Other: Explaining withholding and withdrawing life-sustaining therapies along with a written document']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document', 'interventionNames': ['Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure']}], 'interventions': [{'name': 'Explaining withholding and withdrawing life-sustaining therapies along with a written document', 'type': 'OTHER', 'description': 'The document describes the law and the role of family members and medical team in the decision.', 'armGroupLabels': ['Written document']}, {'name': 'Explaining withholding and withdrawing life-sustaining therapies following standard procedure', 'type': 'OTHER', 'armGroupLabels': ['Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Anesthesiology and Critical Care Depratment, Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}