Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
NCT ID: NCT02329418
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2014-09-30
2018-03-31
Brief Summary
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There 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.
Here 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Written document
Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.
Explaining withholding and withdrawing life-sustaining therapies along with a written document
The document describes the law and the role of family members and medical team in the decision.
Standard
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
Explaining withholding and withdrawing life-sustaining therapies following standard procedure
Interventions
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Explaining withholding and withdrawing life-sustaining therapies along with a written document
The document describes the law and the role of family members and medical team in the decision.
Explaining withholding and withdrawing life-sustaining therapies following standard procedure
Eligibility Criteria
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Inclusion Criteria
* verbal consent to participate
* Able to communicate in French
Exclusion Criteria
* representant of a patient whose stay in ICU lasted less than 48 hours
* representant of a patient without social security
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Anesthesiology and Critical Care Depratment, Grenoble University Hospital
Grenoble, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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2014-A00758-39
Identifier Type: -
Identifier Source: org_study_id