Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit (LATA)
26. december 2019 opdateret af: University Hospital, Grenoble
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
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.
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
74
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Grenoble, Frankrig, 38043
- Anesthesiology and Critical Care Depratment, Grenoble University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
The study will enroll patient representant (family member or close friends designed by the family or pre-admission legal representant).
Inclusion Criteria:
- Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
- verbal consent to participate
- Able to communicate in French
Exclusion Criteria:
- representant of a patient < 18 years old
- representant of a patient whose stay in ICU lasted less than 48 hours
- representant of a patient without social security
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Written document
Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies .
All other procedures are standard.
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The document describes the law and the role of family members and medical team in the decision.
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Aktiv komparator: Standard
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Rate of PTSD
Tidsramme: 3 months
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PTSD is assessed with Impact Event Scale (IES) on the family representative
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of depression
Tidsramme: 3 months
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Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
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3 months
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Rate of anxiety
Tidsramme: 3 months
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Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
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3 months
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Mean level of HADS (anxiety and depression subscales)
Tidsramme: 3 months
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3 months
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Mean level of IES
Tidsramme: 3 months
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3 months
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Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
Tidsramme: An average of 6 days
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An average of 6 days
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Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
Tidsramme: An average of 6 days
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An average of 6 days
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Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital
Tidsramme: ICU discharge (an average of 3 weeks)
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ICU discharge (an average of 3 weeks)
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Medical Doctor satisfaction with the processus
Tidsramme: ICU discharge (an average of 3 weeks)
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ICU discharge (an average of 3 weeks)
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Description of the processus
Tidsramme: ICU discharge (an average of 3 weeks)
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ICU discharge (an average of 3 weeks)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2014
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
1. marts 2018
Datoer for studieregistrering
Først indsendt
29. december 2014
Først indsendt, der opfyldte QC-kriterier
29. december 2014
Først opslået (Skøn)
31. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014-A00758-39
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .