Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit (LATA)
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Grenoble, 프랑스, 38043
- Anesthesiology and Critical Care Depratment, Grenoble University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: Standard
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of PTSD
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of depression
기간: 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
기간: 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)
기간: 3 months
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3 months
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Mean level of IES
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: ICU discharge (an average of 3 weeks)
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ICU discharge (an average of 3 weeks)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2014-A00758-39
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