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.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Grenoble、フランス、38043
- Anesthesiology and Critical Care Depratment, Grenoble University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：Standard
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of PTSD
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of depression
時間枠：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
時間枠：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)
時間枠：3 months
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3 months
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Mean level of IES
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：ICU discharge (an average of 3 weeks)
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ICU discharge (an average of 3 weeks)
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2014-A00758-39
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