Assessment of Factors Involved in the Decision-making for ICU Patients' Care
A new law about the advance directives (AD) has been recently voted in France on February 2, 2016. This " Claeys-Leonetti " law has made the AD more binding, as in other countries. This should lead to a greater respect of the human autonomy principle. However, the interpretation of these guidelines is often difficult and may differ between doctors. Indeed, the subjectivity of these interpretations could lead to different medical decisions by physicians.
The investigators intend to assess the effect of advance directives (AD) on decision making in care by intensivists, using a simulated (hypothetical) situation.
調査の概要
詳細な説明
Observational simulation (hypothetical) study of intensivist decisions for selected real patients.
Each patient writes advance directives (AD) after receiving clear information (videos and interview with an independent intensivist).
Intensivists answer to 5 questions for two simulations (hypothetical) models (scenario) on pneumonia and occlusive syndrome, in 3 times: without the AD, with AD, and with AD by knowing the drafting conditions (information from intensivist).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Clermont-Ferrand、フランス、63003
- CHU Clermont-Ferrand
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Inclusion criteria for patients :
- 20 patients with chronic diseases or 80 years old patient or older,
- 4 patients with chronic cardiac failure challenged in heart transplant
- 4 patients with chronic renal failure challenged in kidney transplant
- 4 COPD patients in terminal stage
- 4 patients with lung cancer challenged in surgery
- 4 patients, 80 years old or older, without cognitive impairment
Inclusion criteria for physician :
- Working in Intensive Care Unit (ICU)
- From the 10 ICUs involved in the protocol
Exclusion Criteria:
- Exclusion criteria for physician :
- Decline to participate
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients with chronic disease
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Study of factors involved in the decision-making for ICU patients' care.
Effect of advance directives (AD).
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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 |
|---|---|---|
|
Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
時間枠：at day 1
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Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients, in 3 times: without AD first, then with AD and AD with knowing they were made with an intensivist, in this order
|
at day 1
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Comparison of answers to 5 questions for the 2 scenarios for each of the 20 patients between the 3 scenarios submission time for each intensivist (intra-individual variability).
時間枠：at day 1
|
at day 1
|
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Comparison for each question
時間枠：at day 1
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at day 1
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Assessment of the concordance between the AD and the intensivists's answers. Direct comparison for objective criteria (organ replacement) between the patients's AD and intensivists's answers. And expert opinion for subjective criteria
時間枠：at day 1
|
at day 1
|
|
Drafting time for the realization of the AD
時間枠：at day 1
|
at day 1
|
協力者と研究者
捜査官
- 主任研究者：Alexandre Lautrette、University Hospital, Clermont-Ferrand
出版物と役立つリンク
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
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