Effects of Repeated Decision Making Among Surrogates of Seriously Ill Patients
2015年1月27日 更新者：Scott Halpern、University of Pennsylvania
Pilot Study of Repeated Decision Making in Surrogates
Decision making capacity fatigues after repeated decisions similar to skeletal muscle.
The result is decision fatigue, in which subsequent decisions are altered toward the status quo.
Surrogates are at risk for decision fatigue yet it has not been studied.
We propose a randomized study in the outpatient setting in surrogates and patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on surrogate self-control and subsequent choices.
調査の概要
詳細な説明
Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made.
This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue.
People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo.
By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities.
Patients and their surrogates often make complex medical decisions for which they may have little experience.
Although clearly at high risk, decision fatigue has not been studied in this population.
To elucidate these questions, we propose a four-arm study of surrogates and patients in a population at high risk for making complex decisions.
Surrogates will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.
研究の種類
介入
入学 (実際)
132
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- Perelman Center for Advanced Medicine at the University of Pennsylvania
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients must have one of the following diagnoses: aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma.
- Patients must have at least one surrogate at their clinic visit who is willing to enroll with them as a pair to be included.
- Surrogates are eligible if an eligible patient identifies them as as a surrogate and both consent for the study.
- All participants must be over the age 18
- All participants must be fluent in English
Exclusion Criteria:
- Patients and surrogates will be excluded if they are illiterate or have a medical condition known to alter Stroop performance. These include individuals who are visually impaired such that they cannot read a computer screen, blind or colorblind, patients given sedating medications during their appointment and individuals with past medical history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness.
- Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the mechanical ventilation hypothetical scenario and the hypothetical life sustaining therapy question.
- Surrogates and patients are ineligible if their paired participant is excluded for any of the above reasons.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 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 |
|---|---|
|
介入なし：DLST Only
Surrogates will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)
|
|
|
実験的：Contemplate only
Surrogates will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question
|
Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
|
実験的：Decide with advice
Surrogates will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question.
Within this arm, surrogates will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention).
These positive and negative recommendations will be randomly assigned upon study enrollment.
With four hypothetical scenarios, there are six possible options for recommendation variations.
|
Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
|
実験的：Decide without advice
Surrogates will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.
|
Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
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 |
|---|---|---|
|
Stroop Test Score
時間枠：Approximately 15 minutes
|
Measurement of score will be done at the conclusion of instrument completion.
The Stroop test is a standard measure of self control that requires three tasks.
The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in.
Standard scoring is the number correct in the Word trial minus the Color-Word trials.
This data will be collected immediately following completion.
|
Approximately 15 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evidence of status quo bias
時間枠：Approximately 10 minutes
|
Evidence of status quo bias as assessed by hypothetical decision to limit life sustaining therapy or to continue treatment.
To assess for status quo bias, we will use the following technique: after the initial four hypothetical questions and Stroop testing, participants will be asked a hypothetical question about life sustaining therapy (LST).
In the question, continuing life sustaining therapy will be counted as maintaining the status quo.
This is based on current norms in American health care where life sustaining therapy is continued until a patient or surrogate specifically request otherwise.
|
Approximately 10 minutes
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Scott D. Halpern, MD, PhD、University of Pennsylvania
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年11月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2013年4月1日
試験登録日
最初に提出
2012年11月1日
QC基準を満たした最初の提出物
2012年11月5日
最初の投稿 (見積もり)
2012年11月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年1月29日
QC基準を満たした最後の更新が送信されました
2015年1月27日
最終確認日
2015年1月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 816697
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。