Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves.
A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.
調査の概要
詳細な説明
Decision support tools, specifically recommended in the 2010 Affordable Care Act, have been shown to improve the quality of decisions and reduce burden on the decision maker in multiple clinical settings, yet almost none have focused on life-sustaining treatments in acute critical illness such as stroke. This study proposes a comprehensive frame shift in how the health care team and surrogates collaborate on decisions regarding life-sustaining treatments for acute illness, by developing a tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
The two project phases are: 1) Decision support intervention development; and 2) Pilot testing in surrogates of hospitalized stroke patients. A novel ordinal prognostic model will be developed and incorporated into the tool.
The project expects 25 surrogate-patient pairs in the control group, and 25 surrogate-patient pairs in the intervention group, which equals a total of 100 subjects.
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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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- The University of Michigan
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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
Surrogates:
Inclusion Criteria:
- Self-identify as the surrogate decision maker for eligible patient
- Able to read and communicate in English without an interpreter
- Limited to one surrogate per patient
Exclusion Criteria:
- No prior relationship with patient
- Dementia or other cognitive or health condition that would impair their ability to participate
Patients:
Inclusion Criteria:
- Ischemic stroke or spontaneous intracerebral hemorrhage
- Impaired decisional capacity (per treating team)
- Enrolled on or before full hospital day 5
Minimum illness severity (either):
- National Institutes of Health Stroke Scale ≥ 10
- Glasgow coma scale ≤12
Exclusion Criteria:
- No surrogate available for study procedures
- Already on comfort measures only
- Physician refuses to allow approach for consent
- Pregnancy
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：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control Surrogate Arm
Usual care control group will complete baseline and follow-up questionnaires with standard decision making techniques.
This group will not be asked to use the decision making tool.
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実験的：Surrogate Decision Tool Arm
This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires.
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A tailored web-based stroke decision support intervention.
This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
他の名前：
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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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Acceptability of the decision tool intervention
時間枠：Immediately post-intervention
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The proportion of cases where the surrogate completes use of the tool with high acceptability using the Acceptability E-Scale.
The Acceptability E-Scale is a 6-item scale.
A score of 1 indicates a negative evaluation and 5 indicates a positive evaluation.
A score of 3 indicates a neutral evaluation.
An individual will be considered to have high acceptability if the average response across the 6 items is 4 or higher)
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Immediately post-intervention
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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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Accuracy of the surrogate's prognostic estimate for functional recovery
時間枠：Within approximately 5 days of admission
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Calculated as the absolute value of the difference between the surrogate's estimate of the probability (0-100%) of return to functional independence by 90 days and the model based estimate of modified Rankin of 0-2.
Range of this measure will be 0-100.
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Within approximately 5 days of admission
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Decisional Self Efficacy scale
時間枠：Within approximately 5 days of admission
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11-item scale (a score of 0 indicates not at all confident and a 4 indicates very confident) with ordered categorical responses, converted to a 0-100 scale based on the average of the responses to each item.
A score of 0 means extremely low self-efficacy and a score of 100 means extremely high self-efficacy
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Within approximately 5 days of admission
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Darin Zahuranec、University of Michigan
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 (実際)
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
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。
Decision toolの臨床試験
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Washington University School of MedicineNational Cancer Institute (NCI)募集
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Necmettin Erbakan UniversityKonya City Hospital募集
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Kaiser PermanenteNational Institute of Mental Health (NIMH); University of Washington招待による登録
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University of Alabama at BirminghamNational Cancer Institute (NCI)積極的、募集していない
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San Diego State UniversityUniversity of California, San Francisco招待による登録
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Madigan Army Medical CenterTelemedicine & Advanced Technology Research Center; Analytics4Medicine, LLC終了しました
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Bispebjerg HospitalOdense University Hospital; Rigshospitalet, Denmark; Danish Cancer Society; Nordsjaellands Hospital と他の協力者完了