Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant (BMTSLPRCT)
Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients
The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.
Completion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).
SECONDARY OBJECTIVES:
I. To evaluate differences in patient preference for choice to prolong life following completion of the ACP tool in each group.
II. To assess uncertainty with decision making regarding end of life care following completion of the ACP tool in each group.
III. To explore patient understanding of and satisfaction with the ACP tool in each group.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
GROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the California (CA) Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
After completion of study, patients are followed up periodically.
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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California
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Palo Alto、California、アメリカ、94304
- Stanford University, School of Medicine
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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
Inclusion Criteria:
- All BMT patients at Stanford who are adults and give consent
Exclusion Criteria:
- Less than 18 years of age
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP.
Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT.
After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
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補助研究
Receive and complete the Stanford Letter
他の名前：
Undergo semi-structured, research staff-led interview
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アクティブコンパレータ：Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP.
Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT.
After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
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補助研究
Undergo semi-structured, research staff-led interview
Receive and complete the CA Advance Health Care Directive Form
他の名前：
|
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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ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
時間枠：Up to BMT day 0
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The chi-square (X^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
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Up to BMT day 0
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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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Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation
時間枠：Up to BMT day 0
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The X^2 test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
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Up to BMT day 0
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Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results
時間枠：Up to BMT day 0
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Will be measured using the DCS uncertainty sub-scale (score 0-15; higher score indicates greater uncertainty).
Scores from each group will be compared by t-tests.
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Up to BMT day 0
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Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
時間枠：within 28 days of ACP completion
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Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making).
Likert scores of understanding of the ACP from each group will be summarized and compared by t-tests.
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within 28 days of ACP completion
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Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
時間枠：within 28 days of ACP completion
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Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making).
Scores from each group will be compared by t-tests.
Likert scores of satisfaction with the ACP will be summarized and compared by group using t-tests.
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within 28 days of ACP completion
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Lori Muffly, MD、Stanford Cancer Institute
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
その他の研究ID番号
- BMT313
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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