A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
調査の概要
詳細な説明
The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework.
The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes.
- Hypothesis 1a: PtDAs will reach over 50% of eligible patients.
- Hypothesis 1b: ICD PtDAs will be effective in improving decision quality in real-world practice.
- Hypothesis 1c: Better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker.
The investigators propose 3 a priori hypotheses:
- The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old);
- The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic);
- The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.
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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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Denver
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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:
- 18 years or older
- English-speaking (videos and surveys have only been validated in English)
- Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation
Exclusion Criteria:
- Prisoners
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: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:Participants will fill out surveys
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
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アクティブコンパレータ:Educational video and/or handout
These participants will receive an educational video and/or handout about the defibrillator process.
Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
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The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients' experiences with their decisions about defibrillators.
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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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Knowledge About Defibrillation at Baseline
時間枠:Baseline
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Multiple survey responses by participants will indicate knowledge changes over time.
The Decision Quality Knowledge Survey measures knowledge about defibrillators.
Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
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Baseline
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Knowledge About Defibrillation at 1 Month
時間枠:1 month
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Multiple survey responses by participants will indicate knowledge changes over time.
The Decision Quality Knowledge Survey measures knowledge about defibrillators.
Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
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1 month
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Knowledge About Defibrillation at 6 Months
時間枠:6 months
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Multiple survey responses by participants will indicate knowledge changes over time.
The Decision Quality Knowledge Survey measures knowledge about defibrillators.
Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
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6 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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Reach of Eligible Patients
時間枠:Baseline
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Measuring how many patients of the eligible patient base are able to view or read the educational materials.
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Baseline
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Differential Effect by Age
時間枠:Baseline, 1 month, 6 months
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The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)
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Baseline, 1 month, 6 months
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Differential Effect by Heart Failure Type
時間枠:Baseline, 1 month, 6 months
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The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
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Baseline, 1 month, 6 months
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Differential Effect by Type of Device
時間枠:Baseline, 1 month, 6 months
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The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
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Baseline, 1 month, 6 months
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協力者と研究者
捜査官
- 主任研究者:Daniel D Matlock, MD, MPH、University of Colorado, Denver
出版物と役立つリンク
研究記録日
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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
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