An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations (WISDOM)
An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)
調査の概要
詳細な説明
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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Denver、Colorado、アメリカ、80045
- University of Colorado - Denver
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- Yale New-Haven Hospital
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Medical Center
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New York
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Bronx、New York、アメリカ、10023
- Montefiore Medical Center
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Hospital of the University of Pennsylvania
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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:
Clinicians:
- At all sites, a core group of approximately 10 heart failure clinicians (physicians, nurses) care exclusively for patients with advanced heart failure in both inpatient and outpatient settings; all of these clinicians are eligible..
Patients:
- Patient does not currently have a ventricular assist device
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone
For Inpatient:
- Has had at least 1 other heart failure in the last year, OR
Meets all three of the following criteria at time of admission:
- BUN > 43
- SBP ≤ 115
- CR > 2.75 OR
- Was on inotropes OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting prior to the current hospital admission
For Outpatient
- Has had 2 or more heart failure related admissions in the last year OR
- Has class IV heart failure in the outpatient setting OR
- Has Class III heart failure in outpatient setting AND 1 heart failure related admission in the last year OR
Has Class III heart failure in outpatient setting AND 2 of the following 4 conditions:
- Age ≥ 70
- BUN ≥ 43
- Cr ≥ 2.75
- SBP≤115 OR
- Is on inotropes (e.g., dobutamine, milrinone) OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting
Caregivers:
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone
Exclusion Criteria for patients:
- Not having an ICD
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:トリプル
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:Communication training for cardiologists
The intervention consists of an educational workshop for heart failure physicians, a reminder system, and a system providing aggregated feedback on their conversations with patients about ICD deactivation.
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Communication training: a 90 minute workshop to discuss ways to improve communication in patients with serious illness. Reminders to Cardiologists. Cardiologists will receive reminders to prompt them to have conversations relating to ICD management with patients enrolled in the study. Audit and feedback. Cardiologists will receive feedback on their rates of conversation as well as data on patient/family satisfaction with their communication skills. |
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プラセボコンパレーター:Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
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Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
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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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Prevalence of Conversations about ICD Deactivation
時間枠:after 1st clinical encounter after enrollment for intervention group
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Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
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after 1st clinical encounter after enrollment for intervention group
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Prevalence of Conversations about ICD Deactivation
時間枠:3rd clinical encounter after enrollment for intervention group
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Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
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3rd clinical encounter after enrollment for intervention group
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Prevalence of Conversations about ICD Deactivation
時間枠:3 months after enrollment for control group
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Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
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3 months after enrollment for control group
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Prevalence of Conversations about ICD Deactivation
時間枠:9 months after enrollment for control group
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Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
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9 months after enrollment for control group
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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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Prevalence of ICD Deactivation
時間枠:After 1st encounter after enrollment for intervention group
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Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
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After 1st encounter after enrollment for intervention group
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Prevalence of ICD Deactivation
時間枠:After 3rd encounter after enrollment for intervention group
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Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
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After 3rd encounter after enrollment for intervention group
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Prevalence of ICD Deactivation
時間枠:After 3 months after enrollment for control group
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Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
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After 3 months after enrollment for control group
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Prevalence of ICD Deactivation
時間枠:After 6 months after enrollment for control group
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Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
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After 6 months after enrollment for control group
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Psychological Outcomes in Bereaved Caregivers
時間枠:4 weeks after patient death
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4 weeks after patient death
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Psychological Outcomes in Bereaved Caregivers
時間枠:6 months after patient death
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6 months after patient death
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協力者と研究者
協力者
捜査官
- 主任研究者:Nathan E. Goldstein, MD、Icahn School of Medicine at Mount Sinai
出版物と役立つリンク
一般刊行物
- Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
- Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399. Erratum In: N Engl J Med. 2005 May 19;352(20):2146.
- Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996 Dec 26;335(26):1933-40. doi: 10.1056/NEJM199612263352601.
- Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. doi: 10.1056/NEJM199912163412503. Erratum In: N Engl J Med 2000 Apr 27;342(17):1300.
- Glikson M, Friedman PA. The implantable cardioverter defibrillator. Lancet. 2001 Apr 7;357(9262):1107-17. doi: 10.1016/S0140-6736(00)04263-X.
- Eckert M, Jones T. How does an implantable cardioverter defibrillator (ICD) affect the lives of patients and their families? Int J Nurs Pract. 2002 Jun;8(3):152-7. doi: 10.1046/j.1440-172x.2002.00357.x.
- Sears SF Jr, Conti JB. Quality of life and psychological functioning of icd patients. Heart. 2002 May;87(5):488-93. doi: 10.1136/heart.87.5.488. No abstract available.
- Gelfman LP, Sudore RL, Mather H, McKendrick K, Hutchinson MD, Lampert RJ, Lipman HI, Matlock DD, Swetz KM, Pinney SP, Morrison RS, Goldstein NE. Prognostic Awareness and Goals of Care Discussions Among Patients With Advanced Heart Failure. Circ Heart Fail. 2020 Sep;13(9):e006502. doi: 10.1161/CIRCHEARTFAILURE.119.006502. Epub 2020 Sep 2.
- Goldstein NE, Mather H, McKendrick K, Gelfman LP, Hutchinson MD, Lampert R, Lipman HI, Matlock DD, Strand JJ, Swetz KM, Kalman J, Kutner JS, Pinney S, Morrison RS. Improving Communication in Heart Failure Patient Care. J Am Coll Cardiol. 2019 Oct 1;74(13):1682-1692. doi: 10.1016/j.jacc.2019.07.058.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
心不全の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)