- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01459744
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)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80045
- University of Colorado - Denver
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale New-Haven Hospital
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Medical Center
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New York
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Bronx, New York, Estados Unidos, 10023
- Montefiore Medical Center
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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.
|
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. |
Comparador de Placebo: Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
|
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Prevalence of Conversations about ICD Deactivation
Prazo: after 1st clinical encounter after enrollment for intervention group
|
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
Prazo: 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
Prazo: 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
|
Prevalence of Conversations about ICD Deactivation
Prazo: 9 months after enrollment for control group
|
Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
|
9 months after enrollment for control group
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Prevalence of ICD Deactivation
Prazo: After 1st encounter after enrollment for intervention group
|
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
|
Prevalence of ICD Deactivation
Prazo: After 3rd encounter after enrollment for intervention group
|
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
Prazo: 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
Prazo: 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
Prazo: 4 weeks after patient death
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4 weeks after patient death
|
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Psychological Outcomes in Bereaved Caregivers
Prazo: 6 months after patient death
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6 months after patient death
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nathan E. Goldstein, MD, Icahn School of Medicine at Mount Sinai
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GCO 09-0618
- 1R01HL102084-01A1 (Concessão/Contrato do NIH dos EUA)
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