- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Colorado
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Denver, Colorado, États-Unis, 80045
- University of Colorado - Denver
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-
Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Yale New-Haven Hospital
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Medical Center
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New York
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Bronx, New York, États-Unis, 10023
- Montefiore Medical Center
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New York, New York, États-Unis, 10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Hospital of the University of Pennsylvania
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur placebo: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of Conversations about ICD Deactivation
Délai: after 1st clinical encounter after enrollment for intervention group
|
Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
|
after 1st clinical encounter after enrollment for intervention group
|
|
Prevalence of Conversations about ICD Deactivation
Délai: 3rd clinical encounter after enrollment for intervention group
|
Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
|
3rd clinical encounter after enrollment for intervention group
|
|
Prevalence of Conversations about ICD Deactivation
Délai: 3 months after enrollment for control group
|
Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
|
3 months after enrollment for control group
|
|
Prevalence of Conversations about ICD Deactivation
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of ICD Deactivation
Délai: After 1st encounter after enrollment for intervention group
|
Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
|
After 1st encounter after enrollment for intervention group
|
|
Prevalence of ICD Deactivation
Délai: After 3rd encounter after enrollment for intervention group
|
Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
|
After 3rd encounter after enrollment for intervention group
|
|
Prevalence of ICD Deactivation
Délai: After 3 months after enrollment for control group
|
Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
|
After 3 months after enrollment for control group
|
|
Prevalence of ICD Deactivation
Délai: 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
Délai: 4 weeks after patient death
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4 weeks after patient death
|
|
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Psychological Outcomes in Bereaved Caregivers
Délai: 6 months after patient death
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6 months after patient death
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nathan E. Goldstein, MD, Icahn School of Medicine at Mount Sinai
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GCO 09-0618
- 1R01HL102084-01A1 (Subvention/contrat des NIH des États-Unis)
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