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An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations (WISDOM)

5 ottobre 2016 aggiornato da: Icahn School of Medicine at Mount Sinai

An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart failure or other diseases. As patients near the end of life, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider deactivating the shocking function of ICDs as patients' clinical status worsens and death is near. This will be a randomized controlled trial of a physician centered counseling and education intervention to improve clinician-patient communication about the management of ICDs.

Panoramica dello studio

Descrizione dettagliata

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with these devices do eventually die, either of heart failure or other chronic diseases. As a patient's disease worsens, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider ICD deactivation as a patient's clinical status worsens and death is near. However, these conversations rarely occur. The investigators propose to conduct a randomized clinical trial of a physician-centered patient counseling and support intervention to improve communication between cardiologists and patients with ICDs. The goals of the study are to determine the effectiveness of the intervention to: 1) increase conversations about ICD deactivation, 2) increase the number of patients who have their devices deactivated, and 3) improve mental health outcomes for bereaved caregivers of deceased patients. The unit of randomization is the hospital, the intervention is aimed at cardiologists, and the unit of analysis is the patient. The investigators have created a network of six academic medical centers across the country. The intervention to be delivered consists of three parts. First, the PI will conduct a workshop on communication specific to ICD-deactivation with cardiologists at the intervention centers. Second, when enrolled patients are admitted to the hospital or seen in the outpatient setting, the cardiologist will receive two reminders (one via email, one in the patient chart) that the patient is appropriate for a conversation about ICD deactivation. Finally, cardiologists will receive aggregated feedback about the number of conversations they have conducted and data on patients' satisfaction with conversations every six months. Physicians at usual care hospitals receive a didactic lecture on advance care planning. All patients and surrogates will be interviewed at baseline and then assessed at regular intervals to determine the outcomes of: 1) the prevalence of conversations about ICD deactivation as reported by the patient/surrogate; and 2) the frequency with which patients have their devices deactivated. Caregivers will continue to be interviewed at regular intervals up to 6 months after the patient dies to determine the relationship of the intervention to caregiver mental health outcomes. Given the exponential increase in the number of patients with ICDs, this intervention has the potential to improve the quality of care for thousands of patients near the end of life and their families.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

562

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Colorado
      • Denver, Colorado, Stati Uniti, 80045
        • University of Colorado - Denver
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06510
        • Yale New-Haven Hospital
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Medical Center
    • New York
      • Bronx, New York, Stati Uniti, 10023
        • Montefiore Medical Center
      • New York, New York, Stati Uniti, 10029
        • Icahn School Of Medicine At Mount Sinai
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Hospital of the University of Pennsylvania

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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:

    1. BUN > 43
    2. SBP ≤ 115
    3. 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:

    1. Age ≥ 70
    2. BUN ≥ 43
    3. Cr ≥ 2.75
    4. 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Comparatore 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of Conversations about ICD Deactivation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of ICD Deactivation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: After 6 months after enrollment for control group
Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
After 6 months after enrollment for control group
Psychological Outcomes in Bereaved Caregivers
Lasso di tempo: 4 weeks after patient death
4 weeks after patient death
Psychological Outcomes in Bereaved Caregivers
Lasso di tempo: 6 months after patient death
6 months after patient death

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2011

Completamento primario (Effettivo)

1 settembre 2016

Completamento dello studio (Effettivo)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

13 ottobre 2011

Primo inviato che soddisfa i criteri di controllo qualità

24 ottobre 2011

Primo Inserito (Stima)

26 ottobre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 ottobre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 ottobre 2016

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GCO 09-0618
  • 1R01HL102084-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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