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

5 oktober 2016 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

562

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Placebo-jämförare: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of Conversations about ICD Deactivation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of ICD Deactivation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 4 weeks after patient death
4 weeks after patient death
Psychological Outcomes in Bereaved Caregivers
Tidsram: 6 months after patient death
6 months after patient death

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2011

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Faktisk)

1 september 2016

Studieregistreringsdatum

Först inskickad

13 oktober 2011

Först inskickad som uppfyllde QC-kriterierna

24 oktober 2011

Första postat (Uppskatta)

26 oktober 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 oktober 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 oktober 2016

Senast verifierad

1 oktober 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GCO 09-0618
  • 1R01HL102084-01A1 (U.S.S. NIH-anslag/kontrakt)

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