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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
University of Colorado, Denver
Mayo Clinic
University of Pennsylvania
Oregon Health and Science University
Montefiore Medical Center
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01459744
First received: October 13, 2011
Last updated: November 11, 2014
Last verified: November 2014

October 13, 2011
November 11, 2014
September 2011
January 2016   (final data collection date for primary outcome measure)
  • Prevalence of Conversations about ICD Deactivation [ Time Frame: after 1st clinical encounter after enrollment for intervention group ] [ Designated as safety issue: No ]
    Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
  • Prevalence of Conversations about ICD Deactivation [ Time Frame: 3rd clinical encounter after enrollment for intervention group ] [ Designated as safety issue: No ]
    Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
  • Prevalence of Conversations about ICD Deactivation [ Time Frame: 3 months after enrollment for control group ] [ Designated as safety issue: No ]
    Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
  • Prevalence of Conversations about ICD Deactivation [ Time Frame: 9 months after enrollment for control group ] [ Designated as safety issue: No ]
    Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
Same as current
Complete list of historical versions of study NCT01459744 on ClinicalTrials.gov Archive Site
  • Prevalence of ICD Deactivation [ Time Frame: After 1st encounter after enrollment for intervention group ] [ Designated as safety issue: No ]
    Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
  • Prevalence of ICD Deactivation [ Time Frame: After 3rd encounter after enrollment for intervention group ] [ Designated as safety issue: No ]
    Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
  • Prevalence of ICD Deactivation [ Time Frame: After 3 months after enrollment for control group ] [ Designated as safety issue: No ]
    Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
  • Prevalence of ICD Deactivation [ Time Frame: After 6 months after enrollment for control group ] [ Designated as safety issue: No ]
    Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
  • Psychological Outcomes in Bereaved Caregivers [ Time Frame: 4 weeks after patient death ] [ Designated as safety issue: No ]
  • Psychological Outcomes in Bereaved Caregivers [ Time Frame: 6 months after patient death ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Communication
  • Heart Failure
  • Behavioral: Communication training for cardiologists.

    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.

  • Other: Control arm
    Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
  • 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.
    Intervention: Behavioral: Communication training for cardiologists.
  • Placebo Comparator: Control arm
    Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
    Intervention: Other: Control arm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Drew Helmus 212-241-0163 Drew.Helmus@mssm.edu
United States
 
NCT01459744
GCO 09-0618, 1R01HL102084-01A1
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Colorado, Denver
  • Mayo Clinic
  • University of Pennsylvania
  • Oregon Health and Science University
  • Montefiore Medical Center
Principal Investigator: Nathan E. Goldstein, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP