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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 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: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Communication
Heart Failure
Behavioral: Communication training for cardiologists.
Other: Control arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Placebo Comparator: Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
Other: Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459744

Contacts
Contact: Drew Helmus 212-241-0163 Drew.Helmus@mssm.edu

Locations
United States, Colorado
University of Colorado - Denver Recruiting
Denver, Colorado, United States, 80045
United States, Connecticut
Yale New-Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
United States, Minnesota
Mayo Medical Center Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10023
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Nathan Goldstein, MD         
Sub-Investigator: R. Sean Morrison, MD         
Sub-Investigator: Jill Kalman, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Mount Sinai School of Medicine
University of Colorado, Denver
Mayo Clinic
University of Pennsylvania
Oregon Health and Science University
Montefiore Medical Center
Investigators
Principal Investigator: Nathan E. Goldstein, MD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01459744     History of Changes
Other Study ID Numbers: GCO 09-0618, 1R01HL102084-01A1
Study First Received: October 13, 2011
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
Heart failure
Palliative care
Communication

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014