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Clinical Trials/NCT01459744
NCT01459744
Completed
N/A

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

Icahn School of Medicine at Mount Sinai6 sites in 1 country562 target enrollmentSeptember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Communication
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
562
Locations
6
Primary Endpoint
Prevalence of Conversations about ICD Deactivation
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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..
  • 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:
  • CR \> 2.75 OR

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prevalence of Conversations about ICD Deactivation

Time Frame: 9 months after enrollment for control group

Whether deactivation discussion occurred difference between 3 and 9 months after enrollment

Secondary Outcomes

  • Prevalence of ICD Deactivation(After 6 months after enrollment for control group)
  • Psychological Outcomes in Bereaved Caregivers(6 months after patient death)

Study Sites (6)

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