An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

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.

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