Clinical trial NCT01459744: An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations
Official title: An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Heart Failure
Keywords: Heart failure
Palliative care
Communication
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Colorado, Denver
name: Mayo Clinic
name: University of Pennsylvania
name: Oregon Health and Science University
name: Montefiore Medical Center
First posted: 2011-10-26
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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..

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

Primary outcomes:
measure: Prevalence of Conversations about ICD Deactivation
timeFrame: after 1st clinical encounter after enrollment for intervention group
measure: Prevalence of Conversations about ICD Deactivation
timeFrame: 3rd clinical encounter after enrollment for intervention group
measure: Prevalence of Conversations about ICD Deactivation
timeFrame: 3 months after enrollment for control group
measure: Prevalence of Conversations about ICD Deactivation
timeFrame: 9 months after enrollment for control group
Secondary outcomes:
measure: Prevalence of ICD Deactivation
timeFrame: After 1st encounter after enrollment for intervention group
measure: Prevalence of ICD Deactivation
timeFrame: After 3rd encounter after enrollment for intervention group
measure: Prevalence of ICD Deactivation
timeFrame: After 3 months after enrollment for control group
measure: Prevalence of ICD Deactivation
timeFrame: After 6 months after enrollment for control group
measure: Psychological Outcomes in Bereaved Caregivers
timeFrame: 4 weeks after patient death
measure: Psychological Outcomes in Bereaved Caregivers
timeFrame: 6 months after patient death
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado - Denver
state: Colorado
city: New Haven
country: United States
facility: Yale New-Haven Hospital
state: Connecticut
city: Rochester
country: United States
facility: Mayo Medical Center
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nathan E. Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
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