An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

NCT ID: NCT01459744

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 562 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Communication; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Communication training for cardiologists.

Intervention Type: BEHAVIORAL

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.

Control arm

Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

Group Type: PLACEBO_COMPARATOR

Control arm

Intervention Type: OTHER

Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

Interventions

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.

Intervention Type: BEHAVIORAL

Control arm

Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

Intervention Type: OTHER

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

• Not having an ICD

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan E. Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

University of Colorado - Denver

Denver, Colorado, United States

Yale New-Haven Hospital

New Haven, Connecticut, United States

Mayo Medical Center

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

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Other Identifiers

1R01HL102084-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 09-0618

Identifier Type: -

Identifier Source: org_study_id