An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations (WISDOM)
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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 |
| 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) |
- 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
- 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: Intervention arm
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
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 |
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:
- Score on the Seattle Heart Failure Model or 2 or more heart failure admission in the last year
- Not being a candidate for life-sustaining therapies such as cardiac transplant or ventricular assist device
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone.
Caregivers:
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone
Exclusion Criteria for patients:
- Not having an ICD
Contacts and Locations| Contact: Omarys I. Herasme, MPH | 212-241-0163 | Omarys.Herasme@mssm.edu |
| United States, Colorado | |
| University of Colorado - Denver | Recruiting |
| Denver, Colorado, United States, 80045 | |
| 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 | |
| Mount Sinai School of Medicine | 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, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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: | 09-0618, 1R01HL102084-01A1 |
| Study First Received: | October 13, 2011 |
| Last Updated: | May 10, 2012 |
| 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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013