An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

Heart Failure Clinical Trial

— WISDOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459744
• Other study ID #: GCO 09-0618
• Secondary ID: 1R01HL102084-01A
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: October 5, 2016
• Start date: September 2011
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Communication
• Heart Failure

Intervention

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.

Other:
• Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Colorado - Denver	Denver	Colorado
United States	Yale New-Haven Hospital	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Medical Center	Rochester	Minnesota

Sponsors (7)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Mayo Clinic, Montefiore Medical Center, National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University, University of Colorado, Denver, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. Erratum in: N Engl J Med. 2005 May 19;352(20):2146. — View Citation

Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. Erratum in: N Engl J Med 2000 Apr 27;342(17):1300. — View Citation

Eckert M, Jones T. How does an implantable cardioverter defibrillator (ICD) affect the lives of patients and their families? Int J Nurs Pract. 2002 Jun;8(3):152-7. — View Citation

Glikson M, Friedman PA. The implantable cardioverter defibrillator. Lancet. 2001 Apr 7;357(9262):1107-17. Review. — View Citation

Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996 Dec 26;335(26):1933-40. — View Citation

Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. Epub 2002 Mar 19. — View Citation

Sears SF Jr, Conti JB. Quality of life and psychological functioning of icd patients. Heart. 2002 May;87(5):488-93. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Conversations about ICD Deactivation	Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment	after 1st clinical encounter after enrollment for intervention group	No
Primary	Prevalence of Conversations about ICD Deactivation	Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment	3rd clinical encounter after enrollment for intervention group	No
Primary	Prevalence of Conversations about ICD Deactivation	Whether deactivation discussion occurred difference between 3 and 9 months after enrollment	3 months after enrollment for control group	No
Primary	Prevalence of Conversations about ICD Deactivation	Whether deactivation discussion occurred difference between 3 and 9 months after enrollment	9 months after enrollment for control group	No
Secondary	Prevalence of ICD Deactivation	Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment	After 1st encounter after enrollment for intervention group	No
Secondary	Prevalence of ICD Deactivation	Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment	After 3rd encounter after enrollment for intervention group	No
Secondary	Prevalence of ICD Deactivation	Whether ICD deactivation occurred difference between 3 and 9 months after enrollment	After 3 months after enrollment for control group	No
Secondary	Prevalence of ICD Deactivation	Whether ICD deactivation occurred difference between 3 and 9 months after enrollment	After 6 months after enrollment for control group	No
Secondary	Psychological Outcomes in Bereaved Caregivers		4 weeks after patient death	No
Secondary	Psychological Outcomes in Bereaved Caregivers		6 months after patient death	No