An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

NCT01459744 | Completed

• 2 other identifiers: GCO 09-06181R01HL102084-01A1
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 6

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.

Conditions

Communication; Heart Failure

Keywords

Heart failure; Palliative care; Communication

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (6)

• Prevalence of ICD Deactivation

  After 1st encounter after enrollment for intervention group

• Prevalence of ICD Deactivation

  After 3rd encounter after enrollment for intervention group

• Prevalence of ICD Deactivation

  After 3 months after enrollment for control group

• Prevalence of ICD Deactivation

  After 6 months after enrollment for control group

• Psychological Outcomes in Bereaved Caregivers

  4 weeks after patient death

Study Arms (2)

Communication training for cardiologists

EXPERIMENTAL

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.

Control arm

PLACEBO COMPARATOR

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

Other: Control arm

Interventions

Communication training for cardiologists. 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.

Communication training for cardiologists

Control arm OTHER

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

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• BUN \> 43
• SBP ≤ 115
• 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

You may not qualify if:

• Not having an ICD

Sponsors & Collaborators

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

Study Sites (6)

University of Colorado - Denver

Denver, Colorado, 80045, United States

Location

Yale New-Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Mayo Medical Center

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10023, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

• 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. doi: 10.1056/NEJM199912163412503.

  PMID: 10601507 BACKGROUND

• 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. doi: 10.1056/NEJM199612263352601.

  PMID: 8960472 BACKGROUND

• 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. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.

  PMID: 11907286 BACKGROUND

• 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. doi: 10.1056/NEJMoa043399.

  PMID: 15659722 BACKGROUND

• Glikson M, Friedman PA. The implantable cardioverter defibrillator. Lancet. 2001 Apr 7;357(9262):1107-17. doi: 10.1016/S0140-6736(00)04263-X.

  PMID: 11297981 BACKGROUND

• 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. doi: 10.1046/j.1440-172x.2002.00357.x.

  PMID: 12000634 BACKGROUND

• Sears SF Jr, Conti JB. Quality of life and psychological functioning of icd patients. Heart. 2002 May;87(5):488-93. doi: 10.1136/heart.87.5.488. No abstract available.

  PMID: 11997430 BACKGROUND

• Gelfman LP, Sudore RL, Mather H, McKendrick K, Hutchinson MD, Lampert RJ, Lipman HI, Matlock DD, Swetz KM, Pinney SP, Morrison RS, Goldstein NE. Prognostic Awareness and Goals of Care Discussions Among Patients With Advanced Heart Failure. Circ Heart Fail. 2020 Sep;13(9):e006502. doi: 10.1161/CIRCHEARTFAILURE.119.006502. Epub 2020 Sep 2.

  PMID: 32873058 DERIVED

• Goldstein NE, Mather H, McKendrick K, Gelfman LP, Hutchinson MD, Lampert R, Lipman HI, Matlock DD, Strand JJ, Swetz KM, Kalman J, Kutner JS, Pinney S, Morrison RS. Improving Communication in Heart Failure Patient Care. J Am Coll Cardiol. 2019 Oct 1;74(13):1682-1692. doi: 10.1016/j.jacc.2019.07.058.

  PMID: 31558252 DERIVED

MeSH Terms

Conditions

Communication; Heart Failure

Interventions

Cardiologists

Condition Hierarchy (Ancestors)

Behavior; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Nathan E. Goldstein, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 26, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-10

Locations

US (6)