A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

NCT02026102 | Completed

• 2 other identifiers: 13-3152121483
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.

Conditions

Systolic Heart Failure; Sudden Cardiac Death

Keywords

decision aid; patient decision making; heart failure; ejection fraction; primary prevention; implantable cardioverter defibrillator; ICD; pilot trial; patient centered health care

Outcome Measures

Primary Outcomes (1)

• Measure the acceptability and feasibility of the decision aids

  Acceptability-measure decision aid acceptability using modified version of decision aid acceptability developed by Barry et al. Feasibility-explore participation rates and adherence to study protocol; weekly team meetings to discuss recruitment strategies Knowledge: 21 item knowledge measure developed in-house Decision Conflict: validated 15-item decision conflict measure developed by O'Connor et al. Decision Regret: validated 5-item decision regret scale Decision choice: ultimate choice patient made about getting an ICD Decision participation: Prior to intervention, we measure patients' preferred role in decision making using the control preferences scale. After the decision, we measure the participants' actual role in decision making. Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS). Chart Review Outcome: For those that had not yet had a procedure, we will review the charts at the end of study to determine if they received an ICD or not.

  pre-ICD discussion - baseline

Secondary Outcomes (3)

• Determine relative value of the four decision aids

  3 months after baseline interview

• Measure the acceptability and feasibility of the decision aids

  within 4 weeks of meeting with electrophysiologist

• Measure the acceptability and feasibility of the decision aids

  3 months after baseline interview

Study Arms (2)

Usual Care

NO INTERVENTION

Patients will receive no additional ICD specific information other than what is offered by the clinic consistent with usual care. The control group will be asked where they went for information in the follow-up interviews.

ICD Decision Aid Toolkit

EXPERIMENTAL

In the intervention arm, research assistants will provide the patients with the toolkit of decision aids. At that time, participants will have the option of using all of the decision aids or just some of the decision aids. Participants who do not have access to the internet, will be offered a DVD (digital video disc) version of the video and they will be asked if they would like to arrange a visit where they can review the website with the research assistant.

Behavioral: ICD Decision Aid Toolkit

Interventions

ICD Decision Aid Toolkit BEHAVIORAL

Research assistants will provide patients with a toolkit of decision aids. Participants will have the option of using all of the decision aids or just some of the decision aids.

ICD Decision Aid Toolkit

Eligibility Criteria

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

You may qualify if:

• systolic heart failure (defined as an ejection fraction less than 35%)
• have been referred for a primary prevention ICD
• Note: Patients referred for an ICD with cardiac resynchronization therapy are NOT excluded.

You may not qualify if:

• Already have an ICD
• Non-English speaking (as the tools we have developed are only available in English currently)
• Other ICD indications (e.g. secondary prevention, hypertrophic obstructive cardiomyopathy)
• Cognitive Impairment defined only as people with an inability to consent

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (3)

University of Colorado Hospital (UCH)

Aurora, Colorado, 80045, United States

Location

Kaiser Permanente of Colorado

Denver, Colorado, 80218, United States

Location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Related Publications (13)

• O'Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA, Moulton BW, Sepucha KR, Sodano AG, King JS. Toward the 'tipping point': decision aids and informed patient choice. Health Aff (Millwood). 2007 May-Jun;26(3):716-25. doi: 10.1377/hlthaff.26.3.716.

  PMID: 17485749 BACKGROUND

• O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner D. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD001431. doi: 10.1002/14651858.CD001431.pub2.

  PMID: 19588325 BACKGROUND

• Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.

  PMID: 19477893 BACKGROUND

• Col NF, Ngo L, Fortin JM, Goldberg RJ, O'Connor AM. Can computerized decision support help patients make complex treatment decisions? A randomized controlled trial of an individualized menopause decision aid. Med Decis Making. 2007 Sep-Oct;27(5):585-98. doi: 10.1177/0272989X07306781. Epub 2007 Sep 14.

  PMID: 17873260 BACKGROUND

• Jibaja-Weiss ML, Volk RJ, Granchi TS, Neff NE, Robinson EK, Spann SJ, Aoki N, Friedman LC, Beck JR. Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy. Patient Educ Couns. 2011 Jul;84(1):41-8. doi: 10.1016/j.pec.2010.06.009. Epub 2010 Jul 7.

  PMID: 20609546 BACKGROUND

• Stevenson LW, Desai AS. Selecting patients for discussion of the ICD as primary prevention for sudden death in heart failure. J Card Fail. 2006 Aug;12(6):407-12. doi: 10.1016/j.cardfail.2006.06.001.

  PMID: 16911905 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

• Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.

  PMID: 15152059 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

• Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004 May 20;350(21):2151-8. doi: 10.1056/NEJMoa033088.

  PMID: 15152060 BACKGROUND

• Goldenberg I, Moss AJ, Hall WJ, McNitt S, Zareba W, Andrews ML, Cannom DS; Multicenter Automatic Defibrillator Implantation Trial (MADIT) II Investigators. Causes and consequences of heart failure after prophylactic implantation of a defibrillator in the multicenter automatic defibrillator implantation trial II. Circulation. 2006 Jun 20;113(24):2810-7. doi: 10.1161/CIRCULATIONAHA.105.577262. Epub 2006 Jun 12.

  PMID: 16769917 BACKGROUND

• Noyes K, Corona E, Zwanziger J, Hall WJ, Zhao H, Wang H, Moss AJ, Dick AW; Multicenter Automatic Defibrillator Implantation Trial II. Health-related quality of life consequences of implantable cardioverter defibrillators: results from MADIT II. Med Care. 2007 May;45(5):377-85. doi: 10.1097/01.mlr.0000257142.12600.c1.

  PMID: 17446823 BACKGROUND

• Mark DB, Anstrom KJ, Sun JL, Clapp-Channing NE, Tsiatis AA, Davidson-Ray L, Lee KL, Bardy GH; Sudden Cardiac Death in Heart Failure Trial Investigators. Quality of life with defibrillator therapy or amiodarone in heart failure. N Engl J Med. 2008 Sep 4;359(10):999-1008. doi: 10.1056/NEJMoa0706719.

  PMID: 18768943 BACKGROUND

Related Links

• Decision Aid for Heart Failure Patients Considering an Implantable Cardioverter Defibrillator

MeSH Terms

Conditions

Heart Failure, Systolic; Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel D Matlock, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 1, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

US (3)