search
Back to results

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

Primary Purpose

Systolic Heart Failure, Sudden Cardiac Death

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICD Decision Aid Toolkit
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Systolic Heart Failure focused on measuring decision aid, patient decision making, heart failure, ejection fraction, primary prevention, implantable cardioverter defibrillator, ICD, pilot trial, patient centered health care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Colorado Hospital (UCH)
  • Kaiser Permanente of Colorado
  • Denver VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

ICD Decision Aid Toolkit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine relative value of the four decision aids
Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site. We will ask participants the following questions: Have you made a decision about getting or not getting the ICD? What information did you use to make your decision? How are you feeling about your decision? What else would have been helpful in making your decision? (Intervention only) Did you use any of the decision aids you were given? If yes, please tell us how you used them? Did the decision aids make you feel better or worse about your decision? Did you like one of them better than the others? Is there any aspect that wasn't helpful? If no, please tell us why not? What would have been helpful? Do you have any advice on the best way to deliver these decision aids to future patients?
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.
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.

Full Information

First Posted
December 12, 2013
Last Updated
October 29, 2019
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT02026102
Brief Title
A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
Official Title
A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Specific Aim 1: Examine acceptability and feasibility of a toolkit of patient decision aids (PtDAs) for patients with heart failure referred for primary prevention implantable cardioverter-defibrillators using a randomized control trial design across three diverse health care systems (Kaiser Colorado, The University of Colorado, and The Denver Veterans Hospital). Measure the acceptability of the decision aids Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites. Conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being. Specific Aim 2: Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
ICD Decision Aid Toolkit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ICD Decision Aid Toolkit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure the acceptability and feasibility of the decision aids
Description
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.
Time Frame
pre-ICD discussion - baseline
Secondary Outcome Measure Information:
Title
Determine relative value of the four decision aids
Description
Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site. We will ask participants the following questions: Have you made a decision about getting or not getting the ICD? What information did you use to make your decision? How are you feeling about your decision? What else would have been helpful in making your decision? (Intervention only) Did you use any of the decision aids you were given? If yes, please tell us how you used them? Did the decision aids make you feel better or worse about your decision? Did you like one of them better than the others? Is there any aspect that wasn't helpful? If no, please tell us why not? What would have been helpful? Do you have any advice on the best way to deliver these decision aids to future patients?
Time Frame
3 months after baseline interview
Title
Measure the acceptability and feasibility of the decision aids
Description
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.
Time Frame
within 4 weeks of meeting with electrophysiologist
Title
Measure the acceptability and feasibility of the decision aids
Description
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.
Time Frame
3 months after baseline interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel D Matlock, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital (UCH)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Kaiser Permanente of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17485749
Citation
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.
Results Reference
background
PubMed Identifier
19588325
Citation
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.
Results Reference
background
PubMed Identifier
19477893
Citation
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.
Results Reference
background
PubMed Identifier
17873260
Citation
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.
Results Reference
background
PubMed Identifier
20609546
Citation
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.
Results Reference
background
PubMed Identifier
16911905
Citation
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.
Results Reference
background
PubMed Identifier
15659722
Citation
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. Erratum In: N Engl J Med. 2005 May 19;352(20):2146.
Results Reference
background
PubMed Identifier
15152059
Citation
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.
Results Reference
background
PubMed Identifier
11907286
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. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
Results Reference
background
PubMed Identifier
15152060
Citation
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.
Results Reference
background
PubMed Identifier
16769917
Citation
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.
Results Reference
background
PubMed Identifier
17446823
Citation
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.
Results Reference
background
PubMed Identifier
18768943
Citation
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.
Results Reference
background
Links:
URL
https://www.patientdecisionaid.org/
Description
Decision Aid for Heart Failure Patients Considering an Implantable Cardioverter Defibrillator

Learn more about this trial

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

We'll reach out to this number within 24 hrs