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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02026102
First received: December 12, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Systolic Heart Failure
Sudden Cardiac Death
Behavioral: ICD Decision Aid Toolkit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Measure the acceptability and feasibility of the decision aids [ Time Frame: pre-ICD discussion - baseline ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months after baseline interview ] [ Designated as safety issue: No ]

    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 [ Time Frame: within 4 weeks of meeting with electrophysiologist ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months after baseline interview ] [ Designated as safety issue: No ]

    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.


  • Determine relative value of the four decision aids [ Time Frame: 3 months after baseline interview ] [ Designated as safety issue: No ]

    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?


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
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.
Experimental: ICD Decision Aid Toolkit
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 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
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.

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).

  1. Measure the acceptability of the decision aids
  2. Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
  3. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026102

Contacts
Contact: Amy Jenkins, MS 303-724-6543 amy.jenkins@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital (UCH) Not yet recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Daniel D. Matlock, MD, MPH         
Denver VA Medical Center Not yet recruiting
Denver, Colorado, United States, 80220
Principal Investigator: Paul Varosy, MD         
Kaiser Permanente of Colorado Not yet recruiting
Denver, Colorado, United States, 80218
Principal Investigator: David Magid, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Daniel D Matlock, MD, MPH University of Colorado, Denver
  More Information

Additional Information:
Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02026102     History of Changes
Other Study ID Numbers: 13-3152, 121483
Study First Received: December 12, 2013
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
decision aid
patient decision making
heart failure
ejection fraction
primary prevention
implantable cardioverter defibrillator
ICD
pilot trial
patient centered health care

Additional relevant MeSH terms:
Heart Failure
Death, Sudden, Cardiac
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Heart Arrest
Death, Sudden
Death
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014