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Completed

NCT Number: NCT02026102

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

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.

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Key information

Conditions

Systolic Heart Failure Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Heart Failure, Systolic Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital (UCH), Aurora, Colorado, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Measure the acceptability and feasibility of the decision aids

    Time frame: pre-ICD discussion - baseline

    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 outcomes

  1. Determine relative value of the four decision aids

    Time frame: 3 months after baseline interview

    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?

  2. Measure the acceptability and feasibility of the decision aids

    Time frame: within 4 weeks of meeting with electrophysiologist

    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.

  3. Measure the acceptability and feasibility of the decision aids

    Time frame: 3 months after baseline interview

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2014
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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