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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Systolic Heart Failure, Sudden Cardiac Death

Intervention / Treatment
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* Behavioral: ICD Decision Aid Toolkit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 3 months after baseline interview | 
| 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. | within 4 weeks of meeting with electrophysiologist | 
| 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. | 3 months after baseline interview | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, decision aid, patient decision making, heart failure, ejection fraction, primary prevention, implantable cardioverter defibrillator, pilot trial, patient centered health care