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

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.

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

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