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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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Colorado Hospital (UCH)
Aurora, Colorado, United States
Kaiser Permanente of Colorado
Denver, Colorado, United States
Denver VA Medical Center
Denver, Colorado, United States
Start Date
September 1, 2014
Primary Completion Date
August 1, 2016
Completion Date
November 1, 2016
Last Updated
October 31, 2019
15
ACTUAL participants
ICD Decision Aid Toolkit
BEHAVIORAL
Lead Sponsor
University of Colorado, Denver
NCT07438938
NCT07372196
Data Source & Attribution
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