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

Sudden Cardiac Death Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02026102
Study type Interventional
Source University of Colorado, Denver
Contact
Status Completed
Phase N/A
Start date September 2014
Completion date November 2016
View Details
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