NCT02026102

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Systolic Heart Failure
• Sudden Cardiac Death

Interventions

Type	Name	Description
BEHAVIORAL	ICD Decision Aid Toolkit	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-08-01
• Completion: 2016-11-01
• First posted: 2014-01-01
• Last updated: 2019-10-31

Locations

3 sites across 1 country: United States