Status:

COMPLETED

A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

Lead Sponsor:

University of Colorado, Denver

Collaborating Sponsors:

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Heart Failure, Systolic

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.

Detailed Description

The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with imple...

Eligibility Criteria

Inclusion

  • 18 years or older
  • English-speaking (videos and surveys have only been validated in English)
  • Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation

Exclusion

  • Prisoners

Key Trial Info

Start Date :

May 28 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2021

Estimated Enrollment :

790 Patients enrolled

Trial Details

Trial ID

NCT03374891

Start Date

May 28 2018

End Date

December 31 2021

Last Update

July 8 2022

Active Locations (1)

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1

University of Colorado Denver

Aurora, Colorado, United States, 80045