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Clinical Trials/NCT03832868
NCT03832868
Completed
Not Applicable

Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation

Emory University3 sites in 1 country25 target enrollmentFebruary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implantable Cardioverter-defibrillators (ICDs)
Sponsor
Emory University
Enrollment
25
Locations
3
Primary Endpoint
Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Detailed Description

There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Registry
clinicaltrials.gov
Start Date
February 20, 2019
End Date
September 6, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Faisal Merchant MD

Assistant Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • 18 years old and older
  • evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants

Time Frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)

Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.

Secondary Outcomes

  • Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants(Date of ICD implantation (up to 60 days from the date of receiving the decision aid))
  • Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants(Date of ICD implantation (up to 60 days from the date of receiving the decision aid))

Study Sites (3)

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