Syngery-Evaluating the Impact of Decision Aid

Not Applicable

Completed

• Conditions: Implantable Cardioverter-defibrillators (ICDs)
• Interventions: Behavioral: Post-visit timing of receipt of the ICDs implantation decision aid; Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aid

• Registration Number: NCT03832868
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Study Start: 2019-02-20
• Status Verified: 2019-09
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-visit decision aid	Post-visit timing of receipt of the ICDs implantation decision aid	Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.
Pre-visit decision aid	Pre-visit timing of receipt of the ICDs implantation decision aid	Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist.

Primary Outcome Measures

Name	Time	Method
Decisional ICDs knowledge 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)	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 Outcome Measures

Name	Time	Method
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)	Patients will receive a survey including 12 questions to measure decisional conflict. The surveys are 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.
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)	Patients will receive a survey including 12 questions to measure values-choice concordance. The surveys are 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.

Trial Locations

Locations (3)

Emory St. Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States