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OpenTrials
Completed

NCT Number: NCT03832868

Syngery-Evaluating the Impact of Decision Aid

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Pre-visit timing of receipt of the ICDs implantation decision aid

Behavioral

The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.

Post-visit timing of receipt of the ICDs implantation decision aid

Behavioral

The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.

Primary outcomes

  1. 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

  1. Decision Conflict Scale 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 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.

  2. Values-choice ICDs concordance 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 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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