Syngery-Evaluating the Impact of Decision Aid

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Implantable Cardioverter-defibrillators (ICDs)

Intervention / Treatment
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* Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aid
* Behavioral: Post-visit timing of receipt of the ICDs implantation decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old and older evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each arm. No blinding will occur.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-visit decision aid<br>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. | Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aid<br>* 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.<br>|
| Experimental: Post-visit decision aid<br>Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward. | Behavioral: Post-visit timing of receipt of the ICDs implantation decision aid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants | 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. | Date of ICD implantation (up to 60 days from the date of receiving the decision aid) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants | 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. | 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 | 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. | Date of ICD implantation (up to 60 days from the date of receiving the decision aid) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision aid