Syngery-Evaluating the Impact of Decision Aid

Implantable Cardioverter-defibrillators (ICDs) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832868
• Other study ID #: IRB00107168
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: September 6, 2019

Study information

• Verified date: September 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and older

• evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)

Related Conditions & MeSH terms

• Implantable Cardioverter-defibrillators (ICDs)

Intervention

Behavioral:
• Pre-visit timing of receipt of the ICDs implantation decision aid
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
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.

Locations

Country	Name	City	State
United States	Emory St. Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)