Syngery-Evaluating the Impact of Decision Aid
September 10, 2019 updated by: Faisal Merchant MD, Emory University
Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30322
- Emory University Hospital Midtown
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Atlanta, Georgia, United States, 30322
- Emory St. Joseph's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years old and older
- evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre-visit 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.
|
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.
|
|
Experimental: Post-visit decision aid
Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Faisal Merchant, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2019
Primary Completion (Actual)
September 6, 2019
Study Completion (Actual)
September 6, 2019
Study Registration Dates
First Submitted
February 4, 2019
First Submitted That Met QC Criteria
February 5, 2019
First Posted (Actual)
February 6, 2019
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00107168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data is being collected in REDCAP and is deidentified.
The study team will have the tool to match subjects if needed.
The team has no current plans to share data, but can if necessary (including the data dictionaries).
All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool.
The decision tool is already available.
Data will be available immediately following publication and for 3 years after.
Those requesting access to data should contact the principal investigator (Dr.
Faisal Merchant).
Requests will be evaluated based on need and data usage agreement.
IPD Sharing Time Frame
Data will be available immediately following publication and for 3 years after.
IPD Sharing Access Criteria
Those requesting access to data should contact the principal investigator (Dr.
Faisal Merchant).
Requests will be evaluated based on need and data usage agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.