An interventional study of Pre-visit timing of receipt of the ICDs implantation decision aid and Post-visit timing of receipt of the ICDs implantation decision aid in Implantable Cardioverter-defibrillators (ICDs), sponsored by Emory University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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.
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.
Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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
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
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.
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.
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.
Time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
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.
Time frame: 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.
Time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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