Implantable Cardioverter-defibrillators (ICDs)
Conditions
Keywords
Decision aid
Brief 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.
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.
Interventions
BEHAVIORALPre-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.
BEHAVIORALPost-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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old and older * evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants | 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
| Measure | Time frame | Description |
|---|---|---|
| Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants | 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. |
| Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants | 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. |
Countries
United States
Outcome results
None listed