Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 60
Summary
- Conditions
- Aortic Valve Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients are randomly assigned to receive the decision aid or usual care.Masking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit approximately 120 patients at Massachusetts General Hospital or at the UCHealth Heart and Vascula...
The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit approximately 120 patients at Massachusetts General Hospital or at the UCHealth Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.
Tracking Information
- NCT #
- NCT04103931
- Collaborators
- University of Colorado, Denver
- Investigators
- Principal Investigator: Karen R Sepucha, PhD Massachusetts General Hospital
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