Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 240
Summary
- Conditions
- Abdominal Aortic Aneurysm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: This is a cluster randomized study. Sites will be randomly assigned to the intervention group - (decision aid +survey), or control group (survey only). The randomization scheme is 9:1, for complex and intermediate VA sites.Masking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
This is a cluster randomized trial comparing two ways to better align Veterans' preferences and treatments for AAA: (1) a validated decision aid describing AAA repair types with a survey measuring Veterans' preference for repair type -- versus (2) the survey alone. Enrolled Veterans will be candidat...
This is a cluster randomized trial comparing two ways to better align Veterans' preferences and treatments for AAA: (1) a validated decision aid describing AAA repair types with a survey measuring Veterans' preference for repair type -- versus (2) the survey alone. Enrolled Veterans will be candidates for either endovascular or open repair, and be followed at VA hospitals by vascular surgery teams who regularly perform both types of repair. In Aim 1, the investigators will determine Veterans' preferences for endovascular or open repair and identify domains associated with each repair type. In Aim 2, the investigators will compare agreement between Veterans' preferences and repair type between the decision aid+survey and survey-alone groups. In Aim 3, the investigators will investigate the facilitators and barriers of implementing a decision aid in a VA surgical clinic. The investigators will identify factors associated with agreement. The investigators' findings will be reported to the National Surgery Office Vascular Surgery Advisory Board to help ensure Veterans' preferences remain at the center of AAA treatment decisions. The investigators have recruited 20 VA Medical Centers and their vascular surgery teams to participate in this trial.
Tracking Information
- NCT #
- NCT03115346
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Philip Goodney, MD White River Junction VA Medical Center, White River Junction, VT
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