Brief Title
Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
Official Title
Alignment of Treatment Preferences and Repair Type for Veterans With AAA
Brief Summary
This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA). The local site investigators (LSI) will enroll Veterans with AAA who are candidates for endovascular or open surgical repair. There are 22-24 VA Medical Centers participating in the trial. 12 sites will be randomly assigned to the intervention group, and 12 sites will be randomly assigned to the control group. Twelve Veterans will be enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a decision aid with information about the two types of surgery for AAA repair, open and endovascular, and complete a survey about their preferences. Veterans at control sites will complete the same survey, but will not receive the decision aid. After their surgery, Veterans will take another survey asking about their satisfaction. The LSI will compare the results of the survey between Veterans' in the intervention and control groups to determine the effect of the decision aid on agreement between preference and repair type.
Detailed 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 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.
Study Type
Interventional
Primary Outcome
Veteran preference for repair type
Secondary Outcome
Decision regret scale
Condition
Abdominal Aortic Aneurysm
Intervention
Decision aid
Study Arms / Comparison Groups
decision aid
Description: the experimental group will receive the decision aid
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
238
Start Date
April 15, 2017
Completion Date
April 15, 2021
Primary Completion Date
December 10, 2020
Eligibility Criteria
Inclusion Criteria: - Veteran with a > or = 5.0 cm AAA who are candidates for both open and endovascular surgical repair, with no previous AAA repair surgery Exclusion Criteria: - Veterans who are not candidates for both open and endovascular repair, and are less than < 5.0 cm AAA in size
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Philip Goodney, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03115346
Organization ID
IIR 15-085
Responsible Party
Sponsor
Study Sponsor
VA Office of Research and Development
Study Sponsor
Philip Goodney, MD, Principal Investigator, White River Junction VA Medical Center, White River Junction, VT
Verification Date
December 2020