Preferences for Open Vs. Endovascular Repair for Aortic Abdominal Aneurysm

Status:	Recruiting
Conditions:	Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	11/10/2018
Start Date:	April 15, 2017
End Date:	April 15, 2021
Contact:	Philip Goodney, MD
Email:	Philip.Goodney@va.gov
Phone:	(802) 295-9363

Alignment of Treatment Preferences and Repair Type for Veterans With AAA

This study tests the use of a decision aid for Veterans who are facing a decision about
surgery for their aortic abdominal aneurysms (AAA). The investigators will enroll Veterans
with AAA who are candidates for endovascular or open surgical repair. There are 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 investigators 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.

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. 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.

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

We found this trial at

sites

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida 32608

Phone: 352-376-1611

from

Gainesville, FL