Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03115346
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2017-04-11
Brief Title:
Preferences for Open Vs Endovascular Repair for Abdominal Aortic Aneurysm
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Alignment of Treatment Preferences and Repair Type for Veterans With AAA
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVE-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 aidsurvey 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None