N/A
N=235
Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT03115346 ↗Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Veteran Preference for Repair Type — 25; 25; 95; 80 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision aid (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Veteran Preference for Repair Type |
25; 25; 95; 80 | — |
| PRIMARY Agreement Between Veterans Preferences for Repair Type and Actual Repair Type |
88; 75; 6; 15 | — |
| SECONDARY Decision Regret Scale |
4.9; 4.95 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03115346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.