Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
- Conditions
- Abdominal Aortic Aneurysm
- Interventions
- Other: Decision aid
- Registration Number
- NCT03115346
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 238
- Veteran with a > or = 5.0 cm AAA who are candidates for both open and endovascular surgical repair, with no previous AAA repair surgery
- Veterans who are not candidates for both open and endovascular repair, and are less than < 5.0 cm AAA in size
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description decision aid Decision aid the experimental group will receive the decision aid
- Primary Outcome Measures
Name Time Method Veteran Preference for Repair Type 30 days The investigators' survey will measure the effect of the decision aid on Veterans preference for repair type for abdominal aortic aneurysms and domains associated with preference for each repair type (endovascular or open)
Agreement Between Veterans Preferences for Repair Type and Actual Repair Type 30 days The investigators' survey instruments will assess the effect of the decision aid on the agreement between Veteran's preference for repair type and actual repair type they receive
- Secondary Outcome Measures
Name Time Method Decision Regret Scale 30 days The investigators will use the patient satisfaction questionnaire short form 18 to assess patient satisfaction. Patient satisfaction will be reported based on the average Decision Process Score for both decision and control groups, with a score of 5 representing the highest level of satisfaction and a score of 0 representing the lowest level of satisfaction.
Trial Locations
- Locations (22)
Michael E. DeBakey VA Medical Center, Houston, TX
🇺🇸Houston, Texas, United States
VA Palo Alto Health Care System, Palo Alto, CA
🇺🇸Palo Alto, California, United States
VA Northern California Health Care System, Mather, CA
🇺🇸Sacramento, California, United States
James A. Haley Veterans' Hospital, Tampa, FL
🇺🇸Tampa, Florida, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
🇺🇸West Los Angeles, California, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
🇺🇸Decatur, Georgia, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
🇺🇸Gainesville, Florida, United States
VA Boston Healthcare System Brockton Campus, Brockton, MA
🇺🇸Brockton, Massachusetts, United States
VA Western New York Healthcare System, Buffalo, NY
🇺🇸Buffalo, New York, United States
Jackson C. Montgomery VA Medical Center, Muskogee, OK
🇺🇸Muskogee, Oklahoma, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
🇺🇸Pittsburgh, Pennsylvania, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
🇺🇸Seattle, Washington, United States
Birmingham VA Medical Center, Birmingham, AL
🇺🇸Birmingham, Alabama, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
🇺🇸Salt Lake City, Utah, United States
Minneapolis VA Health Care System, Minneapolis, MN
🇺🇸Minneapolis, Minnesota, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
🇺🇸Omaha, Nebraska, United States
Durham VA Medical Center, Durham, NC
🇺🇸Durham, North Carolina, United States
Southern Arizona VA Health Care System, Tucson, AZ
🇺🇸Tucson, Arizona, United States
Phoenix VA Health Care System, Phoenix, AZ
🇺🇸Phoenix, Arizona, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
🇺🇸West Haven, Connecticut, United States
White River Junction VA Medical Center, White River Junction, VT
🇺🇸White River Junction, Vermont, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
🇺🇸Ann Arbor, Michigan, United States