Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
NCT ID: NCT03115346
Last Updated: 2024-09-26
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
241 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-04-15
Study Completion Date
2022-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Abdominal Aortic Aneurysm
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
This is a cluster randomized study. Sites will be randomly assigned to the intervention group - (decision aid +survey), or control group (survey only). The randomization scheme is 9:1, for complex and intermediate VA sites.
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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decision aid
the experimental group will receive the decision aid
Group Type
EXPERIMENTAL
Decision aid
Intervention Type
OTHER
Decision aid for repair type for aortic abdominal aneurysms
control
the control group will only receive the survey
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Decision aid
Decision aid for repair type for aortic abdominal aneurysms
Intervention Type
OTHER
Eligibility Criteria
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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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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VA Office of Research and Development
FED
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Philip Goodney, MD
Role: PRINCIPAL_INVESTIGATOR
White River Junction VA Medical Center, White River Junction, VT
Locations
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Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States
Site Status
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
Site Status
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States
Site Status
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Site Status
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
Site Status
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Site Status
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Site Status
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Site Status
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States
Site Status
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
Site Status
VA Boston Healthcare System Brockton Campus, Brockton, MA
Brockton, Massachusetts, United States
Site Status
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Site Status
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Site Status
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States
Site Status
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States
Site Status
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
Site Status
Jackson C. Montgomery VA Medical Center, Muskogee, OK
Muskogee, Oklahoma, United States
Site Status
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Site Status
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
Site Status
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
Site Status
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States
Site Status
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Columbo JA, Kang R, Spangler EL, Newhall K, Brooke BS, Dosluoglu H, Lee ES, Raffetto JD, Henke PK, Tang GS, Mureebe L, Kougias P, Johanning J, Arya S, Scali ST, Stone DH, Suckow BD, Orion K, Halpern V, O'Connell J, Inhat D, Nelson P, Tzeng E, Zhou W, Barry M, Sirovich B, Goodney PP; PROVE-AAA Study Team. Design of the PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial. Ann Vasc Surg. 2020 May;65:247-253. doi: 10.1016/j.avsg.2019.02.034. Epub 2019 May 8.
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Bellamkonda KS, Yousef S, Nassiri N, Dardik A, Guzman RJ, Geirsson A, Ochoa Chaar CI. Trends and outcomes of thoracic endovascular aortic repair with open concomitant cervical debranching. J Vasc Surg. 2021 Apr;73(4):1205-1212.e3. doi: 10.1016/j.jvs.2020.07.103. Epub 2020 Aug 27.
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RESULT
Holeman TA, Peacock J, Beckstrom JL, Brooke BS. Patient-Surgeon Agreement in Assessment of Frailty, Physical Function, & Social Activity. J Surg Res. 2020 Dec;256:368-373. doi: 10.1016/j.jss.2020.06.059. Epub 2020 Jul 30.
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RESULT
DeAngelo MM, Peacock JB, Holeman TA, Maloney M, Beckstrom J, Brooke BS. Long-Term Functional Decline Following Vascular Surgery Among Vulnerable Adults. Ann Vasc Surg. 2021 Oct;76:87-94. doi: 10.1016/j.avsg.2021.04.002. Epub 2021 Apr 22.
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RESULT
Eid MA, Barnes JA, Mehta K, Wanken Z, Columbo J, Kang R, Newhall K, Halpern V, Raffetto J, Kougias P, Henke P, Tang G, Mureebe L, Johanning J, Tzeng E, Scali S, Stone D, Suckow B, Lee E, Arya S, Orion K, O'Connell J, Brooke B, Ihnat D, Dosluoglu H, Zhou W, Nelson P, Spangler E, Barry M, Sirovich B, Goodney P. Factors associated with preference of choice of aortic aneurysm repair in the PReference for Open Versus Endovascular repair of AAA (PROVE-AAA) study. J Vasc Surg. 2022 Dec;76(6):1556-1564. doi: 10.1016/j.jvs.2022.06.018. Epub 2022 Jul 19.
Reference Type
RESULT
Eid MA, Barry MJ, Tang GL, Henke PK, Johanning JM, Tzeng E, Scali ST, Stone DH, Suckow BD, Lee ES, Arya S, Brooke BS, Nelson PR, Spangler EL, Murebee L, Dosluoglu HH, Raffetto JD, Kougais P, Brewster LP, Alabi O, Dardik A, Halpern VJ, O'Connell JB, Ihnat DM, Zhou W, Sirovich BE, Metha K, Moore KO, Voorhees A, Goodney PP; Preferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Study Team. Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial. JAMA Surg. 2022 Sep 1;157(9):e222935. doi: 10.1001/jamasurg.2022.2935. Epub 2022 Sep 14.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IIR 15-085
Identifier Type: -
Identifier Source: org_study_id
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