Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

Official Title

Alignment of Treatment Preferences and Repair Type for Veterans With 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 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.

Study Type

Interventional

Primary Outcome

Veteran preference for repair type

Secondary Outcome

 Decision regret scale

Condition

Abdominal Aortic Aneurysm

Intervention

Decision aid

Study Arms / Comparison Groups

 decision aid
Description:  the experimental group will receive the decision aid

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

240

Start Date

April 15, 2017

Completion Date

April 15, 2021

Primary Completion Date

October 24, 2019

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Philip Goodney, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03115346

Organization ID

IIR 15-085

Responsible Party

Sponsor

Study Sponsor

VA Office of Research and Development

Study Sponsor

Philip Goodney, MD, Principal Investigator, White River Junction VA Medical Center, White River Junction, VT

Verification Date

June 2020