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OpenTrials
Completed

NCT Number: NCT03115346

Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

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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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Aid

Other

Decision aid for repair type for aortic abdominal aneurysms

Primary outcomes

  1. Veteran Preference for Repair Type

    Time frame: 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)

  2. Agreement Between Veterans Preferences for Repair Type and Actual Repair Type

    Time frame: 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 outcomes

  1. Decision Regret Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Alignment of Treatment Preferences and Repair Type for Veterans With AAA

Acronym: PROVE-AAA

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Apr 14, 2017
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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