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Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm (PROVE-AAA)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision aid
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Abdominal Aortic Aneurysm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham VA Medical Center, Birmingham, AL
  • Phoenix VA Health Care System, Phoenix, AZ
  • Southern Arizona VA Health Care System, Tucson, AZ
  • VA Palo Alto Health Care System, Palo Alto, CA
  • VA Northern California Health Care System, Mather, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • North Florida/South Georgia Veterans Health System, Gainesville, FL
  • James A. Haley Veterans' Hospital, Tampa, FL
  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • VA Boston Healthcare System Brockton Campus, Brockton, MA
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Minneapolis VA Health Care System, Minneapolis, MN
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
  • VA Western New York Healthcare System, Buffalo, NY
  • Durham VA Medical Center, Durham, NC
  • Jackson C. Montgomery VA Medical Center, Muskogee, OK
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  • Michael E. DeBakey VA Medical Center, Houston, TX
  • VA Salt Lake City Health Care System, Salt Lake City, UT
  • White River Junction VA Medical Center, White River Junction, VT
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

decision aid

control

Arm Description

the experimental group will receive the decision aid

the control group will only receive the survey

Outcomes

Primary Outcome Measures

Veteran preference for repair type
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
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

Decision regret scale
The investigators will use the patient satisfaction questionnaire short form 18 to assess patient satisfaction

Full Information

First Posted
April 11, 2017
Last Updated
June 9, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03115346
Brief Title
Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
Acronym
PROVE-AAA
Official Title
Alignment of Treatment Preferences and Repair Type for Veterans With AAA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
decision aid
Arm Type
Experimental
Arm Description
the experimental group will receive the decision aid
Arm Title
control
Arm Type
No Intervention
Arm Description
the control group will only receive the survey
Intervention Type
Other
Intervention Name(s)
Decision aid
Intervention Description
Decision aid for repair type for aortic abdominal aneurysms
Primary Outcome Measure Information:
Title
Veteran preference for repair type
Description
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)
Time Frame
30 days
Title
Agreement between Veterans preferences for repair type and actual repair type
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Decision regret scale
Description
The investigators will use the patient satisfaction questionnaire short form 18 to assess patient satisfaction
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Goodney, MD
Organizational Affiliation
White River Junction VA Medical Center, White River Junction, VT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Southern Arizona VA Health Care System, Tucson, AZ
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
VA Boston Healthcare System Brockton Campus, Brockton, MA
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105-1873
Country
United States
Facility Name
VA Western New York Healthcare System, Buffalo, NY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Jackson C. Montgomery VA Medical Center, Muskogee, OK
City
Muskogee
State/Province
Oklahoma
ZIP/Postal Code
74401
Country
United States
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
White River Junction VA Medical Center, White River Junction, VT
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

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