Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

NCT03115346 | Completed Results DMC

• 1 other identifier: IIR 15-085
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 22

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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)

  30 days

• 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

  30 days

Secondary Outcomes (1)

• Decision Regret Scale

  30 days

Study Arms (2)

decision aid

EXPERIMENTAL

the experimental group will receive the decision aid

Other: Decision aid

control

NO INTERVENTION

the control group will only receive the survey

Interventions

Decision aid OTHER

Decision aid for repair type for aortic abdominal aneurysms

decision aid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran with a \> or = 5.0 cm AAA who are candidates for both open and endovascular surgical repair, with no previous AAA repair surgery

You may not qualify if:

• Veterans who are not candidates for both open and endovascular repair, and are less than \< 5.0 cm AAA in size

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (22)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, 02301, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1873, United States

Location

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Jackson C. Montgomery VA Medical Center, Muskogee, OK

Muskogee, Oklahoma, 74401, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

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• 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.

  PMID: 35947375 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

While decision aids for patients facing aortic aneurysm repair are associated with better alignment between preferences and outcomes, use of a decision aid may add time required for clinic visits in real-world practice.

Results Point of Contact

• Title: Dr. Mark Eid
• Organization: VA Hospital

mark.a.eid01@gmail.com

502-295-8961

Study Officials

• Philip Goodney, MD

  White River Junction VA Medical Center, White River Junction, VT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: April 15, 2017
• Primary Completion: December 10, 2020
• Study Completion: May 30, 2022
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)