Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Clinical Trial

— PROVE-AAA  

Official title:

Alignment of Treatment Preferences and Repair Type for Veterans With AAA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03115346
• Other study ID #: IIR 15-085
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: April 30, 2022
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Other:
• Decision aid
Decision aid for repair type for aortic abdominal aneurysms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (29)

Anderson PB, Wanken ZJ, Perri JL, Columbo JA, Kang R, Spangler EL, Newhall K, Brooke BS, Dosluoglu H, Lee ES, Raffetto JD, Henke PK, Tang GL, 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. Patient information sources when facing repair of abdominal aortic aneurysm. J Vasc Surg. 2020 Feb;71(2):497-504. doi: 10.1016/j.jvs.2019.04.460. Epub 2019 Jul 26. — View Citation

Archie M, Archie M, O'Connell J, DeRubertis BG. Underutilization of Thrombolytic Therapy for Patients Diagnosed with Acute Deep Venous Thrombosis in the Outpatient Setting. Ann Vasc Surg. 2018 May;49:255-260. doi: 10.1016/j.avsg.2018.02.005. Epub 2018 Feb 28. — View Citation

Bartline PB, Suckow BD, Brooke BS, Kraiss LW, Mueller MT. Outcomes in Critical Limb Ischemia Compared by Distance from Referral Center. Ann Vasc Surg. 2017 Jan;38:122-129. doi: 10.1016/j.avsg.2016.07.063. Epub 2016 Aug 13. — View Citation

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. — View Citation

Brahmandam A, Gholitabar N, Cardella J, Nassiri N, Dardik A, Georgi M, Ochoa Chaar CI. Discrepancy in Outcomes after Revascularization for Chronic Limb-Threatening Ischemia Warrants Separate Reporting of Rest Pain and Tissue Loss. Ann Vasc Surg. 2021 Jan; — View Citation

Brooke BS, Sarfati MR, Zhang Y, Zhang Y, Presson AP, Greene TH, Kraiss LW. Cardiac Stress Testing during Workup for Abdominal Aortic Aneurysm Repair Is Not Associated with Improved Patient Outcomes. Ann Vasc Surg. 2017 Jul;42:222-230. doi: 10.1016/j.avsg.2016.10.057. Epub 2017 Mar 10. — View Citation

Brooke BS, Slager SL, Swords DS, Weir CR. Patient and caregiver perspectives on care coordination during transitions of surgical care. Transl Behav Med. 2018 May 23;8(3):429-438. doi: 10.1093/tbm/ibx077. — View Citation

Chin JA, Skrip L, Sumpio BE, Cardella JA, Indes JE, Sarac TP, Dardik A, Ochoa Chaar CI. Percutaneous endovascular aneurysm repair in morbidly obese patients. J Vasc Surg. 2017 Mar;65(3):643-650.e1. doi: 10.1016/j.jvs.2016.06.115. Epub 2016 Dec 27. — View Citation

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. Review. — View Citation

David RA, Brooke BS, Hanson KT, Goodney PP, Genovese EA, Baril DT, Gloviczki P, DeMartino RR. Early extubation is associated with reduced length of stay and improved outcomes after elective aortic surgery in the Vascular Quality Initiative. J Vasc Surg. 2017 Jul;66(1):79-94.e14. doi: 10.1016/j.jvs.2016.12.122. Epub 2017 Mar 31. — View Citation

DeMartino RR, Brooke BS, Neal D, Beck AW, Conrad MF, Arya S, Desai S, Aziz F, Ryan P, Cronenwett JL, Kraiss LW; Vascular Quality Initiative. Development of a validated model to predict 30-day stroke and 1-year survival after carotid endarterectomy for asymptomatic stenosis using the Vascular Quality Initiative. J Vasc Surg. 2017 Aug;66(2):433-444.e2. doi: 10.1016/j.jvs.2017.03.427. Epub 2017 Jun 2. — View Citation

Fereydooni A, Nassiri N. Evaluation and management of the lateral marginal vein in Klippel-Trénaunay and other PIK3CA-related overgrowth syndromes. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):482-493. doi: 10.1016/j.jvsv.2019.12.003. Epub 2020 Feb 20 — View Citation

Gelabert HA, Rigberg DA, O'Connell JB, Jabori S, Jimenez JC, Farley S. Transaxillary decompression of thoracic outlet syndrome patients presenting with cervical ribs. J Vasc Surg. 2018 Oct;68(4):1143-1149. doi: 10.1016/j.jvs.2018.01.057. Epub 2018 Apr 25. — View Citation

Ghaffarian AA, Griffin CL, Kraiss LW, Sarfati MR, Brooke BS. Comparative effectiveness of one-stage versus two-stage basilic vein transposition arteriovenous fistulas. J Vasc Surg. 2018 Feb;67(2):529-535.e1. doi: 10.1016/j.jvs.2017.07.115. Epub 2017 Sep 21. — View Citation

Goodney PP, Spangler EL, Newhall K, Brooke BS, Schanzer A, Tan TW, Beck AW, Hallett JH, MacKenzie TA, Edelen MO, Hoel AW, Rigotti NA, Farber A. Feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons in the Vascular Physician Offer and Report (VAPOR) Trial. J Vasc Surg. 2017 Apr;65(4):1152-1160.e2. doi: 10.1016/j.jvs.2016.10.121. Epub 2017 Feb 9. Erratum in: J Vasc Surg. 2018 Jun;67(6):1946. — View Citation

Hoel AW, Faerber AE, Moore KO, Ramkumar N, Brooke BS, Scali ST, Sedrakyan A, Goodney PP. A pilot study for long-term outcome assessment after aortic aneurysm repair using Vascular Quality Initiative data matched to Medicare claims. J Vasc Surg. 2017 Sep;66(3):751-759.e1. doi: 10.1016/j.jvs.2016.12.100. Epub 2017 Feb 17. — View Citation

Jones DW, Schermerhorn ML, Brooke BS, Conrad MF, Goodney PP, Wyers MC, Stone DH; Vascular Quality Initiative. Perioperative clopidogrel is associated with increased bleeding and blood transfusion at the time of lower extremity bypass. J Vasc Surg. 2017 Jun;65(6):1719-1728.e1. doi: 10.1016/j.jvs.2016.12.102. Epub 2017 Feb 20. — View Citation

Kim JJ, Mills JL, Braun J, Barshes N, Kougias P, Younes HK. Arteriovenous fistula maturation rate is not affected by ipsilateral tunneled dialysis catheter. J Vasc Surg. 2019 Nov;70(5):1629-1633. doi: 10.1016/j.jvs.2019.01.084. Epub 2019 Jun 21. — View Citation

Martin LA, Finlayson SRG, Brooke BS. Patient Preparation for Transitions of Surgical Care: Is Failing to Prepare Surgical Patients Preparing Them to Fail? World J Surg. 2017 Jun;41(6):1447-1453. doi: 10.1007/s00268-017-3884-z. — View Citation

Mirabelli LG, Cosker RM, Kraiss LW, Griffin CL, Smith BK, Sarfati MR, Al-Dulaimi R, Brooke BS. Rapid Methods for Routine Frailty Assessment during Vascular Surgery Clinic Visits. Ann Vasc Surg. 2018 Jan;46:134-141. doi: 10.1016/j.avsg.2017.08.010. Epub 2017 Sep 6. — View Citation

Newhall K, Suckow B, Spangler E, Brooke BS, Schanzer A, Tan TW, Burnette M, Edelen MO, Farber A, Goodney P; VAPOR investigators. Impact and Duration of Brief Surgeon-Delivered Smoking Cessation Advice on Attitudes Regarding Nicotine Dependence and Tobacco Harms for Patients with Peripheral Arterial Disease. Ann Vasc Surg. 2017 Jan;38:113-121. doi: 10.1016/j.avsg.2016.06.005. Epub 2016 Aug 10. — View Citation

Pannucci CJ, Swistun L, MacDonald JK, Henke PK, Brooke BS. Individualized Venous Thromboembolism Risk Stratification Using the 2005 Caprini Score to Identify the Benefits and Harms of Chemoprophylaxis in Surgical Patients: A Meta-analysis. Ann Surg. 2017 Jun;265(6):1094-1103. doi: 10.1097/SLA.0000000000002126. — View Citation

Perri JL, Nolan BW, Goodney PP, DeMartino RR, Brooke BS, Arya S, Conrad MF, Cronenwett JL. Factors affecting operative time and outcome of carotid endarterectomy in the Vascular Quality Initiative. J Vasc Surg. 2017 Oct;66(4):1100-1108. doi: 10.1016/j.jvs.2017.03.426. Epub 2017 Jul 14. — View Citation

Sadaghianloo N, Declemy S, Dardik A. Reply. J Vasc Surg. 2017 Mar;65(3):929-930. doi: 10.1016/j.jvs.2016.08.105. — View Citation

Tran HA, O'Connell JB, Lee UK, Polanco JC, Chang TI, Friedlander AH. Relationship between symptomatic lower limb peripheral artery disease and calcified carotid artery plaque detected on panoramic images of neurologically asymptomatic males. Dentomaxillofac Radiol. 2019 Jul;48(5):20180432. doi: 10.1259/dmfr.20180432. Epub 2019 Mar 19. — View Citation

Walsworth MK, de Bie R, Figoni SF, O'Connell JB. Peripheral Artery Disease: What You Need to Know. J Orthop Sports Phys Ther. 2017 Dec;47(12):957-964. doi: 10.2519/jospt.2017.7442. Epub 2017 Oct 9. — View Citation

Wang T, Shu C, Li M, Dardik A, Li QM. In vitro Stent Graft Fenestration to Preserve All Supra-aortic Branches in the Treatment of a Stanford Type A Aortic Arch Dissection. Chin Med J (Engl). 2017 Aug 5;130(15):1878-1879. doi: 10.4103/0366-6999.211544. — View Citation

Wang T, Shu C, Li M, Li QM, Li X, Qiu J, Fang K, Dardik A, Yang CZ. Thoracic Endovascular Aortic Repair With Single/Double Chimney Technique for Aortic Arch Pathologies. J Endovasc Ther. 2017 Jun;24(3):383-393. doi: 10.1177/1526602817698702. Epub 2017 Mar 21. — View Citation

Williams CR, Brooke BS. Effectiveness of open versus endovascular abdominal aortic aneurysm repair in population settings: A systematic review of statewide databases. Surgery. 2017 Oct;162(4):707-720. doi: 10.1016/j.surg.2017.01.014. Epub 2017 Feb 24. Review. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Decision regret scale	The investigators will use the patient satisfaction questionnaire short form 18 to assess patient satisfaction	30 days