BACKGROUND/RATIONALE:
Nearly 5,000 Veterans undergo abdominal aortic aneurysm (AAA) repair each year in VA hospitals. Randomized trials, including the VA-based Open Versus Endovascular Repair (OVER) Trial, have found endovascular AAA repair (EVAR), is associated with lower perioperative morbidity and mortality, less pain, and shorter length of stay than open surgical repair (OSR). However, OSR is more durable, has fewer long-term complications, and Veterans treated with EVAR and OSR have similar survival two years following surgery. Given these tradeoffs, controversy remains as to which method is best suited for an individual Veteran who AAA repair. Shared decision-making is an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options to achieve informed preferences. This trial will help determine how to best use shared decision-making models in the treatment of Veterans with aortic abdominal aneurysms (AAA).

OBJECTIVE(S):
Through this study, we will compare two different ways to align Veteran's preferences and treatments for AAA, a decision aid describing AAA repair types with a survey measuring veteran's preference for repair type, versus a survey alone. In Aim 1, we will identify Veteran and surgeon factors associated with preference for endovascular or open repair. In Aim 2, we will compare agreement between Veterans' preferences and repair type between the decision aid with survey and survey-alone groups. Surgeons are also being recruited to help guide better choices for Veterans and surgeons in the future.

METHODS:
Our study population is 240 Veterans and their vascular surgeons practicing at twenty VA hospitals that perform both endovascular and open repair. Ten sites are randomized to the control arm and ten sites to the intervention arm. At sites in the control group Veterans receive the survey alone. At sites in the intervention group, Veteran's receive the survey + decision aid. In both the intervention and control groups, the Site Principal Investigator reviews imaging tests and electronic health record to identify Veteran's that are candidates for endovascular and open repair. Veterans are invited to participate and provide informed consent when they arrive at the vascular surgery clinic. Study Site Coordinators administer the survey - and at the intervention sites, the decision aid - with Veterans prior to their consultation with the surgeon. A second survey, the Decision Process Score, is administered after their consultation with the surgeon. Surgeons at both intervention and control sites complete the same survey for each Veteran enrolled. Thirty days after their surgery, Veterans complete a Patient Satisfaction Questionnaire. To inform the agreement between preferences and repair type, we compare the preference identified for each Veteran in Aim 1 and the actual AAA repair type the Veteran receives.

FINDINGS/RESULTS:
There are no findings or results. The current enrollment as of 04/03/2018 is nearly halfway complete as we have successfully enrolled 118 of the expected 240 participants nationwide. We are in the early phase of data collection and currently working on data submission from all of the data elements collected.

IMPACT:
While there are no preliminary findings yet from which to draw conclusions, we anticipate that the decision aid may help align Veterans' preferences with treatment and improve outcomes. Misalignment of treatment preferences can result in poorer satisfaction with surgery. This dissatisfaction can have real effects for Veterans. For example, Veterans treated with open repair may have more complications, more work loss, greater rates of depression, and more social isolation because of the longer recovery time. Similarly, for Veterans treated with endovascular repair, the need for continued surveillance with radiation-based CT scans, worries about complications, and the need for family support can have deleterious effects as well. (04/03/2018)

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External Links for this Project

NIH Reporter

Grant Number: I01HX001880-01A2
Link: https://reporter.nih.gov/project-details/9193268

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PUBLICATIONS:

Journal Articles

1. Wang T, Shu C, Li M, Dardik A, Li QM. Stent Graft Fenestration to Preserve All Supra-aortic Branches in the Treatment of a Stanford Type A Aortic Arch Dissection. Chinese medical journal. 2017 Aug 5; 130(15):1878-1879. [view]
2. 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. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Sep 1; 66(3):751-759.e1. [view]
3. Kim JJ, Mills JL, Braun J, Barshes N, Kougias P, Younes HK. Arteriovenous fistula maturation rate is not affected by ipsilateral tunneled dialysis catheter. Journal of Vascular Surgery. 2019 Nov 1; 70(5):1629-1633. [view]
4. 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. Annals of vascular surgery. 2017 Jul 1; 42:222-230. [view]
5. Ghaffarian AA, Griffin CL, Kraiss LW, Sarfati MR, Brooke BS. Comparative effectiveness of one-stage versus two-stage basilic vein transposition arteriovenous fistulas. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2018 Feb 1; 67(2):529-535.e1. [view]
6. 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. Annals of vascular surgery. 2020 May 1; 65:247-253. [view]
7. 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. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Aug 1; 66(2):433-444.e2. [view]
8. 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. Annals of vascular surgery. 2021 Jan 1; 70:237-244. [view]
9. 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. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Jul 1; 66(1):79-94.e14. [view]
10. 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 1; 162(4):707-720. [view]
11. Fereydooni A, Nassiri N. Evaluation and management of the lateral marginal vein in Klippel-Trénaunay and other PIK3CA-related overgrowth syndromes. Journal of vascular surgery. Venous and lymphatic disorders. 2020 May 1; 8(3):482-493. [view]
12. 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. Journal of Vascular Surgery. 2017 Oct 1; 66(4):1100-1108. [view]
13. Eid MA, Barnes JA, Mehta K, Wanken Z, Columbo J, Kang R, Newhall K, Halpern V, Raffetto J, Kougias P, Henke P, Tang G, Mureebe L, Johanning J, Tzeng E, Scali S, Stone D, Suckow B, Lee E, Arya S, Orion K, O'Connell J, Brooke B, Ihnat D, Dosluoglu H, Zhou W, Nelson P, Spangler E, Barry M, Sirovich B, Goodney P. Factors associated with preference of choice of aortic aneurysm repair in the PReference for Open Versus Endovascular repair of AAA (PROVE-AAA) study. Journal of Vascular Surgery. 2022 Dec 1; 76(6):1556-1564. [view]
14. 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. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Apr 1; 65(4):1152-1160.e2. [view]
15. 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. Annals of vascular surgery. 2017 Jan 1; 38:113-121. [view]
16. 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. Annals of surgery. 2017 Jun 1; 265(6):1094-1103. [view]
17. DeAngelo MM, Peacock JB, Holeman TA, Maloney M, Beckstrom J, Brooke BS. Long-Term Functional Decline Following Vascular Surgery Among Vulnerable Adults. Annals of vascular surgery. 2021 Oct 1; 76:87-94. [view]
18. Bartline PB, Suckow BD, Brooke BS, Kraiss LW, Mueller MT. Outcomes in Critical Limb Ischemia Compared by Distance from Referral Center. Annals of vascular surgery. 2017 Jan 1; 38:122-129. [view]
19. Brooke BS, Slager SL, Swords DS, Weir CR. Patient and caregiver perspectives on care coordination during transitions of surgical care. Translational behavioral medicine. 2018 May 23; 8(3):429-438. [view]
20. 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. Journal of Vascular Surgery. 2020 Feb 1; 71(2):497-504. [view]
21. Martin LA, Finlayson SRG, Brooke BS. Patient Preparation for Transitions of Surgical Care: Is Failing to Prepare Surgical Patients Preparing Them to Fail? World Journal of Surgery. 2017 Jun 1; 41(6):1447-1453. [view]
22. Holeman TA, Peacock J, Beckstrom JL, Brooke BS. Patient-Surgeon Agreement in Assessment of Frailty, Physical Function, & Social Activity. The Journal of surgical research. 2020 Dec 1; 256:368-373. [view]
23. 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. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Mar 1; 65(3):643-650.e1. [view]
24. 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. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Jun 1; 65(6):1719-1728.e1. [view]
25. Walsworth MK, de Bie R, Figoni SF, O'Connell JB. Peripheral Artery Disease: What You Need to Know. The Journal of Orthopaedic and Sports Physical Therapy. 2017 Dec 1; 47(12):957-964. [view]
26. 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. Annals of vascular surgery. 2018 Jan 1; 46:134-141. [view]
27. 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. Dento maxillo facial radiology. 2019 Jul 1; 48(5):20180432. [view]
28. 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. Journal of Endovascular Therapy. 2017 Jun 1; 24(3):383-393. [view]
29. Gelabert HA, Rigberg DA, O'Connell JB, Jabori S, Jimenez JC, Farley S. Transaxillary decompression of thoracic outlet syndrome patients presenting with cervical ribs. Journal of Vascular Surgery. 2018 Oct 1; 68(4):1143-1149. [view]
30. 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. Journal of Vascular Surgery. 2021 Apr 1; 73(4):1205-1212.e3. [view]
31. 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. Annals of vascular surgery. 2018 May 1; 49:255-260. [view]

Journal Other

1. Sadaghianloo N, Declemy S, Dardik A. Reply. [Letter to the Editor]. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2017 Mar 1; 65(3):929-930. [view]

DRA: Aging, Older Veterans' Health and Care
DRE: Technology Development and Assessment, Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: Decision-Making, Patient Preferences, Patient-Provider Interaction
MeSH Terms: none