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).
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.
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.
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.
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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Aging, Older Veterans' Health and Care
Technology Development and Assessment, Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Decision-Making, Patient Preferences, Patient-Provider Interaction