A Q&A with Susan (Nicki) Hastings, MD, MHS, & Steven Z. George, PT, PhD, FAPTA

AIM Back Trial

Improving veteran access to nonpharmacological approaches

The AIM Back Trial is looking at increasing and improving veteran access to nonpharmacological approaches by developing and then comparing two different care pathways (one integrated care and one coordinated care) for people with low back pain. 

Susan (Nicki) Hastings, MD, MHS, is a geriatrician and Professor of Medicine and Population Health Sciences at Duke University School of Medicine. Dr. Hastings is also director of ADAPT, a VA Health Services Research Center of Innovation at the Durham VA Health Care System. Her research focuses on improving function and independence for older adults, including developing programs to improve mobility during hospitalization for older adults.

Steven Z. George, PT, PhD is in the Laszlo Ormandy Distinguished Professor in Orthopaedic Surgery and Therapeutic Area Lead for Musculoskeletal and Surgical Sciences for the Duke Clinical Research Institute. Dr. George’s primary research interest centers around the prevention and nonpharmacologic treatment of chronic musculoskeletal pain disorders, with a biopsychosocial approach.  Dr. George is an active member of the American Physical Therapy Association, United States Association for the Study of Pain, and International Association for the Study of Pain.  

 

Nicki Hastings (NH): Steven George, PhD, and I joined forces to design the AIM Back trial, which is an embedded pragmatic clinical trial that's being conducted at 16 clinics within the VA Health Care System.  We are testing two pathways for delivering nonpharmacologic low back pain care and comparing them to see what their effects are in terms of reducing pain and improving function.  I'm really excited about the trial for a couple of reasons.  First, the embedded nature of the trial means that we are testing the impact of delivering these pathways using existing clinical resources and I think this is going to give us a lot of information about which one of these pathways would be most effective in the ‘real-world’ so to speak.  Second, we were able to have a unique development process for this trial.  We had a deliberate process to get input from multiple stakeholders on designing these pathways to optimally achieve their goals of increasing nonpharmacologic care access.  Stakeholders included providers within and outside of the VA Health Care System, and importantly, veterans.  This process increases the likelihood that whichever of these pathways shows to be superior can be implemented in the VA system and perhaps beyond.

Steven George (SG): Some early care options are spinal manipulative therapy, or other forms of chiropractic care, as well as physical therapy.  Additionally, there are some mind-body approaches that can be helpful when introduced earlier, such as yoga and Tai Chi.  Massage is also a viable option.  When appropriately dosed, transcutaneous electrical nerve stimulation (TENS) can offer pain relief.  TENS has been controversial in the literature, but its efficacy depends on appropriate dosing.  Acupuncture is another therapy that certainly has shown some promise for being effective in managing pain. Of course, more options mean a broader spectrum of provider types involved and challenges with ensuring these therapies are delivered to those that need them.

NH: In addition to chiropractic care and physical therapy, things like mindfulness, meditation, Tai Chi, and yoga, are all options that can be very appropriate for pain management and yield improved results.  We need to flip the script and help all patients understand that these are really the first choice options and that these kinds of self-activating therapies are a critical part of managing pain.

NH: The therapies that are being directly delivered within the context of the VA Health System have some advantages since patients have access to many wonderful programs that are available within the VA community. It is easier for veterans and their family members when programs are directly delivered within the VA Health System, and I think those tend to be the ones that patients have the highest potential to engage with over the long term. The challenge is that not all programs are available within each individual VA.  Another part of our PMC study is evaluating patient preferences and interests for certain kinds of therapies, and combining that with a tailored list of what local resources are available.   That way, we can match appropriate therapies to each individual and get veterans engaged in the programs that they're most interested in.

NH: The VA has led the way in pain management, and has particularly embraced the biopsychosocial model of pain care–that the pain experience is individualized and more than just a biomechanical issue that can be addressed with procedures, surgery, and/or medication.   That culture change within the VA has helped, as has the VA stepped care model where primary care providers are encouraged to start with the lower-intensity, evidence-informed therapies.   Also, the Whole Health approach to care emphasizes self-action and direct provision of complementary and integrative services.  This kind of philosophy and patient-centered focus is not consistently available outside of the VA.  The VA Health Care System’s leadership role in this arena sets the stage nicely for a study like ours, where we are looking to find the optimal way to organize non-drug pain care approaches and deliver them effectively and earlier on in the process.  It allows us to individualize pain care, starting with lower intensity options and avoiding things that might be risky, and taking into account the fact that some patients are at higher risk of going on to develop a disability around their pain.

SG: Nonpharmacologic therapies involve interaction between the patient and provider, which adds to their complexity for delivery.  We need to take an approach where we find positive ways to reinforce nonpharmacologic therapies that are helpful.  Some people are still coming to visits looking for everything to be taken care of by the provider, and we know that doesn't work with musculoskeletal pain.

We want providers to encourage patients to be active participants in their pain management plan, both within and outside of the clinical setting. Providers that foster self-efficacy—helping people gain confidence that they can manage their pain—are also important.  Provider visits are opportunities to learn.  A person seeking care should not feel as though the provider has a “secret sauce” and the only times to get better are during those face to face encounters. The provider can assist with problem solving, suggesting new strategies, but the veteran or the soldier (in the case of PMC trials) becomes the person who is testing out treatment options and reporting back on what worked, what didn't work, why they think it didn't work.

NH: From the provider side, it starts with knowledge and awareness of the newer pain guidelines that recommend nonpharmacologic approaches to care as the first option and the first choice. I think that knowledge is growing among providers; however, I think a more challenging aspect is not just knowing what to do, but also knowing how to do it.  It's one thing to know that yoga or Tai Chi, for example, or another physical activity, are evidence-based approaches for first-line management of low back pain, but how do you recommend that to your patient in a way that you feel confident they will be able to engage?  That's the trickier piece.   There are many incentives to prescribe, refer or order tests that are within our clinical wheelhouse since we have confidence in knowing that those things can be delivered to our patients. We need to view this as a holistic approach where these therapies reside in an overall universe of health, not healthcare, but health-related programs and therapies that are available, recommended, and effective.

From the patient's perspective, it is a mindset shift to understand that these therapies are first-line choices. There does not need to be a definitive diagnosis for the cause of low back pain before starting non-drug therapies; often that cause is going to be elusive and it's not going to change how we approach the kinds of therapies that we recommend. There are certainly cases where there are red flag symptoms, but those really are the exception rather than the rule.

SG: Obviously, we are going through a period where people are exploring remote delivery mechanisms for pain management.  Since people have been looking at and providing virtual healthcare delivery, there already is a fair amount of research and data for general care.  In my read of the literature, the outcomes seem comparable for most patient populations, or at least no indication that it is definitely worse. The virtual care models have an advantage in that it’s just easier to access treatments.   I think as people start to build virtual components into their study designs, we will know more about applying telehealth to populations that need to have increased access, especially to pain management.

NH: One of the biggest challenges with many of the evidence-based therapies for low back pain is that, at this point, they are not often fully delivered in clinical settings. This creates a divide between the clinical setting, whether that be the emergency department or primary care doctor’s office, for example, and the setting for the recommended treatment that is delivered outside the healthcare system.  This is a divide that we still do not manage very well, and as healthcare providers we need to get better at making those connections to those therapies outside of the clinical setting, and that's one of the things that our study will be focusing on.

Another aspect that makes low back pain care challenging is that there are a number of therapies that have shown some effectiveness, but there is not a clearly superior first choice. So, we're trying to address some of that decision making in the trial, and while we're waiting for the results to come in, we are thinking about what models are out there currently and how we can improve usual practice.

Also, there can be barriers for patients knowing about these programs and participating in them. There can be cost barriers for participation in programs outside the VA Health System, and other systems, as well.  Additionally, we also have to guard against ageism among providers thinking that older adults wouldn't want to engage in activities like yoga or other forms of exercises for low back pain, because largely they can and certainly should be given the opportunity to consider it as part of their overall treatment plan.

SG: We were still recruiting sites when COVID-19 limited in-patient visits to health care facilities. That pause allowed us to have a faster cadence in talking to sites because we were able to take advantage of slower clinical schedules at some of our sites. So, we actually benefitted from not actively recruiting when everything was disrupted in March.

After COVID, it was pretty clear that travel restrictions would require us to do the implementation phase through the power of Zoom and other virtual platforms, which our clinical pathways had already incorporated elements of, so they were already semi-COVID-friendly. In talking with our trial sites, it became clear that they would be able to implement a hybrid approach where they have some short onsite visits and then transition patients to a structured virtual delivery component. Afterward, patients may be able to come back to site for reevaluation.  One of the biggest changes is that we needed to create virtual site trainings, instead of doing some activities in person.  In the end, the impact of COVID-19 ended up being relatively minor for our trial, compared to others in the PMC—although this is not meant to imply the impact of COVID-19 is minor—and we were still able to move forward with the pathways we originally proposed.

NH: Being part of the Pain Management Collaboratory has been a great experience.  We are connected with a network of people who are interested in studying non-drug pain management approaches in veteran and military health systems. It’s not only about the systems of care that make them unique and a good place to do our studies; it's also about the people that the VA and military health care systems serve. There is a shared commitment among those involved in the Pain Management Collaboratory to improve care for military service members and veterans.  Working within the Collaboratory is also a terrific, intellectual opportunity to learn from all of these different teams who are approaching pain management with a shared goal of increasing access to nonpharmacologic care to pain conditions in so many different ways. I think there have been a lot of efficiencies from working together and learning from one another that will ultimately make the findings from all of the studies that much stronger.

SG: The Collaboratory offers an opportunity to be on the ground floor of a platform on which everyone is working towards the same goal, and we get to know and work with colleagues more directly (i.e. expand our professional network).  I really enjoy the Collaboratory’s emphasis on nonpharmacologic care, so we can talk with many experts about the nuances of delivering care.  That type of comradery is rare in the pain research field and it is exciting to be part of this inaugural class of demonstration projects.

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