Chronic pain is one of the most burdensome conditions in the United States, with lower back pain comprising the largest subset of those conditions, and veterans bearing a disproportionate amount of this societal burden.
Two Duke researchers will lead a new study to change that reality and raise the standard of pain care management with navigated care. The study is funded with $5.8 million from the non-profit, Patient-Centered Outcomes Research Institute (PCORI).
Professor Nicole Hastings, MD, chief of the Division of General Internal Medicine and Steven Z. George, PhD, Laszlo Ormandy Distinguished Professor of Orthopedic Surgery and therapeutic area lead in the Duke Clinical Research Institute have been awarded $5.8 million from the non-profit Patient-Centered Outcomes Research Institute (PCORI) to conduct the 60-month NAV-Back study which will compare strategies to improve non-drug pain relief among adults with low back pain.
Drs. Hastings and George will collaborate with a strong interdisciplinary team consisting of Veterans Affairs and Duke researchers.
Collective data shows an urgent need for better pain management approaches in the U.S., Hastings points out, and while the U.S. Department of Veterans Affairs (VA) is at the forefront of providing access to non-drug therapies for pain, gaps remain.
Scalable and Sustainable
Persistent data on low uptake of these therapies underscore the urgent need to study pathways that can help an already over-taxed primary care system meet the needs of veterans with high-impact chronic low back pain in a way that is scalable and sustainable.
The NAV-Back study will enable investigators to assess the effectiveness of a navigator-assisted program that informs and guides veterans on non-drug pain treatment options, while also gathering information on how this program can be delivered more broadly in other clinics and health systems, Dr. Hastings said.
“We have strong evidence that non-drug treatments like physical therapy, exercise, and behavioral strategies can help
people with low back pain,” Dr. Hastings said. “The next step is figuring out how to combine and match these treatments to each patient’s needs and preferences, and ensuring that people can actually access them. That is the translational gap this research is working to close.”
NAV-Back will include 530 veterans with chronic low back pain across four VA health care sites who will be enrolled and randomized to receive usual care or the Education, Navigated Care, and Supported Self-Management (ENCompaSS) pain care program.
The primary outcome will be pain interference with normal activities and aspects of life, including social, cognitive, emotional, physical, and recreational activities. Key secondary outcomes will include sleep quality, physical function, pain intensity, depression, anxiety, and future health care use.
NAV-Back is a follow-up study to a recently completed pragmatic trial by the investigators, Improving Veteran Access to Integrated Management of Back Pain (AIM-Back), which found that up to 66% of Veterans with low back pain referred from 19 primary care clinics were experiencing high-impact chronic pain, indicating frequent interference with daily activities.
NAV-Back follows on from findings of the AIM Back study, which indicated that a pain navigation program resulted in similar outcomes as a structured care pathway, in particular for veterans with high-impact chronic pain. Thus, there is high potential to improve care standards by more broadly offering pain navigation approaches for individuals seeking care for chronic low back pain.
Accordingly, NAV-Back will determine the effectiveness and implementation of the ENCompaSS pain care program compared to usual care. ENCompaSS was designed by the AIM Back researchers as an improvement on the earlier version of pain navigation used in that trial. The program tested in NAV-Back will empower patients through a care pathway of patient treatment preferences that builds therapeutic alliances, educates, and facilitates referral to services of choice.
In testing the effectiveness of ENCompaSS, researchers will add to the evidence base on clinical pathways for improving outcomes in high-impact chronic lower back pain and gain insight into strategies needed to support translation of findings into real-world clinical care, both within and outside of the VA setting, Hastings adds.
Navigated Care
Most pain-related clinical trials to date have focused on the process of navigation, where the recently completed AIM-Back trial and the new NAV-Back trial are two of the only known lower back pain studies that focus on the outcome of navigation in terms of improved patient-reported outcomes. A pain navigator can help veterans navigate the intricacies of the system, ensuring they receive timely and appropriate care, overcoming existing barriers, and connecting them with resources, services, and treatments that are regionally accessible.
Lower back pain also involves a multidisciplinary approach, so navigators can coordinate treatment and work closely with veterans to understand their specific symptoms, limitations, and preferences for treatment with a personalized approach that can lead to more effective pain management strategies, stronger engagement with treatment, and better outcomes.
Building on experiences and preliminary data from the AIM study, NAV-BACK will address three of the most difficult dilemmas faced by patients, providers, and health systems.
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Patients face the question of how to choose the best non-drug treatment option for low back pain.
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Providers are concerned with how to ensure that a patient is fully informed about options and then sees a provider aligned with their treatment preferences, especially when time is limited.
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Health systems need information on whether outcomes can be improved by offering a specific care pathway for treating low back pain rather than continuing ad hoc referrals through primary care.