September 2021

In This Issue: Helping Veterans Cope with and Conquer Pain
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Complementary and Integrative Health for Pain in the VA Healthcare System

Feature Article

Takeaway: This study will be the first large-scale examination of the effects of complementary and integrative health (CIH) therapies on pain and comorbid outcomes among Veterans – and will examine the question of the effectiveness of practitioner-delivered CIH in combination as compared to only self-care CIH or only practitioner-delivered CIH.

More than half of Veterans report musculoskeletal pain, often with mental health comorbidities. Complementary and integrative health (CIH) therapies are important non-pharmacologic treatment options for these conditions. Practitioner-delivered CIH therapies (i.e., acupuncture, chiropractic care, massage therapy) are promising, but providers would like patients to be more active in their pain management by using self-care (i.e., meditation, Tai Chi/qigong, yoga) instead of relying solely on practitioner-delivered CIH. However, a critical question is whether adding self-care CIH to practitioner-delivered CIH is a more effective approach than either strategy alone. To-date, studying CIH in large VA patient samples has been somewhat difficult because not all facilities validly capture CIH use with VA's standardized codes in the electronic health record (EHR) system, preventing large, multi-site studies.

The APPROACH: Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health study is addressing this question and is part of the NIH-DoD-VA Pain Management Collaboratory. The first aim of the APPROACH pragmatic effectiveness trial (April 2018 – March 2024) is to conduct a three-arm study assessing the effectiveness of: 1) practitioner-delivered CIH (i.e., acupuncture, massage, chiropractic care) combined with self-care (i.e., yoga, Tai Chi/qigong, and meditation); 2) CIH vs either practitioner-delivered; or 3) self-care CIH alone among Veterans with chronic musculoskeletal pain. The second aim is to examine the effectiveness of these therapies individually. Aiming to improve pain experienced by Veterans, several pain-related comorbid conditions, and opioid use, this study is being conducted in partnership with the VA Office of Patient Centered Care and Cultural Transformation (OPCC&CT).

Methodology

Randomization for study participants isn’t feasible or desirable because it would mean withholding available treatments. Thus, this study will employ a pragmatic trial design – and will address selection bias and confounding by using sites’ variations in business practices and other encouragements (nudges) to receiving different CIH therapies as a surrogate for direct randomization using instrumental variables econometric methods. Patient-reported data is being collected by the VA OPCC&CT’s CIH Experience survey, which is being supplemented with VA EHR data, as well as data on the 18 sites’ business practices (i.e., nudges, the instrumental variable). Primary outcomes for this study include pain severity and pain interference, and secondary outcomes include depression, stress, physical health, quality of life, well-being, fatigue, and opioid use. This study is expected to include 18,000 new CIH users with chronic musculoskeletal pain from 18 VA Whole Health Flagship sites.

Anticipated Impact

This study will be the first large-scale examination of the effects of complementary and integrative health use on pain and comorbid outcomes among Veterans. Investigators also will examine the effectiveness of practitioner-delivered CIH in combination with or instead of CIH self-care, which is a priority question for VA and other healthcare systems with limited resources for implementing CIH programs.

Principal Investigators

Stephanie Taylor, PhD, MPH, is part of HSR&D’s Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP) in Los Angeles, CA, and Steve Zeliadt, PhD, is part of HSR&D’s Center of Innovation for Veteran-Centered and Value-Driven Care in Seattle, WA.

Publications

Zeliadt S, Coggeshall S, Gelman H, Shin M, Elwy R, Bokhour B, and Taylor S. Assessing the relative effectiveness of combining self-care with practitioner-delivered complementary and integrative health therapies to improve pain in a pragmatic trial. Pain Medicine. December 12, 2020;21(suppl 2):S100-S109.

Zeliadt D, Coggeshall S, Gelman H, Thomas E, and Taylor S. The APPROACH Trial: Assessing pain, patient-reported outcomes, and complementary and integrative health. Clinical Trials. August 2020,17(4):351–359.

View study abstract