Assessing the Relative Effectiveness of Combining Self-Care with Practitioner-Delivered Complementary and Integrative Health Therapies to Improve Pain in a Pragmatic Trial.

BACKGROUND

Many health care systems are beginning to encourage patients to use complementary and integrative health (CIH) therapies for pain management. Many clinicians have anecdotally reported that patients combining self-care CIH therapies with practitioner-delivered therapies report larger health improvements than do patients using practitioner-delivered or self-care CIH therapies alone. However, we are unaware of any trials in this area.

DESIGN

The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the value of veterans participating in practitioner-delivered CIH therapies alone or self-care CIH therapies alone compared with the combination of self-care and practitioner-delivered care. The study is being conducted in 18 Veterans Health Administration sites that received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage, and self-care therapies include tai chi/qi gong, yoga, and meditation. The primary outcome will be improvement on the Brief Pain Inventory 6 months after initiation of CIH as compared with baseline scores. Patients will enter treatment groups on the basis of the care they receive because randomizing patients to specific CIH therapies would require withholding therapies routinely offered at VA. We will address selection bias and confounding by using sites' variations in business practices and other encouragements to receive different types of CIH therapies as a surrogate for direct randomization by using instrumental variable econometrics methods.

SUMMARY

Real-world evidence about the value of combining self-care and practitioner-delivered CIH therapies from this pragmatic trial will help guide the VA and other health care systems in offering specific nonpharmacological approaches to manage patients' chronic pain.