Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Function and Quality of Life in Veterans

ABSTRACT The overarching goal of this NIH/DoD/VA Pain Management Collaboratory project, wHOPE (Whole Health Options for Pain Education) is to generate evidence for the VA Whole Health model in addressing chronic pain in a national sample of veterans across six geographically distinct VA healthcare systems. Specifically, we will evaluate a Whole Health Team (WHT), including a medical provider with training in integrative medicine, a CIH provider (e.g., yoga instructor, acupuncturist, nutritionist) and a Whole Health coach that collaborates with patients to develop a Personalized Health Plan, emphasizing non-pharmacological approaches to pain management. Specific Aim 1 is to determine whether a Whole Health Team approach is superior to Primary Care Group Education (PC-GE, modified group Cognitive Behavioral Therapy for Chronic Pain), and whether both are superior to VA Usual Primary Care (UPC) in decreasing pain interference in veterans with moderate to severe chronic pain (primary outcome). Secondary outcomes include changes in pain severity, quality of life, non-pharmacological therapies, use of pain medications (including opioids), and mental health symptoms in trial participants across the three study arms. To collect patient-reported outcomes, masked telephone assessments will be conducted at baseline, 3, 6, 9, and 12 months. Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement the two active interventions and control (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=765. This breaks down to n=341 in each of the active interventions (WHT and PC-GE) and n=83 in the control (UPC). Results of this UG3/UH3 Pain Management Collaboratory project will contribute to the overall mission of the NIH/DoD/VA initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel. As the study has been conducted during the COVID-19 pandemic, Aim 3 will use a nationwide cohort of veterans from the entire VA system to investigate the differential impact of the COVID pandemic on racial/ethnic minority, women, and rural Veterans' use of Whole Health and CIH services for chronic pain management.