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

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7. PROJECT SUMARY ABSTRACT The overarching goal of this Pain Management Collaboratory Demonstration project is to implement a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacologic pain self-management that reduces pain symptoms and improves overall functioning and quality of life in veterans. The objective of this UG3/UH3 proposal is to develop and pilot components that will be used to support a pragmatic implementation-effectiveness trial of two pain care delivery approaches that differ in structure, comprehensiveness, and intensity. During the trial phase, over 600 veterans across 4 geographically diverse VA health care facilities with moderate to severe chronic pain (irrespective of chronic opioid therapy) will be randomized to receive an intensive Whole Health Team (WHT) versus a less intensive usual care Primary Care Group Education (PC-GE) approach. All enrolled veterans will be followed for 12 months. In preparation for the trial, specific aims of the 2-year UG3 phase include: UG3 Aim 1: to use an evidence-based implementation framework to conduct a formative evaluation that engages trial stakeholders at the 4 VA enrolling sites, solicits feedback on specific trial components, and identifies barriers to and facilitators of trial implementation, and UG3 Aim 2: to use stakeholder input to adapt, pilot and refine key components for the successful implementation of the pragmatic trial including: non-pharmacologic multi-modal pain self- management education for patients and providers, point-of-care data collection applications, patient reported measures sensitive to whole health interventions, wrist-worn activity monitors, and web/mobile applications to support in vivo monitoring of activity and pain and to provide tools for pain self-management. Assuming transition to the 4-year trial UH3 phase, we will implement these components refined in the UG3 phase. In UH3 Aim 1 we will conduct a 12-month pragmatic effectiveness trial to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: H1: Experience improved pain severity and interference, functioning and quality of life (primary outcome); H2: Decrease use of higher risk pain medications, including opioids, or high risk combinations (secondary); H3: Engage in a greater number of non- pharmacological pain management activities (secondary); H4: Experience improved comorbid mental health symptoms, including sleep problems and suicidality. UH3 Aim 2 is to conduct a process evaluation and budget impact analysis of the implementation of the two interventions to support the development of an implementation toolkit for scaling and dissemination. Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.
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