Trial Summary

This project addresses the significant challenge of implementing effective, non-opioid interventions for chronic pain management in rural and remote dwelling Veteran populations. Pain is now widely recognized as a complex biophysical, psychological, and social (BPS) condition. There is also a growing evidence base to support several complementary and integrative health (CIH) approaches, to address pain in a more holistic way. While the Veterans Administration (VA) has become a leader in advancing CIH through its Whole Health Initiative, there remain many barriers, especially for rural patients with pain.

The Reaching Rural Veterans: Applying Mind-Body Skills for Pain (RAMP) project aims to overcome these barriers. Our team is working with multiple levels of VA stakeholders (including rural patients), to develop an innovative telehealth evidence-based intervention, RAMP, that is cohesive and strategically coalesces multiple evidence based CIH self-management strategies to address Veterans' BPS needs.

The RAMP program is designed to be implemented within the VA through its nationwide Whole Health System initiative. Veterans begin and end the 13-week RAMP program with a 1-to-1 session with a Whole Health coach. In between, Veterans participate in 11 group sessions, which include pre-recorded expert-led education videos, mind-body skill training and practice, and group discussions led by a Whole Health coach. Program content covers pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies.

For the preparatory phase (UG3) we will: 1) conduct stakeholder engagement activities including identifying and developing new community partnerships and using mixed methods data collection from multiple levels of stakeholders (n=35-50 patients, community partners, VA healthcare system leaders and staff), guided by the established RE-AIM/PRISM framework, to learn about key factors that can affect long-term adoption; and 2) conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.

For the future UH3 Phase, we will conduct a randomized hybrid type 2 effectiveness-implementation multi-site pragmatic clinical trial of RAMP compared to usual care, among rural patients (n=500) in the VA healthcare system. UH3 Aim 1 will assess the relative effectiveness of RAMP in terms of the primary effectiveness outcome of pain interference at 13 and 26 weeks and secondary outcomes including opioid use and other HEAL recommended outcomes. In UH3 Aim 2 we will work iteratively with multiple levels of stakeholders (identified in the UG3) to evaluate intervention implementation strategies used in the trial and adapt these strategies to scale up RAMP within the national VA healthcare system. This will include: a) conducting mixed-methods assessments of stakeholder and trial participant views of implementation-related barriers and facilitators, resource needs, and other RE-AIM/PRISM domains; b) working with stakeholders to co-create additional plausible strategies for overcoming barriers to implementation of RAMP; and c) conducting budget impact analyses using models informed by stakeholder views to inform future decision making.

NIH Project Information