Trial Summary

The Veterans Administration (VA) has become a leader in complementary and integrative health through its Whole Health initiative. Yet there remain many barriers, especially for patients with pain in rural communities. The RAMP trial aims to overcome these barriers. The study team is working with partners in the community and the VA, including rural patients, to develop an innovative, evidence-based telehealth intervention, the RAMP program, that brings together multiple evidence-based complementary and integrative health self-management strategies to address rural veterans’ biophysical, psychological, and social needs. The RAMP program consists of 9 weekly group sessions, which include prerecorded, expert-led education videos, mind-body skills training and practice, and group discussions led by a trained facilitator. Program content covers pain education, mindfulness, pain-specific exercises, and cognitive behavioral strategies. In the trial’s planning phase, the study team identified and developed new community partnerships and used mixed-methods data collection from patients, community partners, and VA healthcare system leaders and staff, guided by the RE-AIM/PRISM framework, to understand key factors that may affect long-term adoption of the intervention. A pilot study with 40 rural VA patients with chronic pain assessed the feasibility of delivering the RAMP program in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other metrics. The pilot also assessed the extent to which the program met veterans’ pain self-management needs, as well as areas for refinement and optimization. Pilot results demonstrated that RAMP is feasible and acceptable to rural veterans with chronic pain and helped identify optimization strategies to enhance future program engagement. In the trial’s implementation phase, the study team will conduct a randomized, multicenter, hybrid type 2 effectiveness-implementation pragmatic clinical trial of the RAMP program vs usual care among 500 rural patients in the VA healthcare system. The primary effectiveness outcome is pain interference at 3 and 6 months. Secondary outcomes include opioid use and the NIH HEAL Initiative’s core pain domains. The study team will continue to work with patient, community, and healthcare system partners identified during the planning phase to evaluate the implementation strategies used in the trial and adapt these strategies to scale up RAMP within the VA healthcare system. This will include mixed-methods assessments of research partners’ and trial participants’ views of implementation-related barriers and facilitators, resource needs, and other domains; co-creation of additional plausible strategies for overcoming implementation barriers; and budget impact analyses using models informed by research partners’ views to inform future decision-making.

NIH Project Information