Concept: NIH-DOD-VA Pain Management Collaboratory

Project Concept Review

Council Date: September 10, 2021

Program Directors: Pete Murray, Ph.D.

Background

There is strong evidence that pain, both acute and chronic, and its management are significant public health concerns. Military service members and veterans living in the United States today report pain at significantly higher rates as compared to the general population. Many of these service members and veterans were among the 2.5 million active military deployed since 2001 in Operations Enduring Freedom, Iraqi Freedom, and New Dawn in Iraq and Afghanistan. In this population, pain may be particularly complex because it frequently coexists with other medical conditions, including physical, mental health, and substance use disorders; behavioral health and social risk factors; and other issues.

The overall goal of the National Institutes of Health (NIH)–Department of Defense (DOD)–Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) is to test implementation and evaluation of nonpharmacologic approaches for the management of pain and common co-occurring conditions in the military and veteran health care systems. Originally founded in 2018, the PMC funded 11 large-scale, multisite, pragmatic clinical trials and a resource coordinating center. The Pain Management Collaboratory Coordinating Center (PMC3) supports domain-oriented working groups, which foster collaboration and harmonization across the trials. The PMC also represents a partnership among NIH, the DOD, and the VA. The VA operates the country’s largest health care system. It has more than 1,400 health care facilities and provides care for more than 5 million veterans across the country. The Military Health System provides health care to active duty, reserve component, and retired U.S. military personnel and their dependents. It ensures America’s 1.4 million active duty and 331,000 reserve component personnel are healthy so they can complete their national security missions. These vertically integrated health care systems are unique in the populations they serve and how care is delivered and covered. There are additional challenges in conducting research within these settings.

The PMC, in cooperation with our VA and DOD partners, has been successful with the first 11 pragmatic clinical trials in navigating and supporting the research endeavors in these environments. Development, testing, and implementation of nonpharmacologic pain management continue to be priorities for the VA and the DOD.

The current group of pragmatic trials is focused on real world effectiveness of interventions for the management of pain and includes complementary health interventions such as spinal manipulation, Screening/Brief Intervention/Referral to Treatment (SBIRT), physical therapy, mindfulness, and one noncomplementary health intervention: a percutaneous peripheral nerve stimulation device for postsurgical pain.

Each current study also includes some level of implementation science, with most studies focusing on preimplementation (e.g., identification of potential barriers to adoption of the intervention). However, implementation science is an example of a growth opportunity area, as new projects could focus more on Hybrid Type 2 or Type 3 designs, which place equal or greater emphasis on implementation science alongside clinical effectiveness. Additional opportunities also exist for pragmatic trials that are more focused on the effectiveness of specific complementary health interventions not being directly evaluated in the current group of projects, such as tai chi, yoga, and massage.

Purpose of Proposed Initiative

This initiative will support the continuation of the PMC for an additional 6 years including (1) the continued support of the coordinating center through a limited competition funding opportunity announcement, and (2) a second set of pragmatic clinical trials focusing on effectiveness and/or implementation science research studies conducted in either VA or military treatment facilities. Trials must meet NIH requirements for diversity and inclusion for phase 3 trials. Proposed projects must include at least one complementary health intervention; they may involve evaluating the effectiveness of the complementary health intervention(s) in real world settings and/or testing strategies to integrate evidence-based complementary health intervention(s) into conventional pain management settings. The PMC research projects, with assistance from the coordinating center, will ultimately make available data, tools, resources, and lessons learned to facilitate implementation of successful findings across their respective health care systems.

Much research has been done to establish the efficacy of nonpharmacologic approaches for pain management. Pragmatic trials that focus on effectiveness and implementation science approaches are needed to move these interventions of proven efficacy into widespread uptake and adoption. Expanding this initiative will allow for leveraging of resources, expertise, and partnerships that have been established over the initial 4 years of the PMC. While the current trials of the PMC are ongoing, there are gap areas that were not addressed in the first set of trials, such as more implementation trials to deliver multidisciplinary guideline-concordant care in veteran and military treatment facilities. Such trials will further inform the field about how to scale effective therapies, make existing therapies more feasible, and improve the percentage of patients receiving evidence-based treatments in the future. Expansion will also strengthen the partnerships with the DOD and VA for future research initiatives related to the National Center for Complementary and Integrative Health’s strategic plan objective on whole person health research and the VA’s Whole Health care program. With a solid structure and network in place, continuation will allow for consolidation of current working groups comprised of experts in pain management, establish a data sharing resource for future studies to expand on, further inform decisions about readiness for implementation, and translate into practice health care that relieves this population’s burden of chronic pain.

Objectives

The objectives to be met by this concept include but are not limited to the following:

• Coordinating center
  • Further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of pragmatic clinical effectiveness and implementation science trials in partnership with the VA and DOD health care systems.
  • Work collaboratively with each pragmatic clinical trial study team supported through the PMC to develop, test, and implement the proposed study while providing technical, design, and coordination support.
  • Learn and disseminate the best strategies for implementing effective nonpharmacologic pain management interventions into the VA and DOD health care systems.
  • Create a repository for data for the PMC pragmatic trials and a platform for cross-project analyses.
     
• Pragmatic effectiveness and/or implementation science trials
  • Support pragmatic effectiveness trials to evaluate the impact of nonpharmacologic pain management interventions embedded within the VA or DOD health care systems.
  • Support implementation science trials that will test strategies to adopt, scale up, and scale out evidence-based nonpharmacologic pain management interventions in the VA and DOD health care systems.
  • Conduct pragmatic clinical trials that will reduce the burden of pain for active duty, reserve component, and retired U.S. military personnel and their dependents.