ABSTRACT
Introduction
Within the population of military service members and veterans, chronic pain is highly prevalent, often complex, and frequently related to traumatic experiences that are more likely to occur to members of this demographic, such as individuals with traumatic brain injury or limb loss. In September 2017, the National Institutes of Health (NIH), Department of Defense (DOD), and Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) was formed as a significant and innovative inter-government agency partnership to support a multicomponent research initiative focusing on nonpharmacological approaches for pain management addressing the needs of service members, their dependents, and veterans.
Methods
A Pain Management Collaboratory Coordinating Center (PMC3) was also established to facilitate collective learning across 11 individually funded pragmatic clinical trials (PCTs) designed to optimize the impact of the PMC as an integrated whole. Although the DOD and VA health care systems are ideal sites for the enactment of PCTs, executing these trials within the local context of DOD military treatment facilities (MTFs) can present unique challenges. The Military Treatment Facility Engagement Committee (MTFEC) was created to support the efforts of the PMC3 in its role as a national resource for development and refinement of innovative tools, best practices, and other resources in the conduct of high impact PCTs.
Results
The MTFEC is composed of experts from each service who bring experiences in executing clinical pain management trials that can enhance the planning and execution of the PCTs. It provides expertise and leadership in the execution of research studies at within MTFs and within the DOD health care system, with guidance from PMC3 Directors and in collaboration with NIH, DOD, and VA program and scientific officers.
Discussion/Conclusion
Considering the importance of enacting large-scale, pragmatic studies to implement effective strategies in clinical practice for chronic pain management, the MTFEC has begun to actualize its purpose by identifying potential barriers and challenges to study implementation and exploring how the PMC can support and aid in the execution of PCTs by applying similar approaches to stakeholder and subject matter engagement for their research.
INTRODUCTION
Chronic pain is a significant public health problem estimated to affect as many as 100 million Americans at an estimated cost of approximately $600 billion in treatment expenses and lost productivity.1 Within the population of military service members and veterans, chronic pain is highly prevalent, often complex, and frequently related to traumatic experiences that are more likely to occur to members of this population, such as traumatic brain injury or limb loss.2,3 Estimates suggest that approximately 44% of active duty service members experience chronic pain, with over half reporting nearly daily frequency and severity of moderate to severe.4 Pain is among the most frequently presenting complaint of veterans, particularly among those who have experienced multiple traumas, and data indicate that the prevalence of these complaints is increasing over time.5–7
In September 2017, the National Institutes of Health (NIH), Department of Defense (DOD), and Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) was formed as a significant and innovative inter-government agency partnership to support a multicomponent research initiative focusing on no-pharmacological approaches for pain management addressing the needs of service members, their dependents, and veterans. The PMC represents an investment of approximately $81 million over 6 years, focused on developing and implementing large-scale, real-world pragmatic clinical trials (PCTs) on nonpharmacological approaches for management of pain and related conditions in DOD and VA health care delivery organizations. Twenty Principal Investigators (PIs) support 11 PCTs that were selected based on the importance of the scientific questions and their potential to address impediments to research within health care delivery organizations. The PCTs are designed, in part, in response to concerns about patient harms associated with both long-term and high-dose opioid therapy and invasive procedures. They test interventions in real-world settings, with less tightly controlled environments than are commonly employed in traditional explanatory studies. The DOD and VA health systems, as large integrated learning health systems with robust electronic health records, are practicable sites for robust PCTs.
A Pain Management Collaboratory Coordinating Center (PMC3) was also established to facilitate collective learning across the PCTs and to optimize the impact of the PMC as an integrated whole. The PMC3 provides leadership and serves as a resource for development and refinement of innovative tools, best practices, and other resources in the conduct of PMC clinical trials. Within the PMC, shared learning, harmonization across projects, and problem-solving related to the PCTs largely occurs through participation in seven work groups spanning the domains of (1) biostatistics and study design, (2) phenotypes and outcomes, (3) electronic health record, (4) ethics and regulatory issues, (5) stakeholder engagement, (6) data sharing, and (7) implementation science. The organization of the PMC is outlined in Fig. 1, including these work groups, the PMC3, and other integral components.
FIGURE 1.
Pain Management Collaboratory (PMC) organizational chart schematic. The Military Treatment Facility Engagement Committee (MTFEC) is a component of the coordinating center and serves to support its mission.
Although the DOD and VA health care systems are ideal sites for the enactment of PCTs, executing these trials within the local context of military treatment facilities (MTFs) can present unique challenges. Obtaining support and approval for the enactment of large-scale, pragmatic effectiveness studies from institutional review boards, the research programs office, and military community is a challenging undertaking, especially for PIs whose experience may be restricted to their primary MTF—who have little to no interaction with other MTFs.
Recognizing this need for additional specialized support, the Military Treatment Facility Engagement Committee (MTFEC) was created to help the PMC3 in its role as a national resource in this environment. The MTFEC is composed of experts from around the country and within each service who bring experiences in executing clinical pain management trials that can enhance the planning phase of the PCTs (Fig. 2). These experts vary widely in their specialty areas and specific roles as part of the MTFEC, from the 4 PCT PIs with DOD-focused projects and their study team members, to the PMC3 leadership and their work group co-chairs and program managers, which, in conjunction with representatives from the sponsoring agencies, form an assembly of nearly 30 members in total. The MTFEC provides expertise and leadership in the execution of research studies within the Military Health System (MHS), with guidance from PMC3 Directors and in collaboration with NIH, DOD, and VA program and scientific officers. Additionally, it serves to bring familiarity and connections within these broad organizations.
FIGURE 2.
Military Treatment Facility Engagement Committee (MTFEC) membership and Pragmatic Clinical Trial (PCT) sites.
METHODS
The development of the MTFEC was directed towards supporting the needs of the PCTs in the PMC, with a focus on the unique needs and garnering of support for the large number of trials that are currently in the planning phases. The MTFEC leadership engaged the PIs of each PCT to conduct an MTF site analysis in order to target membership based on planned recruitment and performance sites. After conducting the site analysis, the MTFEC leadership engaged with pain management clinics across the country to receive recommendations on individuals who are currently affiliated with the MTFs where the PCTs would be enacted.
Following recruitment of subject matter experts and representatives from the MTFs, the MTFEC defined key focus areas to support the PCTs. These key focus areas include:
Acting as a liaison for the PCT PIs to help them navigate among the PMC3 leadership and the organizational leadership at the MTFs and within the DOD health care systems.
Ensuring applicability of the PCTs to military populations, from service members and their dependents to veterans, particularly those with complex war-related trauma and their unique pain syndromes.
Providing military pain specialty consultation services from our military subject matter experts.
Assisting in identifying and securing the appropriate resources to execute the trials.
Guiding optimization of subject enrollment and study execution at MTFs by expanding access to military beneficiaries and identifying target MTFs/clinics.
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Participating in the communication and education components of the PMC on behalf of the DOD PIs through:
Communication in support of the trials and dissemination of the results.
Informing the MHS pain community about the PMC3 to solicit instrumental support for enactment.
Educating clinicians on implications for changes in practice in military health care settings.
RESULTS
The MTFEC has successfully managed to recruit participation from all MTFs with a PCT and schedule monthly conference calls to update and troubleshoot common issues. It has provided a forum for engagement and support for collaboration among PCTs and the sites where the trials will be enacted (Table I), thereby assisting them with successful implementation. This fostered sense of community among the DOD researchers has led to shared knowledge with the intent of improving trial execution in several areas. In one noteworthy instance, MTFEC representatives coordinated with PMC leadership and PCT PIs to reduce recruitment redundancy and increase patient flow at MTF sites struggling with overlapping PCT enrollment (Fig. 3A and B). This crucial partnership enabled the PMC3 leadership to directly engage clinical leaders at the MTFs, such as the directors of Pain, Musculoskeletal, and Integrative Medicine, in order to identify active pain trials and other pain interventional initiatives.
TABLE I.
Military Treatment Facility (MTF) Site Overlap—Select Recruitment Sites and Target Patient Populations
| PI(s) | BAMCa | WRNMMCb | NMCSDc | CRDAMCd | WHASCe | Target Patient Population |
|---|---|---|---|---|---|---|
| Ilfeld | X | X | X | Postoperative analgesia—shoulder, knee, ankle, foot | ||
| Farrokhi/Dearth | X | X | X | Physical therapy for low back pain (LBP) in outpatient setting | ||
| McGeary/Goodie | X | X | X | X | Chronic musculoskeletal pain, Primary Care Physician (PCP) clinic | |
| Fritz/Rhon | X | X | X | Chronic LBP, PCP provider |
BAMC, Brooke Army Medical Center.
WRNMMC, Walter Reed National Military Medical Center.
NMCSD, Naval Medical Center San Diego.
CRDAMC, Carl R. Darnall Army Medical Center.
WHASC, Wilford Hall Ambulatory Surgical Center.
FIGURE 3.
(A) Military Treatment Facility (MTF) remediation of overlapping recruitment sites—five types of remediation strategies available to Department of Defense (DOD) Principal Investigators (PIs) and their participating MTFs. (B) MTF remediation of overlapping recruitment sites—distribution of remediation strategies adopted by DOD PIs and their participating MTFs.
Furthermore, the MTFEC regularly communicated with the DOD PIs within the PMC during the initial pilot or demonstration phases of the PCTs to discuss the MTF recruitment sites, current and anticipated obstacles, and troubleshooting plans. For example, two PIs from separate studies decided that the inclusion criteria for one of the studies would target patients with chronic pain in any body location, whereas the other study would specifically recruit patients with chronic low back pain. This clear conversation and decisively distinct recruitment criteria ensured that the patient populations could be unique while still maintaining a degree of flexibility in selecting their respective demographics.
In another instance, one PMC PI prevented potential recruitment overlap with other PMC studies by not including patients with chronic pain lasting longer than 3 months. This PI was very knowledgeable of non-PMC studies at the three MTFs for his study because of his heavy involvement in clinical trials and other research activities across those DOD sites. Through this insight, he was able to better evaluate the likelihood of his study interfering with ongoing research studies and then alter his exclusion criteria accordingly. The MTFEC Chair emphasized the importance of proactively considering additional collaborations by leveraging inter-DOD networks as necessary. The established relationships and internal connections within the MTFs were essential factors in positioning the MTFEC to successfully navigate the possibility of overlapping recruitment sites and demographics through strategizing active remedial measures.
CONCLUSION
The MTFEC has evidenced potential to fulfill its role as a significant and innovative approach to addressing key scientific knowledge and clinical practice gaps in the delivery of high-quality chronic pain treatment in DOD and VA health systems and supporting improved patient outcomes. Its focus on nonpharmacological approaches to management of pain and comorbid conditions in DOD and VA health care systems represents a significant investment and offers a unique opportunity to rapidly advance the science and practice of pain management in these settings. The MTFEC has, thus far, functioned as an effective engagement tool to facilitate MTF studies via optimizing communication of shared experiences that occurs between MTF leadership, PIs, and support staff within these MTFs. The MTFEC will continue to serve as an integral resource to the PMC, supporting and helping advance its mission to foster high-impact chronic pain research in the form of PCTs that aim to improve quality of life for all affected military populations.
Moving forward, the MTFEC must remain diligent in the execution of its core mission while continuing to provide reliable support to its constituents. In order to successfully navigate challenges and overcome obstacles, leadership should strive to be adaptable and continually reevaluate its methods, as needed, to optimize its operations. Perhaps the greatest challenge of this organization, considering its size and scale, will be to maintain continuity throughout the duration of its activity. Military orders, deployment assignments, and staff turnover are common sources of potential disruption that should be anticipated over the course of implementing the MTFEC. Ensuring overlap with new and transitioning staff, providing adequate training, utilizing professional networks and leveraging those communication channels, when appropriate, and establishing contingency plans are all strategies that can help to mitigate both expected and unexpected interruptions, so that the delivery of dependable, quality support is not diminished.
For more information and the latest news about the PMC and its ongoing efforts, including the PMC3 and its work groups, please visit https://painmanagementcollaboratory.org.
Contributor Information
Dylan V Scarton, Center for Rehabilitation Sciences Research, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA; Department of Rehabilitation, Walter Reed National Military Medical Center, Bethesda, MD 20889, USA; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA.
William T Roddy, Center for Rehabilitation Sciences Research, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA; Department of Rehabilitation, Walter Reed National Military Medical Center, Bethesda, MD 20889, USA; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA.
Jerika A Taylor, Center for Rehabilitation Sciences Research, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA; Department of Rehabilitation, Walter Reed National Military Medical Center, Bethesda, MD 20889, USA; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA.
Mary Geda, The Pain Management Collaboratory Coordinating Center, Yale University, New Haven, CT 06510, USA; Department of General Internal Medicine, Yale School of Medicine, New Haven, CT 06520, USA.
Cynthia A Brandt, The Pain Management Collaboratory Coordinating Center, Yale University, New Haven, CT 06510, USA; Department of General Internal Medicine, Yale School of Medicine, New Haven, CT 06520, USA.
Peter Peduzzi, The Pain Management Collaboratory Coordinating Center, Yale University, New Haven, CT 06510, USA; Department of Biostatistics, and Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT 06520, USA.
Robert D Kerns, The Pain Management Collaboratory Coordinating Center, Yale University, New Haven, CT 06510, USA; Veteran’s Administration Connecticut Healthcare System, West Haven, CT 06516, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT 06511, USA.
COL Paul F Pasquina, Center for Rehabilitation Sciences Research, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA; Department of Rehabilitation, Walter Reed National Military Medical Center, Bethesda, MD 20889, USA.
FUNDING
Research reported in this publication was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under Award Number U24AT009769. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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