Year: 2019
Type: article
Abstract: In its seminal report, “Relieving Pain in America: A Blueprint for Transforming Pain Prevention, Care, Education, and Research,” the Institute of Medicine (IOM; now the National Academy of Medicine) asserted that pain is a significant public health problem and estimated that as many as 100 million Americans experience persistent pain, at a cost of as much as $635 billion in treatment costs and lost productivity [1]. Following the recommendations of this report, the Department of Health and Human Services published a National Pain Strategy in March 2016 that offered a comprehensive framework and specific recommendations for transforming pain care in America [2]. Key findings and recommendations for this transformation encouraged integrated, multimodal, and interdisciplinary pain care tailored to each person’s experience of pain and preferences for treatment. Growing concern about harms associated with long-term opioid therapy, other pain medications, and invasive procedures encouraged consideration of alternative approaches. In fact, numerous evidence-based nonpharmacological approaches were identified that may reduce risk of harms and hold special appeal to persons with pain, delivered either in conjunction with or alone as alternatives to traditional medical and rehabilitation approaches. In addition to these National Pain Strategy recommendations, other health professional organizations have similarly promulgated guidelines that recommend nonpharmacological approaches as firstline treatment for chronic pain [3]. Unfortunately, as the National Pain Strategy acknowledged, evidence suggests that these recommendations are rarely enacted due to myriad organizational, clinician-, and patient-level barriers [4]. Military service members and veterans have been identified as particularly vulnerable to the high prevalence and complexity of chronic pain related to their military experiences, including their high risk of musculoskeletal injuries and combat-related trauma. Estimates suggest that approximately 45% of active duty military service members experience pain [5], and low back pain, in particular, is one of the most common reasons service members seek medical care and one of the most likely conditions to interrupt combat duty [6]. As many as 50% of male veterans receiving care in Department of Veterans Affairs (VA) primary care settings report the presence of pain [7], and the prevalence may be as high as 75% among female veterans [8]. In a recent Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention, compared with nonveterans, veterans were significantly more likely to report chronic pain [9]. Pain is among the most frequent presenting complaints for veterans, particularly among those with polytrauma [10]. Data document that the prevalence of pain among veterans is growing steadily with each passing year [11,12]. The presence of pain among veterans receiving primary care in VA facilities is associated with poorer self-rated health, greater utilization of health care resources, greater prevalence of health risk behaviors and factors such as tobacco use, excessive alcohol use, diet/weight concerns, decreased social and physical activity, lower social support, and greater ratings of affective distress [7]. Presence of pain among veterans and military service members is highly comorbid with depressive and anxiety disorders [13], post-traumatic stress disorder [14], and substance use disorders [15]. Among women veterans, pain is associated with high rates of military and nonmilitary sexual harassment and trauma [16]. Finally, pain is also among the most costly disorders treated in VA settings [17]. The National Pain Strategy highlighted a critical gap between the science and practice of pain management, and both the Department of Defense (DoD) and the VA have developed comprehensive strategic initiatives to improve pain care that encourage research to address these gaps, including large-scale, pragmatic effectiveness studies and strategies to implement effective strategies in clinical practice [18,19]. Similarly, in 2015, the National Institutes of Health (NIH)/National Center for Complementary and Integrative Health (NCCIH) Council Working Group Report on “Strengthening Collaborations with DoD and VA” was published and called for an investment in the conduct of pragmatic clinical trials for nonpharmacological approaches to pain and comorbidities in DoD and VA health systems [20]. Pragmatic clinical trials (PCTs) test interventions in real-world settings with fewer restrictions than are commonly employed in explanatory efficacy studies. PCTs distinguish themselves from explanatory trials by 1) having broader eligibility criteria to promote the external validity and generalizability of findings to the larger population for which interventions may be applied; 2) engaging health care providers who may have little research training or experience delivering interventions; 3) delivering interventions in a manner that mimics usual care and attempts to minimally disrupt normal workflow in the clinical setting; and 4) collecting data, when possible, in the context of routine clinical care, often extracting data from electronic health records. The DoD and VA health systems, as large national integrated learning health systems with robust electronic health records, are ideal sites for robust PCTs [21]. Despite growing evidence of the efficacy of nonpharmacological approaches for the management of chronic pain, including studies that address pain and comorbidities in VA and DoD settings, few large-scale PCTs that can inform clinical practice have been conducted [22]. Therefore, efforts to conduct relevant clinical research studies within these settings will require considerable collaboration within these systems, as well as infrastructure support. Ultimately, many unanswered questions remain about how to successfully implement policy-driven models of care such as the VA and DoD Stepped Care Model of Pain Management [23] and the VA Whole Health Initiative [24], how best to address important medical and mental health comorbidities to promote improved outcomes, and how to optimally incorporate nonpharmacological approaches into routine care. Several factors encourage optimism that the time is right to begin to address these scientific knowledge and practice gaps within the DoD and VA health systems. Important advances include methods for optimal use of comprehensive electronic health records; innovation in the design and methods for pragmatic clinical trials; availability of resources and infrastructure to conduct multisite trials such as the existing VA Cooperative Studies Program; dissemination of effective approaches for partnered research conducted by integrated teams of scientists, practitioners, patients, and other stakeholders such as publications describing a formative evaluation and implementation study of the VA’s Stepped Care Model of Pain Management [25]; and advances in quality improvement and dissemination and implementation science methods that address ethical and regulatory challenges and other barriers to the conduct of high-impact PCTs. In September 2017, a significant and innovative intergovernment agency partnership involving the NIH, DoD, and VA was announced to support a multicomponent research initiative focusing on nonpharmacological approaches for pain management addressing the needs of military service members and veterans. The NIH-DoD-VA Pain Management Collaboratory (PMC) represents an investment of approximately $81 million over six years, focused on developing, implementing, and testing cost-effective, large-scale, real-world research on nonpharmacological approaches for management of pain and comorbid medical and mental health conditions in DoD and VA health care delivery organizations. The NIH/NCCIH serves as the lead funding agency or sponsor in partnership with the VA’s Health Services Research and Development Service and the DoD’s Clinical Rehabilitation Medicine Research Program, Military Operational Medicine Research Program. Numerous additional NIH institutes, centers, and offices are supporting the Collaboratory’s projects. The PMC represents a major advance in the field of pain and pain management by developing the first-ever comprehensive guidance for the conduct of PCTs of nonpharmacological approaches for the management of pain in DoD and VA health care settings. Products will take several forms, including technical policy guidelines and summaries of best practices and lessons learned based on the experiences of highly qualified teams of investigators who will conduct the PCTs, complemented by the expertise of a Pain Management Collaboratory Coordinating Center (PMC3). The products of the PMC3 will serve a foundational role for future similar efforts in the field of pain management and related fields and for PCTs in other integrated health care settings. A schematic of the PMC components is presented in Figure 1. Schematic depiction of the components of the Pain Management Collaboratory. The PMC3 supports 11 PCTs selected based on peer review that evaluated the significance of the scientific questions, innovation and quality of the approach, and potential to address impediments to the research with health care delivery organizations. The trials span those focused on examining questions related to specific nonpharmacological approaches (e.g., “dose” of chiropractic care necessary to achieve optimal, sustained benefit; comparative effectiveness of two approaches to delivering mindfulness-based meditation) and/or models of pain care (e.g., comparative effectiveness of a sequenced, integrated multimodal care pathway vs care management via a patient resource group; comparative effectiveness of integrated health care professional teams delivering personalized care planning, health coaching and targeted complementary and integrative health strategies vs traditional primary care–based group education). One project examines acute pain management in the perioperative setting, and the others focus on chronic pain management in outpatient settings. The trials are supported by a phased award mechanism, with a two-year planning phase followed by a four-year implementation phase. All projects are milestone-driven (e.g., regulatory approvals are obtained, feasible recruitment plans are finalized), and moving to the implementation phase will be dependent upon the successful progress made during the planning phase. Table 1 provides a list of each of these projects with principal investigator(s) and sponsors. Pragmatic clinical trials and principal investigators M. Rosen S. Martino C. Goertz C. Long The Spine Institute for Quality Palmer Center for Chiropractic Research S. George S.N. Hastings Durham VA Health Care System & Duke University J. Fritz D. Rhon University of Utah Brooke Army Medical Center K. Seal W. Becker San Francisco VA Health Care System & University of California–San Francisco VA Connecticut Healthcare System & Yale School of Medicine S. Taylor S. Zeliadt VA Greater Los Angeles Healthcare System & UCLA Department of Health Policy and Management VA Puget Sound Health Care System & University of Washington, School of Public Health D. McGeary J. Goodie University of Texas Health Science Center Uniformed Services University of the Health Sciences S. Farrokhi C. Dearth E. Russell Esposito DoD-VA Extremity Trauma and Amputation Center of Excellence (EACE) & Naval Medical Center, San Diego EACE, Walter Reed National Military Medical Center & Uniformed Services University of the Health Sciences EACE, VA Puget Sound, University of Washington & Uniformed Services University of the Health Sciences PCT = pragmatic clinical trial. Following on the heels of a successful Health Care Systems Research Collaboratory, also sponsored by the NIH (https://rethinkingclinicaltrials.org/), the PMC3 was established to facilitate collective learning across the PCTs and to optimize the impact of the PMC as an integrated whole. The PMC3 is based at the Yale School of Medicine and its affiliate, the VA Connecticut Healthcare System. The PMC3 draws on four existing centers, including the Yale Center for Analytical Sciences, the Yale Center for Medical Informatics, the VA Connecticut Pain Research, Informatics, Multimorbidities and Education Center of Innovation, and the VA Cooperative Studies Program Coordinating Center. An additional partnership was established with the Uniformed Services University of the Health Science Center for Rehabilitation Sciences Research to extend the reach of the PMC3 to the DoD research community. 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 PCTs. The leadership of the PMC3 includes three co-directors with complementary expertise in pain management (RDK), health informatics (CAB), and biostatistics/clinical trials (PP). An administrative/operations and communications core ensures a high level of productivity overall and that key milestones are met. Consistent with the successful model enacted for the Health Care Systems Research Collaboratory, shared learning, harmonization across projects, and problem solving related to the PCTs largely occur through participation in seven work groups spanning the domains of 1) biostatistics and study design, 2) phenotypes and outcomes, 3) electronic health records, 4) ethics and regulatory issues, 5) stakeholder engagement, 6) data sharing, and 7) implementation science. Each work group is led by two co-chairs with expertise related to the work group domain, along with representatives from each of the PCT teams, and supported by an experienced project manager. Representatives from the NIH, DoD, and VA, as well as investigators with additional relevant expertise, participate in work group discussions. Work groups usually meet virtually at least monthly; one-on-one sessions are scheduled as necessary with individual PCT teams to address specific issues. Work groups discuss topics of mutual interest, share best practices, and build consensus. The objectives of the work groups are to promote harmonization and synergy among the trials, to optimize the performance and success of the individual trials and the PMC, and to support dissemination of new knowledge. Table 2 presents a summary of work group objectives. Pain Management Collaboratory work group objectives Provide guidance on methodological standards in the design and implementation of nonpharmacologic PCTs of pain management. Collaborate with PCT teams during the planning and execution phases to ensure efficient and robust study design and analysis plans. Review proposed data processes to ensure that collection of all required individual-level data is feasible and well described. Work with collaborators, investigators, and academic institutions to collate and disseminate statistical and methodological issues arising from review of the PCTs. Facilitate methodological work in response to issues identified through PCT project review. Address a wide array of issues related to planning, designing, and implementing the PCTs, including data- and software-sharing plans, and the data standards that will be required for the study implementation, execution, and conduct. Provide a forum for discussion of informatics challenges and solutions across projects. Seek to harmonize data-sharing standards and templates while developing best practices and guidelines for data sharing. Optimize use of existing electronic health record data. Support integration of patient-reported data. Create new data from unstructured text in electronic health records using innovative machine learning and natural language processing tools. Promote data standardization and interoperability across systems and electronic health records. Review, develop, and adapt policies and tools that can be easily shared and adopted in the service of supporting the PCTs. Seek to identify areas of ethical and regulatory importance and address complexities within the VA and DoD health care systems. Develop processes and agreements needed to address regulatory requirements for single and multiple health care systems that provide services to military service members, veterans, and their families. Identify and disseminate information that facilitates the ethical conduct of pragmatic clinical trials in eligible health care settings, obtaining input from health care patients, members, and Support PCTs in developing and dissemination and implementation methods and practices that will facilitate the of evidence-based findings into health care settings with the of the health and of military service members and veterans. Provide PCT with implementation science on each of the inform policy guidance and best practices for the military and health care systems via the collective work across the projects. Identify and phenotypes among for use in examining important treatment and for of study Promote harmonization of when for key Provide a forum for and regulatory issues that related to harmonization of approaches. Develop and that will to findings relevant to veterans and military service members with pain, primary care and health care teams, and health Provide a forum within which these stakeholders can their and expertise to and a and to address identified organizational, clinician-, and patient-level barriers to engagement, and participation in pragmatic clinical trials of nonpharmacological approaches for the management of chronic Optimize the VA and DoD as learning health care systems. DoD = Department of PCT = pragmatic clinical = principal VA = Department of Veterans of the PMC3 to address barriers to the successful conduct and implementation of PCTs. A few of key barriers include obtaining all necessary regulatory approvals from multiple sites the trials will be successfully obtaining and support for the including engaging as study and other in recruitment and electronic health records to incorporate collection of key study within the context of clinical care, among many the by this important initiative to support advances in the design (e.g., and successful of PCTs and to address numerous scientific knowledge and practice gaps related to the role of nonpharmacological approaches to the management of pain and Table presents a summary of these PMC DoD = Department of PCT = pragmatic clinical VA = Department of Veterans The PMC is supported by a of the leadership of the PMC3 work group co-chairs and the PCT and The with the of the PMC, all PCTs, provides input into the policies and processes of the PMC, and long-term issues that impact the PCTs, ensures the management, and regulatory of the PCTs, an integrated and among all PCTs, in the dissemination of policies and processes that research in partnership with the DoD and VA health systems, their patients, and practitioners, and advances knowledge and related to nonpharmacological approaches to pain management. The virtually and in at least are to provide on PCTs and to discuss key or topics that have from work group discussions. As a few the issues including refinement of PCT harmonization of primary and across trials, best practices for of research shared recruitment and regulatory issues related to data sharing. is important to that all PMC trials are by evidence of the of specific nonpharmacological approaches and models of care. the most these trials will likely to the of evidence about are to address important additional scientific knowledge and practice gaps related to the successful implementation of these approaches and models of care in real-world clinical settings, particularly in the VA and As an important of the PMC initiative is that and can have that the approaches and models that are the of the PMC trials are all to be for implementation in routine clinical The PMC will a to disseminate information relevant to the Collaboratory, as well as new knowledge and in advance of the conduct of the PCTs that the PMC, the PMC3 a that is to be an important resource for investigators, and in addressing important scientific knowledge and practice gaps and in the and availability of pain management is a growing array of resources including of evidence relevant to those in delivering pain care, and training and information about best practices, and policy in support of this will be published on the such as summaries of innovative processes or methods that have been employed to address key issues. the of trials will likely be for six years, the of work are to be As and products from the PMC and the individual trials, these will be highlighted on the for dissemination include in scientific and professional at scientific and social such as The PMC to evidence of the potential to its as a significant and innovative to addressing key scientific knowledge and clinical practice gaps in the delivery of pain care in DoD and VA health systems and supporting improved patient A major between the Health Care Systems Research Collaboratory and the PMC is the existing Collaboratory includes trials from multiple domains of health care (e.g., pain the PMC includes a specific focus on nonpharmacological approaches to management of pain and comorbid conditions in DoD and VA health systems. The conduct of these trials in large integrated health systems potential to the Health Care Systems Research Collaboratory, which is conducted in settings. The focus on military service members and veterans is significant due to the of pain to the As the PMC represents a significant investment and a to advance the science and practice of pain management in these settings. D. VA Connecticut Healthcare The NIH-DoD-VA Pain Management Collaboratory is supported by multiple and including the National Institutes of Health National Center for Complementary and Integrative Health National Institute of and National Institute of National Institute of and National Institute for Health and Human Development National Center for Medical Rehabilitation Research of Research on Health and National Institute of Research the Department of Defense (DoD) Clinical and Medicine Research Program and Military Operational Medicine Research Program and the Department of Veterans Affairs (VA) Health Services Research & Development Service of the of Research and of is a of the of and a of the of of A to Health and as of Pain for the and for the Management S. C. in the as a from the University of funding and for other research projects from and a of a and a of All other report of The in this are those of the and the policy of the Department of Health and Human National Institutes of Department of Department of Veterans or and
Source: Pain Medicine
DOI: 10.1093/pm/pnz186
Institutions: VA Connecticut Healthcare System, Yale University
Language: English
Subfield: Pharmacology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: U.S. Department of Defense, U.S. Department of Veterans Affairs, Office of Research and Development, National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, National Institute of Nursing Research, Office of Research on Women's Health, National Center for Advancing Translational Sciences, National Center for Complementary and Integrative Health, National Center for Medical Rehabilitation Research
OpenAlex ID: W2968412955