Engaging Veterans and Military Service Members to Optimize Pragmatic Clinical Trials of Nonpharmacological Approaches for Pain Management

In 2010, Congress created the Patient-Centered Outcomes Research Institute (PCORI), which marked a shift in the focus in how healthcare research was conducted, concentrated, and funded. Health services researchers were challenged to institutionally integrate the interests, needs, and perspectives of the communities they served into the research lifecycle while delivering a value-add to those same communities [1, 2].

The Department of Veterans Affairs’ (VA) Veterans Health Administration’s (VHA) Health Services Research and Development Service (HSR&D) had similarly been implementing various strategies to promote patient engagement for several years. As early as 2011, the lead author for this narrative (A.A.; a Veteran of the Global War on Terrorism), was invited to serve as a member of the Executive Steering Committees for the HSR&D Center of Innovation (COIN) and Polytrauma/Blast-related Injury Quality Enhancement Research Initiative Program at the Minneapolis VA Health Care System, and subsequently at the pain management focused COIN at the VA Connecticut Healthcare System. In this capacity, the author represented the Veteran perspective in strategic planning and ongoing monitoring and evaluation of these Centers’ research portfolios. By the early 2010s, HRS&D encouraged COINs to develop robust Veteran engagement groups in the context of broader strategic efforts to promote participatory research to enhance the meaningfulness and impact of research from the perspective of Veterans.

In 2016, VA partnered with the National Institutes of Health (NIH) and the Department of Defense (DOD) and established the NIH-DOD-VA Pain Management Collaboratory (PMC) to address the critical gap between strong evidence of the effectiveness of nonpharmacological approaches for the management of pain and common co-occurring conditions, and the limited use of these approaches in routine clinical care in Military and Veteran health systems. The PMC supports eleven pragmatic clinical trials of these approaches conducted in these settings [3]. By then, the PMC was prepared to develop a more formal mechanism to link research to the communities they serve, with a specific focus on a cross-functional consultancy group that was intended to assist all four facets of health research—the research side, the patient side, the clinical side, and the community/stakeholder side [4].

In this context, the Patient Resource Group (PRG) was established as a unique PMC advisory council that supports various aspects of engagement during the research lifecycle. The PRG serves as an advocate for the Veterans and Service Members and their dependents participating in healthcare research. The PRG provides consultation to the PMC Principal Investigators (PIs), organizational stakeholders, and external community stakeholders (Military, Veteran, and healthcare communities, including Veteran Service Organizations). As the chair of the PRG, A.A. accepted primary responsibility for recruiting and engaging a diverse group of members. The 13 members are drawn from diverse professional (Officer and Enlisted), racial/ethnic, gender, war-time era, age (range 30’s to 70’s), and socioeconomic status perspectives. All have either lived experience of chronic pain and/or are directly involved in the pain community such as VHA staff or patient caregivers. Several members have experience in health research and the field being studied, and several are members of Veterans Service Organizations (VSOs). The objective was to assemble a group that mirrors America and accounts for the whole community.

The PRG is designed to support the successful completion and impact of the PMC trials by enhancing recruitment materials and strategy, promoting external engagement, and optimizing plans for dissemination and implementation of positive study findings and products. As such, the PRG acts as the “community-connected” consultancy that helps better understand the needs of the communities being studied and promotes the “patient-centeredness” of the trials and their findings. Ultimately, the principal aim of the PRG is to serve as a voice for all those who haven’t traditionally had a “seat at the table”—a Voice for the Voiceless.

The PRG offers consultancy services on-demand throughout the research lifecycle. Figure 1 provides a visual display of this concept. The PRG meets virtually, as a group, on a regular interval basis, and individual members and subgroups participate in additional virtual venues to provide consultation and to discuss emergent issues. The PRG is supported by the PMC Coordinating Center leadership (R.K.) and a designated project manager (L.K.). Complementing the PRG is an independent “External Board” comprised of other key stakeholder groups, including VA and DOD leads for pain-related policy and practice initiatives and representatives from other integrated health systems, similar government-funded research collaboratories, and the Centers for Medicare and Medicaid Services and other third-party payers.

Figure 1.

The PRG research sustainability lifecycle. PRG = Patient Resource Group.

Membership is intended to last for the 6-year funding cycle for the PMC. One of the first steps following organization of the PRG was to provide brief education regarding objectives for the group, roles and responsibilities for participation and the objectives, structure and functioning of the PMC, and the purpose and nature of pragmatic clinical trials. The PMC website (www.painmanagementcollaboratory.org) was used as a resource when providing this training.

Historically, researchers have appropriately focused on addressing key scientific knowledge and practice gaps informed by the existing scientific literature and, in the case of clinician-investigators, their experiences as clinicians. However, the research findings are largely disseminated within the scientific research community and often are not intended for the general community or written in the layperson language. Focusing on the community means that the PRG is working with research leadership to identify priorities of community stakeholders, in this case Veterans and Military Service Members and their families. Informed investigators are better able to tailor their research to optimize its desired impact on patient care [5]. This approach may be particularly relevant for the pragmatic trials that are designed to be patient-centered and effective in “real world” settings with “real patients,” in this case patients with pain and co-occurring medical and mental health conditions that complicate treatment [6]. PRG involvement increases the likelihood that patients and their families will be more receptive to and invested in the results. Mutually identifying objectives and facilitating dialog between the stakeholder community and the research institution advances both the moral cause and strengthens the ties between the organizations sponsoring and conducting research and the community.

Since its formation, and although the process has slowed during the coronavirus disease (COVID-19) pandemic, the PRG has worked with a variety of internal and external stakeholders, as well as carried out various activities such as:

1. Meeting with grant makers and decision authorities to define the scope of stakeholder engagement and identify ways in which patients and stakeholders can be involved with research,

2. Reviewing grant/study application materials to provide thoughts and considerations for study, and to provide letters of support for various patient-engaged research,

3. Contributing to study designs by walking through the protocols with principal investigators (PIs) and providing background on Veteran characteristics not traditionally reported,

4. Reviewing websites and data collection instruments, and providing feedback and clean-up of materials to make them more Veteran/Military friendly,

5. Engaging VSOs to promulgate study enrollment materials with their membership, and increase the number of patient participants in the study,

6. Maintaining an open dialog and ongoing research-focused curriculum for PRG Members less familiar with healthcare research methodologies.

A few specific examples may serve to highlight the ongoing contributions of the PRG. PRG members have been active participants in PMC sponsored conferences, including a “scientific symposium” held in May 2021 during which time pilot project data were presented, and annual PMC Steering Committee (SC) meetings involving the leadership of the Coordinating Center, sponsors, and study PIs The most recent SC meeting held in September 2021 included a PRG panel discussion representing the perspectives of five members of the PRG with regard to their lived experiences of pain and opioid use disorder and implications for the PMC and its trials. As one example of a consultation with PIs, A.A. consulted with the PIs of a project embedded in the VA compensation and pension evaluation process to assist the PIs in developing an action plan to overcome apparent obstacles to recruitment and engagement in the trial. One PRG member contributed as an author to a published article addressing diversity, inclusion and justice in pragmatic clinical trials [7]. PRG members are currently actively contributing content for the PMC website to strengthen its patient and public facing focus.

The PRG is supportive to researchers because it helps identify the current issues affecting the Military and Veteran communities, and subsequently, provides a continuous feedback loop for developing future research proposals. The PRG also helps align the research foci of the investigators with the clinical and research missions of the VA and DOD, as well as other healthcare organizations’ and/or broader community interests.

A prime consideration in research planning is the buy-in from leadership and stakeholders. The PRG works to leverage the relationships and connections between various stakeholders and illustrate the value proposition, while translating the technical proposal into actionable, supportable plans for research that the community and lesser-engaged executives can easily appreciate. PRG members also work to involve other key stakeholders as partners. VSOs are often willing to participate and support study enrollment at the local and national levels. An engaged partner is a supportive partner.

As study results and products begin to materialize, the PRG works with their own contacts, as well as the organizational partnership and community stakeholders identified, to disseminate the results and create impact statements that demonstrate the value of the research and how it affects those specific communities. For example, plans are being made for the PRG members to serve as partners with the research teams when developing materials for briefing clinical and organizational leaders in VA and DOD as positive results and products emerge. Perhaps most important, PRG members will likely take the lead in development of materials for dissemination to Veterans, Military Service Members and their families, and the public, more generally. These come in the form of one-pagers, white papers, and infographics—materials that are easy for the general public to digest. As those communities and stakeholders further realize the benefits of research, agency leaders and influential stakeholders further affirm research priorities and the cycle repeats (Figure 1).

The PRG has improved the performance and congruency with stakeholders’ expectations by refining and sharing best practices, helping PIs adjust study enrollment strategies due to COVID-19, developing and reviewing study materials and communication portals, and assisting PIs in avoiding pitfalls associated with the Military and Veteran culture. These efforts have directly resulted in reduced time spent by PIs pursuing unrealistic ventures, and higher levels of engagement by the VSO community not previously achieved.

Research funders and regulatory authorities have been increasingly supportive of research proposals that have included a PRG element in their submission, and documented strategies and resources for the engagement of stakeholders in research. The authors expect this trend to continue and the support for patient-engaged research to further mature. It may be important to note that similar entities have emerged to support VA HSR&D COINs and related research communities, and NIH is likewise expanding its expectations for participatory research similar to the PRG. Finally, the PRG is well positioned to contribute as active partners in shaping the future priorities and focuses of the PMC.

In conclusion, the PRG offers an innovative, tested, and comprehensive model to appropriately integrate stakeholder and patient perspectives into healthcare research. By including a framework that supports all four facets (researchers, patients, clinicians/clinical leaders, community/stakeholders) of health research throughout the research lifecycle, studies obtain legitimacy and resource support that is not easily found elsewhere. The PRG offers inclusive engagement, external buy-in, and a community-connected perspective that is sure to provide a Voice for the Voiceless.

Authors’ Contributions

The authors are appreciative of additional input in the development and finalization of this manuscript from Cynthia Brandt, MD, MPH, and Peter Peduzzi, PhD, directors of the Pain Management Collaboratory Coordinating Center.

 

Funding sources: Research reported in this publication was made possible by Grant Number U24 AT009769 from the National Center for Complementary and Integrative Health (NCCIH), and the Office of Behavioral and Social Sciences Research (OBSSR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCCIH, OBSSR, and the National Institutes of Health.

Conflicts of interest: The authors have no conflicts of interest to disclose.