Engaging clinical partners in pragmatic clinical trials: lessons learned from the pain management collaboratory

Introduction

The Pain Management Collaboratory (PMC) is an innovative intergovernmental agency trial network. The PMC supports 13 pragmatic clinical trials (PCTs) evaluating nonpharmacological approaches to management of pain and common co-occurring conditions in military and veteran healthcare systems.¹ Beginning in 2018, the cross-trial PMC Stakeholder Engagement Working Group has identified important research stakeholders and anticipate potential challenges of working with these diverse individuals and groups.² We have since changed the term “stakeholders” to “partners” because while the former term underplays the critical role of personnel with vested interests in study performance and results, the latter term recognizes the vital importance of these individuals for the success of research projects and implementation of findings.³ Although longstanding efforts within the pain scientific community have emphasized the value of listening to the voices of people with lived experience to guide research that will yield medically and culturally relevant results, these efforts have focused on patients, caregivers, and families. Herein we discuss how PMC investigators engaged with clinical partners who participated in these pragmatic trials over the past 5 years. This Commentary describes barriers we have encountered and strategies to address partnerships within military and veteran health settings across 3 domains: Sustainable connections with clinical personnel, patient-centered research infrastructure, and building relationships with administrators (see Table 1).

Table 1.

Engaging clinical partners in pragmatic clinical trials: Barriers and solutions.

Domain	Challenges	Solutions
Sustainable connections with clinical staff	Lack of clinical providers for PCT participation (high staff turnover, heavy clinical workload)	• Offset clinical workload by hiring credentialed clinical staff • Incentivize participation by recognizing clinician value and role of providing practical guidance on study design and participant referral
	Burdensome administrative processes and delays	Develop and implement onboarding programs, streamline research and ethics training
Patient-centered research infrastructure	Pandemic-invoked limitations on in-person interactions	Provide/leverage technology and expertise to offer virtual clinical and site visits, interventions (when possible), and informed consent
	Non-standard monitoring of patient-reported outcomes (PROs)	Digitize PROs for capture within electronic health records
	Lagging participant recruitment due to lack of clinical capacity	Engage early and proactively with clinical facilities about space and equipment needs
Building relationships with clinical leadership	High staff turnover and lack of interest in research	• Communicate continuously and frequently with high-level leadership • Communicate across research sites about research goals and value

Sustainable connections with clinical personnel

There are many roles and opportunities for clinical partners to participate in pragmatic trials. These include serving as a research facilitator,⁴ caring for patients according to an established research protocol, and referring potential research participants to study investigators. Other potential roles for clinical partners include sharing clinical responsibilities when possible and providing practical insights for pragmatic trial researchers planning studies that reflect and address real-life conditions.

Clinical staff availability to participate in pragmatic research is a significant issue in health settings that serve military members and veterans. Ongoing conversations with PMC trial teams have pointed to frequent turnover of military clinicians in Department of Defense (DOD)-funded trials—and within Department of Veterans Affairs (VA)-funded trials, a shortage of clinicians to participate in research due to heavy patient loads and insufficient back-up support. Limitations in clinical staff availability to participate in pragmatic research are exacerbated by administrative delays to replace and onboard key clinical staff. As one way to address these issues, several PMC trials developed mentorship programs whereby personnel from sites meeting ongoing recruitment targets and other milestones helped to onboard and mentor clinical personnel at other study sites. These personnel included clinic providers, research personnel, technicians, and front desk staff. PMC trial leaders hired appropriately credentialed research clinicians to deliver virtual interventions or to offset clinician workload by caring for patients who were not enrolled in the study. PMC teams also worked to ensure that trial interventions counted toward a provider’s workload.

Clinicians who deliver care in military and veteran health facilities often have multiple roles and responsibilities and are not compensated financially for participating in research. PMC investigators observed clinicians’ altruistic motivations to participate in clinical research can be weakened by additional burdens, such as institutional review board (IRB)-related paperwork and required training for working with human research participants.⁵ To address these issues, some PMC teams have created mechanisms to streamline required research training and/or offer it virtually. PMC teams have observed that clinicians are often more enthusiastic about participating in research if they perceive clear potential benefit for patients (e.g., access to a promising new therapy or an alternative delivery mechanism). Successful strategies for effective communication with clinicians include respecting their expertise, simplifying research processes, and thanking them for their time and efforts. Clear feedback to clinician partners about both enrollment and outcomes further motivated their participation.

Patient-centered research infrastructure

During the COVID-19 pandemic, many PMC trials added virtual options to their study protocols (some had included telehealth interventions in their original study design).⁶ Local information technology (IT) departments thus became unanticipated partners in these trials when video-conferencing platforms were introduced to support clinical care. New tools to facilitate virtual research activities included methods to obtain informed consent without in-person visits, resources for virtual site visits with administrators and protocol training with study clinicians, virtual intervention delivery to research participants (when feasible), and virtual study follow-ups and data collection. Other IT components tested in PMC trials, such as smartphone apps and interactive voice response systems, were built by external contractors and maintained by study employees using current research funding. Future DOD/VA funding and partnerships with local or national IT resources could facilitate scalable and sustainable system-wide adoption of effective virtual interventions for pain management, especially for individuals who may not have access to, or know how to use, requisite technology.

A feature of pragmatic clinical trials, including most PMC trials, are efforts to optimize the use of electronic health records (EHRs) to collect key measures such as medication adherence and health care use. Patient reported outcomes (PROs), such as measures of pain interference, physical function, and quality of life, have not been consistently included in EHRs across clinical sites.⁷ To counter this issue, PMC teams have encouraged partnerships with DOD/VA administrative and clinical leaders to standardize digital collection of PROs so they routinely incorporate clinical reminders, prompts, and referrals to support dissemination and adoption of nonpharmacological pain management interventions.⁸ Standard approaches for including PROs and clinical pathways in EHRs could improve service delivery, make new clinical trials more pragmatic when relevant, and facilitate ongoing analyses to ensure that patients, providers, researchers, administrators, and funders have the best information for shared decision-making about pain management interventions.

Several PMC trials are testing clinician-delivered interventions that require clinic space and equipment, such as surgical techniques, physical therapy, or chiropractic care. A lack of clinic capacity and resources within health systems, paired with personnel issues described above, may lead to some research sites lagging in participant recruitment. Early and ongoing engagement with managers of clinical facilities to ensure space availability and patient accessibility may help overcome this barrier.

Building relationships with clinical leadership

Gaining and sustaining clinical leadership support for PCTs is critical, and most PMC teams have worked to acquire top-down buy-in for their research. Despite the value of building short- and long-term relationships with administrators, success requires constant communication and is time-consuming. In military settings, clinical leadership is typically provided by uniformed service providers or civilian staff depending on local needs. As noted above, these personnel (in particular, active-duty service members) are subject to frequent turnover in duty tours depending on service-wide needs. Thus, a persistent dilemma is how to build partner support in a health system that is rapidly changing.⁵ In the military system, engagement with hospital leadership (e.g., department chairs, clinical chiefs, and specialty consultants involved in personnel placement) could facilitate extending tours of duty for key study personnel until a research study is complete. Such an approach might sustain research continuity in the event of deployments and replace these individuals with new partners who have a vested research and clinical interest in the questions being studied.

Variable incentives also affect research participation of busy clinicians in health systems that serve veterans and military service members and their dependents. Intentional, proactive engagement with high-level leadership (e.g., hospital commanders and medical center directors) can provide valuable context for designing and conducting research that resonates with agency-specific needs and conditions. These discussions can also improve leadership understanding (and thus buy-in) of research questions being pursued (e.g., to reduce pain-related disability after trauma or surgery and increase retention rates in the military). PMC teams have observed that when one research site is reluctant to participate in a new study; they may be more likely to engage after speaking to clinical personnel and research participants at another site.

Conclusions

Clinical partnerships in nonpharmacological pain management trials are important but challenging to establish and maintain. Collective experiences of the PMC reveal that one size does not fit all, echoing research that documents levels of participation as varying dramatically from minimal to supportive to participatory.⁹

PMC investigators have observed challenges at multiple levels when aiming to partner with clinicians in pragmatic research. Beyond what we have discussed herein, these also include work required by institutional review boards, other oversight groups, and payers, funding agencies, and health care policy makers—which can either directly or indirectly affect clinician involvement. It is our view that a lot can be learned from what makes functional research sites work smoothly. Routine communication within and between studies and effective mentorship can go a long way toward overcoming existing obstacles.

Funding

Research reported in this publication was supported by the National Center for Complementary and Integrative Health (NCCIH), and the Office of Behavioral and Social Sciences Research (OBSSR) of the National Institutes of Health (NIH) under Award Numbers U24AT009769 and UG3/UH3AT009761.

Conflicts of interest: There are no other conflicts of interest to disclose.

Supplement statement

This article appears as part of the supplement entitled “Pain Management Collaboratory: Updates, Lessons Learned, and Future Directions.”

This manuscript is a product of the Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org/.