Leveraging the Clinical Translational Science Award Network to Advance Family Medicine Research

Opportunity #1: Community Engagement with Those Interested and/or Affected

CTSA/CTRA funding announcements acknowledge that translational research requires teams with a wide range of expertise and perspectives relevant to a given area, from researchers and clinicians, to patients, community members and other partners. They also include an explicit commitment to addressing conditions that disproportionately affect rural, minority and other underserved populations. A special communications article by NCATS¹⁰ additionally calls for examining the translational research process with a diversity, equity, inclusion, and accessibility (DEIA) lens to ensure inclusion of diverse perspectives, including from populations and groups that have historically been underrepresented in research. Engagement of diverse interested and/or affected individuals, for example patients as advisor-partners in all aspects of research, from study design and conduct, to result dissemination, implementation, and policy applications, is critical for understanding and addressing the needs and preferences of minoritized, underrepresented groups. Involvement of these key individuals in the research process can increase the relevance of study interventions and outcomes, with a potential for increased acceptability and uptake of evidence-based approaches and, ultimately, improved health of individuals and communities. This can also contribute to a more equitable access to effective treatments, reducing health disparities now experienced by many currently-underserved populations. The NIH¹¹ and the Patient-Centered Outcomes Institute (PCORI)¹² have started prioritizing patient and other interested/affected individuals’ engagement in research as critical components of closing the long lag between research discovery and its real-world applications. For example, these individuals can help shape research by providing input on design and approach,¹³ as well as by becoming involved as research team members to bridge the gap and build trust between researchers and academic institutions and (prospective or existing) study participants, promoting improved enrollment and retention, including among hard-to-reach populations.¹⁴

Family physicians care for individuals and families across the lifespan, from “cradle to grave,” and are often actively and intimately involved in caring and serving as health advocates for the entire communities, particularly within rural areas. They treat the broadest range of conditions and illnesses among all specialties, and comprise the largest health care workforce within primary care, with the most clinic-based patient visits.¹⁵ Family medicine is also the specialty most available in rural counties in the US^15,16 Because most health care in the US is delivered by primary care clinicians, and family medicine dominates this workforce, it is not surprising that a large proportion of populations categorized as vulnerable, marginalized or underserved are cared for by family physicians.^15⇓–17 As such, family physicians and family medicine as a specialty are perfectly positioned to conduct research that is meaningful and acceptable to patients and impactful on a public health level. With appropriate support, such as through CTSA/CTRA-provided resources and services, family medicine and primary care practices and clinicians can advance clinical and translational research, and community engagement toward better health.^18,19 They can offer patients the opportunity to collaborate in research studies as participants or advisors.

Opportunity #2: Practice Based Research Networks

Primary care practice-based research networks (PBRNs) play a crucial role in advancing health care and improving patient outcomes.²⁰ These networks are comprised of health care teams collaborating with researchers and serve as a means for bridging the gap between academic research and real-world clinical practice. Primary care PBRNs generate valuable insights into treatment effectiveness, preventive measures, and health care policies in everyday clinical scenarios. This research can inform evidence-based decision making, enhances the quality of care, and tailor medical practices to the unique needs of their communities. Further, primary care PBRNs foster a culture of continuous learning among health care professionals, encouraging them to adapt and adopt the latest innovations, ultimately contributing to the overall well-being of patients and medical knowledge advancement. The Agency for Health care Research and Quality (AHRQ) has supported PBRNs through competitive grant programs and hosts a PBRN registry on their website. Over 100 PBRNs affiliated with Family Medicine providers were registered through AHRQ.²⁰

Primary care PBRNs are mechanisms for improving the delivery of primary health care services worldwide. To this end, primary care PBRNs present opportunities for CTSAs and IDeA CTR Network programs alike. By leveraging PBRNs, CTSAs can enhance translational research efforts, facilitating the rapid translation of scientific discoveries into clinical practice. Similarly, for IDeA state CTR programs, primary care PBRNs offer a unique opportunity to engage underserved communities, ensuring the inclusivity of research initiatives, and the equitable distribution of health care innovations. In fact, recent funding announcements for CTRs require integration of community engagement and outreach offered by PBRNs.²¹ As such, there is an opportunity for Departments to collaborate with those engaged in these awards to build or grow a PBRN.

Opportunity #3: Research Training, Education, and Workforce Development

CTSA/CTRA-holding institutions offer advanced research funding, infrastructure, resources, and expertise. Family Medicine-based researchers with research skills ranging from modest to expert can immediately benefit from such resources. CTSA/CTRAs also offer training programs for all levels of medical professionals. Faculty within CTSA/CTRA-holding institutions have direct access such training. For those without a CTSA/CTRA, it offers a model from which to develop key elements of structured, actively mentored research training.

The current CTSA UM-1 RFA funding cycle continues to emphasize active trainee mentorship, grant-writing workshops, and networking, all geared toward helping faculty build successful careers as translational scientists. It also emphasizes a shift toward expanding trainings to include all potential members of research teams, including staff and community members. Programs in many CTSA/CTRAs now include opportunities for individual and team science training, collaboration across different disciplines, and faculty and staff career growth.

CTSAs additionally support mentored, longitudinal research training and career development for medical students (predoctoral), and residents and fellows (postdoctoral), along with their nonclinician counterparts, some CTSA support dedicated programs such as TL1 fellowships that provide clinical and translational science (CTS) training.²² These 1 to 2-year programs provide funding (modest stipend and coverage of training-related expenses), structured settings, coursework, and mentorship. Resources provided by CTSAs can also facilitate success of federally-funded formal mentored research training programs such as 2 to 3-year NIH or NRSA supported T32 awards.²² For early career faculty (“early stage investigators”; ESIs), CTSA resources offer formal 2 to 3-year training under the KL2 career development award mechanism.^23,24 CTSAs are also making a strong push to transition to community based participatory research. The authors (AZ, DR) have had particular success in their center through the CTSA Community Engaged Research Core, which provides career training through a fellowship program, resources, and mentorship inclusive of community stakeholders, along with other stakeholder training.

The career-development model offered by CTSA/CTRAs (modest funding, career development awards and research mentorship, and research protected time) can also be used by departments in centers without a CTSA/CTRA. For example, academic family medicine departments can create revenue-neutral (or near-neutral) research fellowships for ESIs interested in gaining research training, securing ample protected time for research and academic career advancement critical to becoming an independent clinician-scientist. Without a deliberate approach to securing protected time, clinical care responsibilities highjack early career faculty’s time, energy, and efforts. A faculty member who does a modest amount of clinical work (20 to 40% FTE), especially if hired at a clinical instructor level, can pay for, or substantially offset, the cost of research/career development protected time (60 to 80% FTE). Active mentorship informed by progressive mentorship structures such as those offered by the National Research Mentorship Network,²⁵ and collaboration with ongoing research-related resources such as those offered by CTSA/CTRAs, help ensure success.

For all trainees and supporting entities, academic medical centers with or without CTSA/CTRAs are associated with medical schools and universities that provide nearly limitless learning opportunities. These include traditional in-person courses and a growing number of virtual courses and other resources. Lectures, seminars, and workshops are now often recorded and cached for later use by those unable to attend in person. Collective digital training repositories such as the DIAMOND portal²⁶ offer numerous research training materials that can be curated to create a comprehensive research training curriculum. Fellowships can leverage trainings to improve research capabilities, covering areas such as study design, data analysis, research methodology, regulatory compliance and research ethics.

Opportunity #4: Research Services and Pilots

CTSA/CTRA programs offer services to assist at many stages of the research conduct process, ranging from consultation on design, implementation of community-engaged and clinical trial studies, analysis, and dissemination. Services may be free or purchased depending on each hub’s institutional arrangements. Often these are available on a fee-for-service basis to those outside a specific institution. Given the nature of these core services, transactions occur in a time-limited way. Using these services to assist in the design, analysis, or conduct of primary care studies rather than replicating this infrastructure within a department may be a cost-efficient approach, as the longitudinal responsibility for salaries and fringe benefits under these models are not borne by a faculty investigator or Department.

All CTSA/CTRA programs offer pilot funding programs, which offer an opportunity for catalyzing additional larger-scale research funding. Pilot opportunities may be general, focusing on a particular population, or focused on specific priority areas. Priority areas that are well-aligned with family medicine research programs include community and interested/affected individuals’ engagement and outreach and dissemination and implementation. Departments should consider assisting faculty with the application process for pilot funding through mechanisms such as aid with budget preparation, assistance in identifying collaborators, and internal peer review before submission.

Opportunity #5: Alignment for Health Informatics Adoption and Integration

Health informatics has become a key component of translational research and is a rapidly expanding part of the CTSA programs. It often refers to the use and adoption of clinical informatics and information technology using existing electronic health records (EHRs), biogenetic data, and advanced statistics with machine learning/artificial intelligence (ML/AI), to augment and automate decision making processes for clinicians, patients, and health systems as a whole.²⁷ Within family medicine, the incorporation of health informatics could be transformational from the perspective of influencing quality and outcomes. Recent studies have demonstrated the benefits of informatics-driven interventions in chronic disease detection²⁸ and management.²⁹ Yet, many existing informatics advancements have been developed for specialty care, and it has been challenging for family practitioners and investigators to access and integrate health informatics for primary care research and clinical practice. As a result, despite overall efforts in advancing health informatics over the past decades, we are just beginning to understand the role of health informatics for primary care-related applications.

Through active collaboration with family medicine departments, the CTSA’s research ecosystem, rich in technical and regulatory expertise, and data security protections, could assist primary care clinicians with accessing and securely “processing” the EHR and population health data necessary for quality improvement and scientific discovery endeavors. This assistance could include support for data storage, query and reporting interfaces, improved algorithms and technology, and the enterprise-level data governance and stewardship. As availability of big data for population health and health services research increases, CTSA hubs can become the foci of core resources to help address the need of increased computational power and technical skills. Such technical assistance would help primary care clinicians effectively access and use big data toward improvements in continuity care and care coordination, the hallmark features of primary care.³⁰

In the era marked by exponential growth of the AI-based technology, tools, and applications, primary care research and practice should include this technology to process real-world clinical data toward better health care and patient outcomes, as well as to minimize potential harm associated with some sensitive features of the data and analysis. The CTSA’s supports can be essential for ensuring appropriate analysis (especially when using AI) of big data and result interpretation to reduce the risk of data and algorithmic biases, which, albeit unintentionally, may propagate the negative stereotypes and further aggravate marginalization and health disparities experienced by some populations.^31,32 Moreover, concerns have been raised that health informatics techniques have often been developed without clinical and other vital partners, and rarely use data from community health care settings where primary care clinicians practice.^33,34 CTSAs could help engage relevant partners to develop a comprehensive roadmap and resources to both support research and decision processing in clinical care, and include necessary infrastructure updates and training opportunities. The expected continued growth in the health informatics field will require progressively increasing capacity and technical expertise with better data/technology adoption in primary care to conduct high-quality research using real-world primary care data. Family medicine informaticists are well poised to collaborate with the CTSA network to partner in these endeavors.

Opportunity #6: Clinical and Translational Science Research Programs

With the explicit focus on translational science, an opportunity exists for larger scale funding from CTSAs to examine solutions to barriers to disseminating evidence-based interventions in real world clinical, public health and community settings. Departments have an opportunity to proactively collaborate with CTSAs in these endeavors, thereby enhancing both their research missions and the quality of clinical care that is provided. For example, dissemination and implementation (D&I) science is required in the new funding opportunity announcement. Family medicine departments could collaborate with CTSAs to hire faculty with this research expertise who focus on primary care. Guided by theory-informed models, faculty with D&I expertise can provide actionable insights that support the implementation process through assessing factors such as readiness and capacity to implement an evidence-based intervention; providing detailed implementation plans that are tailored to different settings; monitoring implementation success through data collection and analysis; and planning for sustainment through quality improvement and financial analysis.³⁵

Opportunity #7: Apply for a New CTSA

As a final big picture idea- what would it look like to have a CTSA or CTRA specifically focused on translational science in primary care? Given expanded interest in primary care research alongside establishment of new medical schools with a primary care-centered mission, perhaps the discipline of family medicine leadership could consider a bold strategy of partnering with one or more of these schools to support future applications. Such a demonstration project could help establish best practices for the discipline and leverage these translational networks while simultaneously advancing the field of primary care research.

In summary, the goals of family medicine and, in general, primary care, are well-aligned with the mission and vision of the NIH supported CTSA/CTRA programs. Departments can leverage the resources provided and thereby support and grow their research endeavor; this in turn advances translational science and the application of its discoveries toward effective dissemination and improved human and public health.