Executive Summary of the Foundation for the National Institutes of Health (FNIH)-National Institutes of Health (NIH) Listening Sessions on Research in Primary Care

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Background
Participants
Workshop Theme: Building Sustainable and Effective Partnerships
Workshop Theme: Engaging Early in Balanced and Bi-directional Partnerships
Workshop Theme: Understanding the Diverse Needs of Communities
Workshop Theme: Demonstrating Trustworthiness
Workshop Theme: Addressing Financial Sustainability
Workshop Theme: Aligning Practice Needs and Research Structures 
Workshop Theme: Considering the Workload of Health Care Providers 
Workshop Theme: Reducing Burden with Innovative Study Design and Technology  
Workshop Theme: Using Advanced Technology and Harmonizing Data Structures

Background #background

The National Institutes of Health (NIH) is planning a program to expand research opportunities by integrating clinical research in primary care settings. This program aims to improve research equity, enabling access to clinical research for populations that are traditionally underrepresented in research via a primary care-focused research network that is disease agnostic. In April and May 2024, NIH and the Foundation for the NIH (FNIH) hosted a series of four listening sessions to inform the design of this network. The listening sessions fostered engaged discussion among attendees and a variety of key themes emerged across sessions. These key themes, expanded on in the following sections, consisted of:

• Building Sustainable and Effective Partnerships
• Engaging Early in Balanced and Bi-directional Partnerships
• Understanding the Diverse Needs of Communities
• Demonstrating Trustworthiness
• Addressing Financial Sustainability 
• Aligning Practice Needs and Research Structures 
• Considering the Workload of Health Care Providers
• Reducing Burden with Innovative Study Design and Technology
• Using Advanced Technology and Harmonizing Data Structures
   

Participants #participants

Each listening session was attended by representatives from a variety of sectors, including patient and community groups, research networks, primary care providers, hospital systems, and federal agencies. In total, seventy-eight unique participants actively participated across the four listening sessions. 
 

Workshop Themes

The four listening sessions encompassed a broad spectrum of themes, primarily focused on the integration of clinical research opportunities into primary care environments. These themes are outlined as follows.
 #buildingsustainable

• Building Sustainable and Effective Partnerships: The participants stressed the importance of sustaining relationships with communities and primary care practices throughout the life of the research project and beyond. Effective partnerships require ongoing engagement, which is often stymied by current, time-bound funding structures or logistical challenges such as location and timing of research activities. Participants spoke to the need to advance from episodic involvement to consistent engagement with community organizations, as sustained relationships are critical to both trust and a deep understanding of community needs; time and repeated interactions are needed to move from talking about trust to truly being trustworthy.
  • Inconsistent partnerships and support make it challenging for primary care practices to build and maintain the infrastructure necessary to integrate research into practice, such as knowledge of regulatory compliance and data collection capabilities. Sustained and ongoing partnerships can also help overcome systemic obstacles for patients like distrust in research entities, language barriers, and socio-economic factors that could limit participation.
  • As health centers have valuable insights and access to diverse populations, incentivizing health centers’ participation in research can enhance the scale, diversity, and impact of studies. As research studies require extra time, resources, and expertise, both financial and non-financial incentives may motivate health centers and providers to engage in research studies, facilitate long-term engagement, and foster a culture of research within health centers. 
    • Based on survey data referenced in the session, more than two times the number of health centers want to participant in research than currently do. These health centers need sustainable and longitudinal support, including ongoing funding for staff to support data collection and respond to research-related grants.
  • In addition to funding to support additional staff at clinical sites, participants spoke to the need for ongoing mentorship from research funders and clinical research networks to the primary care community. This could involve research experts providing continuous guidance and support to primary care professionals, enhancing their understanding of clinical research, and building their capacity to contribute effectively to research activities. 
    • In turn, primary care professionals, with their close ties to the community, can play a vital role in advocating for research participation among patients, addressing their concerns, and facilitating their involvement in research activities. 
    • To enhance the success of clinical research initiatives in engaging diverse populations, the attendees emphasized the importance of sustained engagement with the entire spectrum of primary care practitioners, including physicians, community health partners, hospital systems, Nurse Practitioners, Registered Nurses, and Nursing Assistants. The participants suggested engaging with primary care organizations to understand and align with their priorities, goals, and constraints for successful integration into routine clinical care. This degree of engagement helps to elucidate the unique challenges and needs of communities, especially those that are underserved, that may not be immediately known to outsiders. 
  • The conversations also highlighted the importance of establishing ongoing relationships with local community partners such as the YMCA/YWCA, schools, and faith-based organizations. This group of community partners also includes engaging with members of the research team who live in and regularly engage with the community, serving as a “field team” since these individuals are often embedded within the communities and practices, they serve, making them well known and trusted individuals. 
    • Community partners can help practices identify and recruit suitable participants for research projects, provide training and support, and assist with data collection and analysis, thereby helping to ensure that the research is grounded in the realities and needs of the communities they serve.
    • However, a potential barrier to the success of these partnerships is finding a way to compensate patients and community organizations for their time and services. Finding ways to fairly value their contribution within existing funding structures is key. 
    • Additionally, supporting sustained infrastructure to enable consistent and ongoing engagement can strengthen relationships with community partners. Successful partnerships found ways to maintain relationships beyond research projects, such as a research network that provides funding for local champions to attend annual meetings where they can interact bidirectionally with investigators.
      #engagingearly 
• Engaging Early in Balanced and Bi-directional Partnerships: The discussions underscored the critical nature of community involvement from the initial stages of research. Emphasizing sustainable and equal partnerships, attendees advocated for the establishment of structures allowing the community to “co-create,” and have balanced investment and “research ownership” alongside researchers. This includes jointly shaping the overall research agenda – including determining priorities for research, designing research studies and priorities, and collaborating on materials, such as informational and promotional materials related to the studies. Early and ongoing community engagement is instrumental in creating research initiatives that are relevant, culturally competent, and sensitive to the needs of a given community. 
  • Areas to co-create, include but are not limited to: asking who from the community should be at the table, setting research priorities, designing outreach materials, selecting partners and locations for engagement, and designing interventions to improve health. Involving communities from priority setting through intervention makes them agents of change and feel invested in improving the health of community. 
    • Participants shared examples of co-creating, including a Tribal-led Tribal Advisory Board and a recently developed Tribal Consultation Plan, which are empowering Indigenous people to set research priorities and make decisions on research studies (e.g., research goes through academic and Tribal IRBs). 
    • It is important to co-create community outreach materials with input from the community; understanding their preferences and needs, ranging from font size to the types of images preferred, to create materials that resonate with the community.
  • Engagement and equal partnerships need to carry throughout the entire research process. The community is not just interested in hearing about research outcomes, but also understanding how their input is being used or why it is not resulting in action.
  • Balanced partnerships also need to account for fiduciary balance. Participants stressed the need to provide fair market compensation to organizations and to individuals for their participation in research and in helping researchers navigate local communities. As many research centers control budgets, they need to be mindful of the compensation structures they offer, considering how to appropriately value individual and community organization contributions.  
     #understandingdiverse
• Understanding the Diverse Needs of Communities: There was an acknowledgement of the diversity, fragmentation, and unique needs and priorities of different communities; even within a single community there is a “community of communities.” Therefore, the approach to engage communities in research activities should be adapted to reflect each community’s needs and preferences. 
  • Hearing directly from patients can help elucidate needs. There are opportunities to engage patients in interviews and telling or drawing patient stories.
    • There are natural existing structures to hear needs and engage directly: 1) community health centers have patient representative boards and are governed by members of the community and 2) social media provides robust communities of patients.
  • There is a need to consider the unique needs and considerations from communities that have faced historical injustices in research and medicine. Examples include Public Health Service Untreated Syphilis Study at Tuskegee, Henrietta Lacks, and the forced sterilization of Native American Women. Based on the legacies of these events and others like them, affected populations may have a different perception of clinical research and barriers to participation, including trust. 
    • Similarly, raising cultural competency at the provider level is important for delivering equitable and effective care, as it fosters understanding and respect for diverse patient populations. At the same time, elevating community literacy about clinical research is key to enhancing participation, trust, and understanding of the research process. 
  • Decentralized research studies are designed to place patients at the center of research, providing more flexibility and convenience. For example, studies could be conducted at the location of the patient’s choice (e.g., their homes), which can lead to increased participation, improve the relevance and impact of research, and lead to better health outcomes and changes in primary care practice.
    #demonstratingtrust 
• Demonstrating Trustworthiness: The conversation also highlighted the importance of being physically present in communities to build effective relationships, as trustworthy and consistent relationships often stem from a deep-seated community presence. Through keen observation, providers can more accurately comprehend and address the community's true needs and expand their involvement in research.
  • Researchers can foster trust within the communities by actively participating in community activities and familiarizing themselves with patients in comfortable environments, such as barbershops, religious organizations, street medicine teams, and community health centers.
  • Others may further leverage those existing relationships or build their own by being consistent and trustworthy. 
  • Furthermore, the discussion highlighted the importance of communicating study results to illustrate how the data is utilized to benefit the community. Importantly, the communication should be adapted (e.g., format, approach, language) to be meaningful to the individuals of the community.
  • Community involvement in research agendas is equally important. As the beneficiaries of healthcare services, communities’ needs, and experience should guide research efforts. Their involvement ensures the research’s relevance, credibility, and support, leading to higher participation rates. This approach can result in research findings that significantly improve community health.
     #addressingfinancial
• Addressing Financial Sustainability:  The conversation underscored the necessity of financial sustainability for the successful and long-term integration of clinical research into primary care. Participants highlighted the need for improved funding structures, administrative support for practices/providers conducting research, clear communication of value proposition, and adaptable funding as essential elements for enhancing the sustainability and effectiveness of integrating research into healthcare settings. In addition, the importance of supporting the capacity of practices to conduct research was emphasized, with particular attention directed towards securing funding for sustaining infrastructure. 
  • Participants noted that funding structures of research grants make it challenging to compensate community organizations for their services and engagement in research, though appropriately valuing their participation is essential. During the conversation, participants highlighted having more diversity, including community representation, on grant review panels and throughout the entirety of the grant review process. This could improve the review processes to reflect the utility and need for community partners and associated compensation in grant budgets.
  • The participants suggested it is important to ensure that funding is adaptable to meet care and local needs. These adaptable approaches could refer to the flexibility in research methodologies (e.g., using Artificial Intelligence [AI] to study large data sets), the ability to adjust to changing community circumstances or new findings, or the ability to tailor interventions for local needs. 
  • Financial sustainability should also account for the revenue impact on providers in a fee-for-service model and explore ways to potentially provide financial renumeration to primary care providers to compensate them for time spent on research. Apart from direct compensation, the discussions underscored additional advantages that research could confer upon practices, contributing to indirect financial gain. 
    • Making research involvement more sustainable for practices and providers could include providing funds for administrative support to handle paperwork and logistics associated with research, technology and technical support for issues that arise during research, resources needed for conducting research within primary care settings, and academic support to provide expert advice or literature reviews, all of which could reduce the financial burden on providers and facilitate their participation in research.  
    • The conversation highlighted an example to communicate the value proposition for research participation. For instance, conducting research can diversify workdays for primary care clinicians, which in turn can mitigate burnout, as more varied workdays result in high satisfaction. This reduction in burnout can result in improved retention of clinical staff, as they are likely to find more joy in work, particularly when the integrated research is relevant and impactful to them and their patients. Furthermore, satisfied and engaged clinicians are likely to deliver better patient care, leading to improved patient outcomes, satisfaction, and potentially increased patient retention- all of which contribute to the financial health of the institution. 
    • Additionally, research participation brings new patients into systems, enhancing patient acquisition and retention. The eminence and reputational aspects of research can also grow market share which can incentivize hospital systems to integrate research.
  • Since the current process for payment workflows is complex and requires a large amount of administrative support, simplifying the payment workflows could decrease payment errors and the number of delays.
     #aligningpractice
• Aligning Practice Needs and Research Structures: Primary care providers and practices can serve as “a gateway” to research. Aligning relationships, communication, and timelines to conform to practice preferences can build strong connections for the successful conduct and implementation of research. 
  • Health centers and health providers play a pivotal role in research due to their intimate knowledge of the healthcare landscape and community health needs. They serve as primary contact points for patients and may facilitate research initiatives and offer valuable insights for shaping studies. Their established trust and community relationships make them effective in promoting research participation. Furthermore, their engagement in research can help translate findings into practical applications, enhancing patient care.
    • It is vital to engage with a range of stakeholders, including large healthcare institutions, private practices, and safety net clinics. This diversity in engagement allows for more comprehensive and inclusive research. 
  • Primary care providers, being the first point of contact within the health system, can guide patients towards relevant clinical trials and advanced interventions when they are well-informed. Providers and health centers often have a keen interest in participating in research as it enables them to offer their patients advanced care options, enhancing the overall quality of care and access to innovative treatments. Enhancing information access about clinical trials for both patients and providers can encourage research participation and improve healthcare delivery and outcomes.
  • The fragmentation often observed in the academic workforce can hinder effective collaboration and integration among researchers and healthcare systems. Therefore, researchers need to better understand the operations, goals, and challenges of health centers aligning their studies accordingly. This alignment will ensure that research outcomes are relevant and can be applied to improve patient care. 
  • The misalignment of health system timelines with research times affects collaboration and the overall impact of research. Health systems operate on quick timelines while research requires longer periods for design, data collection, and analysis, which can lead to irrelevant research findings or rushed healthcare-related decisions. Through early and regular communication, flexibility in research designs, and collaborative design, timelines can be closer aligned ensuring relevant, prompt, and impactful research.
     #consideringworkload
• Considering the Workload of Health Care Providers: When planning research studies in healthcare settings, it is important to consider the workload of the clinical team involved, as these teams are often operating under high-pressure environments, have intense workloads, numerous administrative tasks, and continuous learning requirements. Further, adding a research component to their existing responsibility without offering support or reducing other demands can further increase their burden, potentially leading to stress and burnout. 
  • The integration of research into the clinical environment should be completed in a way that will seamlessly integrate into the clinical workflow and routine operations of the clinical team. This requires careful planning and understanding of limitations and concerns, coordination, and consideration of the team’s workload and capacity.
  • Adequate resources and support should be provided to the clinical team to conduct research tasks and may include training to build their research skills, hiring staff to help with research tasks, or implementing technology to automate data collection tasks. 
  • Also, there is a need to consider the sustainability of partnerships with primary care providers. Engaging primary care providers in research should be done in such a way to not add burden to already strained practices. These ideas may include providing technical support to optimize Electronic Health Records (EHRs) for data collection, providing training and mentorship, and long-term financial support to keep on staff who can keep a practice “audit ready.”
    #reducingburden 
• Reducing Burden with Innovative Study Design and Technology: Innovative study designs and technology can help reduce site and provider burden by simplifying the research process, and reducing the time and resources needed for data collection and management. The participants highlighted the potential of multi-method and mixed methods approaches, which integrate quantitative and qualitative research methods to create a more comprehensive understanding of research questions and enhancing the depth of the research findings, making them more informative for patient care and policy work. Additionally, integrating innovative research design with routine clinical care can improve overall health outcomes and advance health equity. 
  • Primary care settings provide the opportunity for new research methods to be developed and incorporated to better answer primary care questions, whether that is through pragmatic clinical trials, nested case control studies, mixed methods, outcomes-related qualitative research, or utilizing AI with large data sets to work across different settings.
  • For example, qualitative research methods can provide insights into patient experiences, beliefs, and behaviors, while quantitative methods offer measurable and statistically valid data.
    #usingadvancedtech 
• Using Advanced Technology and Harmonizing Data Structures: The participants highlighted that data harmonization is important for effective integration and analysis of data from multiple sources in clinical research. Throughout the session, participants emphasized the importance of creating tools or automating aspects of data collection to streamline the process, making it easier to combine and compare data from various sources. 
  • Advanced technology can automate and streamline the process of data collection and management. For example, electronic data capture can enable real-time, accurate recordings of patient data, reducing the risk of errors that may occur during manual entry. Also, mobile applications and wearable devices can help facilitate the collection of patient-generated data outside of the clinical setting, resulting in a more comprehensive overview of patient health. Similarly, teleconferencing platforms, secure messaging systems, and collaborative online workspaces can foster better collaboration among researchers, healthcare providers, and patients.
  • AI and machine learning (ML) can help customize programs to meet the unique needs of the community, such as cultural competency training. For instance, AI and ML can analyze data on working hours to set up programs around times people can most easily participate.
  • Advanced data integration and analytics tools, such as utilizing asynchronous data collection where data is collected through digital platforms, the usage of common data models to enhance the interoperability allowing different systems to effectively communicate and exchange information, and data tokenization, can all be used to simplify data handling and reduce the burden of data protection.