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Executive Summary of the Foundation for the National Institutes of Health (FNIH)-National Institutes of Health (NIH)

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 participation by enabling broader access to clinical research via a primary care-focused research network of networks 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. The workshop themes section below expands on the key themes from the listening sessions.

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.

Listening SessionTotal Participants
Listening Session 1: Early, Sustained Engagement of Patients and Community Organizations22 individuals
Listening Session 2: Clinical Research Network Capabilities and Gaps32 individuals
Listening Session 3: Needs of Providers and Healthcare Systems for Research Participation30 individuals
Listening Session 4: Clinical Research Innovations to Reduce Site and Provider Burden26 individuals

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.

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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.

  • Short-lived 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.
  • Hearing directly from individuals experiencing health challenges strengthens research design.
    • Based on survey data referenced in the session, more than two times the number of health centers want to participate 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.
    • 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.
  • 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” of 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.
    • 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.
      #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.
  • 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 Community Needs

There was an acknowledgement of the 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 are skeptical or mistrusting of research.
  • 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., telehealth), 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. Through deep-seated community presence, providers can more accurately comprehend and address the community's true needs and expand their involvement in research.

  • Researchers can foster trust by familiarizing themselves with patients in comfortable environments, such as barbershops, religious organizations, street medicine teams, and community health centers.
  • The discussion also highlighted the importance of transparently 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.
  • The involvement of community members 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 the importance of 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]), 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.  
     #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. 

  • It is vital to engage with a range of collaborators, including large healthcare systems, private practices, community health centers, and safety net clinics. 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.
  • Primary care providers, being the first point of contact within the health system, can guide patients towards relevant clinical studies 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. Providing easy access to information about clinical studies 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 and design 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 timelines affects collaboration and the overall impact of research. A research study can take years to implement from study design to the sharing of study results that could inform clinical practice. Whereas health systems operate on much shorter timelines in response to the immediate needs of health care delivery. Early and regular communication, flexibility in research designs, and collaboration between health systems and researchers can help to ensure that timelines are closer aligned. 
Considering the Workload of Health Care Providers

When planning research studies in primary care settings, it is important to consider the workload of the primary care providers involved, as they are often operating under high-pressure environments, have intense workloads, numerous administrative tasks, and continuous learning requirements. Adding a research component to their existing responsibilities without offering support or reducing other demands can further increase their burden, potentially leading to stress and burnout.

  • The integration of research into the primary care environment should be completed in a way that will seamlessly fit into the primary care providers’ workflow and routine operations. This requires careful planning and understanding of the team’s workload and capacity.
  • Adequate resources and support should be provided to the primary care providers to conduct research tasks and may include training to build research skills, providing long-term financial support for staff to support research, or implementing technology to automate data collection tasks, such as optimizing Electronic Health Records (EHRs) for data collection. 
    #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. Integrating innovative research design with routine clinical care can improve overall health outcomes.

  • 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.
  • Qualitative research methods can provide insights into patient experiences, beliefs, and behaviors that influence intervention uptake and efficacy, while quantitative methods offer measurable and statistically valid data.
    #usingadvancedtech 
Using Advanced Technologies 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. 

  • Electronic data capture can enable real-time, accurate recordings of patient data, reducing the risk of errors that may occur during manual entry.
  • 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.
  • 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; one example posed was analyzing data on working hours to set up programs around times people can most easily participate.
  • Advanced data integration and analytics tools, such as asynchronous data collection where data is collected through digital platforms or common data models to enhance the interoperability allowing different systems to effectively communicate and exchange information can be used to simplify data handling and enhance security.

This page last reviewed on March 5, 2025