Underresourced Clinics and FQHCs

Federally Qualified Health Centers (FQHCs) and other underresourced clinics are part of the safety net that provides healthcare access to underserved populations in the United States. Community based and funded primarily through Medicaid reimbursements and federal grants, FQHCs operate over 15,000 service sites delivering services to 30 million patients annually regardless of ability to pay. Despite their critical public health role and sizable presence, FQHCs and the populations they serve remain largely underrepresented in healthcare studies (Brandt et al 2015; Inokuchi et al 2023; Walter & O'Brien 2025).

There are important reasons for advocating greater inclusion of FQHCs and similar systems in healthcare research, particularly PCTs. Conducting pragmatic trials in underresourced settings allows participants who are representative of the large number of underserved and often marginalized communities served by these systems. Their inclusion contributes to generating research findings that are applicable to diverse populations, which in turn may help contribute to more generalizable findings, reduce health disparities and enhance health equity.

The NIH Collaboratory has significant experience conducting PCTs in FQHCs. To date, 10 NIH Collaboratory Trials have involved FQHCs. Table 1 summarizes concluded and ongoing trials and their research areas to illustrate depth and scope of commitment to including underresourced systems in PCTs. In 2025, the Collaboratory Community Health Improvement Core and the Heath Care System Interaction Core surveyed PCTs conducting trials in FQHCs to learn about unique concerns and challenges that may arise and what strategies research teams and clinic partners developed to address them. Concerns and best practices that emerged from the survey are discussed in the sections that follow.

Table 1. NIH Collaboratory Trials in Underresourced Settings

Concerns About Conducting PCTs in FQHCs

Potential added burdens to clinics due to trial interventions were a central concern when conducting PCTs in FQHCs. Both research teams and clinic partners expressed worries about the impact of trial participation across multiple roles – physicians, other clinicians, and staff. These concerns regarded possible strain on personnel’s time and capacity and challenges of patient outreach to underserved and diverse populations while ensuring patient inclusivity and satisfaction.

Concerns Regarding Added Burden on Clinic Staff

Embedded PCTs may require modified workflow and additional resources in the form of space, staff, or time. Clinical staff may also need training to recruit subjects and learn how to perform new study procedures or avoid contamination with the control arm. Any of these tasks requires clinical time and resources – often already strained in underresourced systems – and might inadvertently worsen patient access (Chatterjee 2025).

Concerns Regarding Patient Outreach, Satisfaction, and Inclusivity/Diversity of Participant Population

Burdens on patients are also a source of concern when conducting trials in FQHCs. Patients may feel burdened by intervention requirements (additional procedures, receiving text messages) and experience lower satisfaction with the care they receive. From the study’s perspective, outreach to certain patient populations may prove difficult due to a variety of factors. For example, multilingual populations may require recruitment and intervention instructions in multiple languages. Groups of participants who have health records spread across different organizations may be hard to track down, and yet their inclusion may be critical to meeting recruitment targets and ensuring equitable inclusion in a representative sample. Study participants may also experience incidental findings that demand additional care and while this is not unique to PCTs in FQHCs, there may be additional challenges tied to participant socioeconomic and insurance status, as well as clinic capacity to provide or refer participants to additional services.

Best Practices to Address Concerns and Conduct Effective PCTs in FQHCs

The Collaboratory’s recent survey and overall experience with PCTs in FQHCs has allowed the emergence of best practices to address concerns and conduct effective trials in partnership with underresourced systems. These best practices center on engaging system partners and patients/participants early in the research process to accomplish practical goals (e.g., assess project feasibility, ensure diverse participation) and build trust with key interest holders.

Engage FQHC Leadership and Staff Early and Throughout the PCT Process

Engaging research partners early (even during grant development if possible) enables the research team to learn what is feasible, whether health systems and clinics meet minimum trial readiness criteria (as experienced in the STOP-CRC project (Coronado et al 2016)), and what adjustments or support may be needed to help FQHCs participate. An effective engagement strategy may be to hold in-person advisory meetings with clinic representatives and leaders to build common goals, as the STOP-CRC trial project team did.

Another key approach is to use effective messaging to present the intervention to clinic staff and make trial participation more acceptable. This could be accomplished by quantifying and stressing the benefits of participation, as in the IPATH trial, and by providing regular study updates to sustain clinic buy-in. For example, the BeatPain Utah project team attended clinic staff meetings to report on study progress.

Reduce Burden on Clinic Staff

The Collaboratory’s experience with FQHCs highlights several strategies research teams can use to reduce burden on clinic staff. PCTs and their clinic partners can explore ways to adapt the intervention, outsource tasks to research personnel or external resources, and provide additional training to clinic staff.

Adapt the Intervention

Adapting the intervention to research partners’ needs and constraints can reduce staff burden and ease integration with clinical routine. In one example, in the BeatPain Utah trial, the trial team proactively addressed concerns that the intervention referrals would be outside of regular workflows by embedding the referral process within the clinic’s EHR.

Shortening the intervention timeline can lighten trial burdens for clinics, while modifying trial procedures can address specific clinic concerns. In the STEP 2 trial, the study team created an opt in/out choice to address outreach/recruitment difficulties for patients with no EHR number. The OPTIMUM team changed time and location of intervention delivery before pivoting to a virtual study during the COVID pandemic.

Refining instructions and simplifying facilitation materials to better support clinics may be additional ways to mitigate challenges in some settings.

Outsource Tasks

Several PCTs, including STEP 2, STOP-CRC, Chat 4 Heart Health, BackinAction, and BeatPain Utah reduced burdens for clinics by outsourcing study tasks (e.g. recruitment, enrollment, mailings, referrals) to research staff or external resources. Concrete examples include providing or coordinating IT support and patient liaisons to help with care navigation, and enlisting insurance plans to do study-related mailings.

Provide Additional Training for Staff

Providing additional training for staff can make it easier and less burdensome for clinics to participate in research studies. STOP-CRC not only had monthly sessions with clinics but also made videos of some training materials to bolster support for staff.

Provide Incentives for Clinics

Underresourced FQHCs may lack funds, materials, or personnel to absorb extra study activities.  Incentivizing clinics’ participation in PCTs offers concrete help and can foster ongoing positive relationships between researchers and clinic partners. Incentives can include monetary or material support. Among the studies that offered monetary incentives, STEP 2 paid an honorarium to the Medicaid plans to pay for study activities, while Chat 4 Heart Health provided salary support for the implementers at each site.

Material incentives can be minimal and still represent “giving back” to clinic partners. To express gratitude and foster engagement, research teams have given away pens, held “thank you” events, and named clinics in papers and other media.

Investigators should take care that financial incentives flow to clinic staff who bear the added burden of research activities (rather than flowing to a broad organizational budget).

Increase Patient Outreach, Satisfaction, and Inclusivity

PCTs that partner with FQHCs should make sustained efforts to ensure equitable participation by the diverse, underserved, underinsured, and often financially disadvantaged populations served by these health systems. Achieving this goal requires planful approaches to increase patient outreach, improve satisfaction, and secure inclusivity. Researchers should aim to engage patients/study participants early in the study, intentionally incorporate language and geographic diversity, and close insurance gaps when possible.

Engage Patients/Study Participants Early

Co-designing interventions and study materials with patient input can be an effective strategy to engage patients and other participants early in the trial (Zogas et al 2024). Another approach used by research teams was to include patients as study advisors or consultants throughout the study. This can be done as a group activity (e.g, patient or community advisory boards), or on an individual basis (e.g, key informant interviews or asking for expert reviews of documents). In doing so, it is vital to compensate for these roles, recognizing patients as experts.

Increase Outreach and Participation in Hard-to-Reach Populations

To increase participation of hard-to-reach populations, or as some prefer to say “hardly reached” populations, research teams should take care to select widely accessible outreach methods, for example using text messages instead of smartphones or the internet (as demonstrated by the LungSMART Utah study).  The STEP 2 trial utilized a vendor able to verify addresses and track returned mail. Designing recruitment strategies to include economically and geographically diverse populations as in the OPTIMUM trial is another means of broadening participation.

Incorporate Language and Geographic Diversity

Incorporating language and geographic diversity is important when partnering with FQHCs to conduct trials. For instance, studies can be designed to include clinics in different geographic locations with varying populations served. Ensuring multilingual participation in co-design activities helps achieve both inclusivity and patient engagement goals. Making study materials available in multiple languages or in a wordless format (e.g., as a video that can be dubbed later) are additional strategies. Built-in design flexibility allows clinics to tailor intervention materials to local contexts, as shown by clinic staff participating in the STOP-CRC trial who developed fecal immunochemical test (FIT) wordless instructions to meet patients’ needs.

Some teams may choose to simplify recruitment by restricting what languages they include in the trial and in that case, they could think of alternative ways to capture diverse perspectives and experiences. The OPTIMUM PCT did not enroll non-Spanish speaking participants but qualitatively assessed the care seeking experience of Spanish-speaking patients.

Close Insurance Gaps

Conducting PCTs in underresourced settings means that study participants may face economic and insurance related barriers to participation. Research team’s efforts to close insurance gaps support inclusion of disadvantaged patients while helping FQHCs address the needs of the populations they serve. Using sliding scale or charity funds to reimburse patients and limiting recruitment to insured patients can mitigate burdens to already stressed populations. In the STEP 2 trial only patients with Medicaid coverage received the intervention because insurance plans covered related costs, while the LungSMART Utah study helped patients obtain vouchers for lung cancer screening.

Address the Digital Divide

Research teams that partner with FQHCs and other community settings with limited resources or in geographically isolated regions may find that study participants have less access to and comfort with technology. NIH Collaboratory Trials learned to be flexible in their use of technology, offering alternatives to digital formats or low-tech options, such as phone-based participation, provided tech assistance and internet hotspots, and budgeted for devices and internet, replaced technology with hybrid options, and offered printed materials targeted to a fifth-grade level. Providing training on digital tools and receiving encouragement from research teams can help build increased comfort with digital technology and capacity to participate in future studies (Yamazaki et al 2026).