Although the need for pragmatic research in primary care settings is great, conduct of pragmatic clinical trials in these settings remains nascent. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Wendy Weber of the National Center for Complementary and Integrative Health (NCCIH) led a discussion about how to expand pragmatic research into primary care settings.
The panelists included Julie Fritz, principal investigator (PI) for BeatPain Utah; Natalia Morone, PI for OPTIMUM; and Sebastian Tong, co-PI for AIM-CP. They shared some of the challenges of conducting research in primary care.
- Primary care physicians have multiple competing demands for attention and focus, and a range of topics to cover in a single visit.
- The expectation of being offered participation in clinical trials is lower in primary care than in specialty visits.
- There are fewer resources that can be diverted to research in primary care, especially time and personnel.
Key Takeaways
How do we adapt pragmatic clinical trials to primary care?
Identify relevant and meaningful research questions
The panelists suggested that, when planning a trial, investigators should think about the primary care setting and consider what problems keep clinicians up at night. Research will be easier to implement if it helps alleviate these problems.
“In primary care, [primary care physicians] are looking at the entire person,” Tong said. “There has to be value added in how we care for the patients with the condition under study, either where the [physician] sees a difference in their patients’ lives or their own lives with respect to reduced burden,” he said.
The panelists also suggested that, for community health centers, there are certain conditions that are linked to data reporting standards, and aligning research with these standards will make studies easier to champion.
Adapt to different kinds of primary care settings
The panelists stressed the need for adaptably and flexibility in intervention delivery because all primary care settings are different. If possible, researchers should tailor the workflow at each site in a way that is familiar to providers. the panelists also suggested that initial engagement by external researchers is best made with someone who is trusted at the site.
Some clinics, including community health centers, may be new to research and may need additional support. Many do not have an institutional review board or a Federalwide Assurance number, and many do not have experience using the electronic health record for research and developing data use agreements.
About the Trials
- BeatPain Utah, supported by the National Institute of Nursing Research (NINR), is comparing the effectiveness of nonpharmacologic interventions delivered via telehealth for patients with back pain seeking care in federally qualified health centers in Utah.
- OPTIMUM, supported by NCCIH, is assessing the impact of a group-based mindfulness intervention for patients with chronic back pain under usual care circumstances in the primary care setting.
- AIM-CP, supported by NINR, is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations.
This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.
On what has surprised him the most – “Patients and clinicians pretty readily grasp the need and the concept. They want to do it. The data part is a lot harder than most people thought. The technology has come a long way; we can do it now. Probably the hardest thing has actually been that the business models for health systems run counter to generating evidence. It’s something that we really haven’t overcome at this point.”