Grand Rounds October 10, 2025: Integrating the BeatPain Study With PRaCTICe, a New Network Research Hub of the CARE for Health Initiative (Julie M. Fritz, PhD, PT, FAPTA; Sebastian Tong, MD, MPH)

Speakers

Julie M. Fritz, PhD, PT, FAPTA
Distinguished Professor
Department of Physical Therapy & Athletic Training University of Utah

Sebastian Tong, MD, MPH
Associate Professor
University of Washington

Keywords

Engagement; Community-Engaged Research; Rural; Pain; Partnership

Key Points

  • In an assessment of 10 high-income nations, the United States ranked 10th in healthcare system performance despite maintaining a significant lead in terms of healthcare spending.
  • The capacity of clinical research to improve healthcare is limited by a lack of representation. Patients who are older; live in rural locations; are uninsured; have co-morbid conditions; belong to minority groups; and are more likely to receive non-standard treatment are all inadequately represented in trials.
  • The NIH CARE for Health Initiative seeks to address these interrelated challenges. It will develop infrastructure for a clinical research network focused on primary care (PC); establish a foundation for sustained engagement with underrepresented communities; implement innovative study designs; integrate research into routine PC without increasing the burden on providers; and facilitate the adoption of evidence-based research findings.
  • CARE for Health is based in 6 national research hubs. One is the Primary Care Rural and Frontier Clinical Trials Innovation Center (PRaCTICe), a research network partnering with 300 PC practices serving 7 underrepresented population across Oregon, Washington, Wyoming, Alaska, Montana, and Idaho.
  • PRaCTICe utilizes a continuum of community engagement, from outreach to shared leadership. Engagement strategies have included community needs assessment reviews, regional listening sessions, and a new study development process that involves co-designing studies with PRaCTICe partners.
  • In 2024, BeatPain a pragmatic, decentralized, NIH Collaboratory Trial was selected as 1 of 2 trials PRaCTICe would partner with during Year 1. By the presentation date, PRaCTICe had referred 165 patients to the BeatPain team, 95% of which were rural residents.
  • Rural populations simultaneously have higher incidence of chronic pain and are less likely to receive evidence-based, nonpharmacologic treatment for it. BeatPain seeks to serve this population by delivering physical therapy (PT) to federally qualified health center patients with lower back pain.
  • Over the course of their collaboration with PRaCTICe, BeatPain investigators have made strides in terms of localizing the study to partnering communities, building trust with referring providers and patients, and coordinating the end of the trial. Decentralized trial methods hold promise for engaging rural residents and clinics in clinical research.

Discussion Themes

Relationships between research staff and a variety of clinic staff were critical to effective engagement. In one example provided by Dr. Tong, staff helped identify which exercises were most effective when it came to getting providers interested in the referral process. Clinics were not passive recipients, but co-developers.

To deliver PT in a rural setting, the BeatPain team delivered a virtual intervention combining traditional PT, health coaching, motivational interviewing, and pain coping strategies. In some care processes, the hands-on component of PT is essential; less so for chronic pain. Strategic use of technology could expand access to nonpharmacologic care.

Research teams will need to be responsive to shifts in the capacity of rural hospitals and clinics due to funding cuts. This may look like designing interventions that don’t increase the burden on staff; supplying resources; and sharing strategies that clinics can use to be financially sustainable.

IT support proved central to the success of this partnered research. When clinic resources are constrained, the ability to help solve problems related to the electronic health record is essential.

Grand Rounds January 10, 2025: FM-TIPS Community Engagement Methods for Recruitment (Dana Dailey PT, PhD; Heather Schacht Reisinger, PhD)

Speakers

Dana Dailey PT, PhD
Assistant Research Scientist
Physical Therapy and Rehabilitation Science
University of Iowa
Associate Professor, Physical Therapy Department
St. Ambrose University

Heather Schacht Reisinger, PhD
Director, Implementation Science Center
Associate Director for Engagement, Integration, and Implementation
Institute for Clinical and Translational Science
Professor, Division of General Internal Medicine at the University of Iowa

Keywords

Community-Engaged Research; Recruitment

Key Points

  • The Fibromyalgia TENS in Physical Therapy (FM-TIPS) study sought to test the feasibility and effectiveness of adding Transcutaneous Electrical Nerve Stimulation (TENS) to standard physical therapy (PT) care in a real-world PT setting. Their primary outcome was the change in movement pain, from baseline to 50 days.
  • By February 2022, the team had activated 25 active PT clinics across seven Midwestern states. In February 2023, the team received a diversity supplement for community engagement and brought on a Community Engagement Coordinator.
  • After developing a community engagement process and implementing six community engagement strategies, inquiries about the study increased significantly, screening rates held steady, and enrollment rates increased. These effects were more pronounced in targeted clinics.
  • Engagement with the clinics, clinicians, and community had a significant impact on the pragmatic trial. Dr. Dailey noted that clinicians felt more supported and seen as a part of both the clinic and the community. Conversations with participants were also fruitful, helping the researchers understand how participants were feeling when they weren’t in therapy.
  • Clinical research in community physical therapy clinics is not common, and there was a steep learning curve for many of the physical therapists involved. Community support helped them navigate screening and enrollment.
  • The study team developed individualized clinic plans through inquiry of clinicians and clinics. This feedback helped them identify organizations to collaborate with, local events, etc.
  • Process building, including implementation and complete documentation of outcome measures, was important to site evaluation. As a result of these activities, the research team was able to carry lessons over into low-enrolling clinics, adapt, and make productive changes.

Discussion Themes

When researchers think about pragmatic trials involving clinics, Dr. Reisinger noted, it becomes difficult to delineate the concepts of “community members” and “participants.” For example, it’s important to also think about clinicians also as community members who are living and working in those spaces, and who have a deep knowledge of and commitment to their community. All of that knowledge will be important to decision-making.

Intensive and responsive community engagement was made possible for this pragmatic trial by the diversity supplement, which enabled the team to hire two full-time community engagement coordinators. At the rate they were going before they implemented community engagement, the study team would not have hit their enrollment target; in the end, they exceeded it.

Researcher teams should always be adaptive and flexible when doing community engagement, even when it comes to documentation.