December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory

A collage of journal covers with the label "NIH Pragmatic Trials Collaboratory 2025 Publications Roundup"In 2025, NIH Pragmatic Trials Collaboratory investigators published new study designs and trial results, shared insights from program leadership, and developed innovative methods in the design, conduct, implementation, and dissemination of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed 45 articles to the peer-reviewed literature this year, including the primary results of the ACP PEACE, BackInAction, HiLo, INSPIRE, and PRIM‑ER trials. Cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program reached 386.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Distributed Research Network

Core Working Groups

Biostatistics and Study Design Core

Community Health Improvement Core

Electronic Health Records Core

Ethics and Regulatory Core

Health Care Systems Interactions Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

ACP PEACE

ARBOR-Telehealth

BackInAction

BeatPain Utah

BEST-ICU

EMBED

FM-TIPS

GGC4H

GRACE

HiLo

I CAN DO Surgical ACP

IMPACt-LBP

INSPIRE

iPATH

LIRE

MOMs Chat & Care Study

NOHARM

Nudge

OPTIMUM

PRIM-ER

SPOT

TAICHIKNEE

December 11, 2025: New Resource Promotes Community Health Improvement in Pragmatic Trials

Screenshot of the Community Health Improvement in Pragmatic Clinical Trials guideThe NIH Pragmatic Trials Collaboratory’s Community Health Improvement Core has developed a new resource on community health improvement in embedded pragmatic clinical trials (ePCTs).

The Community Health Improvement in Pragmatic Clinical Trials guide includes information for research teams including:

  • A clear definition of community health improvement in the context of ePCTs
  • Examples of challenges to be addressed
  • Information on how community health is integrated within research and ePCTs
  • Examples of efforts to promote community health in clinical trials

“Realizing the goals of community health improvement requires purposeful effort to ensure that all community members can benefit from the innovations being generated through the NIH Collaboratory, especially those who need them most. We hope this new resource helps research teams plan for and embed community health improvement into their trials,” said Rosa Gonzalez-Guarda, cochair of the Community Health Improvement Core and a professor in the Duke University School of Nursing.

The Community Health Improvement Core provides leadership and guidance that will help the NIH Pragmatic Trials Collaboratory, its trials and investigators, and ultimately the research community at large conduct research that can improve the health of all populations. The Core’s work includes supporting ePCTs to address gaps in access to quality care, implementing patient and community engagement strategies, and developing person- and community-centered research and translation methods that are contextually aligned.

July 14, 2025: Researchers Share Tips for Building Relationships With Communities in Pragmatic Research

Engaging with community partners can enrich and inform research through the lifespan of a trial. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Cherise Harrington, cochair of the program’s Community Health Improvement Core, led a discussion about building relationships with communities in pragmatic research.

The panelists included Jennifer Kawi, principal investigator (PI) for APA-SM; Kathleen Sluka, PI for FM-TIPS; Sebastian Tong, PI for AIM-CP; and David Wetter, PI for LungSMART. They shared examples of how community relationships have enriched their trials, along with impediments to meaningful community engagement and successful methods for building relationships with communities.

Key Strategies for Engaging With Communities

  • Build long-standing relationships with community partners, develop shared goals, and practice shared decision-making.
  • Design for sustainability. Design research projects with minimal disruption to the clinical workflow; utilize existing community health workers and programs; and integrate behavioral economics principles (nudges) into study design.
  • Budget for community engagement and include community members in study planning from the beginning.
  • Engage in the preferred language of the community. Ensure there are research staff who are fluent in the community’s preferred language and embedded in the community so they can provide key perspectives and help build trust.
  • Provide community health workers and research staff with training on community engagement.
  • Connect with community members where they spend time, such as community events and fairs, and visit local clinics to share information for referrals.

About the Trials

  • AIM-CP, supported by the National Institute of Nursing Research, is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations.
  • APA-SM, supported by the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke, is testing a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in South Carolina and Texas.
  • FM-TIPS, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia.
  • LungSMART, supported by the National Cancer Institute, is testing telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.