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

• Ensuring virtual vigilance in decentralized clinical trials
• Intervention delivery complexity and adaptations for implementation of non-pharmacologic pain interventions
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

Cross-Core and Cross-Trial Collaborations

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• Collection of patient-reported outcome measures in rural and underserved populations
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

Distributed Research Network

• Generating real-world evidence in early Alzheimer's disease: Considerations for applying the target trial emulation framework to study the safety of anti-amyloid therapies

Core Working Groups

Biostatistics and Study Design Core

• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

Community Health Improvement Core

• Collection of patient-reported outcome measures in rural and underserved populations

Electronic Health Records Core

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials

Ethics and Regulatory Core

• Untapped potential? Representativeness in pragmatic trials
• Ethical considerations for sharing aggregate results from pragmatic clinical trials
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory
• Disentangling informing participants from obtaining their consent
• Empirical research related to the ethics of pragmatic clinical trials: A scoping review
• Reflections on a principal of research ethics: Tom Beauchamp, moral specification, and waivers of informed consent

Health Care Systems Interactions Core

• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

Patient-Centered Outcomes Core

• Collection of patient-reported outcome measures in rural and underserved populations

NIH Collaboratory Trials

ABATE Infection

• Universal vs targeted chlorhexidine bathing and nasal decolonization in hospitalized patients

ACP PEACE

• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory
• [Main outcomes] An intervention to increase advance care planning among older adults with advanced cancer: A randomized clinical trial

ARBOR-Telehealth

• [Study design] ARBOR-Telehealth study: an examination of telerehabilitation to improve function and reduce opioid use in persons with chronic low back pain in rural communities - protocol of a pragmatic, individually randomised group treatment trial

BackInAction

• Recruitment and retention for an acupuncture trial in an underrepresented 65 and older population with chronic low back pain
• Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults
• [Main outcomes] Acupuncture for chronic low back pain in older adults: A randomized clinical trial
• Cost-effectiveness of acupuncture needling for older adults with chronic low back pain

BeatPain Utah

• Collection of patient-reported outcome measures in rural and underserved populations

BEST-ICU

• [Study design] Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST ICU): Study protocol for a multi-site stepped-wedge cluster randomized controlled trial in the USA

EMBED

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

FM-TIPS

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• Collection of patient-reported outcome measures in rural and underserved populations
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory
• Building community through data: The value of a researcher driven open science ecosystem
• Community engagement strategies improve rural enrollment in a pragmatic clinical trial

GGC4H

• Implementation fidelity of a virtual adaptation of the Guiding Good Choices program

GRACE

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• A scoping review of social determinants of health and pain outcomes in sickle cell disease
• Collection of patient-reported outcome measures in rural and underserved populations

HiLo

• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory
• [Main outcomes] Higher versus lower phosphate targets for patients undergoing incenter hemodialysis: A randomized controlled trial

I CAN DO Surgical ACP

• [Study design] I CAN DO Surgical ACP (Improving Completion, Accuracy and Dissemination of Surgical Advanced Care Planning): A protocol for a multisite, single-blinded, pragmatic randomised controlled trial to improve ACP completion in older adults in the presurgical set

IMPACt-LBP

• [Study design] Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt-LBP): Protocol for a healthcare systems embedded multi-site pragmatic cluster-randomized trial

INSPIRE

• [Main outcomes] Improving empiric antibiotic selection for patients hospitalized with skin and soft tissue infection: The INSPIRE 3 Skin and Soft Tissue randomized clinical trial
• [Main outcomes] Improving empiric antibiotic selection for patients hospitalized with abdominal infection: The INSPIRE 4 cluster randomized clinical trial
• Initial antibiotic selection strategy and subsequent antibiotic use: Insights from the INSPIRE trials

iPATH

• Exploring the characteristics associated with diabetes and hypertension performance in community health centers

LIRE

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

MOMs Chat & Care Study

• MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people

NOHARM

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• Collection of patient-reported outcome measures in rural and underserved populations
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory
• Evaluating physical and occupational therapists' experiences implementing an electronic health record-based intervention to support perioperative patients’ use of nonpharmacological pain management techniques
• Delivering an electronic health record based educational intervention promoting peri-operative non-pharmacological pain care as part of a randomized controlled trial: Mixed method evaluation of inpatient nurses' perspectives
• Patients' peri-operative experiences with non-pharmacologic pain care techniques: A secondary qualitative analysis of the NOHARM trial

Nudge

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials

OPTIMUM

• Collection of patient-reported outcome measures in rural and underserved populations
• The hidden complexity of conducting mindfulness-based group medical visits: Comfort, challenge, and the influence of social determinants of health
• Increasing equity within randomized control trials: A qualitative analysis of focus groups from a multi-site, pragmatic clinical trial
• Prevalence of chronic overlapping pain conditions in participants with chronic low back pain enrolled in a pragmatic trial of mindfulnessbased stress reduction

PRIM-ER

• [Main outcomes] Palliative care initiated in the emergency department: A cluster randomized clinical trial
• Palliative care in the emergency department—Reply
• Bayesian hierarchical penalized spline models for immediate and time-varying intervention effects in stepped wedge cluster randomized trials
• Acute care use and prognosis in older adults presenting to the emergency department
• Healthy days at home and prognosis of older adults with cancer and non-cancer serious life-limiting illnesses
• Effect of a multi-component palliative care intervention on goals of care discussions for critical patients in the emergency department

SPOT

• Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
• Monitoring in pragmatic trials: Lessons from the NIH Pragmatic Trials Collaboratory

TAICHIKNEE

• An introduction to implementation science in rehabilitation medicine