February 19, 2026: RAMP Pilot Study Supports Telehealth Mind-Body Program for Rural Veterans With Chronic Pain

Headshots of Diana Burgess, Roni Evans, and Katherine Hadlandsmyth
Diana Burgess, Roni Evans, and Katherine Hadlandsmyth, principal investigators for RAMP

A pilot study of the RAMP intervention suggests that a multimodal, telehealth-delivered intervention is both feasible and acceptable for rural veterans experiencing chronic pain. The findings demonstrate how mind-body and exercise strategies can be successfully delivered to populations that typically face significant barriers to specialized care.

The article was published online ahead of print in Contemporary Clinical Trials.

RAMP, an NIH Collaboratory Trial, is evaluating the use of a mind-body skills training program for rural veterans with chronic pain within the Department of Veterans Affairs (VA) Whole Health initiative.

Veterans living in rural areas experience a higher prevalence of chronic pain than their urban counterparts but often lack access to nonpharmacologic treatments due to travel distances and a shortage of local providers. While the VA has prioritized nonpharmacologic self-management, these programs remain underused among patients in rural areas and patients from marginalized groups. The RAMP intervention was designed to overcome these obstacles by providing a comprehensive self-management program directly to veterans in their homes.

The pilot study enrolled 40 rural VA patients with moderate to severe chronic pain. The intervention consisted of 12 telehealth sessions facilitated by trained health coaches. The sessions included an initial individual session to set personal health goals; 11 weekly group sessions featuring expert-led educational videos, physical exercises, and mind-body skill-building; and instruction in cognitive behavioral strategies, mindfulness, and pain-specific mobility exercises.

The pilot study met several key milestones for feasibility and acceptability. Ninety percent of participants expressed satisfaction with the intervention, and 82% stated they would recommend the program to other veterans with chronic pain. The facilitators successfully delivered 100% of the planned session activities, demonstrating high fidelity to the RAMP program model.

Participants reported that RAMP enhanced their capabilities, opportunities, and motivation to manage their pain. Specifically, the participating veterans felt more confident in their ability to handle “flare-ups,” manage stress, and incorporate physical activity into their daily lives.

“Pilot results demonstrated that RAMP is feasible and acceptable to rural Veterans with chronic pain,” the authors concluded. Because the program uses nonclinician health coaches, it has the potential to be easily integrated into existing VA clinical workflows to reach millions of rural-dwelling veterans.

The research team identified several strategies to optimize the RAMP intervention for a larger, upcoming randomized trial. To reduce participant burden and improve retention, the team plans to shorten the program from 12 to 9 weeks, provide more examples tailored to the rural veteran experience, and introduce text message reminders.

Read the full report.

The RAMP trial is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Institute of Nursing Research.

Learn more about RAMP.

January 26, 2026: New Findings From GRACE Trial Highlight Strategies for Integrating Acupuncture and Guided Relaxation Into Sickle Cell Disease Clinics

GRACE Trial logoNew qualitative findings from the GRACE trial reveal critical barriers and facilitators for incorporating complementary and integrative health interventions into routine clinical care. The study emphasizes that successful integration requires participatory approaches and significant adjustments to clinic workflows.

The article was published online ahead of print in Pain Management Nursing.

GRACE, an NIH Collaboratory Trial, is a pragmatic clinical trial embedded in 3 large healthcare systems to assess the effectiveness of guided relaxation and acupuncture treatments to improve pain control for patients with sickle cell disease. While clinical guidelines promote nonpharmacological treatments to reduce reliance on opioids, integrating therapies like acupuncture and guided relaxation into standard practice remains challenging.

The researchers conducted in-depth interviews with 13 hematologists, nurses, and pharmacists at GRACE trial sites. Two primary themes emerged: the variable impact on clinic operations, and the requirements for introducing complementary and integrative health interventions into clinical practice.

Participants noted that even minor changes can disrupt complex clinic workflows. Specifically, they identified the need for flexible or extended clinic hours to accommodate multiweek courses of acupuncture, as well as space for administering treatments without interrupting other patient visits. Participants also noted that clinics would benefit from streamlined ordering processes to avoid administrative burdens.

The study highlighted a significant need for patient and clinician education. While evidence exists for complementary and integrative health interventions, many clinicians remain hesitant to recommend them due to knowledge gaps. Patients may also feel wary of new therapies, necessitating clear, accessible educational tools like videos, apps, and brochures.

GRACE is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Center for Complementary and Integrative Health. Learn more about GRACE.

January 12, 2026: Enhanced Acupuncture Strategy Found to Be Cost-Saving in Older Adults With Chronic Low Back Pain

Logo for the BackInAction trialAn economic evaluation from the BackInAction trial found that an enhanced course of acupuncture for older adults with chronic low back pain was cost-saving from both the Medicare and healthcare sector perspectives.

The article appears in the upcoming issue of Spine.

In a previously published report, the BackInAction research team established that acupuncture significantly improved pain and disability in patients aged 65 years and older. The new analysis shows the treatment also provides significant value to the healthcare system.

The cost-effectiveness analysis, led by Patricia Herman of the RAND Corporation, analyzed data for 672 participants across 3 large healthcare systems. The study compared 3 treatment strategies: a standard 12 -week course of acupuncture plus usual medical care; standard acupuncture enhanced with up to 6 maintenance sessions plus usual care; and usual care alone.

The research team found that enhanced acupuncture reduced annual back pain–related healthcare costs by an average of $491 per participant and reduced Medicare-reimbursed costs by $421 per participant compared with usual care alone. The savings were primarily driven by a significant reduction in non-acupuncture healthcare utilization.

BackInAction, an NIH Collaboratory Trial, was led by co–principal investigators Lynn DeBar of the Kaiser Permanente Center for Health Research and Andrea Cook of the Kaiser Permanente Washington Health Research Institute.

Read the full report.

Beyond financial savings, participants in the enhanced acupuncture group experienced:

  • Significant gains in quality-adjusted life-years, a standard measure of health-related quality of life
  • An 18.5 percentage-point increase in the number of participants achieving a clinically meaningful improvement in their disability scores

While standard acupuncture was slightly more expensive than usual care, the strategy’s incremental cost-effectiveness ratio of approximately $53,000 per quality-adjusted life-year suggests it may be cost-effective from the perspectives of Medicare and the healthcare sector.

The BackInAction team’s findings are particularly relevant in the context of the Medicare program’s decision in 2020 to begin covering acupuncture for chronic low back pain. The study suggests that the current Medicare benefit, which includes maintenance sessions, aligns with the most cost-effective and beneficial care for this population.

By including a variety of healthcare settings and older adults with multiple medical conditions, this pragmatic clinical trial’s results are intended to be highly generalizable and to inform future treatment policies for the millions of older people in the United States who experience chronic pain.

BackInAction was supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Center for Complementary and Integrative Health. Learn more about BackInAction.

January 8, 2026: Study Design Paper Published for BEST-ICU

Headshots of Dr. Michele Balas and Dr. Eduard Vasilevskis
Dr. Michele Balas and Dr. Eduard Vasilevskis, principal investigators for BEST-ICU

The study design paper for BEST-ICU has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The BEST-ICU trial is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase adoption of the ABCDEF bundle in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care.

The study is being led by Eduard Vasilevskis of the University of Wisconsin and Michele Balas of the University of Nebraska and is supported by a grant award from the National, Heart, Lung, and Blood Institute.

Read the full study design paper.

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 2, 2025: Community Engagement Strategies Boost Rural Enrollment in FM-TIPS Fibromyalgia Trial

FM-TIPS logoNew findings from FM-TIPS show that targeted community engagement methods are highly effective in increasing recruitment and enrollment, particularly among rural participants who are typically underrepresented in clinical research.

The report was published online in the Journal of Clinical and Translational Science.

FM-TIPS, an NIH Collaboratory Trial, is a cluster randomized trial examining whether adding transcutaneous electrical nerve stimulation to routine physical therapy improves outcomes for patients with fibromyalgia receiving care in physical therapy clinics. Recruitment for clinical trials often faces barriers in rural communities, which make up 19% of the US population but experience a significant burden of chronic pain, including fibromyalgia.

To address projected low enrollment rates in certain locations, the FM-TIPS study team implemented specific community engagement strategies partway through the trial for 2 groups: targeted rural clinics and targeted low-enrollment clinics. They compared these groups to a group of untargeted clinics.

The initiative was guided by 2 full-time community engagement coordinators who tailored a multipronged approach for each local community. Strategies included posting individualized flyers in public spaces, conducting physician outreach, and using social media ads and direct mail campaigns. Key to the initiative’s success was establishing strong partnerships with local physical therapy clinics and their staff, who served as trusted community members.

Implementation of these strategies resulted in a significant increase in study inquiries, screening, and enrollment. Average monthly inquiries across all clinics rose from 2 per month to 28, a 760% increase over projected numbers. The most effective strategies for generating inquiries were social media ads and direct mail.

When comparing actual enrollment to projected enrollment, the community engagement efforts boosted enrollment by 23% in the targeted rural clinics and 107% in the targeted low-enrollment clinics. There was no significant increase in enrollment in the untargeted group.

The strategies also successfully increased the enrollment of rural residents. Notably, 99% of rural residents who passed screening went on to enroll in the study, compared to only 32% of urban residents who passed screening—highlighting the rural participants’ high willingness to join the research once barriers were addressed.

“These findings contribute to a growing body of research demonstrating that pragmatic trials, when combined with strong community engagement, can help bridge healthcare disparities in rural populations,” the authors wrote.

Read the full report.

FM-TIPS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.

November 26, 2025: Goals-of-Care Conversations Affect Emergency Department Care in PRIM-ER Substudy

Headshots of Dr. Corita Gruzen and Dr. Keith Goldfeld
Dr. Corita Gruzen and Dr. Keith Goldfeld, principal investigators for PRIM-ER

In a single-site substudy of the PRIM-ER trial, an intervention to initiate palliative care in the emergency department did not increase the proportion of patients having goals-of-care conversations. However, when those conversations did occur, they frequently influenced patients’ care.

The article was published online ahead of print in Internal and Emergency Medicine.

PRIM-ER, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized trial of a palliative care training program in emergency departments in the United States. The program consisted of training in palliative care, simulation-based communication workshops, clinical decision support tools, and audit and feedback.

In the substudy led by Julia Murray of Ohio State University, which was conducted as a quality improvement initiative at a large academic medical center, the researchers wanted to explore whether the PRIM-ER intervention changed physician behavior at the institution. Although the proportion of critically ill patients having a goals-of-care conversation did not change, more than three-quarters of the patients who did have a conversation saw a change in code status, their care plan, hospice care, or updated advance care planning documents.

Read the full article.

PRIM-ER was supported within the NIH Pragmatic Trials Collaboratory by a grant award from the National Institute on Aging. Learn more about PRIM-ER.

November 20, 2025: NOHARM Explores Patients’ and Nurses’ Experiences With a Perioperative Nonpharmacologic Pain Care Education Program

Headshots of Dr. Andrea Cheville and Dr. Jon Tilburt
Dr. Andrea Cheville and Dr. Jon Tilburt, principal investigators for NOHARM

In 2 recent studies, as part of the NOHARM trial, researchers explored the perspectives of patients and nurses on the implementation of a perioperative nonpharmacologic pain care education program.

One study, published in JMIR Nursing, evaluated inpatient nurses’ perceptions of barriers and facilitators to implementing the Healing After Surgery initiative. Healing After Surgery is a program embedded in the electronic health record (EHR) that provides education and support to patients for incorporating nonpharmacologic pain care techniques into their individualized perioperative pain management plans.

The researchers found that the nurses understood the benefits of the program but had difficulty implementing unfamiliar pain care techniques and prioritizing the initiative due to other clinical demands. Read the full report.

In the second study, published in BMC Complementary Medicine and Therapies, the researchers used semistructured qualitative interviews to explore patients’ experiences participating in the Healing After Surgery initiative. Among other things, they found that patients generally liked the program and felt that it aligned with their beliefs about wellness techniques and concerns about opioids. Read the full article.

NOHARM, an NIH Collaboratory Trial, is a stepped-wedge, cluster randomized trial testing an EHR-embedded, bundled intervention comprised of patient- and clinician-facing decision support components that enable patients to integrate nonpharmacologic pain care into their perioperative management. The study is supported within the NIH Pragmatic Trials Collaboratory by a grant award administered by the National Institute on Aging through the NIH HEAL Initiative.

Learn more about NOHARM.

November 18, 2025: OPTIMUM Team Studies the Prevalence of Chronic Overlapping Pain Conditions

OPTIMUM logoPatients with chronic low back pain and other chronic overlapping pain conditions, compared with patients with low back pain alone, experienced more severe pain symptoms and higher levels of anxiety, depression, and fatigue, according to an analysis from the OPTIMUM trial.

The report was published in the October issue of the European Journal of Pain.

Chronic low back pain is one of 10 chronic overlapping pain conditions that are theorized to share the same underlying mechanism of pathophysiology. Little is known about the prevalence and co-occurrence of these conditions.

The other chronic overlapping pain conditions include migraine, chronic tension-type headache, fibromyalgia, irritable bowel syndrome, myalgic encephalomyelitis/chronic fatigue syndrome, temporomandibular disorders, urological chronic pelvic pain syndrome/painful bladder syndrome, endometriosis, and vulvodynia.

Among 285 participants in the OPTIMUM trial, 45% had one chronic overlapping pain condition and 24% had 2 or more of the conditions, in addition to chronic low back pain. The most common conditions were irritable bowel syndrome, myalgia encephalomyelitis/chronic fatigue syndrome, and fibromyalgia. Patients with overlapping pain conditions had worse scores on measures of physical functioning and pain symptoms.

“Given the financial, symptomatic, and frustrating burden of [chronic overlapping pain conditions], it is important that researchers explore these conditions in more detail and seek treatments which address symptoms that patients report as the most detrimental to everyday functioning,” the authors concluded.

Read the full article.

OPTIMUM, an NIH Collaboratory Trial led by Natalia Morone of Boston University and Boston Medical Center, is studying the addition of mindfulness-based stress reduction to usual care for patients with chronic low back pain, with the goal of improving pain outcomes and reducing opioid prescriptions. The study is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant award administered by the National Center for Complementary and Integrative Health. Learn more about OPTIMUM.

October 29, 2025 Virtual Onboarding Meeting: CARNATION

NIH Pragmatic Trials Collaboratory Onboarding Meeting

October 29, 2025
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Lesley Curtis
Wendy Weber*

Overview of the NIH Pragmatic Trials Collaboratory
Lesley Curtis
Wendy Weber*

Working With the NIH Collaboratory Coordinating Center
Kevin Weinfurt

Get to Know the New UG3 NIH Collaboratory Trial 
Coordinated cARe paiN mAnagement Technology ImplementatiON (CARNATION)
Lynn DeBar
Rachel Gold
Nicole Cook

Introduction to the Core Working Groups

 

Closing Remarks
Kevin Weinfurt
Wendy Weber*

 

*Unable to attend the onboarding meeting due to the federal government shutdown.