NIH HEAL Initiative

April 7, 2026: Enrollment Begins for AIM-CP and RAMP Pragmatic Trials

Posted on by Damon Seils

Two of the NIH Collaboratory Trials began enrollment last week. Congratulations to the study teams from AIM-CP and RAMP for reaching this important project milestone!

Headshots of Dr. Sebastian Tong and Dr. Kushang Patel
Sebastian Tong and Kushang Patel, principal investigators for AIM-CP

AIM-CP (Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain) is testing the implementation of a care management model to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The program includes care coordination, cognitive behavioral therapy, and referral to a virtual exercise program. The study is led by principal investigators Sebastian Tong and Kushang Patel of the University of Washington.

The AIM-CP study team recently reported the results of a pilot study showing that their integrated nurse care management model is a feasible and effective way to deliver nonpharmacological chronic pain treatment to patients in rural communities. Learn more about AIM-CP.

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

RAMP (Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention) is evaluating the use of a 9-week mind-body skills training program for rural veterans with pain within the VA’s Whole Health initiative, including a one-on-one session with a health coach followed by weekly group sessions that include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions. The principal investigators are Diana Burgess and Roni Evans of the University of Minnesota and Katherine Hadlandsmyth of the University of Iowa.

A recently published pilot study allowed the research team to identify several strategies to optimize the RAMP intervention for the full-scale randomized trial, including strategies to reduce participant burden and improve retention and tailor the program to the rural veteran experience. Learn more about RAMP.

Both AIM-CP and RAMP are supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by grants administered by the National Institute of Nursing Research.

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

Posted on by Damon Seils

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

Posted on by Damon Seils

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.

December 8, 2025: New Podcast Explores Partnership Between Rural-Focused Research Network and BeatPain, an NIH Collaboratory Trial

Posted on by Sophia Ramirez

In a new episode of the Rethinking Clinical Trials Podcast, Julie Fritz of the University of Utah and Sebastian Tong of the University of Washington expanded on key takeaways from their recent Grand Rounds presentation, “Integrating the BeatPain Study With PRaCTICe, a New Network Research Hub of the CARE for Health Initiative.”

Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud.

In an effort to connect patients in rural areas with innovative care, the Primary Care Rural and Frontier Clinical Trials Innovation Center (PRaCTICe) partnered with BeatPain. In the podcast, Fritz and Tong discuss what made the partnership a good fit.

“The BeatPain study was meeting a need that clinicians that patients had identified: access to non-pharmacological treatments for chronic pain that are evidence-based in many places there just wasn’t access to physical therapy,” said Tong.

Roughly a year into their collaboration, PRaCTICe had referred 165 patients to the BeatPain team, 95% of which were rural residents. Fritz and Tong each shared some of their lessons learned around building trust and capacity in low resource settings.

“Local people who support what you’re doing, that you build relationships with so they know that you’re doing the best you can by the participants that come out of their clinics, I think that’s been key to building successful partnerships. Both at the clinical level and at the patient level,” said Fritz.

BeatPain Utah, an NIH Collaboratory Trial, is comparing the effectiveness of nonpharmacologic intervention strategies for patients with back pain seeking care in federally qualified health centers throughout the state of Utah.

Fritz is the principal investigator for BeatPain Utah and a distinguished professor of physical therapy and athletic training at the University of Utah. Tong is a co–principal investigator for AIM-CP, an NIH Collaboratory Trial, and an associate professor of family medicine at the University of Washington.

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

Posted on by Damon Seils

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

Posted on by Damon Seils
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

Posted on by Damon Seils

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.

November 10, 2025: NIH Pragmatic Trials Collaboratory Welcomes New Trials CARNATION and EquiP PC

Posted on by Damon Seils

We are excited to add 2 new NIH Collaboratory Trials to our portfolio of innovative pragmatic clinical trials embedded in healthcare systems.

CARNATION and EquiP PC are supported by the National Institute of Neurological Disorders and Stroke through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, to address the opioid crisis.

Headshots of Dr. Lynn DeBar, Dr. Rachel Gold, and Dr. Nicole Cook
Dr. Lynn DeBar, Dr. Rachel Gold, and Dr. Nicole Cook, principal investigators for CARNATION

CARNATION (Coordinated Care Pain Management Technology Implementation) will partner with a national network of community health centers to test a multicomponent implementation support intervention designed to enable community health centers’ systematic use of electronic health record technologies for coordinating primary care–based pain care that is congruent with integrative pain management. This type 3 hybrid effectiveness-implementation trial will generate urgently needed empirical evidence for how to make integrative pain management strategies available in community health centers, where limited resources present barriers to the delivery and coordination of such care.

Lynn DeBar, Rachel Gold, and Nicole Cook will serve as the co–principal investigators of the CARNATION trial. DeBar, who led the NIH Collaboratory Trials BackInAction and PPACT, is a distinguished investigator at the Kaiser Permanente Center for Health Research. Gold is a senior investigator and the program director of chronic disease, preventive health, and wellness at OCHIN. Cook is also a research investigator at OCHIN.

Headshots of Dr. Kari Stephens and Dr. Rodger Kessler
Dr. Kari Stephens and Dr. Rodger Kessler, principal investigators for EquiP PC

EquiP PC (Equitable Primary Care for Pain Care) will test the effectiveness of an adapted behavioral health integration toolkit to improve chronic pain care. The trial will assess outcomes such as reduced pain interference, improved integrated behavioral health, implementation success, and access to care with the goal of expanding access to high-quality, team-based chronic pain care in primary care settings.

The co–principal investigators of EquiP PC are Kari Stephens and Rodger Kessler. Stephens is a licensed clinical psychologist and a professor in family medicine at the University of Washington. Kessler is vice president for innovation at the DARTNet Institute.

These 2 new NIH Collaboratory Trials will extend the mission of the NIH Pragmatic Trials Collaboratory to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners. To date, the program has supported 36 NIH Collaboratory Trials covering a range of clinical areas and spanning a dozen NIH Institutes and Centers.

September 15, 2025: In BackInAction Pragmatic Trial, Acupuncture Improved Back Pain–Related Disability in Older Adults

Posted on by Damon Seils

Headshots of Dr. Lynn DeBar and Dr. Andrea Cook
Dr. Lynn DeBar and Dr. Andrea Cook, co–principal investigators for BackInAction

Older patients with chronic low back pain who receive acupuncture treatment have greater improvements in pain and disability compared with patients who receive usual care alone, according to the BackInAction trial.

The results of the study were published online in JAMA Network Open.

BackInAction, an NIH Collaboratory Trial, compared standard and enhanced courses of acupuncture with usual care alone in adults aged 65 years and older with chronic low back pain. Previous studies found acupuncture to be a safe and effective treatment for chronic low back pain in adults, and the American College of Physicians recommends the treatment as first-line therapy. However, few studies, and no large-scale randomized trials, have examined the safety and efficacy of acupuncture in older adults specifically.

“We worked hard to involve adults in multiple regions of the country so that participant demographics were consistent with the US census for older adults,” Lynn DeBar told the NIH. “And we worked with licensed acupuncturists in the community, who are most likely to deliver these services,” she said. DeBar is a senior investigator at the Kaiser Permanente Center for Health Research and a co–principal investigator for BackInAction.

The study team randomly assigned 800 patients to 1 of 3 groups: (1) a standard 12-week course of acupuncture plus usual medical care; (2) standard acupuncture enhanced with 4 to 6 maintenance sessions plus usual care; or (3) usual care alone. The study was conducted in 4 healthcare systems in the Pacific Northwest, Northern California, and New York, including a network of federally qualified health centers in an urban setting, 2 integrated health insurance and care delivery systems serving broad geographic regions, and a fee-for-service system serving a relatively urban and suburban population.

Logo for the BackInAction trial

At 6 months and 12 months after treatment, patients in both the standard and enhanced acupuncture groups experienced significantly greater reductions in pain and pain-related disability than patients in the usual care group. The improvements did not differ significantly between the standard and enhanced courses of acupuncture.

Read the full article.

“Older adults often are dealing with other medical problems in addition to back pain,” said co–principal investigator Andrea Cook, senior biostatistics investigator at the Kaiser Permanente Washington Health Research Institute. “Acupuncture offers a less invasive option that has a better safety profile than a lot of the common treatments for back pain in older adults,” she said.

BackInAction 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 BackInAction.

Essential Elements for Sharing a Data Package (NIH HEAL Initiative)

Essential Elements for Sharing a Data Package
NIH HEAL Initiative Data Stewardship Group
March 20, 2025; 1:00-2:00 pm ET

The HEAL Data Stewardship Group is excited to announce the next Fresh FAIR Webinar! Please join us on Thursday, March 20 from 1:00-2:00 p.m. Eastern Time for Essential Elements for Sharing a Data Package.

Description: Effective data packaging is essential for ensuring that research data remains structured, discoverable, and reusable in alignment with the NIH HEAL Initiative’s goals. This webinar will explore best practices for data packaging across various stages of the research lifecycle, emphasizing the importance of meeting repository requirements and adhering to FAIR data principles.

Sarah Myer, MPH, a HEAL Steward, will highlight the significance of well-structured data within the NIH HEAL Initiative, explaining how data advances research within the biopsychosocial model of pain and addiction, supporting interdisciplinary collaboration and secondary reuse. Attendees will gain insights into the role of metadata in the HEAL Data Ecosystem (HDE) and its impact on data discoverability and secondary use underscoring the value of data packaging components for reusability.

Brienna Larrick, Ph.D., PMP, from the HEAL Platform, will outline the key components of a well-organized data package. The session will explain the common types of files included in a data package by providing an overview distinguishing between processed and raw data files, recommending preferred formats (e.g., CSV, TSV, JSON) for various data types, and demonstrating examples for mapping variables to ontologies and semantic standards such as Common Data Elements (CDEs).

To illustrate these concepts, the webinar will feature HEAL-specific examples of study teams that have successfully packaged and submitted datasets to repositories to illustrate effective approaches to data organization, metadata creation, and adherence to repository requirements.

Attendees will also have access to key resources, including Data Curation Costs for Submitting, the ICPSR Guide to Social Science Data Preparation and Archiving (6th ed.), and the NIH Pragmatic Trials Collaboratory Living Notebook.

A live Q&A session will follow, enabling participants to engage with experts and address specific challenges related to data packaging and submission. The webinar will conclude with a call to action, encouraging researchers to submit their datasets to HEAL repositories using best practices that enhance data accessibility and long-term usability.

Register now!