OPTIMUM Archives - Rethinking Clinical Trials

October 8, 2026: OPTIMUM Team Studies Impact of Telehealth Experience on Recruitment of Underserved Populations

Posted on October 8, 2026October 12, 2026 by Damon Seils

Dr. Natalia Morone, principal investigator for OPTIMUM

In medically underserved communities, patients’ prior experience with virtual doctor visits influenced their willingness to participate in a telehealth-delivered mindfulness program for chronic low back pain.

The analysis from the OPTIMUM trial was published online in JMIR mHealth and uHealth.

OPTIMUM, an NIH Collaboratory Trial, studied the addition of mindfulness-based group telehealth visits to usual care for patients with chronic low back pain, with the goal of improving pain outcomes.

Mindfulness-based stress reduction is included in evidence-based guidelines for initial treatment of chronic low back pain. However, attending in-person group sessions can be difficult for patients facing transportation, scheduling, or economic barriers. While telehealth-based delivery offers a promising solution, little is known about how patients’ comfort and familiarity with digital health tools affect their enrollment in online programs.

Researchers from the OPTIMUM team conducted a cross-sectional analysis of participants from a safety net health center and a federally qualified health center to evaluate how sociodemographic characteristics, internet access, and other factors related to telehealth experience and willingness to enroll in the trial. The authors concluded that targeted outreach and engagement strategies may help to support broader implementation of telehealth for chronic low back pain.

Read the full report.

OPTIMUM 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.

July 14, 2026: Investigators for Closing Pragmatic Trials Reflect on NIH Collaboratory Experience

Posted on July 14, 2026 by Damon Seils

Three studies from the first cohort of NIH Collaboratory Trials in pain management supported through the NIH HEAL Initiative are nearing completion. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we asked investigators Natalia Morone, Andrea Cheville, and Ardith Doorenbos to reflect on their experiences in the program and to share lessons for other researchers starting their own pragmatic trials.

“A commonality across our trials was the effort we put into collecting outcomes, the shared prioritization of how critical this is, guiding each other in ways to maximize our response rates,” said Cheville, co–principal investigator for the NOHARM trial and a professor of physical medicine and rehabilitation at the Mayo Clinic. “Also, I think our trials share an experience of using tele-care, sometimes unplanned because of the pandemic, and experiencing the benefits and the limitations of that.”

NOHARM is testing an electronic health record–embedded, bundled intervention comprised of patient- and clinician-facing decision support components that enable patients to integrate nonpharmacologic pain care into their perioperative management.

Go to the full video.

“The best advice I got…was to be flexible, and I really took that to heart,” said Morone, associate professor of medicine at Boston University and the principal investigator for the OPTIMUM trial. OPTIMUM studied the addition of mindfulness-based group telehealth visits to usual care for patients with chronic low back pain. The trial’s primary results were published last month in JAMA Internal Medicine.

“Especially with pragmatic trials, I think there are more challenges that may arise and more questions as far as how flexible you can be,” added Doorenbos. “Emphasize relationships, value your relationships, and identify the pain points, the opportunities for synergism, how to give back to the sites that are hosting the trials,” she said.

Doorenbos is a co–principal investigator for the GRACE trial and the Harriet H. Werley Endowed Chair for Nursing Research at the University of Illinois Chicago. GRACE is assessing the effectiveness of guided relaxation and acupuncture treatments to improve pain control for patients with sickle cell disease.

OPTIMUM, NOHARM, and GRACE are supported within the NIH Collaboratory through the NIH HEAL Initiative by grants awarded by the National Institute of Neurological Disorders and Stroke and administered by the National Center for Complementary and Integrative Health (OPTIMUM and GRACE) and the National Institute on Aging (NOHARM).

In the coming weeks, we will share more highlights from the 2026 Annual Steering Committee Meeting. Access the complete meeting materials.

Video still from an interview with Drs. Natalia Morone, Andrea Cheville, and Ardith Doorenbos — Dr. Natalia Morone, Dr. Andrea Cheville, and Dr. Ardith Doorenbos

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

Posted on December 15, 2025January 9, 2026 by Damon Seils

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

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

Ethics and Regulatory Core

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

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

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

FM-TIPS

GGC4H

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

GRACE

HiLo

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

iPATH

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

LIRE

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

Nudge

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

OPTIMUM

PRIM-ER

SPOT

TAICHIKNEE

An introduction to implementation science in rehabilitation medicine

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

Posted on November 18, 2025November 18, 2025 by Damon Seils

OPTIMUM logo Patients 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.

Grand Rounds September 12, 2025: Initial Outcomes of the Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) Pragmatic Trial (Natalia E. Morone, MD, MS; Carol M. Greco, PhD; Kim Faurot, PhD, MPH, PA)

Posted on September 17, 2025July 30, 2026 by Sophia Ramirez

Speakers

Natalia E. Morone, MD, MS
Associate Professor
Boston Medical Center/Boston University

Carol M. Greco, PhD
Associate Professor
University of Pittsburgh

Kim Faurot, PhD, MPH, PA
Associate Professor
University of North Carolina at Chapel Hill

Keywords

Pain; Low Back Pain; Mindfulness; Virtual; Group-Based; OPTIMUM

Key Points

OPTIMUM, an NIH Collaboratory trial, tested the effect of a virtual, group-based mindfulness intervention on levels of low back pain, life enjoyment, and activity. 451 participants with chronic low back pain were randomized to receive either the 8-week mindfulness-based stress reduction (MBSR) program or usual care.

The Zoom-based program integrated mindfulness instructors with primary care providers in a group medical visit format. The researchers found that patients in the mindfulness group had significantly lower scores (i.e., less pain) on the Pain, Enjoyment of Life, and General Activity (PEG) Scale from Week 8 through Month 12.

Once the intervention was complete, researchers conducted interviews with each participant. There were 6 emergent themes: ease, level of support, struggle, comfort, social demands at home, and sharing personal spaces.

Discussion Themes

The research team developed a tool to assess participant fidelity. Their measurements indicated that the essential elements of MBSR were maintained in a virtual format with high participant engagement. High participant retention was attributed to a culture of kindness among staff as well as proactive outreach, including monthly check-in calls.

The research team gained support from busy primary care clinics by keeping the ask light, avoiding extra workload for front-desk staff and using EMR-integrated tools.

It’s possible that the results reflect volunteer bias; i.e., individuals who agree to participate in a mindfulness study may differ significantly from the general patient population.

While specific pain scales are important, global impression of change often shows higher satisfaction – possibly because mindfulness provides general wellness benefits beyond physical pain reduction.

September 10, 2025: Initial Outcomes of OPTIMUM, in This Week’s Rethinking Clinical Trials Grand Rounds

Posted on September 10, 2025 by Damon Seils

Headshots of Drs. Natalia Morone, Carol Greco, and Kim Faurot In this Friday’s Rethinking Clinical Trials Grand Rounds, Natalia Morone, Carol Greco, and Kim Faurot will present “Initial Outcomes of the Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) Pragmatic Trial.”

The Grand Rounds session will be held on Friday, September 12, 2025, at 1:00 pm eastern.

OPTIMUM, an NIH Collaboratory Trial, is studying the addition of mindfulness-based stress reduction to usual care for patients with chronic low back pain, compared with usual care alone, with the goal of improving pain outcomes and reducing opioid prescriptions. Learn more about OPTIMUM.

Morone, the principal investigator for OPTIMUM, is an associate professor of medicine at Boston University and a clinical general internist at Boston Medical Center. Greco is an associate professor of psychiatry and psychical therapy at the University of Pittsburgh. Faurot is an assistant professor of physical medicine and rehabilitation at the University of North Carolina at Chapel Hill.

Join the online meeting.

July 16, 2025: OPTIMUM Team Explores Complexities of Virtual Intervention Delivery

Posted on July 16, 2025July 16, 2025 by Damon Seils

OPTIMUM logo Features of the external environment during online medical group visits and interacting with the technology itself emerged as key themes in interviews with patients participating in the OPTIMUM trial.

The findings were published online in Global Advances in Integrative Medicine and Health.

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, compared with usual care alone, with the goal of improving pain outcomes and reducing opioid prescriptions.

Patients’ experiences varied significantly during the online group medical visits and were influenced by social determinants of health. Exploring these differences in a racially and ethnically diverse group of participants enabled the researchers to begin developing a framework for comparing disparate experiences with virtual vs in-person mindfulness-based stress reduction interventions.

“On closer look, there are multiple variables at play that differentially affect how participants interact with the virtual setting,” the authors wrote. Jessica Barnhill of the University of North Carolina at Chapel Hill was the lead author of the report.

Read the full article.

OPTIMUM 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.

July 3, 2025: OPTIMUM Team Identifies Facilitators of Participant Retention and Engagement

Posted on July 3, 2025July 3, 2025 by Damon Seils

Dr. Natalia Morone, principal investigator for OPTIMUM

Trust in their clinicians, positive interactions with study staff, and opportunities for social connection can improve recruitment, retention, and engagement with research participants, according to focus groups of participants in the OPTIMUM trial. These factors can be especially important for first-time research participants and for groups that are historically underrepresented in clinical trials.

The article was published online in Global Advances in Integrative Medicine and Health.

OPTIMUM, an NIH Collaboratory Trial, is studying the addition of mindfulness-based stress reduction to usual care for patients with chronic low back pain, compared with usual care alone, with the goal of improving pain outcomes and reducing opioid prescriptions. Patients in the control group were also offered free mindfulness sessions after the end of the 12-month follow-up period.

Understanding of randomized controlled trials and general research processes emerged as another important theme in the focus groups. In particular, appreciating the value of the control group in a randomized controlled trial can support participants’ ongoing engagement.

“Consistent, positive study staff interactions were particularly important for control group participants who were not immediately receiving the intervention that initially interested them in the trial,” the authors wrote.

The OPTIMUM trial, which is embedded in safety net hospitals and federally qualified health centers, includes a large number of first-time participants in research and patients from racial and ethnic groups that tend to be underrepresented in research. Understanding the needs and perspectives of first-time research participants and those from underrepresented groups can improve recruitment and retention strategies and help ensure the representativeness of study populations.

Read the full report.

OPTIMUM 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.

July 2, 2025: Researchers Share Tips for Embedding Pragmatic Trials Into Primary Care Settings

Posted on July 2, 2025July 3, 2025 by Karen Staman

Headshots of Drs. Wendy Weber, Julie Fritz, Natalia Morone, and Sebastian Tong Although the need for pragmatic research in primary care settings is great, conduct of pragmatic clinical trials in these settings remains nascent. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Wendy Weber of the National Center for Complementary and Integrative Health (NCCIH) led a discussion about how to expand pragmatic research into primary care settings.

The panelists included Julie Fritz, principal investigator (PI) for BeatPain Utah; Natalia Morone, PI for OPTIMUM; and Sebastian Tong, co-PI for AIM-CP. They shared some of the challenges of conducting research in primary care.

Primary care physicians have multiple competing demands for attention and focus, and a range of topics to cover in a single visit.
The expectation of being offered participation in clinical trials is lower in primary care than in specialty visits.
There are fewer resources that can be diverted to research in primary care, especially time and personnel.

Key Takeaways

How do we adapt pragmatic clinical trials to primary care?

Identify relevant and meaningful research questions

The panelists suggested that, when planning a trial, investigators should think about the primary care setting and consider what problems keep clinicians up at night. Research will be easier to implement if it helps alleviate these problems.

“In primary care, [primary care physicians] are looking at the entire person,” Tong said. “There has to be value added in how we care for the patients with the condition under study, either where the [physician] sees a difference in their patients’ lives or their own lives with respect to reduced burden,” he said.

The panelists also suggested that, for community health centers, there are certain conditions that are linked to data reporting standards, and aligning research with these standards will make studies easier to champion.

Adapt to different kinds of primary care settings

The panelists stressed the need for adaptably and flexibility in intervention delivery because all primary care settings are different. If possible, researchers should tailor the workflow at each site in a way that is familiar to providers. the panelists also suggested that initial engagement by external researchers is best made with someone who is trusted at the site.

Some clinics, including community health centers, may be new to research and may need additional support. Many do not have an institutional review board or a Federalwide Assurance number, and many do not have experience using the electronic health record for research and developing data use agreements.

About the Trials

BeatPain Utah, supported by the National Institute of Nursing Research (NINR), is comparing the effectiveness of nonpharmacologic interventions delivered via telehealth for patients with back pain seeking care in federally qualified health centers in Utah.
OPTIMUM, supported by NCCIH, is assessing the impact of a group-based mindfulness intervention for patients with chronic back pain under usual care circumstances in the primary care setting.
AIM-CP, supported by NINR, is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations.

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

December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory

Posted on December 12, 2024December 12, 2025 by Damon Seils

A graphic showing a collection of journal covers. In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis 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 more than 30 articles to the peer-reviewed literature this year, including the primary results of the ICD-Pieces and Nudge trials. Several 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 surpassed 340.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Core Working Groups

Biostatistics and Study Design Core