pragmatic clinical trials

Grand Rounds September 18, 2026: The 4th Trimester Initiative: A Randomized Controlled Trial of Support for Childbearing Medical Trainees (Erika Rangel, MD)

Posted on by terren.green@duke.edu

Speaker

Erika Rangel, MD
Associate Professor of Surgery
Department of Surgery
Harvard Medical School
Medical Director for Clinician Wellbeing
Mass General Brigham

Keywords

Childbearing medical trainees, Burnout, Parental support, Pregnancy support

Key Points

  • Previous studies have shown that surgical residents experience difficulties during medical training and pregnancy and early parenthood. Modified schedules were rare, less than 6 weeks parental leave was common, pumping was difficult, and mentorship regarding balancing family and career was lacking. Many questioned the sustainability of a surgical career affecting an already existing workforce shortage.
  • The aim of this study was to improve the work environment and culture for the vulnerable group of childbearing medical trainees while preserving the rigor and quality of the training program.
  • Study outcomes were chosen in 3 domains that reflect positive return on investment for the workplace. Domains included well-being (burnout), workforce outcomes, and functioning at work and home. Burnout was used as the primary outcome; burnout costs healthcare organizations $4.6 billion a year and has a human cost to the trainee as well.
  • The pragmatic design of the study lessened the burden on participating institutions by including interventions that could be delivered directly to the trainee. The parental support package included a wearable breast pump, a smart bassinet, faculty mentorship, and 24/7 virtual prenatal care via an app.
  • Across 7 institutions, 156 pregnant residents and fellows were enrolled and randomized to either usual support or the parental support package group. All participants were given a fitbit to track sleep and all were asked to track medical errors. The research question was deliberately phrased as ‘what happens when this parental support package was offered at an institution.’
  • The parental support package was used variably by participants. Institutional environments also varied. These variable factors were analyzed separately. The support package appeared to buffer the rise in burnout for the intervention group. Interpersonal disengagement was significantly improved and improved sleep decreased medical error.

Discussion Themes

Institutions understand that burnout is an issue for childbearing medical trainees, and response to the study was enthusiastic. Originally only 3 institutions were targeted, but 7 were ultimately included in the study.

Medical trainees were also enthusiastic to participate with a 92% retention rate. Word of mouth and social media were instrumental in recruitment.

 

Read more about the The 4th Trimester Initiative.

 

August 10, 2026: NIH Collaboratory Trials Offer Lessons in Using Computable Phenotypes With Real-World Data

Posted on by Damon Seils

The journal cover image of JAMIA Open alongside a screenshot of the first page of the article.Members of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core Working Group recorded the experiences of pragmatic trial investigators in using computable phenotypes in their studies.

The article was published online in JAMIA Open.

Using real-world data for research poses many challenges, including variations in data documentation practices. Researchers use computable phenotypes—data queries that use specified codes and logical parameters—to standardize the capture of characteristics of interest from real-world data sources, such as EHRs.

The NIH Collaboratory’s EHR Core collected examples from 4 of the NIH Collaboratory Trials to illustrate how computable phenotypes are developed and used in pragmatic trials. Based on these experiences, the Core made several recommendations:

  • Develop computable phenotypes as part of a team with multiple areas of expertise
  • Use appropriate validation procedures
  • Disseminate salient details about phenotype creation
  • Capture and report any modifications made to phenotypes during the conduct of the trial

Read the full report.

July 20, 2026: Practical Tips for Dissemination: An Interview With Hayden Bosworth and Cherise Harrington

Posted on by Damon Seils

Having patients and other research partners at the table during the planning of dissemination strategies is key to sustaining effective interventions and driving practice change. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with Hayden Bosworth and Cherise Harrington about the value of planning for and following through on dissemination in pragmatic trials.

“How should researchers collaborate with potential stakeholders with regard to dissemination of findings?” Bosworth asked. “The most important thing is to engage as frequently and as early as possible.”

Bosworth is a cochair of the NIH Collaboratory’s Implementation Science Core and professor and vice chair for research in population health sciences at Duke University.

“It’s important to know what your message is, what’s actionable about that message, and who it’s targeted for,” said Harrington, a cochair of the NIH Collaboratory’s Community Health Improvement Core and a professor and senior researcher in public health education at North Carolina Central University.

Go to the full video.

For more highlights from the 2026 Annual Steering Committee Meeting, access the complete meeting materials.

Video still from an interview with Dr. Hayden Bosworth and Dr. Cherise Harrington
Dr. Hayden Bosworth and Dr. Cherise Harrington

June 16, 2026: LungSMART Team Uses Bilingual Formative Evaluation to Hone Study’s Digital Health Content

Posted on by Damon Seils
Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
Left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, co–principal investigators for LungSMART

The LungSMART research team conducted a bilingual messaging study and usability assessment to evaluate and adapt the study’s digital health content for patients in community health centers in Utah. The evaluation led to improvements in content and delivery strategies in preparation for the launch of a full pragmatic clinical trial to promote lung cancer screening in low-resource healthcare settings.

The report was published online in Cancer Control.

LungSMART, an NIH Collaboratory Trial led by Dave Wetter, Guilherme Del Fiol, and Ken Kawamoto of the University of Utah, will test telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

In the first phase of the trial, patients identified in the electronic health record through an automated algorithm as being potentially eligible for lung cancer screening will be randomly assigned to engage with low-barrier digital health tools, such as text messages, health education videos, and a rules-based chatbot. This phase of the trial will direct interested and eligible patients to shared decision-making for referral to lung cancer screening.

Both the messaging study and the usability assessment found that participants were interested in the content and were able to navigate the digital health elements of the intervention. The feedback led to improvements in the clarity of terminology, especially for Spanish-speaking participants, and changes to address anxiety about cancer screening, risk, and cost.

Headshot of Dr. Andy King
Dr. Andy King, lead author of the report

“These insights would have been challenging to identify within traditional translation contexts, suggesting the need for thoughtful cultural adaptation in projects aimed at reducing health disparities,” wrote the report’s coauthors, led by Andy King of the University of Utah.

Read the full article.

LungSMART is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Cancer Institute. Learn more about LungSMART.

June 4, 2026: Feasibility Assessment in Pragmatic Trials: An Interview With Angelo Volandes and Sebastian Tong

Posted on by Damon Seils

The planning phase of a pragmatic clinical trial is a critical time when research teams can hone their research questions, build relationships with healthcare system and community partners, and test assumptions about the trial’s implementation in real-world settings. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with Angelo Volandes and Sebastian Tong about the role of feasibility assessment in planning a successful trial.

“I think the biggest challenge for the feasibility assessment for pragmatic trials is one that we probably don’t talk enough about, and that’s the tension between meeting the timetable, the milestones, and an honest discovery process,” said Volandes. Volandes is the Anna Gundlach Huber Professor in Medicine at the Geisel School of Medicine and a co–principal investigator for ACP PEACE, an NIH Collaboratory Trial.

“So, from a principal investigator’s perspective, the way I suggest to others that they navigate this is to treat it as an investigation: generate hypotheses, collect data,” he said.

Go to the full video.

“[In the NIH Collaboratory’s Core Working Groups], I was open about the problems we had with engaging in rural areas and minoritized populations, and I got a lot of feedback about how we best engage with community partners,” recalled Tong, an associate professor of family medicine at the University of Washington and a co–principal investigator for AIM-CP, an NIH Collaboratory Trial.

“I wouldn’t have gotten that if I hadn’t been open about the problems we were having,” Tong said.

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

A video still from an interview with Dr. Angelo Volandes and Dr. Sebastian Tong
Dr. Angelo Volandes and Dr. Sebastian Tong

May 26, 2026: Continuing Education Units Now Available for Learning Path on Pragmatic Trial Design

Posted on by terren.green@duke.edu

The NIH Pragmatic Trials Collaboratory is excited to announce the availability of AMA PRA Category .75 Credit™ and JA credit AH for the Pragmatic Clinical Trials Study Design learning pathway through the Duke University Health System’s Department of Clinical Education and Professional Development.

This interactive learning path provides researchers with essential knowledge to choose the most appropriate study design for their pragmatic clinical trial. The self-paced modules include expert video by Liz Turner, cochair of the NIH Collaboratory’s Biostatistics and Study Design Core, reference materials, and knowledge checkpoints.

These learning activities are free and require about 1 hour to complete. To access the learning path, visit the NIH Collaboratory Training Resource page and learn more about the Pathways to Learning options. Simply click “get this course” and then “sign up” to create an account in our learning management system.

Continuing Education Credits

In support of improving patient care, the Duke University Health System’s Department of Clinical Education and Professional Development is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the health care team.

Physician Credit: Duke University Health System Department of Clinical Education and Professional Development designates this Pragmatic Clinical Trial Study Design learning path activity for a maximum of .75 AMA PRA Category .75 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

Nurse Credit: Duke University Health System Department of Clinical Education and Professional Development designates this Pragmatic Clinical Trial Study Design learning path activity for up to .75 credit hour for nurses. Nurses should claim only credit commensurate with the extent of their participation in this activity.

Grand Rounds April 24, 2026: Key Insights from the UG3: Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations Trial, and Path Forward for the UH3 (Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN; Hulin Wu, PhD, MS; Jane Bolin, PhD, JD, RN)

Posted on by terren.green@duke.edu

Speakers

Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
Maria C. and Christopher J. Pappas Family Distinguished Chair in Nursing
Lee and Joseph Jamail Distinguished Professor
Department of Research
Cizik School of Nursing at UTHealth Houston

Hulin Wu, PhD, MS
The Betty Wheless Trotter Professor & Chair
Department of Biostatistics & Data Science
School of Public Health at UTHealth Houston

Jane Bolin, PhD, JD, RN
Senior Research Professor
College of Nursing, UNT Health Science Center at Fort Worth
Regents Professor Emeritus
Texas A&M School of Nursing

Keywords

Auricular Point Acupressure, Chronic pain, Pain management, Rural communities.

Key Points

  • Auricular Point Acupressure (APA) uses small seeds embedded into tape and placed on areas of the ear that correspond to areas of the body that are in pain. Placement decisions come from the literature on (APA) locations. APA has been shown to stimulate the central nervous system in fMRI studies, decreased pro-inflammatory substances (IL-ꞵ, TNFα), and increased anti-inflammatory substances (IL-4, IL-10).
  • To scale APA care, our self-managed approach for the Personalized Auricular Point Acupressure for Chronic Pain Self-management in Rural Populations UG3 study used an electronic application that was created to provide participants with tutorial videos, answers to frequently asked questions, and a pain tracking system. A previous study using this self-managed approach in urban areas showed improved physical function and lessoned pain intensity.
  • The current study focused on APA in rural communities that experience challenges with access to pain care, transportation, staff shortages, and technology and internet access. Building trust with rural communities was very important.
  • After the APA intervention, participants felt a regained control over pain and were satisfied with improved comfort. Challenges presented with difficulty reaching points on the back of the ear and discomfort while sleeping.
  • A full UH3 Pragmatic Randomized Clinical Trial is now being organized to expand the reach of the study. This 3-arm trial will randomize 693 participants to a control, APA in-person, or APA remote group. This study aims to determine the effectiveness of APA in chronic musculoskeletal pain, assess the cost-effectiveness, and identify predictive factors for APA treatment response.

Discussion Themes

Supporting rural communities in research requires leveraging existing partners while building new relationships, listening to the needs of the community and adjusting study procedures to meet these needs, and working with community advisory boards to disseminate findings.

The control group for this study was a pain education intervention group. Creating a sham control group for this type of study is difficult because there are many APA points in the ear. Attempting to create a sham control group that targets other points in the ear may inadvertently be influencing other APA points.

 

Read more about the Personalized Auricular Point Acupressure for Chronic Pain Self-management in Rural Populations study.

 

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.

October 16, 2025: New Article Surveys Landscape of Empirical Ethics Research Related to Pragmatic Clinical Trials

Posted on by Damon Seils
Headshots of Dr. Kayla Mehl, Dr. Stephanie Morain, and Dr. Jeremy Sugarman
Left to right: Kayla R. Mehl, Stephanie R. Morain, and Jeremy Sugarman

A new article from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core offers a comprehensive scoping review of published empirical ethics research related to pragmatic clinical trials. These trials, which are designed to assess evidence-based interventions in real-world settings, present a variety of unique ethical and regulatory challenges.

The article was published online ahead of print in Learning Health Systems.

The review analyzed 82 published studies of ethics issues that have been explored in the context of pragmatic clinical trials. The authors, led by Kayla Mehl at Johns Hopkins University, identified 22 distinct ethical themes, with the 5 most prevalent being consent and disclosure, risk assessment, trust and transparency, operational burdens and implementation barriers, and the role of engagement.

  • Consent and disclosure: Traditional written informed consent is often impractical in pragmatic trials, prompting the exploration of alternative approaches such as opt-out or general notification.
  • Risk assessment: Pragmatic trials present challenges in risk assessment, particularly regarding how “minimal risk” is defined and communicated, which complicates regulatory determinations and participant protections.
  • Trust and transparency: Trust-building practices, such as results sharing and transparent data use disclosures, are essential for fostering participant confidence.
  • Burdens, barriers, and costs: Institutions, investigators, and research teams face a variety of operational and logistical burdens in pragmatic trials, especially when integrating interventions into routine care and navigating ethics concerns around data governance and data sharing.
  • Engagement: Engagement practices in pragmatic trials have been limited and inconsistent, highlighting “a persistent gap between the ideal of inclusive, sustained collaboration and the realities of constrained resources, power dynamics, and unclear stakeholder roles.”

Read the full article.

The authors point out that most empirical ethics research related to pragmatic trials has been concentrated in the United States and other Western countries and is heavily reliant on surveys and hypothetical scenarios. This limits the generalizability and real-world applicability of current findings. The authors advocate for future research that is geographically inclusive and that employs innovative methodologies, including nested empirical studies within ongoing pragmatic trials, to provide richer, context-sensitive insights.

Mehl completed a postdoctoral fellowship in the ethics and regulatory aspects of pragmatic clinical trials at the Berman Institute for Bioethics at Johns Hopkins University. Coauthor Stephanie Morain is a core faculty member at the Berman Institute and an associate professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health. Coauthor Jeremy Sugarman is the Harvey M. Meyerhoff Professor of Bioethics and Medicine, professor of medicine, and professor of health policy and management at Johns Hopkins and the deputy director for medicine of the Berman Institute.

Morain and Sugarman are cochairs of the NIH Collaboratory’s Ethics and Regulatory Core.

October 9, 2025: New Living Textbook Chapter Explores Decentralized Elements of Pragmatic Clinical Trials

Posted on by Karen Staman

The NIH Pragmatic Trials Collaboratory this week published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, Decentralized Pragmatic Clinical Trials, covers activities of a pragmatic trial that can occur remotely—at a location separate from an investigator’s location—such as participant engagement, recruitment, consent, study interventions and procedures, collection of patient-reported outcomes, and follow-up.

The chapter describes special considerations for decentralized trials, such as community health considerations and the vigilance needed to assure data quality, particularly as it relates to adherence with the study intervention, outcome ascertainment, and event monitoring.

The new chapter includes the following sections:

  1. What Is a Decentralized Trial?
  2. What Decentralized Elements Are Used in Pragmatic Trials?
  3. Community Health Considerations for Decentralized Approaches
  4. Quality Assurance

Most of NIH Collaboratory Trials have decentralized elements, as described in detail in Section 2.