Steering Committee

August 25, 2025: NIH Collaboratory Researchers Consider Posttrial Responsibilities

Posted on by Damon Seils

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, researchers discussed the obligations pragmatic trials researchers have to research participants, partnering healthcare systems, and each other after a trial is complete.

Panelists for the session included moderators Pearl O’Rourke and Jeremy Sugarman, cochairs of the NIH Collaboratory’s Ethics and Regulatory Core; Stephanie Morain, also from the Ethics and Regulatory Core; Hayden Bosworth from the Implementation Science Core; and Angelo Volandes, co–principal investigator for the ACP PEACE trial. They were joined by Andrea Cook from the BackInAction trial, Shruti Gohil from the INSPIRE trial, and Mike Ho from the Nudge trial and the Chat 4 Heart Health trial.

Morain introduced the ethical foundations for posttrial responsibilities, noting that the Declaration of Helsinki requires that “post-trial provisions must be arranged by sponsors and researchers to be provided…for all participants who still need an intervention identified as beneficial and reasonably safe in the trial.” The Declaration also states that “researchers have a duty to make publicly available the results of their research on human participants.”

Read more: Morain et al, “Post-Trial Responsibilities in Pragmatic Clinical Trials: Fulfilling the Promise of Research to Drive Real-World Change”

Bosworth encouraged attendees to think about sustainability as an integral part of the research process for pragmatic trials. “I may need to continue this intervention in some way, but that means I have to prepare for that even before I have the results,” he said.

Read more: Green et al, “Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review”

Cook, Gohil, and Ho gave examples of how their research teams prepared for posttrial follow-up and implementation. In both BackInAction and INSPIRE, the investigators planned to provide cost-effectiveness information to the partnering healthcare systems to help them make the business case for sustaining the interventions. In Nudge, the investigators were working with partnering healthcare systems to understand how modifications to the intervention could improve adherence to future implementations.

Volandes shared his experience in the ACP PEACE trial, which tested a video decision aid for older patients with advanced cancer, by highlighting focus groups in which the study team asked trial participants what they felt the researchers owed to them after the study.

“They said, we love your tools but some don’t reflect who we are,” Volandes said. “So we went back and updated our tools to reflect the community served by the system, and to mention in the tool that this tool is a product of research conducted by patients in the community.

Volandes showed the modified video decision aid, which featured images and content to highlight that studies conducted in the healthcare system showed that participating patients found the tool to be helpful.

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

July 31, 2025: Pragmatic Trialists Share Strategies for Monitoring Changes in Usual Care

Posted on by Karen Staman

Pragmatic clinical trials are conducted as part of routine healthcare delivery and often compare an intervention to usual care. To do this, researchers must understand, monitor, and document standard care at participating research sites.

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Duke University’s Emily O’Brian asked a panel of trialists about the strategies they used to define and document usual care. The panelists included Rachel Winer, co–principal investigator (PI) of STEP-2;, Richard Platt, co-PI of INSPIRE; and Christine Goertz, co-PI of IMPACt-LBP.

Key Strategies

  • Establish a community of individuals who are interested in and committed to answering the research question
  • Develop relationships: visit each site and have monthly coaching calls
  • Get commitment in advance from sites to hold their practice constant for the duration of the trial
  • Have sites complete readiness surveys or feasibility assessments that include questions about potential upcoming quality improvement initiatives
  • Minimize burden on sites as much as possible

The Navigating the Unknown chapter of the Living Textbook includes  descriptions of unanticipated challenges that may occur during the years-long course of a study that can have profound effects on usual care, including:

These challenges all require close collaboration with research partners to develop solutions.

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

July 22, 2024: Key Decisions for Integrating Digital Tools Into EHR Systems for Pragmatic Trials

Posted on by Karen Staman

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, a team of experts shared key decisions about whether or not to integrate digital tools into the electronic health record (EHR). The panel, moderated by Steve George of the NIH Collaboratory Coordinating Center, explained that the decision hinges on 4 critical factors: complexity, institutional governance, requirements for integration, and involvement of personnel.

Complexity

Complexity depends on the number of participating systems, the type of healthcare systems (such as private clinics, federally qualified health centers, and academic medical centers), and the number of EHR vendors involved. Complexity is also driven by the level of integration required: sending a result or message is fairly easy, while embedding a decision support application within a screen is more difficult.

For more, see the Living Textbook chapter on Intervention Delivery and Complexity.

Institutional Governance

Institutional governance varies by health system. There may be single or multiple review committees, long wait times for implementation and deployment, or multiple levels of approval needed (including corporate and C-suite), all of which can impact possible EHR integration and timelines.

Requirements for Integration

Panelists suggested that investigators weigh whether the trial or intervention requires EHR integration for meaningful results or if integration would just be nice to have. If EHR integration is required, are there pieces that could be removed or deferred if implementation timelines are delayed?

Involvement of Personnel

Finally, the panelists suggested that researchers should be prepared to account for the human factors that affect intervention uptake, fidelity, and sustainability.

Key Questions

  • If the intervention requires someone to push a button or click on something, does that role or person exist at each institution?
  • Has there been buy-in from sites to assess whether the intervention is compatible with clinical workflows to ensure fidelity?
  • What types of updates or modifications are necessary over time? Will sites need to do additional work after the initial implementation? If so, are there plans for handling site IT staff turnover?

The panelists included Keith Marsolo, chair of the EHR Core, Mike Ho, co–principal investigator (PI) for Nudge, Andrea Cheville, PI for NOHARM, and Michele Balas, co-PI for BEST-ICU.

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

July 14, 2025: Researchers Share Tips for Building Relationships With Communities in Pragmatic Research

Posted on by Elizabeth Mccamic

Engaging with community partners can enrich and inform research through the lifespan of a trial. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Cherise Harrington, cochair of the program’s Community Health Improvement Core, led a discussion about building relationships with communities in pragmatic research.

The panelists included Jennifer Kawi, principal investigator (PI) for APA-SM; Kathleen Sluka, PI for FM-TIPS; Sebastian Tong, PI for AIM-CP; and David Wetter, PI for LungSMART. They shared examples of how community relationships have enriched their trials, along with impediments to meaningful community engagement and successful methods for building relationships with communities.

Key Strategies for Engaging With Communities

  • Build long-standing relationships with community partners, develop shared goals, and practice shared decision-making.
  • Design for sustainability. Design research projects with minimal disruption to the clinical workflow; utilize existing community health workers and programs; and integrate behavioral economics principles (nudges) into study design.
  • Budget for community engagement and include community members in study planning from the beginning.
  • Engage in the preferred language of the community. Ensure there are research staff who are fluent in the community’s preferred language and embedded in the community so they can provide key perspectives and help build trust.
  • Provide community health workers and research staff with training on community engagement.
  • Connect with community members where they spend time, such as community events and fairs, and visit local clinics to share information for referrals.

About the Trials

  • AIM-CP, supported by the National Institute of Nursing Research, is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations.
  • APA-SM, supported by the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke, is testing a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in South Carolina and Texas.
  • FM-TIPS, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia.
  • LungSMART, supported by the National Cancer Institute, is testing telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

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

July 10, 2025: Researchers Consider the P Value’s Usefulness in Healthcare Systems Research

Posted on by Karen Staman

The P value is a statistic frequently used in biomedical research for the presentation of study findings. It represents a dichotomous decision about whether a finding is “statistically significant” based on a predetermined level, typically  < .05.

Although the peer-reviewed journals in which researchers aspire to publish their work are anchored to P values, the information used to drive decisions in healthcare is not. At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, a panel led by Greg Simon, leader of the Health Care Systems Interactions Core, discussed P values versus decision-maker perspectives.

Communities, partners, and healthcare systems leaders make decisions based on many, multidimensional factors.

“We care about health outcomes, but we also we care about cost and the satisfaction of members, patients, and employees. Any attempt to roll those up into one statistic is really problematic,” Simon said.

Key Takeaways

  • Where possible, measure and report on what is meaningful to partners, including effect sizes, confidence intervals, cost, and patient and employee satisfaction.
  • Recognize that that P values are a useful metric, but they are only one piece of a larger toolbox.
  • Understand that what is important depends on context, the audience, and local and national priorities.

The panelists included Corita Grudzen, co–principal investigator for the PRIM-ER trial; Rich Platt, co-lead of the NIH Collaboratory’s Distributed Research Network; and Liz Turner, colead of the Biostatistics and Study Design Core.

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

July 1, 2025: As Their Studies Wrap Up, Researchers Share Lessons for Pragmatic Trials

Posted on by Damon Seils

Headshots of Drs. Christine Goertz, Andrea Cook, Shruti Gohil, and Stacy SterlingA key feature of the NIH Pragmatic Trials Collaboratory is its culture of learning and knowledge sharing among investigators who are planning and conducting pragmatic clinical trials. In a session at the program’s 2025 Annual Steering Committee Meeting, a panel of investigators discussed their recently completed NIH Collaboratory Trials and their thoughts about future directions for pragmatic research.

The panelists included Andrea Cook, co–principal investigator (PI) for BackInAction; Shruti Gohil, lead investigator for INSPIRE; and Stacy Sterling, co-PI for GGC4H. Christine Goertz, a co-PI for IMPACt-LBP, moderated the discussion.

Key Takeaways

What do investigators wish they had known before starting a pragmatic trial? Sterling highlighted a need for ongoing engagement with partnering healthcare systems’ senior leaders to ensure they understand the challenges of adopting and sustaining the study intervention. Cook stressed the importance of educating site personnel about what it means to participate in the trial, including the potential for randomization to a usual care arm.

“We also included nonphysician clinicians in the education about the intervention, because they are often doing the steps being targeted by the intervention,” Gohil added.

How can we apply these lessons in future pragmatic trials? “Doing an embedded pragmatic trial is sort of like having a child: You really need the guidance of people who have gone before you and have real-life experience,” Goertz said.

The panelists proposed the development of more standardized materials for the consent process and other trial elements. They also discussed the need for broader dissemination strategies and new ways to promote implementation tools from trials with successful interventions.

Gohil described her research team’s commitment to developing a dissemination toolkit so people will understand how to approach implementation. She noted that, as soon as the trial was completed but before publication, the research team presented the results to the participating sites.

Greg Simon, the PI for SPOT and a member of the NIH Collaboratory Coordinating Center’s leadership team, stressed the importance of including research partners in dissemination.

“Don’t write the discussion section [of your study results paper] until you’ve talked with your healthcare system partners; they might have something to teach us about what the results mean,” he said.

About the Trials

  • BackInAction, supported by the National Center for Complementary and Integrative Health (NCCIH), is comparing standard and advanced courses of acupuncture with usual care for older adults with chronic low back pain.
  • GGC4H, supported by NCCIH, is testing the feasibility and effectiveness of implementing within healthcare systems the Guiding Good Choices program for caregivers of early adolescents to prevent common behavioral problems, such as substance use.
  • IMPACt-LBP, supported by NCCIH, is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain.
  • INSPIRE, supported by the National Institute of Allergy and Infectious Diseases, used personalized clinical decision support to improve judicious antibiotic prescribing for non–critically ill patients hospitalized with abdominal infections or skin and soft tissue infections.
  • SPOT, supported by the National Institute of Mental Health, compared care management and dialectical behavior therapy skills training to usual care for adults at risk of self-harm or suicidal behavior.

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

June 16, 2025: NIH Pragmatic Trials Collaboratory Holds Annual Steering Committee Meeting

Posted on by Damon Seils

The NIH Pragmatic Trials Collaboratory held its 2025 Annual Steering Committee Meeting in Bethesda, Maryland, on May 28 and 29. The program’s leadership discussed evolving approaches to pragmatic clinical trials and considered the latest developments in the landscape of pragmatic research.

All materials from the meeting are now available online.

The NIH Pragmatic Trials Collaboratory added 3 new trials in the past year. The Annual Steering Committee Meeting was a time for new and experienced NIH Collaboratory Trial investigators and program leaders to share challenges and lessons learned in conducting their pragmatic trials.

“The addition of trials to the NIH Collaboratory portfolio is always a highlight of our annual meeting, and this year we were thrilled to welcome 3 new trials,” said Lesley Curtis, chair of the Steering Committee and chair and professor of population health sciences at Duke University.

The LungSMART trial will test telehealth interventions to address barriers to lung cancer screening. The STEP-2 trial will assess the effectiveness of self-testing for cervical cancer. The APA-SM trial will evaluate the effectiveness of self-management of pain using auricular point acupressure.

“These new trials address important public health questions and do so in rural communities and other priority populations,” Curtis noted. Learn more about the NIH Collaboratory Trials.

At the meeting, investigators shared methods for building relationships with communities in pragmatic research, designing and conducting pragmatic trials to support broad implementation, and monitoring and navigating changes in usual care. Investigators and program leaders also considered posttrial obligations, selection of data repositories, and optimal use of digital tools in research.

In the coming weeks, we will share more highlights from the 2025 Annual Steering Committee Meeting. Access the complete meeting materials.

August 13, 2024: EHR Core and Patient-Centered Outcomes Core Reflect on Challenges in Pragmatic Trials

Posted on by Karen Staman

At the NIH Pragmatic Clinical Trials Collaboratory’s 2024 Annual Steering Committee Meeting, leaders of the Electronic Health Records (EHR) Core and the Patient-Centered Outcomes (PCO) Core discussed challenges and lessons learned in the NIH Collaboratory Trials.

EHR cochairs Keith Marsolo and Rachel Richesson shared challenges related to EHR usage, including EHRs switching midtrial, unanticipated changes to the EHR that impacted intervention delivery, and difficulties navigating data sharing policies.

“We continue to be challenged, but we fall back on our core principles, which is looking for good quality data and good quality research with an eye on how we can share the results in the underlying data in the future,” Richesson said.

Over the next year, the EHR Core will explore improving data access, transparency of computable phenotypes, and capturing dietary supplement information in the EHR.

PCO Core cochairs Cristy Zigler and Emily O’Brien shared goals for effective collection PCO data.

“We have advised studies about the importance of delivering patient-reported outcomes to participants in a way that is easy to complete, doesn’t overburden them, and is relevant for their population,” O’Brien said.

The Core has compiled a list of best practices for collecting PCO data and collaborated with the Health Equity Core to create a Health Equity Toolkit, designed to give investigators practical guidance for incorporating health and equity considerations in research.

The Core has also been working closely with Implementation Science Core to consider the sustainability of PCO data systems and facilitate reuse of collection methods.

“We often see separate systems set up to collect PCO data for the trial, and then those systems sunset at the end and are not in place to support an assessment over time,” O’Brien said.

Access the complete meeting materials from the 2024 Annual Steering Committee Meeting.

August 12, 2024: I CAN DO Surgical ACP Seeks to Open the Door to Team-Based Surgical Care

Posted on by Damon Seils

Few of the 20 million older adults who undergo elective surgical procedures in the United States each year engage in advance care planning. I CAN DO Surgical ACP, an NIH Collaboratory Trial, aims to address this missed opportunity to align older patients’ preferences with their surgical decisions and improve patient-clinician communications.

We spoke with co–principal investigator Elizabeth Wick about the I CAN DO Surgical ACP trial at the NIH Collaboratory’s 2024 Annual Steering Committee Meeting.

“We’re really hoping that our trial will open the door to more team-based care in surgery,” Wick said.

Wick is a professor of surgery and the vice chair of quality and safety in the Department of Surgery at the University of California, San Francisco, and cochair of the department’s research committee.

The I CAN DO Surgical ACP trial will will test a system-based approach to help older adults undergoing elective surgery engage in advance care planning. Another goal of the study is to understand digital engagement, language, and social drivers of health that drive engagement in the intervention. The study is supported by the National Institute on Aging.

Learn more about I CAN DO Surgical ACP.

August 8, 2024: FDA Commissioner and NIH Director Share Thoughts on the Future of Pragmatic Clinical Trials

Posted on by Karen Staman

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities.

Califf and Bertagnolli spoke about the role the NIH Collaboratory can play in promoting scientifically rigorous, pragmatic clinical research that addresses the urgent need for better and faster implementation of research findings into patient care. They also addressed shortcomings of the electronic health record (EHR) and the challenges of building a learning health system.

Dr. Monica Bertagnolli and Dr. Robert Califf speak at the NIH Pragmatic Trials Collaboratory's 2024 Annual Steering Committee Meeting

Wendy Weber of the National Center for Complementary and Integrative Health moderated the discussion, which focused on 3 challenges in clinical research and their relation to the NIH Collaboratory:

  • Medical providers and patients lack scientific evidence to support medical decisions
  • A learning health system can help to develop this evidence, but challenges in developing this system remain
  • How can the NIH Pragmatic Trials Collaboratory aid in these challenges?

“The most fundamental flaw we have in general right now is that we don't tell people that their biggest risk is getting standard healthcare in the healthcare system,” Califf said.  “Without evidence, clinicians don't actually know what to do. We act like we know, but we don’t,” he added.

Medical providers and patients alike must often make underinformed decisions. The lack of scientific evidence to support these decisions poses a challenge, as it demands clinicians use their individual experience and judgment when making a recommendation. Here, the deficiencies of the EHR become most obvious, as it fails to meet the needs of the population by not providing sufficient data for providers to refer to. Bertagnolli emphasized this, stating the EHR needed to become a learning environment, facilitating both the collection and dissemination of knowledge even for busy doctors.

“We need to reach every person,” Bertagnolli challenged the researchers in the audience. “We need to get in every corner of the United States with our data, with our research. We need to make it possible for busy doctors and clinics to be in a learning environment,” she said.

“What's the one unifying bit of technology we have that is not delivering what we need? It's the electronic health record,” Bertagnolli added.

Developing a health system that fosters collaboration and constant learning is paramount to obtaining generalizable medical evidence. Califf emphasized this need, calling for a singular “voice” that can represent the population’s prevention and health issues, collectively demonstrating what works.

However, several barriers hinder the development of such a system. The healthcare industry often finds that delivery practices that optimize profit margins are not optimal for patient health outcomes, which creates an environment of ethical uncertainty. Furthermore, the United States spends more on healthcare than do comparable countries with higher life expectancies, leading to unnecessary expenditures and unwillingness to adopt new initiatives.

“We're paying for a lot of things that don't help. So how are we going to figure out what to stop doing?” Bertanolli asked. “The only way is data. And the only people who can bring that data are our care providers to collect those data and learn from them. It is imperative to get a learning health system in progress,” she said.

The NIH Pragmatic Trials Collaboratory has long played a role in establishing cost-effective, large-scale research that treats care providers as research partners to deliver generalizable, actionable data. The program’s efforts in promoting collection of data from clinical care environments ensure that research remains grounded in real-world patient outcomes. Moreover, the NIH Collaboratory's emphasis on gathering data from underrepresented populations enhances the relevance of research findings, addressing disparities in healthcare delivery and outcomes.

Along with data collection, Bertagnolli encouraged the NIH Collaboratory to be an advocate for this new health system and encourage organizations to participate in the development of this system. The NIH Collaboratory brings years of specialized clinical knowledge and input, ensuring that the system is informed by evidence-based practices and responsive to the needs of both care providers and patients.

“It's a matter of convincing people to get over the hump, embrace a learning health system, and participate—and specifically, I'd say get the wheel turning as fast as you can, answer as many questions as you can, and talk about it,” added Califf.

View the full materials from the 2024 Annual Steering Committee Meeting.