August 25, 2026: NOHARM Team Describes Strategies for Posttrial Sustainment of Interventions

Headshot of Shritha Gayathri
Shritha Gayathri, lead author of the report

A new article from the NOHARM team describes the strategies the team identified for supporting posttrial sustainment of the study intervention. Their experience highlights the importance of planning for sustainment and offers lessons for designers of future pragmatic clinical trials.

The article was published online in Learning Health Systems.

NOHARM, an NIH Collaboratory Trial led by Andrea Cheville and Jon Tilburt of Mayo Clinic, is testing an electronic health record–embedded educational bundle that encourages incorporation of nonpharmacologic pain care into perioperative pain management.

The study team interviewed members of the trial’s sustainment committee and reviewed the committee’s meeting minutes to identify strategies and challenges. The strategies and challenges were grouped into 6 themes:

  • automation of low-touch intervention components
  • reliance on internal institutional champions
  • intentional handoff communication
  • institutional attention
  • relaxed implementation fidelity
  • continuous evaluation

The study team highlighted the importance of planning ahead for sustainment, thinking beyond trial settings, and using theoretically grounded approaches.

Read the full article.

NOHARM 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.

 

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

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

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

February 9, 2026: New NIH Collaboratory Resource Highlights Dissemination Opportunities for Pragmatic Trials

The NIH Pragmatic Trials Collaboratory published a new handout describing the variety of dissemination opportunities for pragmatic clinical trials to help investigators plan for broad dissemination.

Pragmatic clinical trials embedded in healthcare systems are designed to answer pressing questions of interest to healthcare system leaders, patients, and frontline clinicians. The results of pragmatic trials can also inform regulators, policymakers, payers, and others. Disseminating findings widely is paramount for these trials to have real-world impact.

The new handout, which was developed by the NIH Collaboratory Coordinating Center with input from investigators for several of the NIH Collaboratory Trials, offers examples of strategies for broad dissemination of trial results beyond academic publications.

View the handout: Dissemination Opportunities for Pragmatic Trials

January 27, 2026: Workshop Materials Available From ‘Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions’

Logo for the 18th Annual Conference on the Science of Dissemination and Implementation in HealthComplete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions.”

The full-day workshop, held on December 14 at AcademyHealth’s 18th Annual Conference on the Science of Dissemination and Implementation in Health, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers. Presenters shared firsthand experiences and case studies from the NIH Collaboratory Trials. The learning objectives of the workshop included:

  • To identify areas of synergy between embedded pragmatic clinical trials and implementation research
  • To introduce participants to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded in diverse healthcare systems, and describe opportunities for integrating implementation research methods into these trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials, and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

Access the complete workshop materials, including slides, speaker biographies, and the full participant guide.

December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Cover image of the journal Clinical TrialsIn a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation.

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

There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants. However, this practice has not been examined in the context of pragmatic clinical trials, which have special features that may complicate the ethics and logistics of sharing aggregate results.

The report’s authors summarize the ethical arguments for sharing aggregate results and describe the features of pragmatic trials that may raise logistical and other barriers to disclosure. They also discuss the important role healthcare system partners play in sharing results from pragmatic trials.

The authors offer the following recommendations:

  • Sharing aggregate results with research participants should be the default, and decisions not to share should be justified
  • Planning for sharing aggregate results should begin early in the planning of the trial
  • The healthcare care systems in which the trial is embedded should be key partners in decisions about what and how to share
  • Proactive sharing of results from a pragmatic trial that was conducted under a waiver or alteration of consent, including an explanation for why consent was not obtained in the study, can promote trust in the investigators and their healthcare system partners

Read the full report.

The article was coauthored by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, including Stephanie Morain, Abigail Brickler, Joseph Ali, Caleigh Propes, and Kayla Mehl of Johns Hopkins University; Pearl O’Rourke, formerly of Partners HealthCare; Kayte Spector-Bagdady of the University of Michigan; Benjamin Wilfond of the Seattle Children’s Hospital; Vasiliki Rahimzadeh of the Baylor College of Medicine; and David Wendler of the NIH Clinical Center.

October 22, 2024: Registration Opens for Pragmatic Trials Workshop at AcademyHealth–NIH Dissemination & Implementation Conference

AcademyHealth D&I Conference logoThe NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

The theme of this year’s D&I conference is “Moving Fast and Slow: Optimizing the Pace of Implementation.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 8, 10:00 am-6:00 pm
Crystal Gateway Marriott, Arlington, Virginia

May 16, 2024: Journal Peer Reviewers Are Familiar With Pragmatic Trials, Want More on Implementation

According to a report from the NIH Pragmatic Trials Collaboratory Coordinating Center, journal editors and peer reviewers were familiar with pragmatic clinical trials and their designs and analytic approaches, but they often asked for more information about intervention implementation.

The report was published this week in the Living Textbook of Pragmatic Clinical Trials.

The report’s authors invited the principal investigators of the first several completed NIH Collaboratory Trials to confidentially share the journal peer reviews of manuscripts reporting the trials’ main outcomes. They independently reviewed the peer reviews of the manuscripts to note common questions and themes.

“We did not generally observe that reviewers were unfamiliar with pragmatic clinical trials or had difficulty understanding the design and analytic approaches of the studies,” the authors reported. Instead, they found that the reviewers in many cases requested more information about implementation outcomes, implementation strategies, and intervention content.

Although many of the NIH Collaboratory Trial teams have published separate implementation-focused papers, the report suggests that reviewers may want or expect some of this information to be included with the report of primary study outcomes to aid in the interpretation of results.

Read the full report.

May 13, 2024: Ongoing Funding Opportunity Supports Studies of Implementation and Sustainability of Interventions

NIH logoAn ongoing funding opportunity from the National Institutes of Health (NIH) is supporting dissemination and implementation research in health. The purpose of the funding opportunity is “to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies.”

Posttrial sustainment and deimplementation of study interventions has been a focus of the NIH Collaboratory’s Implementation Science Core. In a recent article, investigators from 6 of the program’s completed pragmatic clinical trials summarized the posttrial interpretation of their trials’ results and considered the factors that influenced the sustainment or deimplementation of the studies’ interventions.

The article was published early this year in the Journal of General Internal Medicine.

Three lessons emerged from the review:

  • Ineffective interventions may be sustained if they have other measured or perceived benefits.
  • Effective interventions may not be sustained if they require significant resources.
  • Alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions.

Read about the NIH funding opportunity for research that supports the dissemination and implementation of evidence-based interventions.

February 22, 2024: Updated Template Provides Guidance for Reporting of Pragmatic Trial Results

An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials.

The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems in the conduct of pragmatic trials, and special ethical and regulatory considerations.

Download the template.

The updated template is organized by the recommended reporting elements presented in the CONSORT checklist and draws on recent experiences and lessons learned from the NIH Collaboratory Trials. Appendices include links to CONSORT and its relevant extensions, the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tools and resources, and examples of figures to include in pragmatic trial reports.

October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

The theme of this year’s D&I conference is “Raising Expectations for D&I Science: Challenges and Opportunities.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 10, 10:00 am-6:00 pm
Gateway Marriott, Arlington, Virginia