pragmatic clinical trials

January 9, 2024: Ethics Consultation Documents Now Available for iPATH Trial

Posted on by Damon Seils

Ethics and regulatory onboarding documentation is now available for iPATH, one of the NIH Pragmatic Trials Collaboratory's newest pragmatic clinical trials. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the study.

The consultation took place by video conference and included representation from the study's principal investigator and study team, members of the NIH Collaboratory's Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.

The goal of iPATH is to refine and implement an approach to practice transformation that was originally conceived and pilot-tested to support federally qualified health centers (FQHCs) in their pursuit of National Committee for Quality Assurance recognition as patient-centered medical homes for patients with type 2 diabetes. The study will include extensive qualitative work to identify implementation factors in FQHCs that are diverse in terms of geography, race/ethnicity, and diabetes control performance; and to customize and comprehensively evaluate the implementation approach.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

January 3, 2024: Special Biostatistics Series Concludes With Missing Data in Cluster Randomized Trials

Posted on by Damon Seils

In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern.

Wang is an associate professor of population medicine and the director of the Division of Biostatistics in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She is also an associate professor in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health. She is a longtime member of the NIH Pragmatic Trials Collaboratory's Biostatistics and Study Design Core Working Group.

This session's moderator, Fan Li, is an assistant professor of biostatistics at the Yale School of Public Health.

Join the online meeting.

This special Grand Rounds series includes moderated webinar discussions that bring together biostatisticians, clinical trials methodologists, and investigators to discuss challenges and share lessons learned in the design, implementation, and analysis of pragmatic trials. Download the series flyer and see the full schedule below, including archived webinar recordings and slides from previous sessions.

All sessions are free and open to the public. No registration is required.

December 18, 2023: Ethics Consultation Documents Now Available for ARBOR-Telehealth and I CAN DO Surgical ACP

Posted on by Damon Seils

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the ARBOR-Telehealth and I CAN DO Surgical ACP studies.

The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel. Both projects are in their planning phase.

ARBOR-Telehealth will evaluate the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. A secondary aim of the study is to compare the effectiveness of the study's risk-stratification approach.

I CAN DO Surgical ACP will identify a system-based approach to help older adults undergoing elective surgery engage in advance care planning. The project will leverage the existing electronic health record and patient portal, PREPARE for Your Care materials to assist patients with completion of advance care planning, virtual healthcare navigators, and electronic nudges. Another goal of the study is to understand digital engagement, language, and social drivers of health that drive engagement in the intervention.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A collage of journal cover images.Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the Distributed Research Network, and study designs and results from the NIH Collaboratory Trials.

This year, the NIH Collaboratory contributed nearly 30 articles to the peer-reviewed literature, including the study design papers for the GRACE and BackInAction trials.

The total number of published articles from the NIH Collaboratory surpassed 300 this year. Learn more about the program's publications.

Coordinating Center

Cross-Core Collaboration

Distributed Research Network

Biostatistics and Study Design Core

Ethics and Regulatory Core

ACP PEACE

BackInAction

EMBED

GRACE

LIRE

Nudge

OPTIMUM

PRIM-ER

STOP CRC

December 6, 2023: Jumpstarting Communication About Goals of Care, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Drs. Ruth Engelberg, Erin Kross, and Robert LeeIn this Friday's PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present "A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness."

The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm eastern.

Engelberg is a research professor of medicine, Kross is an associate professor of medicine, and Lee is an assistant professor of medicine in pulmonary, critical care, and sleep medicine at the University of Washington.

Join the online meeting.

December 5, 2023: Applications Open for HDRN Canada Pragmatic Trials Training Program

Posted on by Damon Seils

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program.

This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors. Funding will be made available to successful applicants across all 3 streams to facilitate their engagement in the program.

Access the application forms.

Applications will be accepted until Friday, December 22, 2023. The program will commence on April 15, 2024.

There will be an emphasis on experiential learning for future trial leaders and postdoctoral fellows in the program through the development of a pragmatic trial protocol. Moreover, the program is aiming for highly qualified personnel employed by HDRN Canada member organizations to be involved, when possible, in a project-based learning experience. These projects will further HDRN Canada’s ability to support pragmatic trials research in the long term. (Note, however, that the highly qualified personnel stream is not restricted to applicants from HDRN Canada.)

November 29, 2023: Special Biostatistics Series Continues With Guidelines for Stepped-Wedge Trials

Posted on by Damon Seils

In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern.

Hughes is a professor emeritus of biostatistics at the University of Washington. This session’s moderator, Patrick Heagerty, is a professor of biostatistics at the University of Washington and a cochair of the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core.

Join the online meeting.

This special Grand Rounds series will include additional moderated webinar discussions that bring together biostatisticians, clinical trials methodologists, and investigators to discuss challenges and share lessons learned in the design, implementation, and analysis of pragmatic trials. Download the series flyer and see the full schedule below.

All sessions are free and open to the public; no registration is required.

November 28, 2023: Workshop Summary Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Posted on by Karen Staman

The workshop summary is now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

The workshop included 4 panels:

  • Panel 1: How Have Health Systems Made Decisions Based on Evidence Collected in PCTs?

    • Panelists: Devon Check, Vincent Mor, Lynn DeBar, Kathryn Glassberg, Douglas Zatzick, Eileen Bulger, Susan Huang, Kenneth Sands, Edward Septimus; Moderator: Gregory Simon

  • Panel 2: How Do We Generate the Right Evidence to Support Decision-Makers?

    • Panelists: Kenneth Sands, Eileen Bulger, Edward Septimus, Amy Kilbourne, Rosa Gonzalez-Guarda, Patrick Heagerty; Moderator: Hayden Bosworth

  • Panel 3: Learning Faster

    • Panelists: Gloria Coronado, Natalia Morone, Corita Grudzen, Kevin Chan, Pearl O’Rourke, Cheryl Boyce, Andrea Cook; Moderator: Kevin Weinfurt

  • Panel 4: Potential Structures and Incentives for Faster Learning

    • Panelists: David Chambers, Wynne Norton, Tisha Wiley, Kenneth Sands, Edward Septimus, Gloria Coronado, Natalia Morone, Corita Grudzen; Moderator: Richard Platt

Access the complete workshop materials, including slides and videocast recordings, as well as the keynote presentation by Andrew Bindman, executive vice president and chief medical officer for Kaiser Permanente.

November 15, 2023: In This Friday’s PCT Grand Rounds, Results From the Nudge NIH Collaboratory Trial

Posted on by Damon Seils

In this Friday's PCT Grand Rounds, Michael Ho and Sheana Bull of the University of Colorado will present "Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results From the Nudge Study."

The Grand Rounds session will be held on Friday, November 17, 2023, at 1:00 pm eastern.

Nudge is an NIH Collaboratory Trial. Ho is a professor of medicine and Bull is a professor of community and behavioral health at the University of Colorado. They are the co–principal investigators of Nudge.

Join the online meeting.

November 2, 2023: NIH Pragmatic Trials Collaboratory Launches New Online Training Resources

Posted on by Elizabeth Mccamic

The NIH Pragmatic Trials Collaboratory has launched an enhanced training section of rethinkingclinicialtrials.org that includes a new series of video learning modules and reorganized and refreshed pragmatic clinical trials training resources.

The new training section features a series of 8 self-paced, guided video modules on topics that cover every phase of a pragmatic clinical trial. The learning modules feature NIH Pragmatic Trials Collaboratory experts and can be viewed as a series or individually, depending on the goals of the learner.

The revamped training section also includes a newly organized video library, a workshops page, and a resources page with a categorized index of the NIH Collaboratory’s handouts, guides, and worksheets. These new webpages allow learners to more easily find resources that match their interests through the addition of new filters, categories, and improved search functions.

“The NIH Pragmatic Trials Collaboratory has a wealth of resources that are now easier and more engaging to use,” said Kevin Weinfurt, PhD, a co-principal investigator for the NIH Pragmatic Trials Collaboratory Coordinating Center. “I look forward to seeing how learners engage with our enhanced content and hope that the resources inspire future pragmatic clinical trials.”

The NIH Pragmatic Trials Collaboratory Coordinating Center led the training resource enhancements in partnership with Symphony Learning Partners. Additional learning tools will be available in the coming months.

“I’m excited for learners to experience our enhanced training offerings, which include a wealth of knowledge we’ve generated as a program,” said Tammy Reece, MS, PMP, CCRA, program director of the NIH Pragmatic Trials Collaboratory Coordinating Center. “This is a unique online resource in the field of pragmatic research that will continue to expand.”