March 14, 2024: IMPACT Collaboratory Announces New Statistical Tools for Pragmatic Trials

The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available.

The program’s Design and Statistics Core developed the statistical tools and related resources to aid in the design and analyses of pragmatic trials embedded in healthcare systems. These methods, manuscripts, statistical programs, and interactive web applications are available to help researchers calculate sample sizes, intracluster correlations, and statistical power for stepped-wedge and other cluster randomized designs.

The tools and other resources include:

  • Tool to calculate intracluster correlation coefficients for designing cluster randomized trials
  • Tool to simulate intracluster correlation coefficients among Medicare beneficiaries with dementia for hospitalizations, emergency department visits, and deaths across US hospital referral areas
  • Power analyses for stepped-wedge designs with multivariate continuous outcomes
  • Power and sample size requirements for generalized estimating equation analyses of cluster randomized crossover trials
  • Information content of stepped-wedge designs when treatment effect heterogeneity and/or implementation periods are present

More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.

Visit the IMPACT Collaboratory’s Statistical Tools web page.

The IMPACT Collaboratory is supported by a grant from the National Institute on Aging.

March 13, 2024: In This Friday’s PCT Grand Rounds, a Pragmatic Trial of Antibiotic Choice on Renal Outcomes

Headshot of Dr. Edward Qian
Dr. Edward Qian

In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial."

The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern.

The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults. In this innovative study, randomization of eligible patients occurred at the prescriber level within the electronic medical record.

Qian, the principal investigator for ACORN, is an assistant professor of medicine and the assistant director for quality and education of the medical ICU at the Vanderbilt University Medical Center.

Join the online meeting.

March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials

Headshot of Dr. Stepanie Morain
Dr. Stephanie Morain

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.

The open-access article was published this week in Learning Health Systems.

Much of the literature on posttrial responsibilities offers guidance on what is owed to research participants and broader communities at the conclusion of traditional explanatory clinical trials. Similar guidance is lacking for pragmatic trials.

The NIH Collaboratory researchers, led by Stephanie Morain of Johns Hopkins University, explore the distinct considerations that shape posttrial responsibilities in pragmatic trials. These include the responsibilities of the healthcare systems in which these trials are embedded, and decisions about implementation of interventions that show meaningful benefit after their integration into usual care settings, as well as deimplementation of those that do not.

Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from [pragmatic trials] does, in fact, influence real-world practice.

The article was coauthored by members of the NIH Collaboratory’s Ethics and Regulatory Core and Implementation Science Core, including Pearl O’Rourke, formerly of Partners HealthCare; Joseph Ali and Jeremy Sugarman of Johns Hopkins University; Vasiliki Rahimzadeh of the Baylor College of Medicine; and Devon Check and Hayden Bosworth of Duke University.

Read the full article.

 

March 6, 2024: In This Week’s PCT Grand Rounds, Public-Private Partnerships in Health AI

In this Friday’s PCT Grand Rounds, Michael Pencina of Duke University will present “Public-Private Partnerships in the Trustworthy Health AI Ecosystem.”

The Grand Rounds session will be held on Friday, March 8, 2024, at 1:00 pm eastern.

Pencina is a professor of biostatistics and bioinformatics and the vice dean for data science in the Duke University School of Medicine. He is the director of the university’s Duke AI Health initiative and the chief data scientist for Duke Health.

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March 5, 2024: Registration Opens for Pragmatic Trials Workshop at SCT 45th Annual Meeting

The NIH Pragmatic Trials Collaboratory will offer a preconference workshop at the 45th Annual Meeting of the Society for Clinical Trials in Boston. Registration for the workshop is now open.

The workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on engaging stakeholders and measuring outcomes, including patient-reported outcomes.

The workshop will provide an introduction to the opportunities for embedded healthcare systems research, along with strategies for conducting patient-centered clinical trials that provide real-world evidence necessary to inform improvements in healthcare. The workshop format is as follows:

  • A series of didactic presentations, each with ample time for attendee Q & A with presenters. Firsthand experiences with embedded pragmatic clinical trials and case studies from the NIH Pragmatic Trials Collaboratory will support and illustrate the topics presented. Live polling will be used to encourage attendee interaction around the topics.
  • Small group hands-on learning activity in which attendees work together to problem-solve real challenges encountered in embedded pragmatic clinical trials. A report out from the activity will further support collaborative learning.
  • Interactive, facilitated panel discussion with experienced principal investigators from the NIH Collaboratory Trials.

Goals of the workshop:

  1. To clarify the definition of pragmatic clinical trials embedded in healthcare systems and explain their utility.
  2. To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems.
  3. To increase the capacity to address important patient-centered questions with ePCTs in real-world settings.

The theme of this year’s SCT Annual Meeting is “It Takes a Village: Patient Centered Partnerships in Clinical Trials.” The conference brings together the clinical trials community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.

WORKSHOP DETAILS AND REGISTRATION
Sunday, May 19, 8:00 am-12:00 pm
Boston Marriott Copley Place, Boston, Massachusetts

February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.”

The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern.

Doyle is the Erwin H. Schell Professor of Management and Applied Economics at the MIT Sloan School of Management. His healthcare research includes partnering with large healthcare systems to conduct randomized trials of changes in the ways healthcare is delivered.

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February 27, 2024: HCSRN Announces Preconference Grant Writing Workshop, Extends Early-Bird Registration

HCSRN Milwaukee 2024 logoThe Health Care Systems Research Network (HCSRN) extended early-bird registration for its 2024 Annual Conference to February 29. The conference will be held from April 9 to 11 in Milwaukee, Wisconsin.

New this year, a preconference grant writing workshop will take place on Monday, April 8. The workshop will bring together experts throughout HCSRN to assist early investigators with NIH R series applications. Participants will learn how to write compelling specific aims, how to tell a story, and create a conceptual model.

This year’s opening plenary session will feature keynote speaker David Kent, director of the Tufts Predictive Analytics and Comparative Effectiveness Center and a professor of medicine, neurology, and clinical and translational science at Tufts Medical Center and Tufts University School of Medicine. His keynote presentation will address bias and fairness in algorithmic models.

The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. The HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of learning healthcare systems. Learn more about the HCSRN.

This year, the HCSRN is celebrating its 30th anniversary. From its founding in 1994, the HCSRN has hosted an annual conference geared toward bringing together a diverse group of researchers, study managers, clinicians, funding agency personnel, and patient-partners to promote collaboration and share findings about research in real-world care delivery settings. Early-bird registration is open until February 29.

February 26, 2024: In PRIM-ER Qualitative Study, EM Talk Program Improved Serious Illness Conversation Skills

Dr. Oluwaseun Adeyemi, lead author of the report

Communication skills training using the EM Talk model reached a high proportion of clinicians in participating emergency departments and improved their serious illness conversation skills, according to a qualitative study conducted as part of the PRIM-ER trial. The observed reach and effectiveness of the training program has the potential to improve use of these skills in clinical practice.

The results of the study were published last week in BMC Palliative Care.

PRIM-ER, an ongoing NIH Collaboratory Trial, is a stepped-wedge, cluster randomized trial testing a multidisciplinary primary palliative care intervention in a diverse mix of emergency departments in the United States. The intervention consists of education, clinical decision support, and other elements and is intended to improve the delivery of goal-directed emergency care of older adults.

The PRIM-ER intervention includes, among other elements, communication skills training and simulation workshops for emergency medicine clinicians using the EM Talk training program. The program is designed to improve serious illness conversation skills for emergency medicine physicians and advanced practice providers.

The authors of the report, led by Oluwaseun Adeyemi of New York University, under the guidance of principal investigators Corita Grudzen and Keith Goldfeld, found that 85% of emergency medicine physicians and advanced practice providers across 33 emergency departments completed the EM Talk training. In course evaluations completed after the training, participants reported that the training improved their serious illness conversation skills and their attitude toward engaging patients in serious illness conversations. Participants also reported that the training encouraged them to commit to using these skills in clinical practice.

A previously published study by the PRIM-ER research team reported the reach and effectiveness of a related training program for emergency nurses.

PRIM-ER is supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute on Aging. Read more about PRIM-ER.

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.

February 21, 2024: In This Week’s PCT Grand Rounds, Virtual Monitoring in Decentralized Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”

The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern.

Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine. He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Lindsell is the director of data science and biostatistics at the DCRI and professor and cochief of biostatistics in the Department of Biostatistics and Bioinformatics in the Duke University School of Medicine.

Join the online meeting.