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.

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February 19, 2024: Virtual Monitoring in Decentralized Trials, in This Week’s PCT Grand Rounds

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.

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February 14, 2024: In This Friday’s PCT Grand Rounds, Clinical Implications of the MINT Trial

Dr. Jeffrey Carson

In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.”

The Grand Rounds session will be held on Friday, February 16, 2024, at 1:00 pm eastern.

Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard C. Reynolds, MD, Chair in General Internal Medicine at Rutgers Robert Wood Johnson Medical School.

Carson will discuss the clinical implications of the Myocardial Ischemia and Transfusion (MINT) trial, a pragmatic clinical trial that did not show a significant difference between the study arms in the primary outcome yet consistently favored one intervention strategy in the point estimates for the primary and secondary outcomes.

The goal of the MINT trial was to determine whether the risk of recurrent myocardial infarction or death at 30 days differed between a restrictive transfusion strategy and a liberal transfusion strategy among patients with an acute myocardial infarction and anemia. The pragmatic trial’s broad inclusion criteria resulted in a study population with a variety of diagnoses and coexisting illnesses that was generally representative of patients in clinical practice. The trial’s transfusion protocols approximated clinical practice in a variety of healthcare settings.

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February 13, 2024: New Chapter of Living Textbook Highlights Value of Patient Engagement and Provides Practical Strategies

Dr. Steven George

The NIH Pragmatic Trials Collaboratory published a new chapter in its Living Textbook of Pragmatic Clinical Trials. The chapter, Patient Engagement, describes principles and strategies for effectively engaging patient partners.

Because patients can provide valuable insights and perspectives about clinical care for specific conditions, they are key partners for pragmatic clinical trials. The chapter highlights the value of patient engagement and provides practical tactics for patient engagement throughout the life cycle of a pragmatic trial. It also recognizes potential barriers to patient engagement and case studies in the pragmatic trials context.

For more on partnership in pragmatic trials, see the chapters on Building Partnerships and Teams to Ensure a Successful Trial; Participant Recruitment; and Dissemination Approaches for Different Stakeholders.

Read more about the Living Textbook.

February 8, 2024: HCSRN Nears Early-Bird Registration Deadline, Announces Opening Plenary Speaker

HCSRN Milwaukee 2024 logoThe Health Care Systems Research Network (HCSRN) continued early-bird registration and announced the opening plenary speaker for its 2024 Annual Conference, which will be held from April 9 to 11 in Milwaukee, Wisconsin.

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 18.

February 7, 2024: Pragmatic Recruitment of Underrepresented Groups, in This Week’s PCT Grand Rounds

In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.”

The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern.

Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System. Hau recently led a secondary analysis of the Diuretic Comparison Project presenting a centralized electronic health record–based model for the recruitment of participants from underrepresented groups.

Join the online meeting.