Pragmatic clinical trials embedded in healthcare systems rely on partnerships between investigators and healthcare system leaders to conduct research. As the end of a pragmatic trial approaches, research teams and their partners often face uncertainties around this undefined phase when researchers are waiting on results. End-of-trial decision-making, including whether to sustain an intervention, has implications ...

A video decision aid for older patients with advanced cancer, coupled with communication skills training for clinicians, led to higher rates of documented advance care planning in oncology clinics, according to the ACP PEACE study. The results of the study were published in the May issue of JAMA Network Open. Many older adults with advanced cancer do ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Jeffrey Spaeder and Adrian Hernandez will present “Pivoting Clinical Trials Into a New and Evolving World.” The Grand Rounds session will be held on Friday, May 16, 2025, at 1:00 pm eastern. Spaeder is the chief medical and scientific officer at IQVIA. Hernandez, who serves as co–principal investigator of ...

In this Friday’s PCT Grand Rounds, Andrea Cook, Lynn DeBar, and Patricia Herman will present “A Policy-Relevant Pragmatic Trial on Acupuncture Effectiveness for Low Back Pain in Older Adults: Clinical and Cost Outcomes and Lessons Learned.” The Grand Rounds session will be held on Friday, May 9, 2025, at 1:00 pm eastern. The speakers will present the ...

The Nudge Unit at Penn Medicine opened registration and abstract submissions for the 2025 Nudges in Health Care Symposium. The event is “focused on exploring the application of behavioral economics principles and nudges in healthcare settings.” The Nudge Unit is supported by Center for Health Care Transformation and Innovation and the Penn Center for Health Incentives ...

In this Friday’s PCT Grand Rounds, Roland RJ van Kimmenade will present “Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake: The FRESH-UP Study.” The Grand Rounds session will be held on Friday, May 2, 2025, at 1:00 pm eastern. Van Kimmenade is a cardiologist at Radboud University Medical Center in Nijmegen, Netherlands. Join the online meeting.

In this Friday’s PCT Grand Rounds, Ming Tai-Seale of the University of California, San Diego, will present “Automated Response Technology Integrated Into EMR and Physician-Patient Communication.” The Grand Rounds session will be held on Friday, April 25, 2025, at 1:00 pm eastern. Tai-Seale is professor and vice chair of research in the Department of Family Medicine at ...

Even in minimal-risk studies that do not use the standard consent process, there may be value in informing participants about the research. Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory. The open-access article was ...

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory’s newest studies is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the LungSMART trial and the STEP-2 trial. The consultations took place by video conference and included representation from the study ...

Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. The work, which was supported by the NIH Pragmatic Trials Collaboratory’s Distributed Research Network and by a grant from the National Institute on Aging, was published this week in Alzheimer’s & Dementia: ...

In this Friday’s PCT Grand Rounds, Sanjit Jolly of McMaster University will present “Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial.” The Grand Rounds session will be held on Friday, April 18, 2025, at 1:00 pm eastern. Jolly is an interventional cardiologist at Hamilton Health Sciences and the Stuart ...

The TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone! TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis. The practice of tai ...

A program that used automated prompts to deliver patient-specific risk information to clinicians led to significant reductions in the use of extended-spectrum antibiotics for hospitalized patients, according to the INSPIRE trials. The results of the trials were published online ahead of print in JAMA Internal Medicine and JAMA Surgery. INSPIRE, an NIH Collaboratory Trial, consists of 2 ...

In this Friday’s PCT Grand Rounds, Jeremy Shefner of the Barrow Neurological Institute will present “A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial.” The Grand Rounds session will be held on Friday, April 11, 2025, at 1:00 pm eastern. Shefner is a professor of neurology at the Barrow Neurological ...

The study design paper for IMPACt-LBP has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! IMPACt-LBP is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain. The study team is seeking to determine if ...

In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern. Heerman is an associate professor of internal medicine and pediatrics, the William K. ...

In this Friday’s PCT Grand Rounds, Matthew Engelhard and Anivarya Kumar of Duke University will present “A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management.” The Grand Rounds session will be held on Friday, March 28, 2025, at 1:00 pm eastern. Engelhard is an assistant professor ...

Researchers from iPATH, an NIH Collaboratory Trial, described key considerations for integrating artificial intelligence tools into analyses of qualitative data. The report was posted this month on the AcademyHealth Blog. The iPATH trial, led by principal investigator Sara Singer at Stanford University, will test the implementation of a practice transformation strategy for type 2 diabetes in federally ...

In this Friday’s PCT Grand Rounds, Alexander J. “AJ” Blood of Harvard Medical School and Brigham and Women’s Hospital will present “Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care.” The Grand Rounds session will be held on Friday, March 21, 2025, at 1:00 pm eastern. Blood is an instructor of medicine ...

In a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in non–intensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections. The study results were published this month in JAMA Network Open. ABATE Infection, an NIH Collaboratory Trial, was a cluster ...

In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND. Join the online meeting.

The study design paper for the MOMs Chat & Care Study has been published online ahead of print in Contemporary Clinical Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! The MOMs Chat and Care Study is testing the effectiveness of an integrated care model approach at 2 levels ...

In an article published online ahead of print, leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk. Challenges specific to pragmatic trials include: complexity, quality, and timing of ...

In recent months, 5 of the newest NIH Collaboratory Trials have begun to enroll research participants. Congratulations to the study teams from ARBOR-Telehealth, BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and the MOMs Chat & Care Study for reaching this important project milestone!  ARBOR-Telehealth is evaluating the use of a telehealth physical therapy ...

In this Friday’s PCT Grand Rounds, F. Perry Wilson of Yale University will present “A Trial of a “Kidney Action Team” for Hospitalized Patients with Acute Kidney Injury.” The Grand Rounds session will be held on Friday, March 7, 2025, at 1:00 pm eastern. Wilson is an associate professor of medicine and public health and the director ...

Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications. The article was published online in Statistics in Medicine. In cluster randomized trials with stepped-wedge designs, ...

In a survey of pragmatic clinical trials across 3 NIH research networks, the complexity of delivering nonpharmacological interventions was similar between pain-related trials and non–pain-related trials. However, pain trials tended to have more intervention components, add more new tasks, and require modifications to existing workflows. The results of the study were published online ahead of print ...

In this Friday’s PCT Grand Rounds, Michele Balas and Ed Vasilevskis will present “Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST-ICU): Protocol, Challenges, and Major Updates.” The Grand Rounds session will be held on Friday, February 28, 2025, at 1:00 pm eastern. BEST-ICU, an NIH Collaboratory Trial ...

The NIH HEAL Initiative’s Common Data Elements (CDE) program this week announced the release of an online tool to calculate morphine milligram equivalents (MME), a standardized metric for reporting prescribed opioid use. In a webinar scheduled for Friday, March 7, speakers from the CDE program will explain the tool, demonstrate how researchers can use the tool ...

New study snapshots and updated ethics and regulatory documentation are now available for the AIM-CP, ARBOR-Telehealth, and RAMP trials. The 3 NIH Collaboratory Trials, all supported through the NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, reflect a special emphasis on developing strategies for the management of chronic pain in rural and remote ...

In this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull will present “Texting for Behavior Change: Lessons Learned Across 2 Interventions to Improve Chronic Care Management.” The Grand Rounds session will be held on Friday, February 21, 2025, at 1:00 pm eastern. This Grand Rounds session will report the results of Chat 4 Heart Health, an ...

The Health Care Systems Research Network (HCSRN) extended the early-bird registration deadline for its 2025 Annual Conference to February 28. The conference will be held from April 8 to 10 in St. Louis, Missouri. The theme of this year’s conference is “Optimizing Collaborations to Advance Health In a Dynamic Research Landscape.” The conference will provide networking ...

In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).” The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern. ACP PEACE, an NIH Collaboratory ...

In this Friday’s PCT Grand Rounds, Lillian Sung of the Hospital for Sick Children will present “Improving Symptom Control in Pediatric Cancer Patients With SSPedi and SPARK.” The Grand Rounds session will be held on Friday, February 7, 2025, at 1:00 pm eastern. The Symptom Screening in Pediatrics Tool (SSPedi) is a validated approach to measuring bothersome ...

A workshop summary, videocast recordings, and other materials are now available from the NIH Pragmatic Trials Collaboratory’s 2024 virtual workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.“ The 2-day workshop, hosted by the NIH, featured a keynote address by Monica Bertagnolli exploring how to identify high-priority healthcare ...

In this Friday’s PCT Grand Rounds, Richard Skolasky and Kevin McLaughlin of Johns Hopkins University will present “Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned.” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of ...

A new study snapshot and updated ethics and regulatory documentation are now available for the TAICHIKNEE trial. One year into the study, and after receiving approval to transition from the planning phase to the implementation phase, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. New resources ...

In this Friday’s PCT Grand Rounds, Jeffrey Samet of Boston University will present “The HEALing Communities Study—10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths.” The Grand Rounds session will be held on Friday, January 24, 2025, at 1:00 pm eastern. Samet is the John Noble Professor in General Internal Medicine ...

An evidence-based training program to improve the capacity of emergency department care teams to communicate with seriously ill older patients about palliative care did not lead to lower rates of hospital admission, according to the results of the PRIM-ER trial. The results were published online ahead of print in JAMA. More than three-quarters of seriously ill older ...

In this Friday’s PCT Grand Rounds, Chris Lindsell of Duke University will present “Design for Diversity.” The Grand Rounds session will be held on Friday, January 17, 2025, at 1:00 pm eastern. Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics ...

Ethics and regulatory onboarding documentation for one 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 APA-SM trial. The consultations took place by video conference and included representation from the study team, members of the ...

The NIH Pragmatic Trials Collaboratory is pleased to welcome the STEP-2 trial (Self-Testing for Cervical Cancer in Priority Populations) to its portfolio of innovative NIH Collaboratory Trials. Only half of eligible patients in US federally qualified health centers were screened for cervical cancer in 2021. The COVID-19 pandemic exacerbated these disparities. Distribution of human papillomavirus (HPV) ...

In this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.” The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern. FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to ...

In an upcoming session of the VA Spotlight on Pain Management Cyberseminars series curated by the Pain Management Collaboratory (PMC), Julie Fritz and Dan Rhon will present “Supporting Whole Person Pain Management in the Military Health System.” The session will be held on Tuesday, January 7, from 11:00 am to 12:00 pm eastern. Improving care for ...

A new study snapshot and updated ethics and regulatory documentation are now available for the I CAN DO Surgical ACP trial. As part of the study’s transition from the planning phase to the implementation phase this fall, the investigators reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. Read the updated ...

In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH ...

In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, December 13, 2024, at 1:00 pm eastern. Ogedegbe is the Dr. Adolph ...

Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety ...

In this Friday’s PCT Grand Rounds, Michael Matheny of Vanderbilt University will present “Opportunities and Challenges in the Use of Large Language Models for Postmarketing Surveillance of Medical Products.” The Grand Rounds session will be held on Friday, December 6, 2024, at 1:00 pm eastern. Matheny is a professor of biomedical informatics, biostatistics, and medicine and the ...

In 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 ...