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 ...

The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials. Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in ...

In an article published online this week, leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities. The electronic health record and other digital modes ...

Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems. “Teams need to be aware of—and perhaps proactively investigate—possible changes ...

In a JAMA Viewpoint published online this week, coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices. In a decentralized clinical trial, some or all of the trial-related activities take ...

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA. Authors Caleigh Propes, Kayla Mehl, and Stephanie Morain ...

In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif ...

Greg Simon, a longtime member of the Coordinating Center leadership team for the NIH Pragmatic Trials Collaboratory, was selected by the Health Care Systems Research Network (HCSRN) Governing Board of Directors to receive the organization’s inaugural Founders’ Award. The new award recognizes individuals who best exemplify the spirit of the HCSRN’s early founders in their ...

The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominations for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. The committee will include: health professionals and scientists who are leaders in the field of pain research patients with pain-related conditions, patient-advocates, and community organizations for individuals ...

To build upon the progress of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH is holding workshops to gather input to inform strategic research priorities and advance the mission of HEAL pain research. The workshops will be held over the next few months (ET), as follows: Non-Addictive Pain Therapeutics Development November 15 @ 10:00 ...

In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern. Delgado is an associate professor of emergency medicine and epidemiology at ...

On November 18, 2024 at 2 pm eastern, the Duke Margolis Institute for Health Policy and Duke Health will co-host “From Principles to Practice: Exploring AI Governance in Health Systems.” In this public webinar, Duke-Margolis and Duke Health will discuss their newly released white paper on how health systems are navigating the role of AI ...

In this Friday’s PCT Grand Rounds, Sumit Agarwal of the University of Michigan will present “The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support.” The Grand Rounds session will be held on Friday, November 8, 2024, at 1:00 pm eastern. Agarwal is an assistant professor of internal medicine ...

A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study, an NIH Collaboratory Trial, is testing the ...

The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH. The updated chapter now includes information about how to develop a ...

In this Friday’s PCT Grand Rounds, Thomas Carton of the Louisiana Public Health Institute and Anitha John of George Washington University and the Children’s National Hospital will present “Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study.” The Grand Rounds session will be held on Friday, November 1, 2024, at 1:00 pm ...

Research-identifiable Medicare data can come from traditional fee-for-service Medicare claims or from Medicare Advantage claims. A new contribution to the Living Textbook of Pragmatic Clinical Trials published this month, Use of Medicare Data in PCTs, describes the important differences between these data. At the healthcare system level, differences in incentives for documenting diagnoses can affect the ...

The NIH Pragmatic Trials Collaboratory is pleased to welcome APA-SM (Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations) to its portfolio of innovative NIH Collaboratory Trials. The new project is supported by an award from the National Institute of Neurological Disorders and Stroke, with administrative oversight from the National Center for Complementary ...

In this Friday’s PCT Grand Rounds, Nicholas Bloom of Stanford University will present “Hybrid Working From Home Improves Retention Without Damaging Performance.” The Grand Rounds session will be held on Friday, October 25, 2024, at 1:00 pm eastern. Bloom is the William D. Eberle Professor of Economics at Stanford University, a senior fellow of the Stanford Institute ...

The 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 ...

Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute. BEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, ...

In a pilot study for the GGC4H trial, researchers found that a virtual version of the Guiando Buenas Decisiones program delivered in the context of pediatric primary care was feasible, acceptable, and appealing to pediatricians and parents. The program is a Spanish-language version of the Guiding Good Choices intervention being implemented in the GGC4H trial. The ...