A program consisting of video decision aids for patients and communication skills training for clinicians was associated with higher rates of documentation of advance care planning among older adults, especially African American and Hispanic patients, in a recent study from the NIH Pragmatic Trials Collaboratory. The COVID-19 pandemic has led to disproportionately higher death rates among ...

In this Friday’s PCT Grand Rounds, Dr. Natalia Morone of Boston University and Boston Medical Center will present “A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons With Chronic Low Back Pain.” The Grand Rounds session will be held on Friday, March 25, at 1:00 pm eastern. Mindfulness-based stress reduction is now recommended by the American College ...

The Agency for Healthcare Research and Quality (AHRQ) published a new Toolkit for Decolonization of Non-ICU Patients With Devices to help clinical teams implement a protocol to reduce bloodstream infections by approximately 30% in patients with specific medical devices. The new toolkit is based on intervention materials successfully used in the ABATE Infection trial, one of ...

The NIH released a request for applications (RFA) for new NIH Pragmatic Trials Collaboratory Trial grants that address health disparities. NIH program and review staff will discuss the funding opportunity in an upcoming webinar. Registration for the webinar is required. The RFA for this funding opportunity encourages applications that focus on improving health outcomes in populations ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Edward Mills of McMaster University and Dr. Craig Rayner of Monash University will present “Better Data on Ivermectin Is Finally Here: Results from the TOGETHER Trial.” The Grand Rounds session will be held on Friday, March 18, at 1:00 pm eastern. Join the online meeting. The NIH Pragmatic Trials ...

The NIA IMPACT Collaboratory has created an new document with Best Practices for Integrating Health Equity into Pragmatic Clinical Trials for Dementia Care The IMPACT Collaboratory’s Leadership and Health Equity Team developed the document to bolster the inclusion of underrepresented people living with dementia in pragmatic trials embedded in healthcare systems, including trials that study Alzheimer ...

In this Friday’s PCT Grand Rounds, Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore of the University of Michigan will present “Understanding a Patient’s Daily Experience Through Mobile Devices and Wearables: Lessons Learned From the 8000 Patient MIPACT Study and Implementation in a National Pragmatic Trial.” The Grand Rounds session will be held on ...

Members of the NIH Pragmatic Trials Collaboratory Ethics and Regulatory Core published a new article in Contemporary Clinical Trials exploring the ethical and epistemic advantages and challenges specific to pragmatic stepped-wedge cluster randomized trial designs. The article titled “Ethical and Epistemic Issues in the Design and Conduct of Pragmatic Stepped-wedge Cluster Randomized Clinical Trials” was published ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Angelo Volandes of Massachusetts General Hospital and Dr. James Tulsky and Sophia Zupanc of Dana-Farber Cancer Institute will present “ACP COVID: A Trial to Evaluate an Advance Care Planning Video and Communication Skills Training Intervention for Older Adults During an Evolving Pandemic.” The study is supported by ...

A downloadable study snapshot and updated ethics and regulatory documentation are now available for BeatPain Utah, an NIH Pragmatic Trials Collaboratory Trial. BeatPain Utah recently transitioned from the planning phase to the implementation phase. As part of the transition, the study team reviewed and updated the minutes of their initial ethics and regulatory consultation with the ...

Offering care management to adult outpatients experiencing suicidal ideation did not reduce their risk of self-harm compared to usual care. Patients offered dialectical behavior therapy (DBT) skills training had significantly greater risk of self-harm compared to usual care. These were the main findings of the Suicide Prevention Outreach Trial (SPOT), an NIH Pragmatic Trials Collaboratory Trial. The ...

The NIH Pragmatic Trials Collaboratory is partnering with the Health Care Systems Research Network (HCSRN) to offer a workshop at the 2022 HCSRN Conference to be held in April in Pasadena, California. The workshop, Essentials of Embedded Pragmatic Clinical Trials, will introduce concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs). ePCTs are randomized ...

In this Friday’s PCT Grand Rounds, Dr. John Spertus of the University of Missouri–Kansas City will present “The Next Generation of Patient-Centered Trials – No Site Visits, Home Delivery of Meds and Patient-Reported Outcomes – The CHIEF-HF Trial.” The Grand Rounds session will be held on Friday, February 25, at 1:00 pm eastern. The CHIEF-HF trial ...

The NIH Pragmatic Trials Collaboratory is pleased to announce a new training workshop now available on the ePCT Training Workshop webpage.     On December 13, 2021 The NIH Pragmatic Trials Collaboratory and the NIA IMPACT Collaboratory co-hosted a Pre-Conference Workshop “Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials” for Academy Health’s Annual Conference on the Science ...

In this Friday’s PCT Grand Rounds, Dr. Perdita Taylor-Zapata of the National Institute of Child Health and Human Development (NICHD) will present “Building a Resource: The Process of Developing a Trans-Stakeholder Framework to Enable Pediatric Drug Development.” The Grand Rounds session will be held on Friday, February 18, at 1:00 pm eastern. Dr. Taylor-Zapata, a board-certified ...

This week’s NIA IMPACT Collaboratory Grand Rounds session will highlight the first decade of the NIH Pragmatic Trials Collaboratory. The Grand Rounds session—“Lessons From the First Decade of the NIH Pragmatic Trials Collaboratory”—will be held on Thursday, February 17, at 12:00 pm eastern. The co–principal investigators of the NIH Pragmatic Trials Collaboratory Coordinating Center at Duke ...

In this Friday’s PCT Grand Rounds, Dr. Hope Weissler of Duke University and Dr. Erich Huang of Onduo will present “Great Power and Great Responsibility: Machine Learning in Clinical Research.” The Grand Rounds session will be held on Friday, February 11, at 1:00 pm eastern. Join the online meeting.

In new additions to the Living Textbook, the Patient-Centered Outcomes Core of the NIH Pragmatic Trials Collaboratory explores lessons learned from the NIH Collaboratory Trials and provides information about including patient-reported outcomes (PROs) in pragmatic clinical trials. The new content includes: A Case Study from Guiding Good Choices for Health in which the principal investigators provide their ...

The NIA IMPACT Collaboratory is seeking letters of intent from interested applicants for Cycle 4A of its Pilot Grants Program. The 1-year pilot grant awards will fund up to $175,000 in direct costs for pilot studies that aim to generate preliminary data for full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons ...

In this Friday’s PCT Grand Rounds, Dr. Adam DeVore of Duke University and Dr. Lars Lund of the Karolinska Institutet will present “SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-Based Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, February 4, at 1:00 pm eastern. SPIRRIT-HFpEF is using a registry-based randomized clinical trial ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Christopher Lindsell and Dr. Adrian Hernandez continue the discussion about research outcomes and the importance of understanding stakeholder perspectives in choosing the correct outcomes for outpatient trials. The full January 14 Grand Rounds webinar with Dr. Lindsell is also available.

In this Friday’s PCT Grand Rounds, the principal investigators of EMBED, an NIH Collaboratory Trial, will announce the study’s primary results. Co–principal investigators Dr. Edward Melnick and Dr. Gail D’Onofrio of Yale University will present “EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.” The Grand ...

In a new article, members of the Ethics and Regulatory Core of the NIH Pragmatic Trials Collaboratory explore the ethical obligation of investigators to address signals of behavioral and mental health risk in pragmatic clinical trials. The article was published online ahead of print in Contemporary Clinical Trials and will appear in a forthcoming special issue ...

In this Friday’s PCT Grand Rounds, the principal investigator of PRIM-ER, an NIH Collaboratory Trial, will share an update on the implementation of this innovative pragmatic clinical trial. Principal investigator Dr. Corita Grudzen of the NYU Grossman School of Medicine will present “Primary Palliative Care for Emergency Medicine.” The Grand Rounds session will be held on ...

Meeting minutes and supplementary materials summarizing a recent discussion of ethics and regulatory issues associated with the new IMPACt-LBP NIH Collaboratory Trial are now available. The consultation took place by video conference and included representation from the study’s principal investigators and project manager, members of the NIH Collaboratory’s Ethics and Regulatory Core, NIH staff, and ...

In this Friday’s COVID-19 Grand Rounds session, Christopher Lindsell of Vanderbilt University will present “Searching for A Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials.” Lindsell will discuss lessons about choosing endpoints in outpatient COVID-19 trials. The Grand Rounds session will be held on Friday, January 14, at 1:00 pm eastern. Join the online ...

The NIA IMPACT Collaboratory announced 2 new funding opportunities for researchers at all levels who are interested in pragmatic clinical trials embedded in healthcare systems (ePCTs). They include career development awards for early-stage researchers and a scholars program for midlevel and senior researchers. Career Development Award: The IMPACT Collaboratory will fund 2-year career development awards to ...

The NIH Health Care Systems Research Collaboratory is excited to launch into its tenth year with a new name: NIH Pragmatic Trials Collaboratory. This new moniker reflects the NIH Collaboratory’s core mission and will carry the highly successful program into the future with a continued commitment to transforming clinical research.     The past decade has been a ...

The NIH announced the availability of an administrative supplement to fund research on ethical considerations related to biomedical research and projects that support capacity building in bioethics. Over the past 3 years, the NIH Office of the Director has partnered with NIH Institutes and Centers to support projects spanning the wide range of intersections between bioethics ...

A new tool from the NIH Collaboratory assists investigators in identifying impacts of the COVID-19 public health emergency on ongoing pragmatic clinical trials. The Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts summarizes impacts on trial conduct that study teams should document, measure, analyze, and report. The new checklist was developed by the NIH Collaboratory’s Biostatistics ...

In this Friday’s PCT Grand Rounds, Dr. Eric Perakslis of Duke University will present “Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None.” The Grand Rounds session will be held on Friday, December 17, at 1:00 pm eastern. Dr. Perakslis is the chief science and digital officer for the Duke Clinical ...

NIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials. So far this year, the NIH ...

The BeatPain Utah study and the GRACE trial have begun enrollment of study participants. Both projects were awarded continuation into the UH3 implementation phase in the summer. The studies make up the second cohort of NIH Collaboratory Trials to be supported through the NIH HEAL Initiative’s PRISM program. Congratulations to both study teams for reaching this ...

The NIH Collaboratory is partnering with the IMPACT Collaboratory to offer a pre-conference workshop on December 13 at AcademyHealth’s 14th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop, Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials, will provide an introduction to investigative opportunities for pragmatic clinical trials embedded ...

In this Friday’s PCT Grand Rounds session, Dr. Adrian Hernandez of Duke University will present “Decentralized Trials: Naughty or Nice?” Dr. Hernandez is a professor of medicine at Duke University and a co–principal investigator of the NIH Collaboratory Coordinating Center. The Grand Rounds session will be held on Friday, December 10, at 1:00 pm eastern. Join the ...

In this Friday’s PCT Grand Rounds, the principal investigator of the PPACT study, an NIH Collaboratory Trial, will announce the study’s primary results. Principal investigator Dr. Lynn DeBar of the Kaiser Permanente Washington Health Research Institute, will present “Primary Care-Based Behavioral Treatment for Long Term Opioid Users With Chronic Pain: Primary Results and Lessons Learned From ...

Members of the NIH Collaboratory’s Ethics and Regulatory Core examined the use of incentives and payments to patients included in pragmatic clinical trials. Their findings and preliminary recommendations are published in the December issue of Clinical Trials. Incentives and payments to patients are used in both pragmatic trials and conventional explanatory trials. However, because pragmatic trials ...

In this Friday’s PCT Grand Rounds session, Dr. Anish Agarwal of the University of Pennsylvania will present “Exploring Approaches in Using Digital and Mobile Health in Patient-Oriented Research: Pearls and Pitfalls.” Dr. Agarwal is an assistant professor of emergency medicine at Penn and the clinical innovation manager at the Penn Medicine Center for Health Care Innovation. The ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Charlene Wong of Duke University will present “Using Financial Incentives to Increase COVID-19 Vaccine Uptake.” Wong is the chief health policy officer for COVID-19 at the North Carolina Department of Health and Human Services. The Grand Rounds session will be held on Friday, November 12, at 1:00 pm ...

Patients who participated in a cognitive behavioral therapy (CBT) intervention as part of their regular care for chronic pain showed improved function and reduced pain compared to standard treatment, according to the results of the Pain Program for Active Coping and Training (PPACT) study. Although CBT did not reduce opioid use, patients who participated in ...

In this Friday’s PCT Grand Rounds session, Dr. James Grotta of Memorial Hermann Hospital-Texas Medical Center will present “Benefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services: The BEST-MSU Study.” The BEST-MSU study, supported by the Patient-Centered Outcomes Research Institute (PCORI), examined the effectiveness of prehospital diagnosis ...

In this Friday’s PCT Grand Rounds session, Dr. Matthew Semler and Dr. Jonathan Casey of Vanderbilt University will present “Embedding Pragmatic Trials Into Emergency and Critical Care.” Drs. Semler and Casey are leaders of the Pragmatic Critical Care Research Group, a network of clinical centers conducting comparative effectiveness clinical trials of common interventions in critical care. The Grand Rounds ...

In a new article published recently in Learning Health Systems, colleagues from the Pain Management Collaboratory examined challenges related to justice and equity in pragmatic clinical trials (PCTs) on pain management. Based on our experience with PCTs in health systems that serve military and veteran populations,  we suggest it is particularly important to recognize that: (a) ...

The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM recently announced a funding opportunity for new studies that aim to develop, test, and implement interventions that mitigate bias, discrimination, socioeconomic, or environmental barriers to quality pain assessment, treatment, and management for populations that experience health disparities (HDPs) in the United States. For the purposes ...

The NIH Collaboratory is excited to announce the addition of a new large-scale pragmatic clinical trial to its portfolio: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP). Co-led by investigators at the Duke Clinical Research Institute, IMPACt-LBP is a pragmatic, multisite, 2-arm cluster randomized trial that will evaluate the effect of a ...

The Health Care Systems Research Network (HCSRN) is accepting abstracts and panel presentation submissions for the HCSRN 2022 Annual Conference until November 5, 2021. This year’s meeting will be held in Pasadena, California, from April 12 to 14, 2022. Read complete submission information here. The HCSRN is a 19-member research network focused on supporting research institutes aligned ...

In this Friday’s PCT Grand Rounds session, Dr. Terri Fried of Yale University will present “The STAMP Trial: Increasing Engagement in Advance Care Planning and Lessons Learned From Partnering With Community Ambulatory Practices.” The Sharing and Talking About My Preferences (STAMP) trial tested a telephone-based intervention to encourage more patients to complete advance care planning. The ...

The NIH recently released a request for applications (RFA) for new NIH Collaboratory Trial grants. The RFA encourages applications that focus on improving health outcomes in populations that experience health disparities, such as higher rates of disease or mortality compared with the general population. These populations may be defined by race, ethnicity, geography, or socioeconomic ...

The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2022-2023 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Jason Abaluck of Yale University will present “The Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh.” The Grand Rounds session will be held on Friday, October 15, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is using its popular Grand Rounds ...