The IMPACT Collaboratory last week published a request for applications for the second cycle of its NIH Collaboratory Trials Program. IMPACT will fund up to 2 full-scale embedded pragmatic clinical trials that test, measure, and evaluate the effects of a nonpharmacological care delivery intervention program in a healthcare system for people living with Alzheimer disease and ...

In this Friday’s PCT Grand Rounds, Madelaine Faulkner Modrow of the University of California, San Francisco, and Dr. Schuyler Jones of Duke University will present “Lessons Learned and Patient Partnership in ADAPTABLE.” The Grand Rounds session will be held on Friday, October 8, at 1:00 pm eastern. Join the online meeting. For webinar recordings and slides from previous Grand ...

A team of researchers from the NIH Collaboratory and the Johns Hopkins Berman Institute of Bioethics recently completed a multi-method investigation of the ethical and regulatory implications of “collateral findings” in pragmatic clinical trials. Lessons from the project—the Management of Trial Incidental Findings Study (MOTIFS)—were published online ahead of print in the journal Healthcare. Collateral findings ...

The US Food and Drug Administration (FDA) last month published draft guidance on the use of electronic health records (EHRs) and claims data to support regulatory decision making. “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products” is part of the FDA’s series of guidances to ...

In a new NIH Collaboratory study, 20 NIH Collaboratory Trials responded to a survey about challenges encountered when using the electronic health record (EHR) for pragmatic clinical research. The goal of the study was to elucidate challenges and develop solutions—or prerequisites for pragmatic research—to enable healthcare system leaders, policy makers, and EHR designers to improve ...

The NIH Collaboratory is pleased to announce that the BeatPain Utah and GRACE NIH Collaboratory Trials received approval this month to transition from the planning phase to the implementation phase of their studies. As projects funded through the NIH HEAL Initiative’s PRISM program, these pragmatic clinical trials embedded in healthcare systems are directly addressing the ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Carolyn Bramante, Dr. Thomas Murray, and Dr. Jared Huling of the University of Minnesota will present “COVID-OUT: From Computer Modeling to a Phase III Trial of Early Outpatient Treatment for SARS-CoV-2 Infection.” COVID-OUT is a factorial randomized clinical trial of metformin, ivermectin, fluvoxamine, or a combination of these ...

Leaders of the NIH Collaboratory’s Patient-Centered Outcomes (PCO) Core Working Group spoke in a recent Zoom-based interview about the Core’s latest accomplishments and ongoing collaborations with the NIH Collaboratory Trials. “The purpose of the Core is to provide reusable and sustainable resources and tools to help project teams incorporate patient-centered outcomes and other patient-reported data in ...

In this Friday’s PCT Grand Rounds, Dr. Theresa Coles and Dr. Kevin Weinfurt of Duke University will discuss the use of patient-reported outcome measures in clinical trials, using examples from cardiovascular trials. The Grand Rounds session will be held on Friday, September 24, at 1:00 pm eastern. Join the online meeting. For webinar recordings and slides from ...

The IMPACT Collaboratory is inviting applications from early- and mid-career researchers for its second annual training workshop, “Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) Among People Living With Dementia (PLWD) and Their Care Partners.” A limited number of participants will be accepted to attend the event on January 26 and 27, 2022. This virtual ...

Dr. Vince Mor, a longtime NIH Collaboratory investigator, will present “Challenges Implementing Innovative Programs in Long Term Care: Examples From Pragmatic Trials” at IMPACT Grand Rounds. Join the grand rounds session on Wednesday, September 22, 2021 from 12:00 to 1:00 pm ET. From the IMPACT Collaboratory announcement: Vincent Mor, PhD, is a professor of health services, policy & ...

In this Friday’s PCT Grand Rounds, investigators from the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Trial, will announce the study’s primary results. Principal investigator Dr. Greg Simon and biostatistician Dr. Susan Shortreed, both of the Kaiser Permanente Washington Health Research Institute, will present “Population-Based Outreach to Prevent Suicidal Behavior: A Pragmatic Randomized Trial (SPOT ...

The Health Care Systems Research Network (HCSRN) is seeking feedback from early investigators on how to create resources and programs to support all early-career researchers in healthcare systems. If you are an investigator and completed your terminal degree in 2018 or later or are within 3 years of your first research appointment, please consider taking ...

In this Friday’s PCT Grand Rounds, Dr. Bruce Neal of the George Institute Australia and UNSW Sydney will share findings from a clinical trial of the effect of salt substitution on cardiovascular events and death. The Grand Rounds session will be held on Friday, September 10, at 1:00 pm eastern. Join the online meeting. For webinar recordings ...

The National Institute on Aging is awarding a grant expected to total $55.6 million to the Adult Changes in Thought (ACT) study, led by Kaiser Permanente Washington, the University of Washington School of Medicine, and the University of California, San Diego. The funds will be used to advance the understanding of Alzheimer disease and to ...

The NIA IMPACT Collaboratory is seeking letters of intent from interested applicants for Cycle 3B of its Pilot Grants Program. More information is available on the IMPACT Collaboratory website. The 1-year pilot grant awards will likely be eligible for funding of up to $175,000 in direct costs. The awards will support pilot projects that aim to generate ...

The Living Textbook has recently published materials that explore how randomized trials can be designed to promote both internal and external validity. The new contributions, from Drs. Merrick Zwarenstein, Ahmed Al-Jaishi, and Amit Garg, explain that consideration of the trial’s intention, whether pragmatic or explanatory, is the key to designing a trial that successfully answers ...

Dr. Fan Li, a longtime member of the NIH Collaboratory’s Biostatistics and Study Design Core, has received approval for a $1 million grant award from the Patient-Centered Outcomes Research Institute (PCORI) to develop methods and software for designing cluster randomized trials. Li is an assistant professor of biostatistics in the Yale School of Public Health. The ...

The Good Clinical Trials Collaborative has opened a 6-week public consultation period on its draft guidance for randomized controlled trials. The consultation period will last until September 15. Launched in June 2020 with the support of Wellcome, the Bill & Melinda Gates Foundation, and the African Academy of Sciences, the Collaborative is developing guidance “to enable ...

In this Friday’s PCT Grand Rounds, Dr. Benjamin Hibbert of the University of Ottawa Heart Institute will share findings from the DOREMI trial of milrinone vs dobutamine for the treatment of cardiogenic shock. The Grand Rounds session will be held on Friday, August 27, at 1:00 pm eastern. Join the online meeting. For webinar recordings and slides ...

The National Center for Complementary and Integrative Health (NCCIH) will lead a trans-NIH workshop on methodological approaches for whole person research. The workshop will focus on the methods needed for rigorous research on interconnected systems, multicomponent interventions, and multisystem or multiorgan outcomes. Registration for this event is required. Event: Methodological Approaches for Whole Person Research Workshop Date and ...

BeatPain Utah, an NIH Collaboratory Trial, is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back pain. Dr. Julie Fritz, the principal investigator of BeatPain Utah, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.  “ is focused on overcoming access barriers and providing ...

Leaders of the NIH Collaboratory’s Biostatistics and Study Design Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials, including the 2 newest projects, BeatPain Utah and GRACE. “BeatPain Utah and GRACE are fascinating studies, as all our NIH Collaboratory Trials are, and are giving us ...

Patients’ reactions to a letter notifying them about collateral findings from a pragmatic clinical trial were unrelated to who signed the letter, the type of collateral finding, or the letter’s level of detail about the trial, according to a new study from the NIH Collaboratory. The article was published online ahead of print in the Journal ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Eric Lenze of the Washington University School of Medicine will present “Fluvoxamine for Early Treatment of COVID-19: the STOP COVID Clinical Trials.” The Grand Rounds session will be held on Friday, August 20, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is using its ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez interviews Diana Berrent, JD, founder of Survivor Corps, Nick Guthe, Survivor Corps member and advisor, and Natalie Lambert, PhD, of the Indiana University School of Medicine, around best practices for medical professionals treating patients experiencing the debilitating effects of long-term COVID-19. The ...

Leaders of the NIH Collaboratory’s Electronic Health Records (EHR) Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on pragmatic trials. They also talked about upcoming projects and a recent survey of the NIH Collaboratory Trials.   “The pandemic amplified themes that we’ve heard all along, which is how to get ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Davey Smith of the University of California San Diego will present “Got Anything for This Cough? Outpatient Treatment Trials in the Time of COVID.” The Grand Rounds session will be held on Friday, August 13, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is ...

Leaders of the NIH Collaboratory’s Health Care Systems Interactions Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials. “Some of the projects are facing healthcare systems that are on pause for research,” said Leah Tuzzio, a senior research associate at Kaiser Permanente Washington Health Research ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Robin Boineau concludes the diversity workshop series, ‘Inclusion of Diverse Participants in Pragmatic Clinical Trials’ in a discussion with Dr. David Chambers, Dr. Lesley Curtis, Dr. Emily O’Brien, Dr. Wendy Weber, and Dr. Kanecia Zimmerman. Listen to all 5 episodes in the Grand Rounds ...

The GRACE trial, an NIH Collaboratory Trial, is studying real-world implementation of nonpharmacologic pain management strategies for patients with sickle cell disease. Dr. Robert Molokie, a GRACE co–principal investigator, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting. One innovation the GRACE trial is bringing to the NIH Collaboratory’s portfolio ...

A recent PCT Grand Rounds webinar and slides presenting the results from TSOS, an NIH Collaboratory Trial, are now available. TSOS was a stepped-wedge, cluster randomized pragmatic clinical trial testing the delivery of a stepped collaborative care intervention vs usual care for 635 injured patients with PTSD symptoms and comorbid conditions at 25 level I ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Edward Mills of McMaster University will present “The TOGETHER Early Treatment of COVID Trial: Building Platform Trial Infrastructure for Infectious Diseases.” The Grand Rounds session will be held on Friday, August 6, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is using its popular ...

A supplemental grant to the ACP PEACE study team will test the ability of a telehealth program to improve rates of advance care planning among older patients in primary care in a large healthcare system. Dr. Angelo Volandes and Dr. James Tulsky discussed the new study in a Zoom-based interview after the NIH Collaboratory’s annual ...

Principal investigators of the NIH Collaboratory Trials reported several common challenges to implementation of their studies as a result of the COVID-19 pandemic, according to a recent survey. Dr. Emily O’Brien discussed the results of the survey in an interview after the NIH Collaboratory’s annual steering committee meeting.     “Last spring, we started to hear reports of ...

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials. In this Friday’s session—“Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?”—Dr. Lesley Curtis, co–principal investigator of the NIH Collaboratory Coordinating Center, will host ...

In a recent interview, Dr. Wendy Weber shared that the National Advisory Council for Complementary and Integrative Health has approved a concept for the NIH Collaboratory to continue with the support of NIH Institutes and Centers, as the program completes its term as an NIH Common Fund initiative.     “We’re quite excited for some new directions in ...

In this Friday’s COVID-19 Grand Rounds session, Diana Berrent, Natalie Lambert, and Nick Guthe of Survivor Corps will present “Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care.” The Grand Rounds session will be held on Friday, July 23, at 1:00 pm eastern. Join the online meeting. Survivor Corps is an ...

Longtime NIH Collaboratory investigator Dr. Richard Platt will serve as co–principal investigator of a new embedded pragmatic clinical trial with Dr. Xiaojuan Li as part of the IMPACT Collaboratory. The IMPACT Collaboratory announced Li and Platt as awardees of its NIH Collaboratory Trials Program for their project Co-CARE-AD, the Collaborative Care Coordination Program for Alzheimer’s ...

The Collaboratory’s Ethics and Regulatory Core has recently explored issues around data monitoring in pragmatic clinical trials (PCTs). Important considerations for data monitoring in this context are related to the design, intent, and operational features specific to PCTs. Data Monitoring in Pragmatic Clinical Trials: Points to Consider suggests a set of key areas to evaluate: Composition ...

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials. In this Friday’s session—“Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?”—Dr. David Chambers of the National Cancer Institute (NCI) will facilitate a discussion about lessons from implementation science for maximizing ...

Readers are invited to visit a recent addition to the chapter Monitoring Intervention Fidelity and Adaptations in the Living Textbook. The new content offers considerations for study teams who are preparing to track the fidelity of an embedded—and potentially complex—clinical intervention. Considerations include identifying which features of the intervention (i.e., functions) are so essential to ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Hana El Sahly of the Baylor College of Medicine will present “COVID-19 Vaccine Efficacy Studies: Challenges and Successes.” The Grand Rounds session will be held on Friday, July 9, at 1:00 pm eastern. Join the online meeting. The NIH Collaboratory Coordinating Center is using its popular Grand Rounds ...

The NIH Collaboratory is pleased to share a new resource to help clinical investigators successfully partner with healthcare system leaders. The Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships provides advice from NIH Collaboratory and healthcare system leadership and serves as an annotated table of contents for the Living Textbook, pointing readers to ...

In an article published today in the New England Journal of Medicine, Drs. Richard Platt, Adrian Hernandez, and Greg Simon of the NIH Collaboratory discuss barriers to healthcare system participation in embedded research and strategies for improvement. “We advocate creating a robust national capability to generate evidence to guide decisions by patients, ...

AcademyHealth is accepting abstracts for the 14th Annual Conference on the Science of Dissemination and Implementation in Health until July 27, 2021. This year’s meeting will be held virtually from December 14 to 16. Read the complete call for abstracts. The theme of this year’s virtual online meeting is “Broadening Horizons for Impact: Incorporating Multisectoral Approaches into ...

Medical Decision Making, an official journal of the Society for Medical Decision Making, has extended the submission deadline in its call for papers for a special theme issue on the use of electronic health record (EHR) data in health decision research. The new submission deadline is September 30, 2021. “EHRs remain a rich and promising longitudinal ...

In a new article in Healthcare’s special issue on embedded research, Leah Tuzzio and colleagues use experiences from the NIH Collaboratory to describe how quality improvement activities may pose challenges for embedded pragmatic clinical trials (ePCTs), especially if there are overlapping goals and timelines. For ePCTs to be rigorous, study teams must monitor, adapt, and respond ...

The NIH will host a webinar titled “Streamlining Access to Controlled Data at NIH: Tackling Challenges and Identifying Opportunities” on July 9 from 10:00 am to 1:00 pm ET. Registration for the event is open to all interested participants. This webinar will explore perspectives on the challenges and opportunities in accessing controlled data stewarded by the ...

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials. In this Friday’s session—“Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity”—Dr. Wendy Weber of the National Center for Complementary and Integrative Health will host a panel of investigators for ...