The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, working alongside faculty members involved with the ethics and regulatory aspects of large-scale pragmatic clinical trials (PCTs), and participating in the Hecht-Levi Postdoctoral Fellowship in Bioethics. ...

The GGC4H NIH Collaboratory Trial, now in its implementation phase, has begun enrollment of study participants. Congratulations to Drs. Kuklinski, Sterling, and Catalano and the entire GGC4H study team! GGC4H is a cluster-randomized trial that is testing the feasibility and effectiveness of implementing Guiding Good Choices—a universal evidence-based anticipatory guidance curriculum for parents of early adolescents—in ...

The NIH Health Care Systems Research Collaboratory program is excited to announce that it has received funding to serve as the Resource Coordinating Center for a new group of large-scale embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing. As part of the NIH Collaboratory, the Pragmatic and Implementation Studies for the ...

The NIH Collaboratory Coordinating Center launched an online survey to collect feedback from clinical investigators, healthcare system partners, and the broader research community about the Living Textbook of Pragmatic Clinical Trials. Responses to the survey will help the Coordinating Center enhance its resources for users interested in pragmatic research. “We are eager to receive feedback on ...

The investigators of HiLo, an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Myles Wolf and the HiLo study team for their excellent work! HiLo (Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis) is designed to answer ...

The submission deadline has been extended to October 28, 2019, for a special supplement on embedded health services research in Healthcare: The Journal of Delivery Science and Innovation, the partner journal of AcademyHealth. Embedded research is a critical part of the learning health system in mining and analyzing health system data to improve patient care ...

The National Institute on Aging (NIA) Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory is soliciting letters of intent for several 1-year pilot grant awards of up to $150,000. The awards will provide funds to pilot projects that aim to generate preliminary data necessary to design and conduct full-scale embedded pragmatic clinical trials of nonpharmacologic interventions ...

In a study using national claims data for more than 73 million pediatric visits from the NIH Collaboratory’s Distributed Research Network, researchers found uneven declines in potentially inappropriate antibiotic dispensing between 2006 and 2016. The findings suggest a need for antibiotic stewardship programs, especially interventions focusing on the use of broad-spectrum antibiotics in outpatient settings. The ...

At the May 2019 meeting of the NIH Collaboratory Steering Committee, we talked with Judith Carrithers, coleader of the Ethics and Regulatory Core. The task of the Core is to develop a framework for conducting embedded pragmatic clinical trials (ePCTs) in an ethical manner and in compliance with federal and state regulations. Ms. Carrithers joined ...

The NIH released a request for information from the scientific research and medical education community and the general public regarding Centers of Excellence in Pain Education (CoEPEs), general pain education, and curricula addressing opioid misuse or use disorder. Topics of interest include: the content and delivery of institutions’ current curricula on pain, pain management, and opioid use disorder; highest-priority ...

A new section of the NIH Collaboratory’s Living Textbook of Pragmatic Clinical Trials discusses challenges associated with missing data that result from noncompliance, crossover, and dropout. Many randomized controlled trials use an intention-to-treat (ITT) analysis to measure the real-world effects of the intervention. The newly published section, Missing Data and Intention-to-Treat Analyses, considers the population-level causal effects ...

The investigators of Nudge, an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Michael Ho, Dr. Sheana Bull, and the Nudge study team for their excellent work! Nudge (Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications) is ...

The National Institute on Aging (NIA) recently approved the Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE) trial, an NIH Collaboratory Trial, to move from the planning phase to the implementation phase. The goal of ACP PEACE is to evaluate a comprehensive advance care planning program that combines clinician communication ...

Primary Palliative Care for Emergency Medicine (PRIM-ER), an NIH Collaboratory Trial, received approval this month to enter its implementation phase. PRIM-ER is a pragmatic, cluster randomized trial of a multidisciplinary primary palliative care education and decision support intervention in a diverse sample of emergency departments that differ in their specialty geriatric and palliative care capacity, ...

Findings from a new article suggest that the majority of patients do not feel a personal responsibility to participate in clinical research. In the article, Kevin Weinfurt, Li Lin, and Jeremy Sugarman report the results of a national survey of nearly 3000 people regarding their attitudes towards research responsibilities as well as their trust in ...

A new section in the Living Textbook describes the considerations for using “real-world” data for inpatient-based event ascertainment. There are many sources for acquiring this information, and they have different time lags in their availability and varying degrees of error and bias. In order to use inpatient endpoints in pragmatic clinical trials, these factors must ...

The investigators of Guiding Good Choices for Health (GGC4H), an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to the GGC4H study team for their excellent work! At the May 2019 NIH Collaboratory Steering Committee meeting, we talked with Drs. Stacy Sterling, Margaret Kuklinski, ...

At the May 2019 meeting of the NIH Collaboratory Steering Committee, we talked with Drs. Ted Melnick and Gail D’Onofrio of EMBED, an NIH Collaboratory Trial, to hear about progress and challenges during the UG3 planning phase. The goal of EMBED is to test whether implementation of a user-centered clinical decision support system increases adoption ...

At the NIH Collaboratory Steering Committee Meeting in May 2019, participants shared their perspectives on the evolving landscape of embedded pragmatic clinical trials (ePCTs). Three initiatives were presented: the Patient-Centered Outcomes Research Institute (PCORI), the NIH-DoD-VA Pain Management Collaboratory, and the HEAL (Helping to End Addiction Long-term) Initiative. Although many challenges remain, the conduct of ...

Nearly 50 researchers attended a preconference seminar at the 2019 AcademyHealth Annual Research Meeting in Washington, DC, to learn the essentials of embedded pragmatic clinical trials (ePCTs). The full-day seminar, offered by the NIH Collaboratory in partnership with AcademyHealth, introduced attendees to concepts in the design, conduct, and implementation of ePCTs, with a particular focus ...

The Collaboratory has made available all the presentations from their recent Steering Committee meeting held in Bethesda May 1-2, 2019. Highlights of Day 1 included updates on the progress and sustainability of the NIH Collaboratory, perspectives on the landscape of embedded PCTs (ePCTs) and the need for real-world evidence, challenges and lessons learned from the UH3 ...

An important advantage of embedding pragmatic clinical trials within health care systems is the availability of detailed clinical data on potential participants during trial design. These data can be used to determine eligibility criteria, predict changes in participant characteristics over time, and inform sample size calculations and other design features. Investigators from the Suicide Prevention Outreach ...

A new perspective article by NIH Collaboratory investigators describes the unique, unexpected challenges researchers face when clinical practice guidelines and policies change during the conduct of a pragmatic clinical trial (PCT). The article was published online this week in Clinical Trials. The NIH Collaboratory Trials are PCTs that test interventions to address urgent public health problems. ...

The NIH published 3 new funding opportunity announcements to support innovative approaches to the implementation of evidence-based interventions and the de-implementation of ineffective interventions. The announcement also encourages studies that advance dissemination and implementation research methods. The 3 funding opportunities are as follows: Dissemination and Implementation Research in Health (R01 Clinical Trial Optional): The next due ...

The Journal of General Internal Medicine (JGIM) has announced a call for papers that report findings from research at the intersection of implementation science (IS) and quality improvement (QI). Submissions are due September 3, 2019, and should focus on providing information that healthcare delivery systems need about strategies to improve patient and population outcomes. The research ...

At the Lifesavers Gala in New York last night, Dr. Greg Simon received the American Foundation for Suicide Prevention (AFSP’s) Research Award for his contributions to suicide prevention. Dr. Simon leads the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Trial that builds on previous work demonstrating that patients who answer “yes” to thoughts of ...

A cost-effectiveness analysis of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Trial, revealed wide variation across participating health centers. The study’s findings reflect the complexity of implementing an intervention in pragmatic research involving community health clinics with diverse patient populations, clinic structures, and resources. The study was ...

The primary results of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial, an NIH Collaboratory Trial, were published online this month in the Journal of the American Society of Nephrology. The study confirmed the feasibility of embedding a large pragmatic clinical trial in clinical care delivery. Although maintenance hemodialysis has long been a staple ...

In an eGEMs commentary published this month, Leah Tuzzio and Dr. Eric Larson of the NIH Collaboratory’s Health Care Systems Interactions Core discuss the value and impact of embedded pragmatic clinical trials for learning health systems. Pragmatic trials embedded in healthcare systems are designed to align with the care delivery goals of the health system to ...

The NIH Health Care Systems Research Collaboratory is hosting a one-day workshop on the Design & Analysis of Embedded Pragmatic Clinical Trials (ePCTs) on May 2, 2019, in the Lister Hill Auditorium on the NIH Campus. The workshop will include a series of moderated discussions that focus on issues of measuring trial outcomes from available data ...

The investigators of EMBED, an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Ted Melnick, Dr. Gail D’Onofrio, and the EMBED study team for their excellent work! “The opioid crisis is taking a devastating toll on Americans, their families, and their communities. The ...

The NIH Collaboratory is partnering with AcademyHealth to offer a full-day pre-conference seminar at the 2019 Annual Research Meeting in Washington, D.C. Essentials of Embedded Pragmatic Clinical Trials will provide an introduction to the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform ...

The NIH Collaboratory Trial Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is testing the effectiveness of a novel advance care planning (ACP) video education program in 360 nursing homes within 2 large nursing home healthcare systems. The investigators of PROVEN recently published a study that examines the characteristics of nursing homes associated with ...

The Active Bathing to Eliminate (ABATE) Infection trial compared routine bathing to decolonization with universal chlorhexidine and targeted nasal mupirocin in non-critical-care units. Similar interventions have been found to reduce multidrug-resistant pathogens and bloodstream infections in intensive care units (ICUs), and this was the first large-scale trial in non-critical-care units. The primary outcome was methicillin-resistant ...

Using death as an endpoint in pragmatic clinical trials is challenging because there are no standardized processes for ascertaining patient deaths in the United States. If a patient dies outside of a clinical care system, ascertaining if and how a death has occurred is considerably complicated. There are multiple sources of vital statistics data, each ...

The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid (CMS) have announced a proposed rule intended to advance interoperability and support the access, exchange, and use of electronic health information. Notably, the rule would require that patients have the ability to electronically access their health information ...

Members of the NIH Collaboratory’s Biostatistics and Study Design Core contributed 3 new sections to the Living Textbook exploring issues in the design and analysis of pragmatic clinical trials. The new sections offer insights into emerging issues in embedded pragmatic clinical trials and lessons learned from the NIH Collaboratory’s first round of NIH Collaboratory Trials. The Designing ...

Proposals are due March 15 in response to an NIH funding opportunity announcement for embedded pragmatic clinical trials that address pain management and the opioid crisis. The NIH will support 1 to 2 pragmatic trials that evaluate acupuncture treatment in older adults with chronic low back pain. The projects will join the NIH Health Care Systems ...

The NIH Collaboratory is pleased to announce the availability of a new self-paced, 10-module introductory course on how to design, conduct, and disseminate embedded PCTs (ePCTs). This course presents condensed material from the inaugural ePCT Training Workshop held in 2018 and provides users with important things to know and do when designing an ePCT, along ...

NIH Collaboratory leadership and NIH Collaboratory Trial Principal Investigators have responded to the U.S. Food and Drug Administration’s (FDA’s) proposed rule to allow for a waiver or alteration of informed consent. “We applaud the proposed rule to allow for a waiver or alteration of informed consent for clinical investigations posing no more than minimal risk to ...

To help fulfill the requirements of the 21st Century Cures Act by accelerating medical product development and fostering innovation and advances in medicine, FDA recently created a framework for evaluating the use of real-world evidence. The framework is intended to help evaluate trials that use real-world data for the creation of real-world evidence. Real-world data: routinely ...

The NIH Collaboratory program contributed knowledge from pragmatic clinical research with 12 peer-reviewed publications in 2018, including several reports of findings from DNIH Collaboratory Trials and more: NIH Collaboratory Coordinating Center Identifying and supporting nonpharmacological dementia interventions ready for pragmatic trials: results from an expert workshop. J Am Med Dir Assoc. 2018;19(7):560-562. NIH Collaboratory Distributed Research Network Cancer screening ...

A new pragmatic trial planning grant supported by the National Institute on Aging will use the NIH Collaboratory’s Distributed Research Network (DRN) to characterize eligible patients and develop an intervention that tests the value of engaging health plan members and their caregivers, in addition to prescribers, to reduce potentially harmful medication use in patients with ...

A new chapter in the Living Textbook provides expert advice for investigators submitting an application for a pragmatic clinical trial to the NIH. The chapter covers finding the right Program Official and opportunity announcement, writing a strong proposal, addressing review criteria, and award status. “First and foremost, develop and clearly define a clinical research question with ...

The NIH has announced two new funding opportunity announcements (FOAs) for 7 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. The two announcements are: Pragmatic Randomized Controlled Trials of Acupuncture for Management of ...

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Gregory Simon and Dr. Susan Shortreed of the Kaiser Permanente Washington Health Research Institute. In their conversation, Drs. Curtis, Simon, and Shortreed discuss computable phenotypes and if results should change a trial’s pre-specified primary outcome. Drs. Simon and Shortreed explain how they ...

The Food and Drug Administration (FDA) is proposing a rule to allow for a waiver or alteration of informed consent for clinical investigations posing no more than minimal risk to human participants. This rule would align FDA regulations with the Common Rule, reduce burden and costs for Institutional Review Boards, and be expected to lead ...

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Tom Carton, of the REACHnet Clinical Data Research Network, and Dr. Keith Marsolo, of the Duke School of Medicine, regarding data linkage within, beyond, and across The National Patient-Centered Clinical Research Network (PCORnet). In their conversation with Dr. Curtis, Drs. Carton ...

The NIH has announced an intent to publish new funding opportunity announcements (FOAs) for 5 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. Both FOAs will be published in early December ...

Embedded pragmatic clinical trials (ePCTs) are conducted by gathering data during the course of routine care. Accordingly, health care system personnel—not research personnel—will be collecting data and delivering the intervention. A new Living Textbook chapter describes the considerations for team composition to help ensure the success of an ePCT. “Many different people are involved in the ...