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 ...

The NIH Collaboratory recently convened a workshop to explore embedded pragmatic clinical trials comparing two or more therapeutic medical interventions. These “A vs B” trials are meant to test existing, viable treatment alternatives where there is uncertainty about which treatment is best in which populations. There are unique barriers that make these types of pragmatic ...

The National Institutes of Health (NIH) Office of Disease Prevention (ODP) needs your help to enhance the quality of research supported by the NIH. The ODP is building a directory of experts in research methods and study designs that can help NIH Scientific Review Officers identify the most appropriate reviewers for NIH research applications. Adding ...

In this episode of the NIH Collaboratory Grand Rounds podcast, Renee Mitchell, Terrie Reed, and Roseann White discuss the MDEpiNet RAPID and SPEED Projects. In their conversation with Dr. Adrian Hernandez, Renee, Terrie, and Roseann discuss the concept behind the projects, the collaborative nature, associated challenges, next phases, and the future. Listen to the episode here: Renee Mitchell, Terrie Reed, ...

In a new video, Drs. Wendy Weber and Dave Clark discuss the NIH-DoD-VA Pain Management Collaboratory, which is modeled after the NIH Health Care Systems Research Collaboratory. The Pain Management Collaboratory has a centralized Coordinating Center and is supporting a series of 11 pragmatic trials in military and veteran health care delivery organizations focusing on ...

In a new article in the Journal of General Internal Medicine, over 100 million person-years of curated claims data were evaluated to assess new rates and follow-up procedures for colorectal, breast, and cervical cancer. These observational data were collected from national and regional insurers participating in the NIH Collaboratory distributed research network. The proportion of ...

A panel funded by the Patient-Centered Outcomes Research Institute (PCORI) recently published recommendations for the oversight of patients who participate in research roles other than as “research subject.” Patients and caregivers participate in many roles, such as co-investigators, study personnel, and advisors in research studies, and this creates novel ethical and regulatory challenges. The panel ...

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Jeffrey Botkin and Dr. Consuelo Wilkins discuss returning individual research results to participants. In their conversation with Dr. Adrian Hernandez, Drs. Botkin and Wilkins emphasize the importance of returning results to participants, the present challenges, and hopes for the process in the next five years. For ...

In a new video, Dr. Greg Simon explains the intraclass correlation coefficient (ICC) with an analogy to a pie eating contest. The ICC is a descriptive statistic that measures the correlations among members of a group, and it is an important tool for cluster-randomized pragmatic trials because this calculation helps determine the sample size needed ...

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the new UG3 NIH Collaboratory Trials. These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH ...

In a new video, Dr. Wendy Weber, the Program Officer for the NIH Collaboratory Coordinating Center, provides some expert advice for investigators who are considering submitting an application for a pragmatic clinical trial to the NIH. “Don’t assume that the study panel is going to understand what pragmatic means. They may have their own completely different ...

The NIH Collaboratory is pleased to announce new training resources available on the Living Textbook. These resources are being shared with the research community to provide guidance about building partnerships with health systems and overcoming the challenges of conducting embedded pragmatic clinical trials (ePCTs). The materials reflect the knowledge, insight, and best practices acquired by ...

Kidney transplantation is the preferred treatment for patients with end-stage renal disease (ESRD), but an insufficient organ supply renders dialysis the only viable treatment option for most patients. Though clinical outcomes among patients receiving dialysis have improved modestly in recent years, annual rates of hospitalization and mortality remain unacceptably high, and quality of life is ...

Because many clinicians do not have the skill set to engage patients in conversations about advance care planning (ACP), many older Americans with advanced cancer receive aggressive interventions at the end of life that do not reflect their values, goals, and preferences. The ACP PEACE trial is investigating whether a comprehensive approach to ACP improves ...

Before the end of high school, more than half of all adolescents will use an illicit drug, about a quarter will meet the criteria for depression, and many others will engage in behaviors such as delinquency and violence. Guiding Good Choices is a universal evidence-based anticipatory guidance curriculum for parents of early adolescents that has ...

In the United States, half of persons 65 years and older have an emergency department visit in the last month of life, and three-quarters have an emergency department visit in the last 6 months of life. Admissions to intensive care units by emergency clinicians are on the rise, especially for older patients. Meanwhile, three-quarters of ...

More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management ...

The ADAPTABLE pragmatic trial relies on patients to report key information at baseline and throughout follow-up. To capture these data, ADAPTABLE investigators developed a LOINC (Logical Observation Identifiers Names and Codes) patient-reported item set, which is now publicly available. The development of the item set is part of the ADAPTABLE Supplement, an initiative funded by the ...