November 20, 2018: Upcoming NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

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 with applications due as early as February 2019.

The two notices are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

November 16, 2018: Primary Palliative Care for Emergency Medicine (PRIM-ER) (Corita Grudzen, MD, MSHS)

Speakers

Corita R. Grudzen, MD, MSHS, FACEP
Vice Chair for Research
Associate Professor of Emergency Medicine and Population Health
Ronald O. Perelman Department of Emergency Medicine
NYU School of Medicine

Topic

Primary Palliative Care for Emergency Medicine (PRIM-ER)

Keywords

PRIM-ER; Emergency department; Palliative care; Demonstration project; Pragmatic trial; Stepped-wedge study design; Clinical decision support; Best practice alerts; Advance care planning

Key Point

  • The PRIM-ER trial is a pragmatic, cluster-randomized, stepped wedge Demonstration Project that will implement primary palliative care in emergency medicine across a diverse group of 35 emergency departments (EDs).
  • PRIM-ER’s clinical decision support intervention is tailored to each ED site. The study aims to enable system, organizational, and provider change in the emergency department workflow.
  • The study team is identifying and preparing site champions by conducting communication skills training in serious illness for emergency physicians and staff using the EM Talk program.

Discussion Themes

It is important to consider sustainability of the intervention during the planning phase of the trial. Plan for staff turnover and how new staff will be educated and oriented to the intervention.

The volume and sophistication of best practice alerts (BPAs) received by physicians varies across U.S. emergency departments. Alert “fatigue” can be a concern.

For more information on the PRIM-ER Demonstration Project, visit the PRIM-ER website on the Living Textbook.

Tags

@Collaboratory1, #pctGR, #EmergencyMedicine

November 16, 2018: New Living Textbook Chapter on Team Composition for Pragmatic Trials

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 conduct of an ePCT, and when designing a trial, an investigator will need to carefully consider the roles of potential team members, including which roles are essential, and who will fill the roles.”

—Dr. Lesley Curtis in ePCT Team Composition

November 13, 2018: Summary of Workshop on Pragmatic Trials of Therapeutic A vs B Interventions Now Available

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 trials especially challenging to implement. For the workshop, a panel of experts gathered to discuss challenges and solutions regarding partnering with healthcare systems to conduct the trials, unique legal and ethical issues, and design and operational considerations. The summary of the workshop is now available: Workshop Summary: Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions

 

Additional Resources:

Embedded pragmatic clinical trials of therapeutic A vs. B interventions workshop videocast.

 

November 7, 2018: The NIH-DoD-VA Pain Management Collaboratory Builds on the Success of the NIH Health Care Systems Research Collaboratory

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 non-pharmacological approaches to pain management.

Dave Clark, Wendy Weber from NIH Collaboratory on Vimeo.

“All of the projects are pragmatic trials done either within the VA or the Military Health System and they all address non-pharmacological approaches to pain management. Our goal is partnering with the VA and the DoD to really see if we can find other ways of managing pain other than opioid medication.” —Dr. Wendy Weber, Acting Deputy Director for the National Center for Complementary and Integrative Health (NCCIH)

This collaboration marks one of the first times the National Institutes of Health (NIH), the U.S. Department of Defense (DoD), and the U.S. Department of Veterans Affairs (VA) have worked together.

November 2, 2018: EMBED Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (Ted Melnick, MD, Gail D’Onofrio, MD)

Speakers

Ted Melnick, MD, MHS
Assistant Professor of Emergency Medicine
Program Director, ACGME Clinical Informatics Fellowship
Yale School of Medicine

Gail D’Onofrio, MD
Professor and Chair of Emergency Medicine, Yale School of Medicine
Physician-in-Chief of Emergency Services Yale-New Haven Hospital

Topic

EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Keywords

EMBED; Embedded PCT; Pragmatic clinical trial; Opioid use disorder; Clinical decision support; Emergency department; Buprenorphine

Key Points

  • The EMBED pragmatic trial is evaluating a clinical decision support tool designed to automatically identify and facilitate management of eligible patients with opioid use disorder in the emergency department (ED).
  • From July 2016 to Sep 2017, there was a 30% increase in visits to the ED for opioid overdose (Morbidity and Mortality Weekly Report, March 9, 2018).
  • With medication-assisted treatment, patients are 2 times more likely to be engaged in addiction treatment at 30 days.
  • EMBED’s user-centered design aims to streamline workflows, address barriers to adoption, embed ED-initiated buprenorphine into routine ED care, and optimize adoption, dissemination, implementation, and scalability.

Discussion Themes

Poor usability of health information technology (HIT) is major source of frustration for clinicians. Electronic health record usability is a fundamental barrier to implementation of evidence-based medicine.

The science of usability in healthcare is still in the early stages. The EMBED study wants to improve the HIT experience.

How much does the study rely on EHR data for outcomes, and how detailed are the pilot outcomes data requested from each system? How do you plan to verify the accuracy of those data?

For more information on treatment of opioid use disorder in the emergency department, visit the National Institute on Drug Abuse (NIDA) website’s Initiating Buprenorphine Treatment in the Emergency Department.

Tags

@Ted_Melnick, @DonofrioGail, @yaleem2, @YaleMed, @Collaboratory1, #pctGR, #EmergencyMedicine

October 1, 2018: Meeting Minutes from NIH Collaboratory’s Regulatory/Ethics Core Discussions with the New Demonstration Projects

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the new UG3 Demonstration Projects. These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Regulatory/Ethics Core, NIH staff, and NIH Collaboratory Coordinating Center personnel as well as some IRBs responsible for oversight of the projects.

September 14, 2018: Tips for Submitting a Pragmatic Trial Application to 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 definition than you, and it’s important that you get on the same page early on in your application.” —Wendy Weber, PhD, Acting Deputy Director, National Center for Complementary and Integrative Health (NCCIH)

September 7, 2018: NIH Collaboratory: Research Transformation in Progress (Adrian Hernandez MD, MHS, Kevin Weinfurt, PhD, Lesley Curtis, PhD)

Speakers

Adrian F. Hernandez, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine

Kevin Weinfurt, PhD
Professor and Vice Chair for Research
Department of Population Health Sciences
Duke University School of Medicine

Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Duke University School of Medicine
Interim Executive Director, Duke Clinical Research Institute

Topic

NIH Collaboratory: Research Transformation in Progress

Keywords

Clinical trials; Research studies; Healthcare delivery; Clinical care; embedded pragmatic clinical trials; ePCTs; Peer-reviewed journals; Demonstration projects; NIH funding

Key Points

  • The goal of the NIH Collaboratory is to strengthen the national capacity to implement cost-effective large-scale research studies that engage healthcare delivery organizations as research partners.
  • Embedded pragmatic clinical trials bridge research into clinical care.
  • The NIH Collaboratory has contributed to 80 publications about embedded pragmatic trials in peer-reviewed journals.
  • Six new demonstration projects were recently added to the NIH Collaboratory portfolio:
    • Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training (ACP PEACE)
    • Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
    • Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (GGC4H: Guiding Good Choices for Health)
    • Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED)
    • Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
      Primary Palliative Care for Emergency Medicine (PRIM-ER)

Discussion Themes

The NIH Collaboratory is addressing many of the challenges and logistical barriers to conducting pragmatic clinical trials embedded in healthcare systems. There is still progress to be made in explaining the value and benefit of embedded PCTs (ePCTs) to healthcare leadership.

The NIH Collaboratory workshops have had a positive impact and have increased NIH’s interest in supporting the conduct of ePCTs.

Determining how pragmatic clinical trials can be conducted more routinely will be critical to their impact.

 

Tags

@texhern, @lmhcurtis, @PCTGrandRounds, #pctGR #ClinicalResearch, #researchstudies, #clinicaltrials, #clinicalcare, #peerreviewed

September 10: NIH Collaboratory Launches New ePCT Training Resources

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 the NIH Collaboratory program and its Demonstration Projects.

Resources include:

  • Materials from the inaugural ePCT Training Workshop held in February 2018 to provide training to mid- and senior-level investigators interested in conducting ePCTs
  • A slide presentation of the NIH Collaboratory’s goals and organizational structure along with a brief introduction to each Demonstration Project
  • An infographic introducing the elements of the NIH Collaboratory program and the value of engaging in pragmatic research
  • A slide presentation and worksheet on essential things to think about and do when designing, conducting, and disseminating ePCTs
  • An introductory video from NIH Collaboratory leadership on the rationale and aims for the ePCT training resources

“The workshop reinforced that there is a demand for these kinds of training opportunities across the clinical research community.” Lesley Curtis, PhD

Visit the new training resources webpage.