December 14, 2018: New Alzheimer Trial to Be Planned Using the NIH Collaboratory Distributed Research Network

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 Alzheimer disease and related dementias (ADRD).

Patients with Alzheimer disease are at high risk for “prescribing cascades,” in which patients receive multiple, potentially unnecessary drug prescriptions to address side effects of their other medications. The Controlling and Stopping Cascades Leading to Adverse Drug Effects Study in Alzheimer’s Disease (CASCADES-AD) will be an embedded pragmatic clinical trial in 2 large healthcare systems. It would be the first evaluation of a large-scale, health plan–based educational intervention to improve medication safety and reduce the occurrence of preventable medication-related complications among patients with ADRD.

The study will characterize more than 22,500 patients with ADRD who will be identified through the DRN’s distributed data resources. The NIH Collaboratory DRN enables researchers to send queries to data partners and receive aggregate data without confidential information. Through its multiple data partners, the DRN has access to data for more than 90 million lives.

View an NIH Collaboratory Grand Rounds presentation about the status of the DRN, and learn more about the DRN in the Living Textbook.

December 13, 2018: New Living Textbook Chapter: Developing a Compelling Grant Application

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 a testable hypothesis and then select an experimental design best suited to answering the research question. The study question drives the research design.” —From Developing a Compelling Grant Application

Dr. Wendy Weber, the Program Officer for the NIH Collaboratory Coordinating Center, and Dr. Marcel Salive, a Program Officer from the National Institute on Aging, contributed to this chapter.

December 11, 2018: Two New NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

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:

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.

December 7, 2018: Cluster Randomized Trials in Health Care Delivery Systems: Lessons from STIC2IT (Niteesh K. Choudhry, MD, PhD)

Speaker

Niteesh K. Choudhry, MD, PhD
Professor, Harvard Medical School
Executive Director, Center for Healthcare Delivery Sciences, Brigham and Women’s Hospital

Topic

Cluster Randomized Trials in Health Care Delivery Systems: Lessons from STIC2IT

Keywords

STIC2IT; Pragmatic clinical trial; Learning health system; Cluster randomization; Medication adherence; Telepharmacy; Electronic health record; Stakeholder engagement

Key Points

  • STIC2IT, a pragmatic, cluster-randomized trial, evaluated a telepharmacy intervention to improve medication adherence for people with chronic diseases.
  • Pragmatic aspects of STIC2IT included outcomes assessed using routinely collected data, cluster randomization by physician practice, intention-to-treat analysis, and use of the EHR to collect research data.
  •  While medication adherence did improve in the STIC2IT intervention group, secondary clinical outcomes did not improve. Future trials within health systems should incorporate multilevel engagement across the health system, physicians and staff, and patients.

Discussion Themes

It is important to do ongoing outreach at the health system leadership level to ensure understanding and commitment to the study and keep providers aware of the trial. Study teams should be mindful of the priorities of their partner health system.

Using the EHR for research data required some upfront work building special modules and generating custom reports.

For more information on conducting PCTs in health delivery systems, visit the Living Textbook chapter on engaging stakeholders and building partnerships.

Tags

@Collaboratory1, #pctGR, #HarvardMed, #telepharmacy

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)

Speaker

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