In this episode of the NIH Collaboratory podcast, Drs. Greg Simon and Lorella Palazzo discuss their recent Living Textbook Chapter, “End-of-Trial Decision-Making.”
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Eduard Vasilevskis, MD, MPH
Professor of Medicine
Department of Medicine, Division of Hospital Medicine
University of Wisconsin-Madison
Michele C. Balas PhD, RN, CCRN-K, FCCM, FAAN
Associate Dean of Research
Dorothy Hodges Olson Distinguished Professor of Nursing
University of Nebraska Medical Center College of Nursing
Intensive Care; ICU; Implementation; Evidence-Based Practices
Patient-reported pain was the only outcome that didn’t improve following full implementation of ABCDEF bundle. Dr. Balas noted that patients who aren’t in a coma anymore can then report pain. Dr. Vasilevskis pointed out that the same goes for delirium, which is far preferable to coma from a mortality perspective.
Dr. Balas suggested that a patient who is more cognitively engaged and able to report pain is actually in a better spot, as it enables medical staff to treat them.
John Fortney, PhD
Professor
Department of Psychiatry and Behavioral Sciences
University of Washington
Senior Research Career Scientist
HSR Center of Innovation for Veteran-Centered and Value-Driven Care
VA Puget Sound Health Care System
Pragmatic; Implementation; Hybrid-Effectiveness; Trial Types
The distinction between artificial implementation strategies and evidence-based, or practical, implementation strategies is not always black and white, and will often fall somewhere on the Artificial → Practical continuum.
This research team laid out some of the subtler differences in research objectives between study types, and the elements studies need to successfully address those objectives. Reviewers and researchers alike need to be careful in thinking these distinctions through and understanding them.
Gregg C. Fonarow, MD, FACC, FAHA, FHFSA
Eliot Corday Professor of Cardiovascular Medicine and Science
Director, Ahmanson-UCLA Cardiomyopathy Center
Codirector, UCLA Preventative Cardiology Program
UCLA Division of Cardiology
Heart failure; HFrEF; guideline-directed medical therapy; implementation; systematic review
– Do you still see lack of education as a major problem that needs to be approached differently, or should we really be focusing on something else? I do think it need to be further studied. I think our educational efforts around the clinician need to center on the really practical aspects, on what the common pitfalls are in trying to apply and uptitrate these medications. Interdisciplinary teams and cross-discipline education are critically important. [The study results] don’t mean that education shouldn’t be part of further interventions, but I think we need to look at what’s truly going to see a meaningful increase in medication titration and persistence of GDMT.
– The polypill could address some of the clinical inertia issues and patient resistance. Patients hate it when you keep adding on four different medications and you’re increasing the doses. Is it being studied in this context? There is work going on, editorials have been written about it, the concept has been laid out. There are small pilot studies that have been done. There are challenges; is titration necessary? You’ll need a series of polypills to uptitrate, or you’ll get the therapy started and then you’ll bring them together as a polypill. One thing I do want to highlight, though, is that starting medications simultaneously defeats that patient question of, “Why are you adding this extra medication? Are the prior medications not working?” It’s a different mindset upfront: “Here are these four medications you’re going to be on.”
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The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.
The learning objectives of the workshop include:
The theme of this year’s D&I conference is “Raising Expectations for D&I Science: Challenges and Opportunities.” The annual conference is cohosted by the NIH and AcademyHealth.
WORKSHOP DETAILS AND REGISTRATION
Sunday, December 10, 10:00 am-6:00 pm
Gateway Marriott, Arlington, Virginia
Organizational culture, clinician training and support, the ability to link patients to ongoing treatment, and the ability to tailor implementation to each clinical site were key determinants of successful implementation of an intervention to promote buprenorphine initiation in emergency departments, according to a qualitative study conducted as part of the EMBED pragmatic clinical trial.
The study’s findings were published recently in Implementation Science Communications.
EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial tested the effectiveness of a clinical decision support tool integrated into the electronic health record in improving rates of buprenorphine initiation in the emergency department for the treatment of opioid use disorder. The intervention led to a modest increase in buprenorphine initiation and little impact on patient outcomes.
A secondary aim of the study was to identify determinants of adopting, implementing, and maintaining the clinical decision support tool at the trial sites. Among the key determinants were:
EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.
In this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H, an NIH Pragmatic Trials Collaboratory Trial.
The Grand Rounds session will be held on Friday, March 3, 2023, at 1:00 pm eastern.
Kuklinski is an associate professor of social work and the director of the Social Development Research Group in the University of Washington School of Social Work. Sterling is a senior research scientist in the Kaiser Permanente Division of Research.
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.
The learning objectives of the workshop include:
The theme of this year’s D&I conference is “(Re)Building Better Systems: Being Proactive, Nimble, and Responsive.” The annual conference is cohosted by the NIH and AcademyHealth.
WORKSHOP DETAILS AND REGISTRATION
Sunday, December 11, 8:00 am-4:45 pm
Walter E. Washington Convention Center, Washington, DC
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.
The learning objectives of the workshop include:
The theme of this year’s D&I conference is “(Re)Building Better Systems: Being Proactive, Nimble, and Responsive.” The annual conference is cohosted by the NIH and AcademyHealth.
WORKSHOP DETAILS AND REGISTRATION
Sunday, December 11, 8:00 am-4:45 pm
Walter E. Washington Convention Center, Washington, DC
In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Steven George discussed how to successfully implement an intervention in a pragmatic clinical trial and how intervention complexity affects implementation across various sites with different local contexts.
“Variation is everywhere, and you have to be willing to ride that wave. It is kind of like being out there waiting to catch a wave into shore, you’re not going to be able to pick how rough that surf is on any given day.”
Successfully implementing and delivering an intervention across multiple organizations is dependent on many factors, including the complexity of the intervention, the stability of the control, and barriers to and promoters of uptake.
Dr. George’s advice is to “Be willing to listen to patients, sites, and providers to help make what you envision for your trial work in a local environment. That flexibility is way to show respect with someone that you are collaborating with. They know their local environment, and if we’re going to ask them as pragmatic trialists to help deliver the intervention, we need to flexible.”
Read Dr. George’s presentation on the implementing and delivering interventions across healthcare systems from the April Steering Committee Meeting.
