Implementation

Grand Rounds August 14, 2026: Designing for Impact: Introducing Translational Design Studies (Christopher J. Lindsell, PhD; Lloyd Michener, MD; Justin B. Moore, PhD, MS; Boris Volkov, PhD; Reuben Adatorwovor, PhD)

Posted on by Sophia Ramirez

Speakers

Christopher J. Lindsell, PhD
Vice Dean for Data Science and AI
Duke University School of Medicine

Lloyd Michener, MD
Professor & Chair Emeritus
Department of Family Medicine & Community Health
Duke University School of Medicine
Adjunct Professor, Public Health Leadership
UNC Gillings School of Global Public Health

Justin B. Moore, PhD, MS
Professor and Chair (interim)
Department of Implementation Science
Director for Dissemination, Implementation, and Continuous Quality Improvement
Clinical and Translational Science Institute
Wake Forest School of Medicine

Boris Volkov, PhD
Evaluation Director and Assistant Professor
University of Minnesota Clinical and Translational Science Institute & Institute for Health Informatics

Reuben Adatorwovor, PhD
Assistant Professor of Biostatistics
Institute of Informatics, Data Science and Biostatistics
Department of Emergency Medicine
Washington University in St. Louis

Keywords

Study Design; Translation; Translational Science; Failure; Engagement; Biostatistics; Informatics; Implementation; Evaluation

Key Points

  • Translational failure often begins before the trial. The labels we use – eg, recruitment failure, stakeholder resistance, and poor generalizability – indicate where failure becomes visible, not where it originates. However, trial design remains largely unevidenced. If a decision determines whether downstream work can succeed, the presenters argued, the basis for that decision belongs in the scientific record.
  • A translational design study is a systematic inquiry conducted before, or alongside, planned translational work. It seeks to reduce a named design uncertainty. The category is defined by intent, not by method; qualitative, quantitative, and mixed methods all qualify. The presenters introduced 4 lenses on design uncertainty: community engagement; evaluation; biostatistics and informatics; and implementation science. These are to be used in conjunction, not held as separate disciplines.
  • Attendees were encouraged to submit their design-phase work for publication, especially if their findings forced them to change course. If it includes a clear design question, an explicit assumption, reproducible methods, and results that others can apply, adapt, and build on, it qualifies.

Discussion Themes

While industry focuses on scalability, the presenters argued that the academic community should lead in design innovation.

ACTIV-6 is a real-world example. In that large decentralized trial, evidence-based protocol changes served as a model for transferable design learning.

June 8, 2026: AcademyHealth Issues Call for Presentations for 2026 D&I Conference

Posted on by Damon Seils

Banner for the 2026 AcademyHealth D&I ConferenceAcademyHealth issued a call for presentations for its 19th Annual Conference on the Science of Dissemination and Implementation (D&I) in Health.

The theme of this year’s conference is “Elevating the Science of Dissemination: Leveraging Tools to Improve Clinical, Community, and Public Health Practice.” The conference will be held from December 13 to 16, 2026, at the Gaylord National Resort & Convention Center in National Harbor, Maryland.

From the call for presentations:

Get your research out there! The 19th Annual Conference on the Science of Dissemination and Implementation (D&I) in Health encourages presentation submissions to nine thematic tracks that present evidence-based approaches to a multitude of clinical and community settings via public health practice, health care delivery, and health care policy.

The submission deadline is July 16, 2026. Read the complete submission and review criteria.

Podcast September 17, 2025: End-of-Trial Decision-Making (Greg Simon, MD, MPH; Lorella Palazzo, PhD)

Posted on by Sophia Ramirez

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.”

Read the transcript. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud.

Grand Rounds February 28, 2025: Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST-ICU): Protocol, Challenges, and Major Updates (Eduard Vasilevskis, MD, MPH; Michele C. Balas PhD, RN, CCRN-K, FCCM, FAAN)

Posted on by Sophia Ramirez

Speakers

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

Keywords

Intensive Care; ICU; Implementation; Evidence-Based Practices

Key Points

  • With recent increases in survivorship for Intensive Care Unit (ICU) patients has come the rise of Post-ICU Syndrome, or PICS. PICS is characterized by cognitive and physical impairment; financial toxicity; and family impacts. Some of the factors associated with PICS are modifiable: Sedation use, for example, immobility, and mechanical ventilation.
  • A set of evidence-based best practices based on these modifiable factors are encapsulated in the ABCDEF Bundle: Assess, prevent, and manage pain; Both spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs); Choice of analgesia and sedation; Delirium: assess, prevent, and manage; Early exercise and mobility; and Family engagement.
  • In a study of 68 ICUs, patients treated with all elements of the ABCDEF bundle in a given day had better outcomes. The next day, they were 70% less likely to be on a mechanical ventilator; 65% less likely to be in a coma; and 40% less likely to be delirious. Though there wasn’t a significant impact on pain, the likelihood of being discharged from the hospital increased by 20%.
  • We have a safe and efficacious set of evidence-based practices that people can deliver in the ICU. However, many of them are not being delivered to critically ill patients. And they’re not being delivered due to numerous implementation challenges clinicians experience in everyday care.
  • The Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST-ICU) study aims to evaluate 2 strategies grounded in behavioral economic and implementation science theory to increase adoption of the ABCDEF bundle. The strategies target a variety of ICU team members and known behavioral determinants of ABCDEF bundle performance.
  • BEST-ICU is ongoing. The hybrid type III effectiveness-implementation pragmatic trial will take place in 3 hospitals and 12 ICUs across 33 months. The study team will monitor fidelity through real-time monthly tracking of audit and feedback information and through direct observation by Registered Nurse (RN) Implementation Facilitators.
  • Over 3,000 work intensity surveys have already been completed, split between RNs and non-nurses. Given the intensive nature of these surveys and the dearth of studies investigating work intensity in the ICU, this alone will be a notable contribution to the literature.
  • The research team outlined some of their sticking points around dashboard development and data acquisition/sharing, as well as how they’ve addressed these challenges. Solutions included the standardization of definitions for bundle process elements and engagement of clinical, operational, and legal leadership from the University & Health system.

Discussion Themes

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.

Grand Rounds September 20, 2024: Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials (John Fortney, PhD)

Posted on by Sophia Ramirez

Speaker

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

Keywords

Pragmatic; Implementation; Hybrid-Effectiveness; Trial Types

Key Points

  • Pragmatic trials are primarily designed to determine the effectiveness of a clinical intervention under the usual conditions in which it will be applied. A hybrid-effectiveness implementation trial assesses both clinical effectiveness and implementation.
  • Dr. Fortney walked through the translational research pipeline, which flows from explanatory trials to pragmatic trials to implementation research. Ideally, the end product is improved processes and outcomes.
  • While the differences between explanatory, pragmatic, and implementation trials is well understood, the differences and similarities between pragmatic trials and hybrid type trials are not well understood.
  • Pragmatic Trials (PTs) and Hybrid Type 1 Trials (HT1) aim to test the effectiveness of clinical interventions, with patient outcomes as their primary outcomes. Hybrid Type 3 Trials (HT3) look at whether a given implementation strategy successfully promotes intervention uptake. Hybrid Type 2 Trials (HT2) compare two clinical interventions and one or two implementation strategies.
  • Whereas HT1s utilize artificial implementation strategies, PTs, HT2s, and HT3s utilize practical implementation strategies that they expect to be replicable outside of a research context.
  • Dr. Fortney provided resources, including a question tree and case examples, to aid researchers in identifying or choosing a trial type. He also provided several guidelines, including:
    • HT1 trial types should be used to determine whether a clinical intervention can be effective when delivered in routine care.
    • Pragmatic and HT2 trial types should be used to determine whether an evidence-based clinical intervention(s) is effective when delivered with practical implementation strategies in routine care.
    • HT2 and HT3 trial types should be used to determine whether practical and novel implementation strategies successfully promote the uptake of evidence-based clinical interventions.

Discussion Themes

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.

Grand Rounds July 26, 2024: Interventions for Optimization of Guideline-Directed Medical Therapy for Heart Failure (Gregg C. Fonarow, MD, FACC, FAHA, FHFSA)

Posted on by Sophia Ramirez

Speaker

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

Keywords

Heart failure; HFrEF; guideline-directed medical therapy; implementation; systematic review

Key Points

  • Despite the availability of effective therapies for heart failure (HF), a large number of eligible patients are not receiving one or more evidence-based, guideline-recommended therapies. This implementation gap has stymied improvements in morbidity and mortality.
  • The benefits of evidence-based heart failure medications are cumulative. If all therapies are used, there is a relative risk reduction of 74.0% and an absolute risk reduction of 25.9%. Simultaneous or rapid initiation of therapies reduces HF hospitalizations, rehospitalizations, and mortality.
  • Reasons for underutilization of Guideline-Directed Medical Therapy (GDMT) for heart failure include a lack of systems to reliably implement therapies; gaps in knowledge and awareness of guidelines; therapeutic inertia; and insufficient urgency.
  • Dr. Fonarow’s team conducted a systematic review of interventions for the optimization of GDMT, including 28 randomized clinical trials with an aggregate sample of over 19,000 patients. They found that the initiatives that used interdisciplinary teams, largely comprised of nurses and pharmacists, most consistently led to improvements in GDMT. Clinician education, electronic health record initiatives, and patient interventions, on the other hand, resulted in no or modest improvements in GDMT.
  • Implementation of GDMT needs to improve in all clinical settings. Programs that successfully implement GDMT often have access to current and accurate data on treatment outcomes; administrative and clinician support; use care maps and pathways; and use data to provide feedback. There is also a need for further implementation science innovation and testing.

 

Discussion Themes

– 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.”

 

 

Tags

#pctGR, @Collaboratory1

October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

Posted on by Damon Seils

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:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

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

May 15, 2023: EMBED Offers Lessons for Intervention Adoption, Implementation, and Maintenance

Posted on by Damon Seils

EMBED logoOrganizational 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:

  • establishing buprenorphine initiation as a cultural norm within healthcare organizations;
  • organizational commitment to implementing and sustaining the intervention;
  • clinician training and support on opioid use disorder and buprenorphine initiation in emergency departments;
  • availability of referral resources to link patients who were initiated on buprenorphine in the emergency to ongoing treatment; and
  • the ability to tailor the intervention to clinic workflows that fit the resources and characteristics of the local clinic.

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.

Read the full report.

March 1, 2023: This Week’s PCT Grand Rounds Highlights Implementation Lessons From GGC4H

Posted on by Damon Seils

Headshots of Margaret Kuklinski and Stacy Sterling with the GGC4H logoIn 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.

Join the online meeting.

November 3, 2022: Pragmatic Trials Workshop at 2022 D&I Science Conference Open for Registration

Posted on by Damon Seils

AcademyHealth and NIH logosThe 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:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with pragmatic clinical trials and share lessons from implementation science for increasing engagement of diverse participants

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