Evidence-Based Practices

Grand Rounds September 5, 2025: The Non-Learning Health System (Robert Califf, MD)

Posted on by Sophia Ramirez

Speaker

Robert Califf, MD
Instructor in Medicine
Duke University Medical Center
Former Commissioner of Food and Drugs

Keywords

Healthcare; Learning Health System; Evidence-Based Practices; Health Outcomes

Q&A

The following reflects key takeaways from a fireside chat with Dr. Robert Califf, in which he shared his perspective on the “non-learning” health system. For a comprehensive account of Dr. Califf’s insights, watch the recording.

What do you mean by the “non-learning” health system?

25 years ago, certain visionaries looked at the advancement of computing, electronic health records, and other digital data and noted that data could and should be used to improve healthcare delivery and, in turn, health outcomes.

But increasingly, the healthcare system in the United States is “learning” based on institutional financial outcomes as opposed to patient outcomes. That’s not to say it’s a zero-sum game—but efforts are being directed towards expensive technologies that offer marginal benefit (but deliver good economic returns) as opposed to primary care, prevention, and interventions that address basic risk factors.

How can we reshape those incentives?

If the goal is to optimize the longevity, well-being, and functionality of the American population, incentives within the healthcare system should be aligned with health outcomes.

Why has it been so difficult to integrate evidence-based practices into healthcare settings? And how can we begin to change that?

If we align health care systems’ incentives with health outcomes, they will figure out how to operationalize these practices. But if we assume the incentives will not be realigned in the near future, we will need to eke out areas of alignment with decision-makers, incremental improvements that are not so disruptive that they get squashed. And finally, we need to develop disruptive external systems to challenge health systems.

What tasks should this community focus on?

Keep working on pragmatic trials; show that interventions have practical applications. Keep developing the skills to communicate about your work to the public. And be prepared to put our system back together when it breaks.

Discussion Themes

Other discussion themes included the critical role of randomized trials and the potential role of AI in answering scientific questions; what the research community can learn from other industries; and anticipated changes to the healthcare system and research landscape.

Grand Rounds August 22, 2025: Avoiding the Fumble: Building on a Decade of Lessons from Pragmatic Clinical Trials (Emily O’Brien, PhD, FAHA)

Posted on by Sophia Ramirez

Speaker

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Keywords

Pragmatic Trials; Best Practices; PCORnet; Evidence-Based Practices

Key Points

  • Historically, the healthcare industry has been limited by an insufficient body of evidence driving everyday clinical decision-making. Roughly a decade ago, pragmatic clinical trials (PCTs) began to gain traction as a promising solution.
  • There are several advantages of PCTs. They can be embedded within healthcare systems without disrupting the clinical workflow; answer questions of major public health importance; streamline procedures and infrastructure by making use of existing data; and include diverse, representative study populations for highly generalizable results.
  • But a recent analysis of clinical research site challenges noted that protocol complexity, site workload, and patient burden have increased since 2015. Though the analysis was not specific to pragmatic trials, a fundamental shift in how researchers think about study design is required across the clinical trials space.
  • Additionally, evidence-based practices – even those that have been stress-tested in PCTs – are not always adopted by health systems. Trial success does not necessarily coincide with system priorities; different audiences, i.e. systems and funders, require different kinds of evidence; and 5- to 10-year studies are misaligned with systems’ 2- to 3-year decision horizons.
  • The NIH Pragmatic Trials Collaboratory philosophy holds that fumbles are part of the game; we can’t improve if we only share wins, and transparency and teamwork has helped this community iterate and improve. Accordingly, the PCORnet team developed “The Playbook,” inspired by the NIH Collaboratory’s Living Textbook, as a tool for sharing and refining the best approach to national-scale research.
  • The Playbook contains practical “drills” for avoiding common fumbles in recruitment, workflow, and outcome capture, and was created using a user-centered design process. They engaged PCORnet groups, partners, and members of the Playbook’s intended audience to inform and guide the content.
  • Modules 1 – 5 of the Playbook, launching this year, will provide an introduction to the network. They include sections on getting started with PCORnet, utilizing the network’s resources, dissemination and implementation expectations for PCORnet studies, and case studies.
  • In the long-term, the PCORnet team plans to actively review, maintain, and expand the Playbook. Additional modules are in process and targeted for release in 2026.

Discussion Themes

The success of the Playbook may depend on the willingness of investigators to share both their “best plays” and their mistakes. Dr. O’Brien was optimistic that research teams will buy into this philosophy and acknowledge it as an important piece of the evidence generation process.

The case studies that the team selected serve to illustrate A) that PCORnet trials are unique, innovative, and approaching challenges in a thoughtful, inspiring way and B) the many ways to engage with the network.

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 January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Posted on by Sophia Ramirez

Speaker

Jeffrey H. Samet, MD, MA, MPH
John Noble Professor in General Internal Medicine & Professor of Public Health
Boston University Chobanian and Avedisian School of Medicine and School of Public Health
Boston Medical Center

Keywords

Opioid Epidemic; Evidence-Based Practices; NIH HEAL Initiative; MOUD; OEND; Harm Reduction

Key Points

  • Over roughly 20 years, opioid overdose (OD) mortality in the U.S. increased tenfold: from a little over 8,000 in 1999 to over 80,000 in 2022. Health authorities urged medical professionals to address the crisis through stigma reduction, uptake of opioid use disorder (OUD) treatment, and other evidence-based practices (EBPs).
  • The goal of the HEALing Communities Study (HCS) was to reduce opioid OD through implementation of EBPs, including overdose education and naloxone distribution (OEND); access to medications for OUD (MOUD); and safer opioid prescribing and dispensing practices.
  • The research team conducted the cluster randomized trial in 67 communities across Ohio, Kentucky, New York, and Massachusetts – a total study population of about 10 million. HCS is the largest implementation science study funded by NIDA.
  • The primary objective of HCS was to compare the number of opioid OD deaths in adults during the comparison period (July 2021 – June 2022) between the intervention and control communities. Secondary outcomes included the rates of naloxone distribution; access to or utilization of MOUD; opioid + stimulant OD deaths; and non-fatal overdose events.
  • The intervention involved 3 pathways for implementing OUD EBPs: community engagement; the Opioid Reduction Continuum of Care Approach (ORCCA), consisting of a menu of strategies to support implementation of EBPs; and community-based health communications campaigns. Multi-level partnerships, Dr. Samet noted, are critical to the success of community-engaged research.
  • Between the intervention group and the control group, there was no difference in the number of opioid OD deaths. OD deaths involving opioids and psychostimulants (excluding cocaine) decreased by 37% in the intervention group, and there was a 15% reduction in nonfatal overdoses.
  • Factors that may have impacted results included the complex array of strategies; a limited period of time in which to achieve full benefits from the implementation of EBPs; COVID-19-related demands on coalition members and healthcare personnel; increasing rates of fentanyl in the drug supply with stimulant contamination; and statistical power.
  • Limitations included the fact that control communities could still access non-HCS funds to address the opioid epidemic and a variation in the affected population size within each community.

Discussion Themes

The research team had 18 months to get the intervention up and running; when the comparison period began, they were at 35% implementation – lower than their goal. This was partially a product of the stakes; the death toll of the opioid epidemic was high and the team was motivated to make quick progress. The COVID-19 pandemic also slowed things down.

Dr. Samet emphasized that the HCS team wasn’t testing whether MOUD and OEND worked; there is significant evidence demonstrating that these strategies are effective. Rather, the team was testing whether communities adopted them and if they had an effect on OD reduction.

When the team shared the results back with community partners, they heard anecdotal reports about the positive effects their partners had witnessed in their communities.

Engagement coalitions formed across communities. Ohio and Kentucky utilized existing coalitions while New York and Massachusetts built new ones. Dr. Samet noted that each of the four states performed well in different realms.