Grand Rounds Archive

Grand Rounds March 6, 2026: Bringing Primary Care Clinical Trials Research Into the 21st Century: Lessons Learned and Developments From Large-Scale European Adaptive Platform Trials of Therapeutics for Acute Respiratory Infections (Christopher C. Butler, BA, MBChB, DCH, CCH, MD, FRCGP)

Posted on by Sophia Ramirez

Speaker

Christopher C. Butler, BA, MBChB, DCH, CCH, MD, FRCGP
Associate Head for Research
Professor of Primary Care
Professorial Fellow, Trinity College
Clinical Director, Primary Care Clinical Trials Unit
University of Oxford

Keywords

Primary Care; COVID-19; Respiratory Medicine; Adaptive Platform Trials; Large-Scale Trials; Pandemic; General Practitioners

Key Points

  • Effective primary care (PC) interventions have the potential to reach a significant portion of the community and, concurrently, have a significant impact. PC is also a good vehicle for early, self-initiated interventions, which can limit illness and enhance the sustainability of health care. However, traditional clinical trials face several challenges in PC, including general practitioners’ workload crisis, opportunistic recruitment, and geographical constraints.
  • The research team sought to address these challenges by conducting adaptive platform trials (APTs) that utilized sophisticated digital methods in a PC setting. PRINCIPLE and PANORAMIC evaluated multiple COVID-19 treatments simultaneously using innovative methods like remote eligibility checks, e-consent, and direct-to-participant drug delivery. The use of APTs demonstrated that large-scale, rigorous research can be successfully conducted outside of hospitals and provide real-world evidence.
  • Next, the research team will conduct the ECRAID-Prime trial: An international community-based APT evaluating early treatments for acute respiratory infections to prevent hospitalizations and reduce societal illness duration. They are currently in the recruitment phase, having shifted from traditional site-based recruitment to a more decentralized approach.

Discussion Themes

The National Health Service (NHS) and publicly funded clinical trials units are mission-critical because they prioritize health outcomes over profit and provide a “warm base” for rapid research.

Dr. Butler noted that busy general practitioners participated because they bought into the values and the importance of the research questions, especially when administrative burdens were minimized.

Grand Rounds February 27, 2026: Optimal Transfusion Strategy in High Cardiac Risk Patients After Major Surgery: Results of the TOP Trial (Panos Kougias, MD, MSc; Sherene Sharath, PhD, MPH)

Posted on by Sophia Ramirez

Speakers

Panos Kougias, MD, MSc
Professor and Chair
Department of Surgery, SUNY Downstate Health Sciences University

Sherene Sharath, PhD, MPH
Assistant Professor
Department of Surgery, SUNY Downstate Health Sciences University

Keywords

Blood Transfusion; Surgery; Cardiology; Cardiac Outcomes

Key Points

  • Postoperative anemia is common after major operations. While the current guidelines recommend transfusion for hemoglobin (Hb) below 7 g/dL, the safety of this restrictive strategy is unclear – particularly after major operations and in high cardiac risk patients.
  • The study team sought to evaluate whether a more liberal transfusion strategy reduces the risk of mortality or major ischemic events in high cardiac risk patients undergoing major operations. They randomized eligible veterans from 16 VA medical centers to receive transfusion at either Hb<10 g/dL (the “liberal” arm) or Hb<7 g/dL (the “restrictive” arm).
  • They found that the rates of mortality and major ischemic events were similar between the groups. While the rates of most secondary outcomes were also similar, a composite outcome of heart failure and arrhythmias was more frequent in the restrictive arm.
  • The study team noted that a one-size-fits-all approach may not be applicable for transfusion strategies. Potential cardiac-outcome related benefits should be explored in future trials.

Discussion Themes

In the weighting of composite outcomes, the analysis treated all events (e.g., death vs. minor complications) as having equal clinical severity. This may have reduced the trial’s statistical power.

The actual event rate (10%) was much lower than the anticipated 30%. The study team attributed this to improved perioperative care and better cardiovascular outcomes over the last decade compared to the historical data used for initial calculations.

Communicating nuanced findings may require some extra legwork; clinicians often struggle to interpret results that are not clear-cut “wins” or “losses.”

Grand Rounds February 20, 2026: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP): Early Progress and Lessons Learned (Diana Burgess, PhD; Roni Evans, DC, MS, PhD; Katie Hadlandsmyth, PhD)

Posted on by Sophia Ramirez

Speakers

Diana Burgess, PhD
Professor of Medicine,
University of Minnesota
Director, VA Advanced Fellowship Program in Health Systems Research, Center for Care Delivery and Outcomes Research (CCDOR),
Minneapolis Veterans Affairs Healthcare System
Director, QUERI Complementary and Integrative Health Evaluation Center (CIHEC),
Veterans Affairs Healthcare System

Roni Evans, DC, MS, PhD
Research Professor
Director, Integrative Health & Wellbeing Research Program
Earl E. Bakken Center for Spirituality & Healing,
University of Minnesota

Katie Hadlandsmyth, PhD
Associate Professor
College of Nursing
University of Iowa

Keywords

Chronic Pain; Whole-Health; Biopsychosocial; Veterans Administration (VA); Rural Populations

Key Points

  • Rural Veterans exist at the intersection of 2 populations that are disproportionately affected by chronic pain. Compared to urban Veterans, rural Veterans are less likely to receive comprehensive and specialty pain care; are more likely to be prescribed opioid medication; and utilize pain self-management strategies at lower rates. The Veterans Administration (VA) serves 2.7 million rural veterans.
  • Seeking to improve pain management and reduce opioid use among rural patients, VA researchers developed the Rural Veterans Applying Mind Body Skills for Pain (RAMP) intervention. RAMP addresses pain as a biopsychosocial condition, providing rural VA patients with the opportunities and resources to enhance their capabilities and motivations to engage in helpful pain self-management behaviors.
  • A pilot study found that the intervention met milestones for enrollment, satisfaction, and fidelity. The researchers concluded that a full-scale randomized trial of a complementary and integrative health telehealth program for rural VA patients with chronic pain is feasible and can meet pain self-management needs. Their intervention and study processes have been refined to increase engagement and data collection.
  • In March 2026, the team will begin enrollment for a Type II randomized hybrid-effectiveness implementation trial.

Discussion Themes

The team emphasized the need for “resilient interventions” that can withstand external disruptions, such as natural disasters and VA workforce restructuring.

Relationship-building with high-level and local stakeholders was essential for navigating the VA’s complex and dynamic organizational structure. The researchers detailed their strategy for managing stakeholder panels, which included roughly 21 core members (i.e., patients and community advisors) and 10 internal VA stakeholders.

Grand Rounds February 13, 2026: The Making of the COMPARE-Pediatric IBD Study (Michael D. Kappelman, MD, MPH)

Posted on by Sophia Ramirez

Speaker

Michael D. Kappelman, MD, MPH
Professor, Pediatric Gastroenterology
University of North Carolina at Chapel Hill

Keywords

PCORnet; PCORI; Inflammatory Bowel Disease; Pediatrics; Common Data Model; Study Design

Key Points

  • Inflammatory Bowel Disease (IBD) is a chronic gastrointestinal condition affecting roughly 100,000 youth in the United States. It has a profound impact on nutrition, growth, physical, and psychosocial development. Anti-TNF biologics are the only FDA-approved advanced therapies for children, and approximately 30% of patients experience treatment failure within 2 years. There’s an urgent need for comparative effectiveness research that can guide treatment decisions when anti-TNF fails.
  • COMPARE-Pediatrics IBD, a PCORnet® study, includes 2 parallel multi-center, prospective cohort studies and retrospective cohort studies. The former, developed with multi-stakeholder input, will compare the effectiveness of emerging therapies in children with IBD; the latter will characterize the safety of these treatments and explore the heterogeneity of treatment effects across subgroups.
  • The study is utilizing PCORnet’s® infrastructure, including Prep-to-Research Queries and the PCORnet® Common Data Model (CDM), to inform the study design; identify administrative efficiencies; support recruitment; ease site burden; assess representativeness of the study population; and otherwise bolster their research.

Discussion Themes

Planning a PCORnet® study is a lot of work (and takes time). Start the process early and know that benefits may be on the back-end.

The study team opted not to conduct a randomized pragmatic trial because they anticipated that desperate families would be reluctant “roll the dice” with randomization and because insurance coverage for expensive off-label medications often dictates which therapy a patient can receive.

While the CDM is effective for structured data (like labs and diagnoses), Dr. Kappelman noted it cannot yet capture nuanced interpretations, such as specific MRI findings, which require more advanced AI or manual review.

Grand Rounds January 30, 2026: A Pragmatic Randomized Controlled Trial of Ambient Artificial Intelligence to Improve Health Practitioner Well-Being (Majid Afshar, MD, MS; Mary Ryan Baumann, PhD)

Posted on by Sophia Ramirez

Speakers

Majid Afshar, MD, MS
Associate Professor
Director, Learning Health Systems
Departments of Medicine and Biostatistics & Medical Informatics
University of Wisconsin-Madison

Mary Ryan Baumann, PhD
Assistant Professor
Departments of Population Health Sciences and Biostatistics & Medical Informatics
University of Wisconsin-Madison

Keywords

Artificial Intelligence; Burnout; Provider Well-Being; Learning Health System

Key Points

  • Documentation in the Electronic Health Record (EHR) is a driver of clinician burnout; it can reduce their capacity to connect with patients during an appointment and spill over into daily life, i.e. “work outside of work.” The research team sought to assess whether the use of an ambient Artificial Intelligence (AI) scribe could improve clinician well-being by automating the documentation process.
  • The stepped-wedge, individually randomized trial took place over 24 weeks at UW Health. 66 providers across various specialties were randomized to receive access to ambient AI at Week 1, Week 7, or Week 13. The primary endpoint was physician well-being, measured by the Professional Fulfillment subscale and a burnout composite.
  • The research team found a 20% reduction in burnout and a trend towards improvement in professional fulfillment. These effects were sustained over the course of the trial. Use of the technology also decreased “work outside of work” by an average of 30 minutes and “time in notes” by 21 minutes.

Discussion Themes

Qualitative interviews found that patients of the clinicians in the trial appreciated the reduced computer interaction and felt that communication was clearer and more open.

The research team worked with the EHR company to develop a rubric for evaluating the AI-generated notes for accuracy, i.e. the presence of AI hallucinations or falsifications.

Following the trial’s success, UW Health scaled the project from 66 to over 600 licenses. An operational dashboard was developed for real-time monitoring of utilization and documentation metrics to ensure sustained performance and coding compliance.

Grand Rounds January 23, 2026: DASH-Patterned Groceries Reduce Blood Pressure: Results from the GoFresh Randomized Clinical Trial (Stephen P. Juraschek, MD, PhD, FAHA, AHSCP-CHS)

Posted on by Sophia Ramirez

Speaker

Stephen P. Juraschek, MD, PhD, FAHA, AHSCP-CHS
Associate Professor of Medicine
HCA Hypertension Center Director & Beth Israel Deaconess Medical Center

Keywords

Hypertension; Groceries; Diet; Grocery Access; DASH

Key Points

  • Hypertension affects 55% of Black adults, more than any other demographic in the US. Diet is the most important mediator of excess hypertension risk among Black adults, and the DASH diet – which emphasizes low-sodium, heart-healthy items like fruits, vegetables, whole grains, and lean proteins – has been shown to be especially efficacious (albeit in tightly controlled settings).
  • The study team sought to test whether 3 months of dietician-assisted, home-delivered, DASH-patterned grocery delivery to Black residents of communities with few grocery stores would improve their blood pressure. The comparator group received 3 $500 stipends, one every 4 weeks, for self-directed grocery shopping.
  • The research team found that the intervention reduced urine sodium, systolic blood pressure, diastolic blood pressure, and LDL-cholesterol. Longer-term maintenance of these benefits will likely require sustained access to healthy groceries and nutrition counseling.

Discussion Themes

The 3.4 mmHg reduction in systolic blood pressure is more modest than the 7–10 mmHg typically expected from first-line antihypertensive drugs. Dr. Juraschek emphasized that GoFresh was a prevention cohort for adults not yet on medication.

The health benefits largely decayed after the active intervention ended. While providing food works, structural barriers to accessing healthy food remain a primary challenge. Ongoing qualitative interviews are exploring the specific barriers and facilitators that affected whether participants could maintain the DASH diet after the study ended.

Grand Rounds January 16, 2026: Financial Incentives to Promote Diverse Participation in Alzheimer’s Disease Research (Mireille Jacobson, PhD)

Posted on by Sophia Ramirez

Speaker

Mireille Jacobson, PhD
Professor, University of Southern California Davis
School of Gerontology and Schaeffer Institute

Keywords

Incentives; Financial incentives; Alzheimer’s Disease; Participation; Dementia

Key Points

  • There are nearly 6 million people living with Alzheimer’s Disease and related dementias (AD/ADRD) in the United States, a number projected to double by 2060. Despite the feact that the highest rates of AD/ADRD are found in Black and Hispanic populations, diversity in Alzheimer’s Trials is limited; between 2000 and 2019, 90% of completed trials had 75% – 100% non-Hispanic White participants.
  • The Alzehimer’s Prevention Webstudy (APT Webstudy) is a remote registry in which participants, aged 50 and older, take quarterly memory assessments. The research team sought to assess whether financial incentives could increase diversity in the APT webstudy. 45,000 patients were invited to enroll; the first ~15,000 (Arm 1) were invited via message only, Arm 2 was offered a $25 incentive, and Arm 3 was offered the chance to win $2,500.
  • The study team found that the $25 guaranteed incentives increased enrollment the most, but messages alone were the most cost-effective. 29% of new enrollees were Black or Hispanic patients, an improvement over the APT Webstudy baseline of 5.4%. However, the study team concluded, more needs to be done to enroll people of diverse backgrounds specifically.

Discussion Themes

Attendees considered the ethical implications of the $25 and whether it qualified as coercive when offered to low-income communities. Dr. Jacobson believed that $25 was not enough to be coercive in the context of a low-risk registry study, but that the ethics might differ in a clinical trial involving medication risks.

While higher amounts might increase participation, Dr. Jacobson suggested that messaging frequency may be a more critical factor than increasing the dollar amount.

Grand Rounds January 9, 2026: Pragmatic Care Embedded Randomization: Insights From the KP-VACCINATE Megatrial (Ankeet S. Bhatt, MD, MBA, ScM)

Posted on by Sophia Ramirez

Speaker

Ankeet S. Bhatt, MD, MBA, ScM
Cardiologist, Kaiser Permanente San Francisco Medical Center
Research Scientist, Kaiser Permanente Northern California Division of Research
Assistant Professor, Kaiser Permanente Bernard J. Tyson School of Medicine
Adjunct Professor, Stanford University School of Medicine

Keywords

Vaccination; Learning Health System; Implementation Science; Nudges; Influenza; Cardiovascular

Key Points

  • Every year, influenza leads to over 500,000 deaths and 3-5 million severe cases globally. It increases the risk of cardiovascular (CV) events like myocardial infarction and heart failure. Though health guidelines strongly recommend annual influenza vaccination, rates remain suboptimal globally and persistent inequities exist. There’s an urgent need for novel, effective, and scalable strategies to improve influenza vaccination rates.
  • The KP-VACCINATE trial is one of the largest ever conducted, randomizing over 3.6 million patients in under 30 days. It included several pragmatic elements, such as coordination with existing vaccine promotion efforts; randomization performed by operational health system teams; and endpoint capture fully embedded in the electronic health record.
  • The study team assessed the effect of a cardiovascular-focused nudge communication on influenza vaccination rates and found that there was no effect. Despite the negative results, the trial establishes that pragmatic and rapid randomization of communication strategies is operationally feasible at scale with routine healthcare workflows in the US.

Discussion Themes

The study team targeted a larger-than-usual population in order to 1) demonstrate the feasibility of randomization within a large-scale health system, and 2) be well-powered for subgroup analyses that could help tailor future interventions.

Dr. Bhatt viewed the negative result as an illustration of the importance of design and context for interventions based in behavioral science, rather than an indication that nudges are ineffective.

Future directions may include involvement of the broader care team, with primary care providers and specialty providers playing a potentially critical role in nudging patients towards vaccine uptake.

Grand Rounds December 19, 2025: Use of Ambient AI Scribes to Reduce Administrative Burden and Professional Burnout: Lessons Learned and Future Directions (Kristine Olson, MD, MSc; Daniella Meeker, PhD; Lee H. Schwamm, MD)

Posted on by terren.green@duke.edu

Speakers

Lee H. Schwamm, MD
Sr Vice President and Chief Digital Health Officer
Yale New Haven Health System
Associate Dean, Digital Strategy & Transformation,
Professor of Neurology and of Biomedical Informatics and Data Sciences
Yale School of Medicine

Kristine Olson, MD, MSc
Assistant Clinical Professor
Department of Medicine, Yale School of Medicine

Daniella Meeker, PhD
Associate Professor of Biomedical Informatics and Data Science, Yale School of Medicine
Chief Research Information Officer, Yale New Haven Health System

Keywords

Ambient AI scribe, Ambulatory clinics, Burnout, Clinical notes, Electronic health record.

Key Points

  • Physicians in clinic-based ambulatory care spend more than half of the workday documenting patient care in the electronic health record leading to burnout.
  • Both human and older technology ambient scribes have been shown to reduce burnout in single center studies.
  • From February to October 2024, researchers from the Yale University conducted a multi-center study in 6 health systems enrolling 263 medical professionals in ambulatory clinics to determine if an ambient scribe system reduced provider burnout.
  • After patient selection and obtaining consent, the Abridge ambient AI scribe (Abridge AI, Inc) generated a standard medical note of the patient visit while a secure online portal allowed for later viewing and editing. The transcript was imported into the clinic’s EHR note template, after which audio was deleted.
  • The researchers worked with Abridge to modify an existing client satisfaction survey, including 1 item from the mini-Z burnout metric and 3 items from the NASA Task Load Index, to capture change in physician burnout. Participants completed the survey before and after the 30-day intervention.
  • Analysis of the survey found that the ambient AI scribe reduced burnout from 51.9% to
    38.8% – a statistically significant reduction of burnout by 70% in 30 days. Significant improvements were also seen in the cognitive task load required to complete patient documentation. Focus on patients also increased.

Discussion Themes

The study team approached this project as an evaluation of an existing deployment of ambient AI to provide a measure of the ambient AI’s impact due to the perceived crisis around the burden of the electronic health record (EHR) and the need to increase patient access to providers by freeing up provider time. A step-wedge approach may be the best design approach for a study of this nature.

Ambient AI improves the quality of notes in several ways. The billable level of the notes improves, and the transcript provides transparent auditability.

Certain specialties are not seeing as much impact from the ambient AI assisted notes, such as pediatricians examining a non-verbal young child or baby. The physician in this case must learn to verbalize information they gather during their exam in order for the ambient AI to capture this information in the notes.

Patients may benefit from ambient AI as well. Providers may have greater focus and attention on the patient. Providers may capture more information and be able to provide better care.

 

Read more about this ambient AI study.

 

Grand Rounds December 12, 2025: From Eligibility to Enrollment Without a Clinic Visit: The Eat Well Produce Prescription Trial for Patients with Diabetes at Risk of Food Insecurity (Connor Drake, PhD, MPA; Susan Spratt, MD; Abigail Rader, MS)

Posted on by Sophia Ramirez

Speakers

Connor Drake, PhD, MPA
Research Health Scientist
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)
Durham VA Health System HSR&D
Assistant Professor
Department of Population Health Sciences
Duke University School of Medicine

Susan Spratt, MD
Department of Medicine
Division of Endocrinology, Metabolism, and Nutrition
Department of Family Medicine and Community Health
Duke University School of Medicine

Abigail Rader, MS
PhD Candidate
Department of Population Health Sciences
Duke University School of Medicine

Keywords

Food Insecurity; Groceries; Food as Medicine; Diabetes; Cardiovascular Health; Cardiovascular Disease; Cardiometabolic Health

Key Points

  • In 2022, an estimated 12.8% of American households experienced food insecurity (FI): a lack of consistent access to safe, nutritious, or sufficient food for every person in a household to live an active, healthy life. FI is also associated with increased cardiometabolic health risk. While promising interventions to improve food security (and, by extension, cardiometabolic health) exist, methodological limitations such as a lack of pragmatic designs limit conclusions on their effectiveness.
  • The Eat Well pragmatic trial sought to better understand the real-world effectiveness of a produce prescription program when it came to improving cardiometabolic health-related outcomes and utilization patterns. They found that Eat Well did not improve outcomes among diabetic patients at risk for food insecurity. However, an affirmative outreach approach supported rapid scaling of the program.
  • Produce prescription programs may require greater duration, dose, intensity, and attention to household and implementation factors, including a focus on different at-risk groups, to improve health outcomes. Reducing cost barriers to purchasing fruits and vegetables alone may not be sufficient to improve food security – at least, not enough to improve cardiometabolic health outcomes.

Discussion Themes

Based on initial descriptive analyses, the amount spent on the card had no significant clinical effect – even among the most adherent participants.

Patients often face multiple overlapping social needs (housing, transportation, etc.), and addressing food alone may not be enough for those with the highest complexity. While the intervention was kept simple for scalability’s sake, diabetes management likely requires a more integrated, multi-sector approach that looks at factors like food, exercise, medications, education, behavioral health support, and monitoring.

Future research should identify opportunities to improve implementation, test interventions in higher-risk populations, and collect additional details on patient-reported outcomes.