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)

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.

Grand Rounds November 1, 2024: Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study (Thomas W. Carton, PhD, MS; Anitha S. John, MD, PhD)

Speakers:

Thomas W. Carton, PhD, MS
Chief Data and Strategy Officer
Louisiana Public Health Institute

Anitha S. John, MD, PhD
Medical Director
Washington Adult Congenital Heart Program
Professor of Pediatrics
Children’s National Hospital
George Washington University

Title: Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study

Date: Friday, November 1, 2024, 1:00-2:00 p.m. ET

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Grand Rounds July 19, 2024: Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial (Deborah J. Wexler, MD, MSc; Brendan M Everett, MD, MPH)

Speakers

Deborah J. Wexler, MD, MSc
Associate Professor of Medicine and Diabetes Unit Chief
Massachusetts General Hospital and Harvard Medical School

Brendan M. Everett, MD, MPH
Associate Professor of Medicine
Divisions of Cardiology and Preventive Medicine
Brigham and Women’s Hospital and Harvard Medical School

Keywords

Cardiovascular Health; Kidney Disease; Patient Engagement

Key Points

  • Comparative effectiveness of SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1 RA) for cardiac and kidney outcomes is a major question in cardiac-kidney-metabolic health.
  • More broadly, comparative effectiveness of on-patent medications is crucial, yet not mandated, with little incentive (and some disincentive) for pharmaceutical companies to participate.
  • The PRECIDENTD trial will seek to test one approach to evaluating the comparative effectiveness of expensive new therapies. Their primary aim is to conduct a head-to-head evaluation of SGLT2i versus GLP-1 RA for the prevention of major adverse cardiovascular/kidney events and death.
  • Partnerships with patients, providers and stakeholders will be crucial to the success of PRECIDENTD. Patient engagement strategies include Community Engagement Studios, a Center for Effective Health Communication, and an interactive text messaging system to assess adherence.
  • The research team sees the trial, which involves two expensive, brand-name drugs and requires extensive collaboration, as a true test of a pragmatic trial of branded pharmaceutical medications.
  • Obtaining informed consent isn’t going to be pragmatic; it is time-consuming, challenging, and individualized.
  • Constrained funding in the feasibility phase may hamper the growth of the trial. In a bureaucratic research environment, the administrative burden can take time and energy from a study.

Discussion Themes

Patients have been more interested in participating given that this trial compares one effective, well-understood active drug to another, so there’s no risk of being assigned to a placebo group.

The pragmatic nature of the trial means that the study team is recruiting participants who can go either way when it comes to the two treatment options. The highest-risk people won’t be enrolled.