Dr. Taylor-Zapata, a board-certified pediatrician, leads the NICHD’s Best Pharmaceuticals for Children Act clinical program, a drug development program that sponsors clinical trials to inform and improve pediatric drug labeling.
The STAMP (Sharing and Talking about My Preferences) Trial is a cluster randomized controlled trial aimed at increasing engagement in Advanced Care Planning (ACP).
The STAMP Trial first aimed to re-conceptualize advance care planning (ACP) to achieve the ultimate goal of enabling the patient or surrogate to make decisions in a future moment rather than making decisions in advance. In this way, ACP is a flexible act of communication that allows for in-the-moment advice of a patients care providers about the nuances of a particular clinical situation.
ACP is a Health Behavior that involves stages of change. The STAMP Trial uses a 10 minute survey to assess how ready a patient is to start the ACP communication process.
Patients are given ACP materials based on their stage of readiness as assessed by the survey.
Results showed a small increase in ACP planning for groups randomized to the study interventions, but that small increase applied over large numbers of patients could have a significant impact on the number of people participating in ACP.
Discussion Themes
Cluster randomized trial design is complex unless you are working with an intervention that is implemented in a whole health care system rather than individual patients.
Determining a denominator in a cluster randomized trial at the patient level was very difficult.
Read more about Dr. Fried’s work on the STAMP Trial.
The NIH Collaboratory is pleased to share a new resource to help clinical investigators successfully partner with healthcare system leaders. The Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships provides advice from NIH Collaboratory and healthcare system leadership and serves as an annotated table of contents for the Living Textbook, pointing readers to essential content.
The Quick Start Guide is part of a series of tools intended to support the successful conduct of ePCTs within healthcare systems. The first guide in the series, the Quick Start Guide for Investigators, is designed for clinical investigators interested in learning how to conduct an ePCT. The NIH Collaboratory Coordinating Center is developing more Quick Start Guides for different audiences and use cases.
The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.
In this Friday’s session—“Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity”—Dr. Wendy Weber of the National Center for Complementary and Integrative Health will host investigators from 2 of the NIH Collaboratory Demonstration Projects for a discussion about strategies for site selection and stakeholder engagement to maximize diversity.
In BeatPain Utah, Dr. Julie Fritz, Dr. David Wetter, and their team are designing interventions in federally qualified health center (FQHC) clinics to overcome barriers specific to rural and lower-income communities through innovative use of telehealth resources.
In STOP CRC, Dr. Gloria Coronado, Amanda Petrik, and their team worked with FQHC clinics to improve colorectal cancer screening rates in racial/ethnic minority and low-income populations.
The Grand Rounds session will be held on Friday, June 4, at 1:00 pm eastern. Join the online meeting.
Other upcoming sessions in the diversity workshop series include:
The Health Care Systems (HCS) Interactions Core of the NIH Collaboratory has created a new guidance document: Resources for Frequently Asked Questions. The document compiles common questions from researchers and points to resources that provide potential solutions, including Living Textbook chapters and journal articles. The topics include evaluation strategies, anticipating and adapting to changes, dissemination and implementation, and stakeholder engagement.
Josie Briggs, MD
Acting Chief Science Director
PCORI
Susanna Naggie, MD
Principal Investigator, HERO-HCQ Clinical Trial
Duke University
Emily O’Brien, PhD
Principal Investigator, HERO-Registry
Duke University
Russell Rothman, MD, MPP
Chair, HERO Steering Committee
Vanderbilt University
Chris Forrest, MD, PhD
Chair, HERO Registry
Children’s Hospital of Pennsylvania
Topic
The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence
Keywords
Coronavirus; Virus pandemic; COVID-19; PCORI; Patient-Centered Outcomes Research Institute; Frontline health workers; Hydroxychloroquine; Healthcare systems; HERO-HCQ
Key Points
With the onset of the coronavirus pandemic, the U.S. healthcare system faces an unprecedented stress test to adapt to meet new demands.
Those on the frontline of caring for patients—healthcare workers—are at risk of developing or transmitting COVID-19. Evidence is urgently needed to keep healthcare workers and their families safe and healthy, which ultimately will help protect us all.
The HERO (Healthcare Worker Exposure Response & Outcomes) Program has three broad focus areas to develop rapid evidence around healthcare workers’ outcomes related to COVID-19:
Emphasis on the adaptations in how healthcare is delivered
Emphasis on vulnerable populations
Emphasis on the well-being of the healthcare worker
HERO will consist of a registry study of healthcare workers and a randomized controlled trial called HERO-HCQ that will evaluate the safety and efficacy of hydroxychloroquine to prevent COVID-19 clinical infections in healthcare workers.
Discussion Themes
The goal of the HERO registry is to understand all aspects of healthcare workers’ lives—those with direct impact and those with indirect impact.
What mechanisms are you envisioning for new study proposals that would be conducted via the HERO platform?
Serologic testing will have a significant role in understanding prior infection and potential immunity.
The HERO Registry is open to any healthcare worker to join at https://heroesresearch.org/. Enrollment takes only a few minutes; participation is free and voluntary. It is not restricted by profession. All data are kept confidential.
In a recent video interview, Dr. Eric Larson, chair of the Collaboratory’s Health Care Systems Interactions Core, and Leah Tuzzio, research associate, describe ways the Core is supporting the PRISM Demonstration Projects. A priority for conducting embedded PCTs (ePCTs) is establishing strong, sustainable relationships between the study team and health system leadership, clinicians, and staff.
For researchers who are evaluating pain management interventions, the Core advises remaining flexible when integrating the intervention and being mindful of documenting any adaptations made throughout the trial. Other best practices include understanding the context of the health setting, anticipating road blocks, and incorporating the intervention with minimal burden to clinicians and staff.
“Pain is a complicated area. It’s not a specific disease, it’s a state, and it’s a state that everybody experiences.”
In a new section of the Living Textbook on Building Partnerships to Ensure a Successful Trial, Kenneth Sands, the chief epidemiologist and chief patient safety officer at HCA, and Jonathan Perlin, the chief medical officer and president of clinical services at HCA, offer advice to investigators who wish to conduct pragmatic clinical trials.
“Healthcare systems have constrained bandwidth, and participating in learning activities involves significant costs and challenges: there are direct costs but also intangible costs, which can be substantial, such as personnel time, IT time, distraction of clinical staff, and the potential for supply chain issues.” — Advice from Healthcare System Leadership
The authors establish principles of partnership that include establishing and maintaining a durable partnership, selecting topics of mutual interest, and giving precedence to operational imperatives.
Mitesh S. Patel, MD, MBA
Ralph Muller Presidential Assistant Professor
Perelman School of Medicine & Wharton School
University of Pennsylvania
Director, Penn Medicine Nudge Unit
Topic
Using Nudges to Improve the Delivery of Health Care
Keywords
Motivational nudges; Medical decision-making; Behavioral economics; Nudge units; Health behaviors
Key Points
Nudges remind, guide, or motivate a decision. In a healthcare setting, medical nudges use principles of behavioral economics and psychology to “steer medical decision-making toward higher value and improved patient outcomes.”
A “nudge unit” is a behavioral design team that systematically tests ways to improve decisions and change behavior.
It is important that medical nudges be testable and rigorously evaluated. Well-designed nudges have the right fit for the context, are aligned with health system and patient care goals, are scalable, and make a significant impact.
Nudges can be used to help clinicians promote evidence-based care, and help patients increase engagement and change health behaviors.
Discussion Themes
Nudges are prevalent in other industries; for example, when asked to add trip insurance to the purchase of an airfare.
In a healthcare setting, effective nudges can help achieve care delivery priorities (for example, improved screening, follow up, adherence) as well as reduce clinician burden.
Understanding the health system’s culture and workflow is essential for the sustainability and effectiveness of nudges.
Greg Simon, MD, MPH
Senior Investigator
Kaiser Permanente Washington Health Research Institute
Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Duke University School of Medicine
Interim Executive Director, Duke Clinical Research Institute
Topic
Pragmatic Clinical Trials: How Do I Start?
Keywords
Pragmatic clinical trials; PRECIS-2; Real-world evidence; Health systems research; Stakeholders; Clinical workflow; Study team
Key Points
Embedded pragmatic clinical trials (ePCTs) are large, efficient studies conducted in the real world that provide evidence for adoption of an intervention into clinical practice.
ePCTs are conducted in partnership with healthcare systems, use streamlined procedures and existing infrastructure, and answer important medical questions. However, high relevance to real-world decision-making can sometimes come at the expense of trial efficiency.
The PRECIS-2 scores are not absolute virtues; rather, the tool helps researchers determine if their trial is fit for purpose based on their study question.
For greater generalizability, ePCTs should be conducted in a diverse range of patients, and study results should be reported transparently.
Discussion Themes
How might we support health systems that serve more diverse populations to participate in a pragmatic clinical trial?
What concerns might be voiced by health system leaders regarding potential reputational risk of a PCT, and perhaps downstream issues about the results publication?
The question “Can everyone do this study?” is different from “Can everyone believe the research results?”
To see upcoming topics in the Living Textbook Grand Rounds series, download the flyer and share with your colleagues and institution. To learn more about the fundamentals of designing and launching a successful ePCT visit the Living Textbook.