Nudge

August 28, 2018: Spotlight on a New NIH Collaboratory Trial: Nudge

Posted on by Damon Seils

More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management offer new opportunities to influence patients’ health behaviors and improve health outcomes.

“One of the real benefits of using technology is that it can be widely disseminated. Studying that dissemination process is really where we are in the field. So a pragmatic trial makes a lot of sense.” — Sheana Bull, PhD, MPH

The NIH Collaboratory is pleased to welcome the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) study to its portfolio of NIH Collaboratory Trials. The Nudge study will use mobile phone text messages and an artificial intelligence chatbot to deliver behavioral “nudges” to patients to improve medication adherence. The study will access population-level pharmacy data in 3 integrated healthcare delivery systems to test the effectiveness of the nudges on adherence and outcomes among patients with chronic cardiovascular conditions who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia.

The Nudge study is led by co–principal investigators Drs. Sheana Bull and Michael Ho of the University of Colorado with support from the National Heart, Lung, and Blood Institute. Watch a video interview with Drs. Bull and Ho, and read more about Nudge.

 

May 2018 Steering Committee and Onboarding Meeting: Nudge, PRIM-ER, P4TH, EMBED, ACP PEACE, and HiLo

Steering Committee Meeting

May 14-16, 2018
Bethesda, MD

Main Purpose

Day 1: Welcome the new UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and an understanding of the Core Working Groups; and discuss lessons learned, data sharing, and current ethics and regulatory issues.

Day 2: Celebrate the Collaboratory's progress; kick off the next 5 years; receive updates from the Core Working Groups; and hear about the top barriers/challenges and lessons learned from the UH3s.

Day 3: Intensive workshop to start discussions on embedded A vs. B pragmatic clinical trials.

Monday, May 14, 2018

Welcome, Opening Remarks, and Introductions
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Overview of a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

Overview of the NIH HCS Research Collaboratory Program
David Shurtleff, PhD

Panel of Directors: Richard Hodes, MD; Wilson Compton, MD; David Murray, PhD; Bill Riley, PhD; Gary Gibbons, MD; Rob Star, MD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Jonathan McCall, MS

Policies and Guidance Documents

NIH Collaboratory Data Sharing Policy and Considerations
Adrian Hernandez, MD, MHS

Publications and Products Process
Eric Larson, MD, MPH

Data Quality
Rachel Richesson, PhD, MPH

New UG3 NIH Collaboratory Trials Updates
Brief overview of the projects

NIH and Other Requirements for ClinicalTrials.gov Reporting
Deborah Zarin, MD

Results Reporting of ePCTs
Adrian Hernandez, MD, MHS

Distributed Research Network Query Capabilities
Richard Platt, MD; Lesley Curtis, PhD

Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD 

Tuesday, May 15, 2018

Welcome and Opening Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Landscape of National ePCT Initiatives
Explanation of initiatives that are promoting ePCTs and future directions

Health Systems Engagement Issues and Lessons Learned from the Health Care Systems Interactions Core
Eric Larson, MD, MPH

UH3 NIH Collaboratory Trials
Top barriers/challenges and recent generalizable lessons learned

 

Tuesday, May 15, 2018 (Continued)

Discussion From New UG3 NIH Collaboratory Trials
Overview of project and discussion

CMS Quality Measures
Reena Duseja, MD

Lessons Learned From Core Groups
Discussion on generalizable knowledge created out of the Cores, how it can be used, and future work of the Cores

Data Sharing Principles and Lessons Learned
Greg Simon, MD, MPH

Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Wednesday, May 16, 2018

Welcome and Introduction
David Shurtleff, PhD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, PhD, MPH

Panel Discussions

Panel 1: Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success Moderator: Rich Platt, MD, MSc

  • Steve Friedhoff, MD
  • Kenneth Sands, MD, MPH
  • Joseph Chin, MD

Panel 2: Examples in Action: Embedded A vs. B Trials Moderator: Beverly Green, MD, MPH

  • Ryan Ferguson, ScD, MPH
  • Susan Huang, MD, MPH
  • Michael Kappelman, MD, MPH

Panel 3: Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials Moderator: Greg Simon, MD, MPH

  • Scott Solomon, MD
  • Rachael Fleurence, PhD
  • Kourtney Davis, PhD, MSPH

Panel 4: Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials Moderator: Adrian Hernandez 

  • Jacqueline Corrigan-Curay, MD, JD
  • Owen Faris, PhD
  • Julie Kaneshiro, MA

Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator: David Wendler, PhD

  • Barbara Bierer, MD
  • Spencer Hey, PhD
  • Judith Carrithers, JD, MPA

Summary Expert Panel Discussion Moderator: Cathy Meyers, MD

  • Adrian Hernandez, MD
  • Rich Platt, MD, MSc
  • Beverly Green, MD, MPH
  • Greg Simon, MD, MPH
  • Dave Wendler, PhD

Concluding Remarks 
Adrian Hernandez, MD, MHS; Rich Platt, MD, MSc