February 7, 2020: Using Nudges to Improve the Delivery of Health Care (Mitesh S. Patel, MD, MBA)

Speaker

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.

Read more about nudges in Using Nudges to Improve Value by Increasing Imaging-Based Cancer Screening (Patel et al, Journal of the American College of Radiology, 2019).

Tags
#pctGR, @Collaboratory1, @miteshspatel, @PennNudgeUnit

January 31, 2020: Living Textbook Grand Rounds Series Part 1: Pragmatic Clinical Trials: How Do I Start? (Lesley H. Curtis, PhD, Greg Simon, MD, MPH)

Speakers

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.

Tags
#pctGR, @Collaboratory1

January 30, 2020: Meeting Materials from the NIH Collaboratory PRISM Kickoff Meeting

The Collaboratory has made available all the presentations from their recent PRISM Kickoff meeting held in Bethesda November 19-20, 2019.

PRISM Demonstration Project Investigators
Left to right: Kathleen Sluka, PT, PhD (FM TIPS); Andrea Cheville, MD (NOHARM); Karen Sherman, PhD, MPH (AcuOA); Jon Tilburt, MD (NOHARM); Lynn DeBar, PhD, MPH (AcuOA); Leslie Crofford, MD (FM TIPS); and Natalia Morone, MD (OPTIMUM).

The PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program is a component of the NIH HEAL Initiative to address the opioid crisis. Highlights of Day 1 included welcoming the 4 new PRISM UG3 Demonstration Projects—AcuOA, FM TIPS, NOHARM, and OPTIMUM—and introducing the study teams to the NIH Collaboratory Program and Coordinating Center, hearing an overview of the HEAL Initiative goals and cooperative agreement, and learning about the aims of the new studies. Day 2 included face-to-face meetings between each PRISM Demonstration Project and the Collaboratory Core working groups to discuss anticipated challenges in design, implementation, analysis, and dissemination.

View or download the meeting materials on the website.

 

 

January 10, 2020: Pragmatic Trials of Behavioral Economic Interventions to Increase Colorectal Cancer Screening (Shivan Mehta, MD, MBA)

Speaker

Shivan Mehta, MD, MBA
Assistant Professor of Medicine and Health Policy
University of Pennsylvania

Topic

Pragmatic Trials of Behavioral Economic Interventions to Increase Colorectal Cancer Screening

Keywords

Behavioral economics; Colorectal cancer; Pragmatic clinical trials; Health technology; Communication modality; Informed consent

Key Points

  • Colorectal cancer is the second leading cause of cancer deaths in the United States. Increased rates of screening can reduce mortality from colorectal cancer by 30% to 70%.
  • Use of behavioral economics can help us understand human motivation and behavior related to participating in clinical studies. How the message to patients is framed—and how choices are offered—can alter the response.
  • In the example pragmatic trial, the “choice architecture” for the colorectal cancer screening was designed by the study team in collaboration with health system stakeholders and clinical operations. Changing the framing from opt in to opt out had the effect of increasing participation in screening.

Discussion Themes

In some settings, choice overload can have a negative effect on participation.

When designing embedded pragmatic trials, researchers must be mindful not to increase burden on clinicians’ workflow.

While behavioral economics offers suggestions for how to increase colorectal cancer screening rates, its effectiveness in different contexts needs to be evaluated.

Read more about Dr. Mehta and colleagues’ study in Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial (JAMA Network Open, 2019).

Tags
#pctGR, @Collaboratory1, @Shivan_Mehta

December 18, 2019: NIH Collaboratory Shares New Findings and Fresh Insights in 2019

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the Demonstration Projects.

So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ABATE Infection Demonstration Project

EMBED Demonstration Project

PPACT Demonstration Project

PRIM-ER Demonstration Project

PROVEN Demonstration Project

SPOT Demonstration Project

STOP CRC Demonstration Project

TiME Demonstration Project

TSOS Demonstration Project

December 13, 2019: EMBED Update: Challenges and Solutions (Edward Melnick, MD, Gail D’Onofrio, MD)

Speakers

Edward R. Melnick, MD, MHS
Assistant Professor of Emergency Medicine
Program Director, Yale-VA Clinical Informatics Fellowship Program
Principal Investigator, EMBED Trial

Gail D’Onofrio, MD
Professor & Chair
Department of Emergency Medicine
Yale School of Medicine

Topic

EMBED Update: Challenges and Solutions

Keywords

Embedded clinical research; Buprenorphine; EMBED; Opioid use disorder; Emergency department; Electronic health record; Clinical decision support tool; User-centered design; Clinical informatics

Key Points

  • Evidence shows that buprenorphine (BUP) treatment for patients with opioid use disorder (OUD) can safely and effectively be initiated from the emergency department (ED). As yet, BUP is rarely initiated as a part of routine ED care. Clinical decision support could accelerate adoption of ED-initiated BUP into routine emergency care.
  • The EMBED pragmatic trial is evaluating the effectiveness of a user-friendly, web-based clinical decision support tool to enable ED-initiated buprenorphine treatment for OUD. The goal is to optimize the tool’s usability, EHR integration, automation of EHR workflow, and scalability across a variety of healthcare systems.
  • EMBED is being conducted in 20 EDs across 5 healthcare systems.

Discussion Themes

The study team developed a computable phenotype to identify ED patients with OUD. Validation was conducted through physician chart review.

EMBED clinical decision support is a flexible tool that supports clinicians with varied levels of experience with the intervention by providing one-click options for direct activation of care pathways and user-activated support for critical decision points.

Newer versions of EHR systems have integrated pathways to allow for more automation of clinical decision support.

Read more about the challenges of the EMBED pragmatic trial and visit the EMBED web page.

Tags
#pctGR, @Collaboratory1

December 13, 2019: Reissuance of Funding Opportunity Announcement for HEAL Initiative/PRISM Coming January 2020

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, intends to reissue Funding Opportunity Announcement (FOA) HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain To Reduce Opioid Prescribing (PRISM) (UG3/UH3 Clinical Trial Optional).

This RFA solicits applications for phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications in the health care delivery setting. The re-issuance of the FOA will prioritize the following areas for pragmatic trials to integrate multimodal or multiple interventions that have demonstrated efficacy into health care systems or implement health care system changes to improve adherence to evidence-based guidelines:

  • Pain management in emergency departments, dental clinics, primary care, and hospitals
  • Chronic overlapping pain conditions
  • Pain management in individuals at risk of or with opioid use disorder
  • Pain management in those with co-occurring mental health disorders
  • Noncancer pain management in persons with medical comorbid conditions

The FOA is expected to be published in January 2020 with an expected application due date in March 2020.

The announcement is part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

 

December 13, 2019: New ePCT Training Materials Focus on Nephrology Research

Presentations from a recent seminar offered by the NIH Collaboratory in partnership with the American Society of Nephrology are now available on the Living Textbook. The seminar, Embedded Pragmatic Clinical Trials: Accelerating Evidence Generation in Nephrology, was held at ASN Kidney Week 2019. The sessions provide an introduction to concepts in the design of embedded pragmatic clinical trials (ePCTs), with a focus on interventions that are relevant to the nephrology research community.

Visit the NIH Collaboratory Training Resources to download the presentations.

November 8, 2019: Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned (Jeffrey Jarvik, MD, MPH, Patrick Heagerty, PhD)

Speakers

Jeffrey (Jerry) G. Jarvik MD MPH
Professor, Radiology, Neurological Surgery and Health Services
Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine
University of Washington

Patrick Heagerty, PhD
Professor and Chair
Department of Biostatistics
University of Washington

Topic

Lumbar Imaging with Reporting of Epidemiology: Initial Results and Some Lessons Learned

Keywords

Embedded pragmatic clinical trials; Radiology imaging; LIRE; Stepped-wedge; Cluster randomization; Epidemiology; Back pain

Key Points

  • The LIRE Demonstration Project evaluated whether prevalence benchmark data inserted into lumbar spine imaging reports would reduce overall spine-related healthcare utilization for patients referred from primary care.
  • The inserted intervention text urges caution when interpreting the presence of certain findings that are common in normal, pain-free volunteers.
  • While the study team found no decrease in spine-related healthcare utilization for the overall cohort, there was a small but potentially important effect on reducing opioid prescriptions.

Discussion Themes

A characteristic of stepped-wedge study design is that it yields two comparisons: between-group comparisons (clinic A vs clinic B) and within-group comparisons. But temporal trends can have an impact and must be adjusted for in the analysis.

For what type of intervention would a stepped-wedge design be suitable?

The hope is for a wider dissemination about interventions where radiologic testing is done and incidental findings are common.

Read more about the LIRE Demonstration Project.

Tags
#pctGR, #PragmaticTrials, @Collaboratory1

November 1, 2019: NIH Collaboratory: Looking Back, Looking Forward (Adrian Hernandez, MD, MHS, Lesley Curtis, PhD, Kevin Weinfurt, PhD)

Speakers

Adrian F. Hernandez, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine

Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Duke University School of Medicine
Interim Executive Director, Duke Clinical Research Institute

Kevin Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine

Topic

NIH Collaboratory: Looking Back, Looking Forward

Keywords

Embedded pragmatic clinical trials; ePCTs; NIH Collaboratory; Health care systems research; Demonstration Projects; Living Textbook; HEAL Initiative; Coordinating Center; Research dissemination; Learning health systems; Real-world evidence

Key Points

Discussion Themes

How can we harmonize the different ideas about what it is to be “pragmatic” for NIH study sections, IRBs, and DSMB reviews? For example, if your DSMB isn’t knowledgeable about PCTs, you could end up with a very explanatory trial.

A willingness to share imperfections is an important part of learning and helps the clinical trial ecosystem evolve.

An important future topic would be how the NIH Collaboratory and PCORnet fit together.

Read more about the NIH Collaboratory Program and the Living Textbook of Pragmatic Clinical Trials.

Tags
#pctGR, #PragmaticTrials, @Collaboratory1, @texhern, @lmhcurtis, @KevinWeinfurt