study design

February 21, 2020: Nudge Study Updates (Michael Ho, MD, PhD; Sheana Bull, PhD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Michael Ho, MD, PhD
Professor of Medicine, University of Colorado School of Medicine
Staff Cardiologist, Rocky Mountain Regional VA Medical Center

Sheana Bull, PhD, MPH
Professor, Colorado School of Public Health
Director, mHealth Impact Laboratory

Topic

Nudge Study Updates

Keywords

Cardiovascular health; Behavioral nudges; Disease self-management; Pharmacy data; Text messaging; mHealth; Medication adherence; Choice architecture

Key Points

  • Up to 50% of patients do not take their cardiovascular medications as prescribed. Nonadherence is associated with increased cardiovascular events.
  • Nudges prompt small, incremental changes in behavior and can be delivered through text messaging.
  • The Nudge pragmatic study was piloted across 3 integrated healthcare systems. The intervention uses pharmacy data to monitor gaps in patients’ cardiovascular medication refills. Patients with gaps receive text messages on their mobile phone to remind them to refill their medication.

Discussion Themes

A “chatbot” is used in one of the study arms to interact with the patient through the mobile phone application. As part of the analytic plan, the study team will be evaluating engagement with the interactive chatbot and the dose response.

The Nudge study gives patients two opportunities to opt out of participating. The study team is tracking demographics of patients who opted out as well as their reasons for opting out.

How do you handle the roughly 10% of people who receive care from more than one health system? That is, patients may be receiving conflicting advice, including directions to discontinue their medications.

Learn more about the Nudge NIH Collaboratory Trial.

Tags
#pctGR, @Collaboratory1

February 24, 2020: Study Snapshots for Six UH3 NIH Collaboratory Trials Are Available

Posted on by Gina Uhlenbrauck

Want to know more about the goals and challenges of the NIH Collaboratory Trials? New downloadable handouts summarize the study aims, implementation lessons, and recent publications and presentations from these innovative pragmatic clinical trials.

Study Snapshots are accessible from each NIH Collaboratory Trial page and the links below:

  • ACP PEACE: Improving Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
  • EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder
  • GGC4H: Guiding Good Choices for Health: Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems
  • HiLo: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
  • Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
  • PRIM-ER: Primary Palliative Care for Emergency Medicine

February 21, 2020: New Video Interviews Highlight Goals of the NIH HEAL Initiative and PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Recently, the Collaboratory Coordinating Center conducted video interviews describing the critical work being done in the NIH HEAL Initiative program to address the national opioid crisis. As part of this program, the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) NIH Collaboratory Trials present exciting new possibilities for answering important questions along with unique challenges.

Drs. Rebecca Baker and Wendy Weber discuss the aims of the HEAL Initiative, including:

  • Leveraging expertise across all NIH institutes and centers to enhance pain management and improve prevention and treatment strategies for opioid use disorder and addiction
  • Generating evidence to help clinicians and patients make the right treatment decisions

 

Drs. Meyers, Hernandez, and Weber discuss aspects of collaborating with the four PRISM NIH Collaboratory Trials, including:

  • Leveraging broad expertise in the Collaboratory program to support embedded healthcare systems research in pain management
  • Developing new understanding across different care models such as physical therapy, surgery, acupuncture therapy, and primary care settings
  • Learning about patient-reported outcomes that will be the most meaningful to establish best practices in pain management

Learn more about the PRISM NIH Collaboratory Trials on their webpages:

  • AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
  • OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting

February 14, 2020: Do Our Current Research Models Meet the Needs of a Learning Health Care System? (David Atkins, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

David Atkins, MD, MPH
Director, Health Services Research and Development
Office of Research and Development
Department of Veterans Affairs

Topic

Do Our Current Research Models Meet the Needs of a Learning Health Care System?

Keywords

Learning health system; Research collaborations; Veterans Affairs

Key Points

  • A unique advantage of the VA is that it is an integrated, publicly funded healthcare system with social, educational, housing, and disability services and benefits. Yet the changing political environment and leadership turnover make it hard to align with operations.
  • In a learning healthcare system, learning happens continuously, in real time. Embedded researchers are needed because they bring a deeper knowledge of data, design, inference, and objectivity.
  • Solutions include new funding mechanisms, new models for research that involve health system partnerships, new incentives for better impact, and enhanced attention to implementation.

Discussion Themes

Deep health system partnerships cannot be mandated; they must be built from the ground up.

Are there ways to develop meaningful incentives for investigators to participate in collaboratory-like enterprises to compete with the current incentives to get their own work done?

Learn more about large-scale pragmatic clinical research at the Pain Management Collaboratory, a joint initiative of the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs.

Tags
#pctGR, @Collaboratory1

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

Posted on by Gina Uhlenbrauck

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)

Posted on by Gina Uhlenbrauck

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.

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

Posted on by Gina Uhlenbrauck

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

PRISM NIH Collaboratory Trial 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 NIH Collaboratory Trials—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 NIH Collaboratory Trial 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)

Posted on by Gina Uhlenbrauck

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

Posted on by Damon Seils

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 NIH Collaboratory Trials.

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 NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TiME NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

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

Posted on by Gina Uhlenbrauck

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