clinical trials

March 6, 2020: Creating a Learning Health System Through Randomization (Leora Horwitz, MD, MHS)

Posted on by Gina Uhlenbrauck

Speaker

Leora Horwitz, MD, MHS
Associate Professor, Population Health and Medicine
Director, Center for Healthcare Innovation and Delivery Science, NYU Langone Health
Director, Division of Healthcare Delivery Science, Department of Population Health, NYU Grossman School of Medicine

Topic

Creating a Learning Health System Through Randomization

Keywords

Embedded research; Electronic health records; Randomization; Quality improvement (QI); Learning health systems

Key Points

  • Randomized QI projects are needed in order to know whether such system-level programs/interventions are effective.
  • The best candidates for QI randomization projects have a high volume of cases and short-term outcomes that are already being collected.
  • These randomized QI projects were developed in collaboration with the frontline care providers and staff to ensure seamless implementation with no additional burden. Also essential was buy-in from senior-level administration.

Discussion Themes

Statistical significance is not always the right threshold for decision making in a health system.

What amount of resources are needed to do these projects (eg, researcher/analysts, project managers)? Is the work self-sustaining?

Disappointing QI findings are important to know, so that ineffective activities can be discontinued.

Read more about this project in Creating a Learning Health System through Rapid-Cycle, Randomized Testing (Horwitz et al., New Engl J Med, Sep 2019).

Tags
#pctGR, @Collaboratory1

March 10, 2020: Supporting the New PRISM NIH Collaboratory Trials Addressing Pain Management Within Care Delivery

Posted on by Gina Uhlenbrauck

In a new video interview, Dr. Lesley Curtis, chair of the NIH Collaboratory Steering Committee, describes the importance of the four PRISM NIH Collaboratory Trials, which are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments. “We are particularly excited about the answers that will come out of these trials,” she says. Now in their UG3 planning year, the PRISM investigators are strongly encouraged to take full advantage of the Collaboratory’s resources, such as the significant expertise found across the Core Working Groups.

 

 

For more interviews about the HEAL and PRISM projects, check out the February 21 news story.

February 28, 2020: Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Posted on by Gina Uhlenbrauck

Speakers

Vincent Mor, PhD
Florence Pirce Grant University Professor
Department of Health Services Policy & Practice
Brown University School of Public Health

Leah Tuzzio, MPH
Research Associate
Kaiser Permanente Washington Health Research Institute

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

Topic

Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Keywords

Embedded research; Implementation; Healthcare systems; Nursing homes; Radiology reports; Electronic health records; Data collection; Pragmatic clinical trials

Key Points

  • Early engagement between study teams and health system leaders and staff can help ease the embedded intervention into the clinical workflow. Consider, for example, who will deliver the intervention and how difficult it will be to implement.
  • In the pilot phase, show that you can implement the intervention effectively. For example, demonstrate that you can collect the outcome data you will need within the pilot’s time frame. Ensure that your study questions are important to the partner healthcare system.

Discussion Themes

It is essential to anticipate, identify, and make a plan to address changes in the healthcare system as your trial is being conducted.

Among the NIH Collaboratory Trials, many have good measures of how much site-to-site variation there is, which helps to understand what the preconditions are for high levels of implementation.

Use the pilot study to maximize acceptability, maintain affordability, and consider the scalability of the intervention.

These topics and more are on the Living Textbook of Pragmatic Clinical Trials. Plan to hear the next topics in the Living Textbook Grand Rounds series.

Tags
#pctGR, @Collaboratory1

February 28, 2020: Meeting Minutes from NIH Collaboratory’s Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the UG3 PRISM NIH Collaboratory Trials. These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel as well as some IRBs responsible for oversight of the projects.

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 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 11, 2020: ADAPTABLE Roundtable Produces Consensus Statement on Analysis and Integration of Patient-Reported Data in Clinical Trials

Posted on by Damon Seils

A roundtable discussion organized by the NIH Collaboratory in 2017 has produced consensus findings on the analysis and integration of patient-reported health (PRH) data in clinical trials. The report is part of an effort by the ADAPTABLE Supplement project team “to address best practices for capturing PRH data in pragmatic studies and optimal analytic approaches for integrating PRH with other data sources.”

The consensus statement was published online ahead of print this month in the Journal of the American Medical Informatics Association.

The report discusses strengths and limitations of PRH data, approaches for ascertaining and classifying study end points, and methods for addressing incompleteness, data alignment, and data concordance. Roundtable participants used experiences from the ADAPTABLE trial as a case study to inform their discussions.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and PRH data.

This work was supported by a supplemental grant award to the NIH Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.

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.