learning health systems

March 30, 2020: New Living Textbook Chapter Describes Ways to Monitor Intervention Fidelity and Adaptations During the Conduct of ePCTs

Posted on by Gina Uhlenbrauck

The new Monitoring Intervention Fidelity and Adaptations chapter of the Living Textbook was developed to introduce how to evaluate changes that may be encountered while conducting an embedded pragmatic clinical trial (ePCT). For example, a health system might experience competing clinical initiatives; turnover in leadership, clinicians, or staff; changes in technologies; new clinical practice guidelines; or regulatory changes.

The chapter offers strategies for study teams to anticipate, monitor, and document adaptations to the intervention in order to support study analysis and set the stage for dissemination and implementation of successful interventions in other healthcare settings. The chapter was developed by experts from the Collaboratory’s Health Care Systems Interactions Core, along with principal investigators conducting ePCT Demonstration Projects.

Topics include:

  • Anticipating changes that might impact intervention fidelity
  • Frameworks to assist in monitoring fidelity and adaptations
  • Strategies and case examples from the NIH Collaboratory Demonstration Projects
  • Pointers to additional resources

We encourage you to explore this new content.

 

March 12, 2020: Transforming Our Understanding of How to Conduct Research in a Real-World Setting

Posted on by Gina Uhlenbrauck

In a recent video interview, Dr. Helene Langevin, director of the National Center for Complementary and Integrative Health at the NIH, discusses the important work of the NIH Collaboratory in sharing knowledge and lessons learned as well as in harnessing expertise across the 19 Demonstration Projects it supports. “It is very important that we understand how research can be successfully implemented and tested in real-world clinical practice.”

 

 

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

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

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 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

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.

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

Posted on by Gina Uhlenbrauck

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.

 

November 22, 2019: It’s Time to Learn From Patients Like Mine (Nigam H. Shah, MBBS, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Nigam H. Shah, MBBS, PhD
Associate Professor of Medicine
Stanford University

Topic

It’s Time to Learn From Patients Like Mine

Keywords

Clinical informatics; Clinical data warehouse; Aggregate patient data; Consult service; Cohort search engine

Key Points

  • The “Green Button” service consists of software, data, and personnel. Multiple datasets are used in the analysis, along with a human filter.
  • The search engine can find matching patients by searching across diagnosis and procedure codes, concepts extracted from clinical notes, laboratory test results, vital signs, as well as visit types and duration of inpatient stays, and then compare their outcomes.
  • Questions that remain include:
    • Does having such a consult service change patient outcomes?
    • How could we enable such consults nationwide?
    • Could we automate such analyses to be “always on”?
    • Could we get such a “curbside consult” from multiple health systems?
    • Could patients benefit from having access to such reports?

Discussion Themes

Could this technology be applied in emergent, critical patient settings where the care is more diagnostic, and where predictive modeling using health system data could be helpful?

What’s missing from the data that would improve accuracy or relevance? For example, social, demographic, and environmental data.

Read more about Stanford’s Green Button clinical informatics consult project.

Tags
#pctGR, @Collaboratory1