June 24, 2021: New Article Offers Guidance on Accounting for Quality Improvement Activities During Embedded Pragmatic Trials

Cover of the journal HealthcareIn a new article in Healthcare’s special issue on embedded research, Leah Tuzzio and colleagues use experiences from the NIH Collaboratory to describe how quality improvement activities may pose challenges for embedded pragmatic clinical trials (ePCTs), especially if there are overlapping goals and timelines.

For ePCTs to be rigorous, study teams must monitor, adapt, and respond to QI during the design and the trial implementation. Both ePCTs and QI happen within the same context and aim to improve patient care, and they are inherently interconnected. — Tuzzio et al, Healthcare, 2021

ePCTs tend to be larger and more broadly generalizable than quality improvement initiatives and may generate high-quality evidence for care and clinical practice guidelines. Quality improvement initiatives may address the same high-impact health questions, but if they co-occur with ePCTs, they may dilute or confound the ability to detect change. As a result, study teams may need to monitor, adapt, and respond to quality improvement initiatives during the design and conduct of the trial. The authors suggest that routine collaboration with healthcare system stakeholders can help align research and quality improvement to support high-quality, patient-centered care.

Publication of the special issue was supported by AcademyHealth.

For more, see the Living Textbook Chapters on Advice from Health Care System Leadership,  Building Partnerships to Ensure a Successful Trial, and Monitoring Intervention Fidelity and Adaptations.

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

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

May 13, 2019: JGIM Issues Call for Papers on Implementation Science and Quality Improvement

The Journal of General Internal Medicine (JGIM) has announced a call for papers that report findings from research at the intersection of implementation science (IS) and quality improvement (QI). Submissions are due September 3, 2019, and should focus on providing information that healthcare delivery systems need about strategies to improve patient and population outcomes. The research should involve multiple settings or systems and apply rigorous scientific methods to test the effectiveness, quality, or utility of QI/IS methods in routine care.

“These articles will illustrate how foundational knowledge and skills from QI and IS help general internal medicine clinicians, educators, and researchers achieve evidence to anchor high quality and reliable care in a learning health system environment.” — JGIM Call for Papers