In 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.