Randomized Quality Improvement Trials: An Overview and Proposed Framework for Ethical Oversight.

Abstract

Quality improvement (QI) is a routine part of health care delivery, but ineffective QI can have unintended consequences, waste resources, and paradoxically worsen health care quality. Randomized QI (RQI) trials use randomization to assign the QI intervention to some but not all patients or clinicians. An RQI trial can provide strong evidence to health care leaders making decisions about whether to scale up, modify, or abandon a QI intervention, but such trials are infrequently used due primarily to a lack of clarity about how regulations and ethical principles apply to these studies. We propose a definition for RQI trials and a streamlined, fit-for-purpose approach to ethical oversight that is consistent with federal regulations. Conducting RQI trials requires careful ethical justification as informed consent is generally impracticable. For this reason, we argue that ethical oversight is needed, even if the project does not qualify as research, and that regular monitoring should be conducted to help decide when the trial should end. Installing technical systems and processes for internal registration, point-of-care randomization, and standardized statistical analyses will help health systems use RQI trials routinely to learn what works to improve the quality of care they deliver for patients.