Can continuous quality improvement be assessed using randomized trials?

Study Question. Continuous quality improvement (CQI) has been implemented a t least to some degree in many health care settings, yet randomized control led trials (RCTs) of CQI are rare. We ask whether, when, and how RCTs of CQ I might be designed. Study Design. We consider two applications of CQI: as a general philosophy of management and (by analogy with the use of conceptual models from the be havioral sciences) as a conceptual model for developing specific interventi ons. The example of warfarin therapy for stroke prevention among patients w ith atrial fibrillation is used throughout. Principal Findings. While it is impractical to use RCTs to study CQI as a g eneral management philosophy, RCT methodology is appropriate for studying C QI as a conceptual model for generating interventions. RCTs of CQI might be considered when the process change under consideration is very large, its implications (e.g., in terms of cost, outcomes of care, etc.) are very grea t, and the best approach is uncertain. When designing RCTs of CQI, critical decisions include (1) the unit of randomization; (2) whether the focus is on CQI as a method for generating interventions or, instead, is on specific interventions in and of themselves; and (3) the flexibility available to l ocal personnel to modify the intervention's operational details. Conclusions. RCTs of CQI as a conceptual model for generating interventions are feasible.