Combining Lean and Applied Research methods to improve rigor and efficiency in acute care outcomes research: A case study.

Hospital care is the single, largest contributor to health spending, yet evidence to guide value transformation is lacking. The large, real-world studies required to fill this void are challenging to conduct in the complex and fast-paced acute care environment. To address these challenges, we created a framework that combines Lean manufacturing methodology and Applied Research principles. We deployed this framework to design, pilot, and iteratively improve a study protocol testing the effectiveness of an innovative care pathway for patients hospitalized with acute exacerbations of Chronic Obstructive Pulmonary Disease. Over a three month period, the protocol was successfully piloted and refined at a single site, subsequently becoming the basis for a large system-wide randomized controlled trial. This framework combining Lean and Applied Research methods resulted in synergies that neither method could accomplish alone and may serve as a template for learning healthcare systems to efficiently generate real-world evidence in the acute care setting.