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

Abstract

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.

The Science of Learning Health Systems: Scoping Review of Empirical Research

“…Most assessed feasibility (8/16, 50%) [ 28 , 46 - 54 ], appropriateness (7/16, 43.8%) [ 28 , 41 , 44 - 46 , 52 , 54 , 55 ], acceptability (6/16, 37.5%) [ 28 , 44 - 46 , 52 , 56 ], and adoption (6/16, 37.5%) [ 28 , 35 , 45 , 46 , 57 , 58 ]. Less commonly studied implementation outcomes were implementation cost (3/16, 18.8%) [ 28 , 47 , 48 ], fidelity (2/16, 12.5%) [ 28 , 46 ], sustainability (1/16, 6.3%) [ 35 ], and penetration (1/16, 6.3%) [ 46 ]. This emphasis on the outcomes that are salient at earlier stages of implementation, such as the feasibility, appropriateness, and acceptability of an LHS, highlights the burgeoning nature of the field, with few LHSs having progressed to questions around sustainability, penetration, and fidelity.…”

Interprofessional, multitiered daily rounding management in a high-acuity hospital

“…At MUMC+, lean, Six Sigma and rounding by hospital leaders led to a reduction in the number of delayed operations due to missing equipment by 68% (Edelman et al , 2017). This was an example of how lean methodology facilitated understanding care processes and areas of improvement, leading to more clearly defined and informed interventions (McWilliams et al , 2019).…”

Lean six sigma and stroke in rural hospital – The case of Baruch Padeh Medical Center

“…The recent push toward a value-based system drives new research aimed at understanding how to decrease or control the costs, while maintaining or improving the high-level quality of healthcare services (McWilliams et al, 2019). This is particularly true with acute ischemic stroke (AIS), where timeliness and responsiveness are key factors in treating patients effectively.…”

“…In this frame, the adoption of quality improvement methodologies such as lean, six sigma or lean six sigma (LSS) presents multiple advantages in reaching efficacy and timeliness (McWilliams et al, 2019;Liberatore, 2013;Martens et al, 2014;Toledo et al, 2013). These methodologies are particularly suited to overcome the institution-related barriers affecting IV-tPA administration.…”

“…The recent push toward a value-based system drives new research aimed at understanding how to decrease or control the costs, while maintaining or improving the high-level quality of healthcare services (McWilliams et al. , 2019).…”