Stephen Shortell, PhD, MPH, MBA The Center for Lean Engagement and Research CLEAR Stephen Shortell, PhD, MPH, MBA Blue Cross of California Distinguished Professor of Health Policy & Management Co-Director - Center for Lean Engagement and Research (CLEAR) in Healthcare School of Public Health UC, Berkeley Thomas Rundall, PhD Henry J. Kaiser Professor Emeritus Co-Director - Center for Lean Engagement and Research (CLEAR) in Healthcare School of Public Health UC, Berkeley LEAN Design Forum Berkeley, California January 26, 2017

Today’s Learning Objectives Understand the current state of research on lean in healthcare organizations Understand a useful conceptual framework for researching lean implementations in healthcare organizations Understand the origin, vision, mission and goals of CLEAR Identify major research questions that CLEAR research projects will address Discuss CLEAR’s three initial research initiatives JB: removed question on first item, made text box wider

WORKING DEFINITION OF LEAN The development of a culture that enables an overall management system to create value for customers by eliminating waste and solves problems through the daily application of the scientific method in creating standard work. JB: I’d prefer to use sentence case for the text of the definition

The State of Research Evidence on the Effects of Lean in Healthcare Organizations There is some evidence showing positive effects of lean on patient care processes, outcomes, and efficiency. JB: Adjusted text box formatting

Source: Mark Chassin and Jerod Loeb, “High Reliability Health Care: Getting There from Here.” The Milbank Quarterly, 2013, 91,(3): 459-490.

The State of Research Evidence on the Effects of Lean in Healthcare Organizations However, systematic reviews of the existing published research indicate that overall the reported effects of lean on organizational and patient metrics are quite mixed, with many studies showing no positive effects and some studies showing negative effects JB: adjusted text box size and line breaks

FROM RECENT SYSTEMATIC REVIEW ¹ FINDINGS No significant association with patient satisfaction or health outcomes. Higher costs (taking into account money spent implementing Lean). Poorer worker satisfaction. Inconsistent association with process outcomes like patient flow and safety. CONCLUSION “The evidence to date does not support the belief that Lean leads to healthcare quality improvements.” Call for more rigorous, higher quality and better conducted scientific research. ¹ J. Moraros, M. Lemstra, and C. Nwankwo, “Lean interventions in healthcare – Do they actually work? A systematic literature review” International Journal for Quality in Health Care Advance Access, 2015, 28 (2): 150-165

Problems With the Research Literature on Lean in Healthcare Organizations There is little reporting of the external stimulus or context for lean (e.g. market factors), key organizational factors (e.g. how culture affects the lean implementation, and sustainability). Most reports from peer-reviewed and grey literature are single case studies of limited internal and external validity. Most reports focus on one organization, department, and project, making it very difficult to determine what external factors or organizational characteristics are important for successful implementation and maintenance of lean. JB: adjusted text box size and line breaks

Problems With the Research Literature on Lean in Healthcare Organizations Studies generally fail to use more rigorous quasi-experimental designs or comparative and longitudinal case study designs. Outcomes measured are primarily efficiency and quality and, less frequently safety and patient satisfaction. There is a positive publication bias in the lean literature. Lean studies lack a conceptual framework.

Carman, Paez, Stephens, et al. Improving Care Delivery Through Lean: Implementation Case Studies. AHRQ Publication No. 13(15)-0056. November 2014.

“It is important that the research community recognizes healthcare management is every bit as important as clinical medicine for research. In fact, it may be the most important research area from a patient safety standpoint.” John Toussaint, MD President and CEO Catalysis (formerly the ThedaCare Center for Healthcare Value)

Lean Enterprise Institute FOUNDING SPONSORS Catalysis Lean Enterprise Institute Rona & Associates JB: I couldn’t tell if you left ThedaCare purposely, but I pasted in the Catalysis logo if you want to use that instead.

STRATEGIC ADVISORY COUNCIL Kathryn Correia – HealthEast Care System James Hereford – Fairview Health Services Alice Lee - Lean Enterprise Institute John Toussaint –Catalysis Craig Vercruysse - Rona & Associates Peter Ward - Ohio State University Helen Zak - Catalysis

MOVING THE EVIDENCE BASE FORWARD DEVELOPING “ACTIONABLE” KNOWLEDGE The Center for Lean Engagement and Research (CLEAR) in Healthcare Vision The vision of CLEAR is to transform healthcare delivery by providing the knowledge to help organizations eliminate waste and to create greater value resulting in the continuous improvement of patients’ outcomes and experience of care, population health, and reduced growth in the cost of care. Mission CLEAR’s mission is to conduct timely, relevant, and actionable research on LEAN whole system transformation initiatives in healthcare. JB: I’m unsure about the all-caps for “LEAN” here – maybe “Lean” instead?

MAJOR TOPICS/QUESTIONS TO BE ADDRESSED Assess whether lean positively affects key outcomes of interest to healthcare organizations. From a hospital’s perspective, does lean improve quality, efficiency, costs, employee satisfaction, patient satisfaction, and organizational culture? Identify internal and external factors that are associated with variations in outcomes and processes, so that potential users can understand which experiences are relevant to their own situation. Identify challenges to implementing lean, potential solutions to challenges, and lessons learned.

Initial Research Initiatives Conduct in-house leading edge research on Lean in healthcare, beginning with the first national survey of Lean in hospitals Collaborate with specific healthcare organizations and other health services researchers on focused studies of the effects of Lean in particular organizations and departments Explore forming a Lean Action Research Collaborative with about 10 hospitals/health systems Facilitate research among other researchers and healthcare delivery organizations through resources and information available on our website (e.g. annotated bibliography of research on Lean in healthcare organizations). JB: capitalized “Lean” in item 3 Website: www.clear.berkeley.edu

WHAT IS NEEDED, WHAT WE PROPOSE Use of an evidence-based conceptual framework Examine enterprise-wide, as well as department-specific, lean deployments More Rigorous Evaluation Designs to Rule Out Alternative Explanation for Study Results - Experimental and Quasi-Experimental Measures Relevant to the Intervention Detailed Description of the Intervention Thorough Examination of Contextual Effects Assessments of Sustainability – Longitudinal Study Designs Studies of Spread – Diffusion to Other Units, Other Organizations will Require Effective Partnerships Between Lean Organizations and Researchers JB: I don’t understand this item. Is it supposed to be two items? “Assessments of Sustainability One Time – Longitudinal Study Designs”. Also, I think it’s nicer to use sentence case here.

Isn’t that where the fruit is? Why not go out on a limb? Isn’t that where the fruit is? Frank Scully

Stephen Shortell, PhD, MPH, MBA Thank You Clear.Berkeley.edu Stephen Shortell, PhD, MPH, MBA Shortell@Berkeley.edu Thomas Rundall, PhD Trundall@Berkeley.edu