Primary Care Practice Characteristics Associated With Medical Assistant Staffing Ratios.

This study characterized adult primary care medical assistant (MA) staffing. National Survey of Healthcare Organizations and Systems (n = 1,252) data were analyzed to examine primary care practice characteristics associated with MA per primary care clinician (PCC) staffing ratios. In 2021, few practices (11.4%) had ratios of 2 or more MAs per PCCs. Compared with system-owned practices, independent (odds ratio [OR] = 1.76, P <0.05) and medical group-owned (OR = 2.09, P <0.05) practices were more likely to have ratios of 2 or more MAs per PCCs, as were practices with organizational cultures oriented to innovation (P <0.05). Most primary care practices do not have adequate MA staffing.

Associations Between Lean IT Management and Financial Performance in US Hospitals.

BACKGROUND AND OBJECTIVES: To understand the relationship between Lean implementation in information technology (IT) departments and hospital performance, particularly with respect to operational and financial outcomes. METHODS: Primary data were sourced from 1222 hospitals that responded to the National Survey of Lean (NSL)/Transformational Performance Improvement, which was fielded to 4500 general medical-surgical hospitals across the United States. Secondary sources included hospital performance data from the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare & Medicaid Services (CMS). We performed 2 sets of multivariable regressions using data gathered from US hospitals, linked to AHRQ and CMS performance outcomes. We examined 10 different outcomes measuring financial performance, quality of care, and patient experience, and their associations with Lean adoption within hospital IT departments. We then focused only on those hospitals that adopted Lean in IT to identify specific practices associated with performance. RESULTS: Controlling for other factors, adoption of Lean IT management was associated with lower length of stay ( b = -0.098, P = .018) and inpatient expense per discharge ( b = -0.112, P = .090). Specifically, use of visual management tools (eg, A3 storyboards, status sheets) was associated with lower adjusted inpatient expense per discharge ( b = -0.176, P = .034) and higher earnings before interest, taxes, depreciation, and amortization margin ( b = 0.124, P = .042). Such tools were also associated with hospital participation in bundled payment programs (odds ratio = 2.326; P = .046; 95% confidence interval, 0.979-5.527) and percentage of net revenue paid on a shared risk basis ( b = 0.188, P = .031). CONCLUSIONS: Lean IT management was associated with positive financial performance, particularly with hospital participation in value-based payment. More detailed study is needed to understand other influential factors and types of work processes, activities, or mechanisms by which high-functioning IT can contribute to financial outcomes.

Lean Performance Indicators and Facilitators of Outcomes in U.S. Public Hospitals.

GOAL: This study investigated the association between Lean and performance outcomes in U.S. public hospitals. Public hospitals face substantial pressure to deliver high-quality care with limited resources. Lean-based management systems can provide these hospitals with alternative approaches to improve efficiency and effectiveness. Prior research shows that Lean can have positive impacts in hospitals ranging in ownership type, but more study is needed, specifically in publicly owned hospitals. METHODS: We performed multivariable regressions using data from the 2017 National Survey of Lean/Transformational Performance Improvement. The data were linked to publicly available hospital performance data from the Agency for Healthcare Research and Quality and the Centers for Medicare & Medicaid Services. We examined 11 outcomes measuring financial performance, quality of care, and patient experience and their associations with Lean adoption. We also explored potential drivers of positive outcomes by examining Lean implementation in each hospital, measured as the number of units using Lean tools and practices; leader commitment to Lean principles; Lean training and education among physicians, nurses, and managers; and use of a daily management system among C-suite leaders and managers. PRINCIPAL FINDINGS: Lean adoption and implementation were associated with improved performance in U.S. public hospitals. Compared with hospitals that did not adopt Lean, those that did had significantly lower adjusted inpatient expenses per discharge and higher-than-average national scores on the appropriate use of medical imaging and timeliness of care. The study results also showed marginally significant improvements in patient experience and hospital earnings before interest, taxes, depreciation, and amortization margins. Focusing on these select outcomes, we found that drivers of such improvements involved the extent of Lean implementation, as reflected by leadership commitment, daily management, and training/education while controlling for the number of years using Lean. PRACTICAL APPLICATIONS: Lean is a method of continuous improvement centered around a culture of providing high-value care for patients. Our findings provide insight into the potential benefits of Lean in U.S. public hospitals. Notably, they suggest that leader buy-in is key to success. When executives and managers support Lean initiatives and provide proper training for the workforce, improved financial and operational performance can result. This commitment, starting with upper management, may also play a broader role in the effort to reform healthcare while having a positive impact on patient care in U.S. public hospitals.

Managing Through a Pandemic: A Daily Management System for COVID-19 Response and Recovery.

GOAL: This study explored the use of a Lean daily management system (DMS) for COVID-19 response and recovery in U.S. hospitals and health systems. Originally developed in manufacturing, Lean is an evidence-based approach to quality and process improvement in healthcare. Although Lean has been studied in individual hospital units and outpatient practices, it has not been examined as a whole system response to crisis events. METHODS: We conducted qualitative interviews with 46 executive leaders, clinical leaders, and frontline staff in four hospitals and health systems across the United States. We developed a semistructured interview guide to understand DMS implementation in these care delivery organizations. As interviews took place 6-8 months following the onset of the pandemic, a subset of our interview questions centered on DMS use to meet the demands of COVID-19. Based on a deductive approach to qualitative analysis, we identified clusters of themes that described how DMS facilitated rapid system response to the public health emergency. PRINCIPAL FINDINGS: There were many important ways in which U.S. hospitals and health systems leveraged their DMS to address COVID-19 challenges. These included the use of tiered huddles to facilitate rapid communication, the creation of standard work for redeployed staff, and structured problem-solving to prioritize new areas for improvement. We also discovered ways that the pandemic itself affected DMS implementation in all organizations. COVID-19 universally created greater DMS visibility by opening lines of communication among leadership, strengthening measurement and accountability, and empowering staff to develop solutions at the front lines. Many lessons learned using DMS for crisis management will carry forward into COVID-19 recovery efforts. Lessons include expanding telehealth, reactivating incident command systems as needed, and efficiently coordinating resources amid potential future shortages. PRACTICAL APPLICATIONS: Overall, the Lean DMS functioned as a robust property that enabled quick organizational response to unpredictable events. Our findings on the use of DMS are consistent with organizational resilience that emphasizes collective sense-making and awareness of incident status, team decision-making, and frequent interaction and coordination. These features of resilience are supported by DMS practices such as tiered huddles for rapid information dissemination and alignment across organizational hierarchies. When used in conjunction with plan-do-study-act methodology, huddles provide teams with enhanced feedback that strengthens their ability to make changes as needed. Moreover, gaps between work-as-imagined (how work should be done) and work-as-done (how work is actually done) may be exacerbated in the initial chaos of emergency events but can be minimized through the development of standard work protocols. As a facilitator of resilience, the Lean DMS may be used in a variety of challenging situations to ensure high standards of care.

Transformational Performance Improvement: Why Is Progress so Slow?

In this chapter, we identify three distinct transformational performance improvement (TPI) approaches commonly used to redesign work processes in health care organizations. We describe the unique components or tools that each approach uses to improve the delivery of health services. We also summarize what is empirically known about the effectiveness of each TPI approach according to systematic reviews and recent studies published in the peer-reviewed literature. Based on examination of this research, we discuss what knowledge is still needed to strengthen the evidence for whole system transformation. This involves the use of conceptual frameworks to assess and guide implementation efforts, and facilitators and barriers to change as revealed in a recent evaluation of one major initiative, the Lean Enterprise Transformation (LET) at the Veterans Health Administration. The analysis suggests ways in which TPI facilitators can be developed and barriers reduced to improve the effectiveness and sustainability of quality initiatives. Finally, we discuss appropriate study designs to evaluate TPI interventions that may strengthen the evidence for their effectiveness in real world practice settings.

Lean Practices for Resource Use, Timeliness, and Coordination of Care in Breast Cancer Navigation.

BACKGROUND: Cancer care is described as insufficiently patient-centered, requiring improved accessibility and coordination. Breast oncology nurse navigators may help provide timely patient care by improving care coordination. OBJECTIVES: This study evaluated a breast cancer navigation (BCN) program in a large ambulatory healthcare system. It examined measures related to quality and value, including timely service delivery, appropriate use of resources, and care coordination. METHODS: Using Lean methods, a BCN program focused on women receiving a breast biopsy was developed at a pilot site and later implemented throughout the healthcare system. Study data evaluated timely disclosure of biopsy results, prompt scheduling of initial consultations, outpatient use of cancer specialists, and coordination between primary care and oncology practices. FINDINGS: After implementing the BCN program, more timely biopsy results were delivered to patients. Patients were more likely to complete an initial consultation within two weeks of biopsy and made fewer outpatient visits. Referrals to cancer specialists within a month of biopsy increased, and primary care encounters with patients decreased.

Road to Better Work-Life Balance? Lean Redesigns and Daily Work Time among Primary Care Physicians.

PURPOSE: To assess the impact of Lean primary care redesigns on the amount of time that physicians spent working each day. METHODS: This observational study was based on 92 million time-stamped Epic® EHR access logs captured among 317 primary care physicians in a large ambulatory care delivery system. Seventeen clinic facilities housing 46 primary care departments were included for study. We conducted interrupted time series analysis to monitor changes in physician work patterns over 6 years. Key measures included total daily work time; time spent on "desktop medicine" outside the exam room; time spent with patients during office visits; time still working after clinic, i.e., after seeing the last patient each day; and remote work time. RESULTS: The amount of time that physicians spent on desktop EHR activities throughout the day, including after clinic hours, decreased by 10.9% (95% CI: -22.2, -2.03) and 8.3% (95% CI: -13.8, -2.12), respectively, during the first year of Lean implementation. Total daily work hours among physicians, which included both desktop activity and time in office visits, decreased by 20% (95% CI: -29.2, -9.60) by the third year of Lean implementation. CONCLUSIONS: These findings suggest that Lean redesign may be associated with time savings for primary care physicians. However, since this was an observational analysis, further study is warranted (e.g., randomized trial) -to determine the impact of Lean interventions on physician work experiences.

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences.

BACKGROUND: Patient navigators can improve patient experiences of care and outcomes, but little is known about how navigation programs may affect physician workflows and experience. OBJECTIVES: This study aimed to understand patient and physician experiences with a breast cancer navigation (BCN) program using Lean design principles. METHODS: Surveys were developed and distributed from 2019 to 2020 to 255 patients diagnosed with breast cancer and 128 physicians in primary care and cancer-related specialties. Descriptive analyses were conducted. FINDINGS: Eighty-three physicians and 94 patients completed the survey. A large majority of physicians reported that the BCN program "made their day easier" and improved flow, care coordination, and patient experience. A large majority of patients reported receiving the right level of support during diagnosis communication and high satisfaction in other domains measured.

Chromosome microarray characterisation of chromosome arm 12p loss associated with complex molecular karyotype and recurrent adverse cytogenetic markers in multiple myeloma.

Copy number loss within chromosome 12 short arm (12p) has gained attention as an adverse cytogenetic marker in multiple myeloma. The prognostic significance and characterisation of the common minimal deleted region remains controversial between various studies with loss of CD27 proposed as the putative critical gene. We aimed to determine the frequency of 12p loss, its correlation with adverse cytogenetic markers further to define and characterise 12p deletions. Our study included a prospective cohort of 574 multiple myeloma patients referred for cytogenetic testing, including interphase fluorescence in situ hybridisation for IGH (14q32.33) translocations and chromosome microarray. Loss of 12p was detected in 54/574 (9.4%) patients and when compared with the non-12p loss group [520/574 (90.6%)], 12p loss patients demonstrated a statistically significant association with specific recurrent cytogenetic markers: complex molecular karyotypes (98.1% vs 45.2%), 1p loss (50.0% vs 20.2%), t(4;14) (20.4% vs 7.7%), 8p loss (37.0% vs 15.0%), 13/13q loss (70.4% vs 41.7%), and 17p loss (33.3% vs 6.5%). The size and location of 12p losses were heterogeneous with a common 0.88 Mb minimally deleted region that included ~9 genes from ETV6 to CDKN1B in 52/54 (~96.3%) patients but did not include CD27. Our findings support 12p loss being a secondary chromosome abnormality frequently co-occurring with adverse cytogenetic markers and complex molecular karyotypes indicative of chromosome instability.

Patient experiences after implementing lean primary care redesigns.

OBJECTIVE: To examine the effect of Lean primary care redesigns on patient satisfaction with care and timeliness of care received. DATA/SETTING: We used patient surveys and time-stamped electronic health record (EHR) data in a large ambulatory care system. DESIGN: Lean-based changes to clinical spaces and care team workflows were implemented in one pilot site and then scaled to all primary care departments across the system. Redesigns included standardizing equipment and patient education materials in examination rooms, streamlining call management functions, co-locating physician and medical assistant dyads in a shared workspace, and creating new care team workflows. We used a non-randomized stepped-wedge study design and segmented regression with interrupted time series analysis to examine Lean impacts on patient outcomes. DATA COLLECTION: We analyzed patient satisfaction ratings and wait times as documented by the EHR. These longitudinal data were collected for 317 physician-led teams in 46 primary care departments from January 2011 to December 2016. PRINCIPAL FINDINGS: After implementation of Lean redesigns, patients reported a 44.8 percent increase in satisfaction with the adequacy of time spent with care providers during office visits (P < .05). They also reported 71.6 percent higher satisfaction with their care provider's ability to listen to their concerns, and a 55.4 percent increase in perceived staff helpfulness at the visit (P < .01). Based on monthly EHR data, the amount of time elapsed between a patient request for a routine appointment and the scheduled visit day decreased from baseline by an average 2 percent per month (P < .01). On the day of the visit, patient wait times to be seen also decreased gradually by an average 1.2 percent per month (P < .05). CONCLUSIONS: Patient experiences of care after Lean implementations have not been widely studied in primary care settings. We found that Lean redesign yielded improvements that may strengthen clinical operations while enhancing value for patients.

Implementing Lean Quality Improvement in Primary Care: Impact on Efficiency in Performing Common Clinical Tasks.

BACKGROUND: Many primary care practices have adopted Lean techniques to reduce the amount of time spent completing routine tasks. Few studies have evaluated both immediate and sustained impacts of Lean to improve this aspect of primary care work efficiency. OBJECTIVE: To examine 3-year impacts of Lean implementation on the amount of time taken for physicians to complete common clinical tasks. DESIGN: Non-randomized stepped wedge with segmented regression and interrupted time series analysis (January 2011-December 2016). PARTICIPANTS: A total of 317 physician-led teams in 46 primary care departments in a large ambulatory care delivery system. INTERVENTION: Lean redesign was initiated in one pilot site followed by system-wide spread across all primary care departments. Redesigns included standardization of exam room equipment and supplies, streamlining of call management processes, care team co-location, and team management of the electronic inbox. MEASURES: Time-stamped EHR tracking of physicians' completion time for 4 common tasks: (1) office visit documentation and closure of patient charts; (2) telephone call resolution; (3) prescription refill renewal; and (4) response to electronic patient messages. RESULTS: After Lean implementation, we found decreases in the amount of time to complete: office visit documentation (- 29.2% [95% CI: - 44.2, - 10.1]), telephone resolution (- 22.2% [95% CI: - 38.1, - 2.27]), and renewal of prescription refills (- 2.96% per month [95% CI: - 4.21, - 1.78]). These decreases were sustained over several years. Response time to electronic patient messages did not change significantly. CONCLUSIONS: Lean redesigns led to improvements in timely completion of 3 out of 4 common clinical tasks. Our findings support the use of Lean techniques to engage teams in routine aspects of patient care. More research is warranted to understand the mechanisms by which Lean promotes quality improvement and effectiveness of care team workflows.

Diversity of XMEN Disease: Description of 2 Novel Variants and Analysis of the Lymphocyte Phenotype.

Variants in MAGT1 have been identified as the cause of an immune deficiency termed X-linked immunodeficiency with magnesium defect, Epstein-Barr virus (EBV) infection and neoplasia (XMEN) disease. Here, we describe 2 cases of XMEN disease due to novel mutations in MAGT1, one of whom presented with classical features of XMEN disease and another who presented with a novel phenotype including probable CNS vasculitis, HHV-8 negative multicentric Castelman disease and severe molluscum contagiosum, thus highlighting the clinical diversity that may be seen in this condition. Peripheral blood immunophenotyping of these 2 patients, together with an additional 4 XMEN patients, revealed reduced NKG2D expression, impaired CD28 expression on CD8+ T cells, CD4+ T cell lymphopenia, an inverted CD4:CD8 ratio and decreased memory B cells. In addition, we showed for the first time alterations to the CD8+ T cell memory compartment, reduced CD56hi NK cells, MAIT and iNKT cells, as well as compromised differentiation of naïve CD4+ T cells into IL-21-producing Tfh-type cells in vitro. Both patients were treated with supplemental magnesium with limited benefit. However, one patient has undergone allogeneic haematopoietic stem cell transplant, with full donor chimerism and immune reconstitution. These results expand our understanding of the clinical and immunological phenotype in XMEN disease, adding to the current literature, which we further discuss here.

Contextual Conditions and Performance Improvement in Primary Care.

BACKGROUND: Although organizational context can affect the implementation of quality initiatives, we know less about the influence of contextual conditions on quality outcomes. We examined organizational features of primary care clinics that achieved greatest performance improvements after implementing Lean redesigns. METHODS: We used operational data and baseline (ie, pre-Lean implementation) surveys of 1333 physicians and staff in 43 primary care clinics located across a large ambulatory care system. Segmented regression with interrupted time series analysis was used to identify clinics with highest improvements in workflow efficiency, physician productivity, and patient satisfaction following Lean redesign. We conducted independent-samples t tests to identify contextual features of clinics that showed greatest improvements in performance outcomes. RESULTS: Clinics with highest increases in efficiency had most prior experience with quality improvement, compared with all other clinics. Efficiency gains were also found in clinics reporting highest levels of burnout and work stress prior to redesign. Highest improvements in physician productivity were associated with a history of change, staff participation, and leadership support for redesigns. Greatest improvements in patient satisfaction occurred in least stressful environments with highest levels of teamwork, staff engagement/efficacy, and leadership support. CONCLUSIONS: Our findings encourage careful evaluation of clinic characteristics and capacity to effectively implement redesigns. Such evaluations may help leaders select interventions most appropriate for certain clinics, while identifying others that may need extra support with implementing change.

Sustainment of Lean Redesigns for Primary Care Teams.

BACKGROUND: Quality improvements are notoriously followed by "backsliding" or relapse to the status quo. This mixed-methods study examined the sustainment of Lean workflow redesigns for primary care teams several years after being implemented in a large, ambulatory care delivery system. METHODS: We conducted qualitative interviews of 57 leaders and frontline providers, and fielded post-Lean implementation surveys to 1164 physicians and staff in 17 primary care clinics across the system. We analyzed interviews and conducted independent sample t tests to identify key factors that facilitated the sustainment of new workflows among primary care teams. All analyses were conducted after Lean redesigns were implemented and scaled across the system in 3 consecutive phases. RESULTS: Adherence to Lean redesigns was highest in the pilot clinic, despite having the longest postdesign measurement period. Members of the pilot clinic reported greatest participation in designing workflows, were most highly engaged in quality improvement efforts, and held most favorable beliefs about Lean changes. Adherence to redesigns was lowest among clinic members in the second phase of implementation; these members also reported highest levels of burnout. CONCLUSIONS: Staff participation in Lean redesign is a key to facilitating buy-in and adherence to changes. Change ownership and continued availability of time for improvement activities are also critical to the long-term success of Lean implementation in primary care.

Nurses' Perspectives on Lean Redesigns to Patient Flow and Inpatient Discharge Process Efficiency.

As hospitals around the world increasingly face pressure to improve efficiency, "Lean" process improvement has become a popular approach to improving patient flow. In this article, we examine nurses' perspectives on the implementation of Lean redesigns to the inpatient discharge process. We found that nurses experienced competing demands and tensions related to their time and professional roles and responsibilities as a result of Lean. Four main themes included (a) addressing the needs of individual patients, while still maintaining overall patient flow; (b) meeting discharge efficiency targets while also achieving high patient satisfaction scores; (c) "wasting time" to save time; and (d) the "real" work of providing clinical care versus the "Lean" work of process improvement. Our findings highlight the importance of soliciting hospital nurses' perspectives when implementing Lean process improvements to improve efficiency and patient flow.

Physician Engagement With Metrics in Lean Primary Care Transformation.

OBJECTIVE: Data and metrics play important roles in quality and process improvement efforts. For one specific process improvement method, Lean or Lean health care, data and metrics are central components, allowing users to identify areas that need improvement and to assess the degree to which improvements have been realized. This article explores the role that metrics and measurement played in a wide-reaching "Lean"-based continuous quality improvement effort carried out in the primary care departments of a large, ambulatory care health care organization. METHODS: This article is based on qualitative data collected through in-depth interviews with physicians, staff, and health care leaders. RESULTS: Suggestions for improving the ways that metrics may be optimally used, presented, and approached while carrying out health care improvement efforts include having accurate and compelling data throughout the improvement process, ensuring that metrics are professionally meaningful to physicians, and presenting metrics in a manner that increases the likelihood that they will be digested and ultimately used to improve health care. CONCLUSIONS: Effective strategies for selecting and presenting metrics to practicing physicians are an important part of a successful quality improvement effort.

Experiences of primary care physicians and staff following lean workflow redesign.

BACKGROUND: In response to growing pressures on primary care, leaders have introduced a wide range of workforce and practice innovations, including team redesigns that delegate some physician tasks to nonphysicians. One important question is how such innovations affect care team members, particularly in view of growing dissatisfaction and burnout among healthcare professionals. We examine the work experiences of primary care physicians and staff after implementing Lean-based workflow redesigns. This included co-locating physician and medical assistant dyads, delegating significant responsibilities to nonphysician staff, and mandating greater coordination and communication among all care team members. METHODS: The redesigns were implemented and scaled in three phases across 46 primary care departments in a large ambulatory care delivery system. We fielded 1164 baseline and 1333 follow-up surveys to physicians and other nonphysician staff (average 73% response rate) to assess workforce engagement (e.g., job satisfaction, motivation), perceptions of the work environment, and job-related burnout. We conducted multivariate regressions to detect changes in experiences after the redesign, adjusting for respondent characteristics and clustering of within-clinic responses. RESULTS: We found that both physicians and nonphysician staff reported higher levels of engagement and teamwork after implementing redesigns. However, they also experienced higher levels of burnout and perceptions of the workplace as stressful. Trends were the same for both occupational groups, but the increased reports of stress were greater among physicians. Additionally, members of all clinics, except for the pilot site that developed the new workflows, reported higher burnout, while perceptions of workplace stress increased in all clinics after the redesign. CONCLUSIONS: Our findings partially align with expectations of work redesign as a route to improving physician and staff experiences in delivering care. Although teamwork and engagement increased, the redesigns in our study were not enough to moderate long-standing challenges facing primary care. Yet higher levels of empowerment and engagement, as observed in the pilot clinic, may be particularly effective in facilitating improvements while combating fatigue. To help practices cope with increasing burdens, interventions must directly benefit healthcare professionals without overtaxing an already overstretched workforce.

Framework for Research on Implementation of Process Redesigns.

BACKGROUND: Complex system interventions benefit from close attention to factors affecting implementation and resultant outcomes. This article describes a framework for examining these factors in process redesign (PR) and for assessing PR outcomes. METHODS: Using literature scans and expert comment on draft frameworks based on the Consolidated Framework for Implementation Research, a team of researchers developed the PR framework for the Agency for Healthcare Research and Quality. As a case study, an independent team of researchers in a large care system subsequently applied the PR framework to implementation of Lean-based primary care redesigns. RESULTS: The PR framework adds 2 domains to the Consolidated Framework for Implementation Research, focused on relevant measures of implementation and outcomes, as well as some new constructs to the Consolidated Framework for Implementation Research. Using the PR framework to guide a study of primary care PR, researchers found that the health care reform environment encouraged staff recognition of need for redesign, but physicians worried about key redesign issues, including colocation with care team partners and the competencies of the individuals assigned to manage new workflows. Team member acceptance of the redesign was also influenced by other features of the implementation process and contextual features, including the decision style of the local clinic. CONCLUSIONS: The PR framework helped guide the qualitative study and aided researchers in informing their leadership about critical issues affecting PR implementation.