Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability.

The complexity and inter-connectedness of operating in a global world for drug product supply has become an undeniable reality, further underscored by the COVID-19 pandemic. For Post-Approval Changes (PACs) that are an inevitable part of a product's commercial life, the impact of the growing global regulatory complexity and related drug shortages has brought the Global PAC Management System to an inflection point in particular for companies that have their products marketed in many countries.This paper illustrates through data analyzed for the first time from 145,000 + PACs for 156 countries, collected by 18 global pharma companies over a 3-year period (2019-2021), how severe the problem of global regulatory complexity is. Only PACs requiring national regulatory agency (NRA) approval prior to implementation were included in the data set. 1 of the 156 country NRAs approved all submitted PACs within a period of 6 months. The 6-month timeline was chosen because it is the recommended review timeline for major changes in the WHO guidance for vaccines and biotherapeutic products. 10 out of the 156 (6%) countries had no more than 10% of the PACs reviewed and approved in > 6 months. In 33 (22%) countries more than half of the PACs took > 6 months for approval. It is rare that the same PAC is approved globally within 6 months as individual NRAs take from a few months to years (in some cases > 5 years) for their review.The global PAC management complexity has steadily grown over the past 20 years. Attempts thus far to solve this problem have not made any meaningful difference. Senior leaders and decision-makers across the interdependent components of the complex Global PAC Management System (industry and regulators) must come together and collaboratively manage the problem holistically with the objective of ensuring global drug product availability instead of continuing with distinct stakeholder or country-focused solutions, which can tend to worsen the problem.In this paper, the Chief Quality Officers (CQOs) from 18 of the largest innovator pharma companies (see Acknowledgements) are speaking with One-Voice-of-Quality for PACs (1VQ for PACs Initiative). They are recommending a set of 8 approaches to activate a holistic transformation of the Global PAC Management System. This article presents their view on the problem of global regulatory complexity for managing PACs, it's impact on continual improvement and the risk to drug product supply, as well as approaches that can help alleviate the problem.

Toward a Theory of Organizational DNA: Routines, Principles, and Beliefs (RPBs) for Successful and Sustainable Organizational Change.

Organizational change is a key mechanism to ensure the sustainability of healthcare systems. However, healthcare organizations are persistently difficult to change, and literature is riddled with examples of failed change endeavors. In this chapter, we attempt to unravel the underlying causes for failed organizational change. We distinguish three types of change with different levels of depth that require different change approaches. Transformations are the deepest forms of change where beliefs and principles need to be modified to successfully influence routines. Renewals are deep forms of change where principles need to be modified to successfully influence routines. Improvements are shallow forms of change where only modifications at the level of routines are needed. Using deoxyribonucleic acid (DNA) as our metaphor, we propose a theory of "organizational DNA" to understand organizations and these three types of organizational changes. We posit that organizations are made up of a double helix consisting of a so-called "social string," which contains the "soft" interaction or communication among the organization's members, and a so-called "technical string," which contains "hard" organizational aspects such as structure and technology. Ladders of organizational nucleotides (i.e., Routines, Principles, and Beliefs) connect this double helix in various combinations. Together, the double helix and accompanying nucleotides make up the DNA of an organization. Without knowledge of the architecture of organizational DNA and whether a change addresses beliefs, principles, and/or routines, we believe that organizational change is constrained and based on luck rather than change management expertise. Following this metaphor, we show that organizational change fails when it attempts to change one part of the DNA (e.g., routines) in a way that renders it incompatible with the connecting components (e.g., principles and beliefs). We discuss how the theory can be applied in practice using an exemplar case.

Measure Twice, Change Once: Using Simulation to Support Change Management in Rural Healthcare Delivery.

Barriers to adequate healthcare in rural areas remain a grand challenge for local healthcare systems. In addition to patients' travel burdens, lack of health insurance, and lower health literacy, rural healthcare systems also experience significant resource shortages, as well as issues with recruitment and retention of healthcare providers, particularly specialists. These factors combined result in complex change management-focused challenges for rural healthcare systems. Change management initiatives are often resource intensive, and in rural health organizations already strapped for resources, it may be particularly risky to embark on change initiatives. One way to address these change management concerns is by leveraging socio-technical simulation models to estimate techno-economic feasibility (e.g., is it technologically feasible, and is it economical?) as well as socio-utility feasibility (e.g., how will the changes be utilized?). We present a framework for how healthcare systems can integrate modeling and simulation techniques from systems engineering into a change management process. Modeling and simulation are particularly useful for investigating the amount of uncertainty about potential outcomes, guiding decision-making that considers different scenarios, and validating theories to determine if they accurately reflect real-life processes. The results of these simulations can be integrated into critical change management recommendations related to developing readiness for change and addressing resistance to change. As part of our integration, we present a case study showcasing how simulation modeling has been used to determine feasibility and potential resistance to change considerations for implementing a mobile radiation oncology unit. Recommendations and implications are discussed.

Say Goodbye to the 'Paper on Screen', Rethinking Presentation of and Interaction with Medical Information.

Traditionally, Electronic Medical Records (EMR) have been designed to mimic paper records. Organizing and presenting medical information along the lines that evolved for non-digital records over the decades, reduced change management for medical users, but failed to make use of the potential of organizing digital data. We proposed a method to create clinical dashboards to increase the usability of information in the medical records. Official clinical guidelines were studied by a working group, including dashboard target users. Necessary clinical concepts contained in the medical records were identified according to the clinical context and finally, dedicated technical tools with standard terminologies were used to represent categories of information. We used this method to generate and implement a dashboard for sepsis. The dashboard was found to be appropriate and easy to use by the target users.

A practical tool for managing change: cross-sectional psychometric assessment of the safe surgery organizational readiness tool.

BACKGROUND: Strengthening health systems through planned safety and quality improvement initiatives is an imperative to achieve more equitable, resilient, and effective care. And yet, years of organizational behavior research demonstrate that change initiatives often fall short because managers fail to account for organizational readiness for change. This finding remains true especially among surgical safety and quality improvement initiatives in low-income countries and middle-income countries. In this study, our aim was to psychometrically assess the construct validity and internal consistency of the Safe Surgery Organizational Readiness Tool (SSORT), a short survey tool designed to provide change leaders with insight into facility infrastructure that supports learning and readiness to undertake change. MATERIALS AND METHODS: To demonstrate generalizability and achieve a large sample size ( n =1706) to conduct exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), a collaboration between seven surgical and anesthesia safety and quality improvement initiatives was formed. Collected survey data from health care workers were divided into pilot, exploration, and confirmation samples. The pilot sample was used to assess feasibility. The exploration sample was used to conduct EFA, while the confirmation sample was used to conduct CFA. Factor internal consistency was assessed using Cronbach's alpha coefficient. RESULTS: Results of the EFA retained 9 of the 16 proposed factors associated with readiness to change. CFA results of the identified 9 factor model, measured by 28 survey items, demonstrated excellent fit to data. These factors (appropriateness, resistance to change, team efficacy, team learning orientation, team valence, communication about change, learning environment, vision for sustainability, and facility capacity) were also found to be internally consistent. CONCLUSION: Our findings suggest that communication, team learning, and supportive environment are components of change readiness that can be reliably measured prior to implementation of projects that promote surgical safety and quality improvement in low-income countries and middle-income countries. Future research can link performance on identified factors to outcomes that matter most to patients.

Using the information-motivation-behavioral skills model for targeting older adults' climate change management practices: in the road of COP27.

BACKGROUND: Climate change is a rapidly evolving public health problem warranting global attention in the 21st century. The World Health Organization declared that climate illiteracy is highly prevalent among older adults, especially in lower- and middle-income nations. AIM: To determine the effect of the Information-Motivation-Behavioral Skills Model-based intervention for climate change management practices among older adults. DESIGN: A quasi-experimental employed a pre-posttest, two-group research design. PARTICIPANTS: The studied sample comprised 80 older adults (aged 60 years and above), assigned to study and control groups (n = 40 each) after completing a baseline survey of six validated measures. RESULTS: The study group of proposed intervention based on IMB model demonstrated significant improvement in the mean scores of information (98.62 ± 3.56), motivation (90.14 ± 3.02), actual skills (84.13 ± 8.76), and practices (85.80 ± 3.94), p = 0.001. CONCLUSION: The intervention based on the Information-Motivation-Behavioral Skills Model has demonstrated credible feasibility in significantly improving the climate change-related information, motivation, skills, and management practices of older adults immediately after the posttest. It should be emphasized that this improvement showed a significant decline at the six-week mark; albeit the study participants' scores remained significantly higher than their pre-test values, there is clearly a need for reinforcement to maintain positive outcomes over the long term. The existing outcomes call for replication of this intervention in other cohorts, such as uneducated older adults and those residing in assisted-living facilities.

A Trainee-Led Quality Improvement Project Using Change Management Theory to Improve Bedside Rounding.

OBJECTIVE: The coronavirus disease 2019 pandemic disrupted the practice of family-centered rounds. After the height of the pandemic, a trainee-led team identified a low percentage of bedside rounds on general pediatrics resident teams and combined a quality improvement framework and change management theory to increase bedside rounds. Initial efforts focused on a single general pediatrics team with the aim to increase bedside rounds from 18% to 50% within 6 months and sustain improvement for 12 months. A second aim was to increase bedside rounds from 7% to 50% for all general pediatrics resident teams within 6 months of spread. METHODS: The Model for Improvement informed the identification of 3 primary drivers of bedside rounds: knowledge, culture, and logistics. Twelve plan-do-study-act (PDSA) cycles were implemented. Measures included the percentage of bedside rounds (primary outcome), caregiver attendance (secondary outcome), and nurse attendance and rounding time (balancing measures). RESULTS: For the initial team, 13 522 patient days were analyzed for the primary outcome with the average percentage of weekly bedside rounds increasing from 18% to 89% with 12 months of sustained improvement. The spread of the intervention to all teams revealed an increase in bedside rounding from 7% to 54%. The most significant improvements occurred after PDSA cycle 2, a communication bundle, and PDSA cycle 5, when the project was spread to all teams. CONCLUSIONS: This trainee-led initiative reveals the strength of the incorporation of change management theory within a quality improvement framework, resulting in rapid and sustainable increase in bedside rounds.

Change Management and Health Care Culture.

Change management in health care is the process of implementing new policies, procedures, and practices in order to improve the quality of patient care. It involves understanding the need for change, identifying the stakeholders involved, and developing a plan to implement and manage the change. Change management in health care requires a comprehensive and collaborative approach to ensure that changes are properly implemented, communicated, and monitored. It is essential for health care providers to be aware of the current trends in health care and to stay up to date with the latest technology in order to provide the best care possible.

Introducing change management education program for family medicine residents: a demonstration project.

Implication Statement: The project presents an innovative mixed learning approach program to provide basic change management training for family medicine residents. Developed by a team of faculty experts in the Department of Family Medicine at the University of Manitoba, this three-to-four-hour training program provided residents an understanding of an approach to change management that systematically plans, implements, and evaluates new initiatives in healthcare settings. Students reported that change management is important for their success as healthcare professionals. This program could easily be replicated. Énoncé des implications de la recherche: Ce projet consiste en programme novateur fondé sur une approche d'apprentissage mixte visant à offrir une formation de base en gestion du changement aux résidents en médecine familiale. Élaborée par une équipe de professeurs experts du département de médecine familiale de l'Université du Manitoba, cette formation d'une durée de trois à quatre heures a permis aux résidents de se familiariser avec une approche de la gestion du changement qui consiste à planifier, à mettre en œuvre et à évaluer systématiquement de nouvelles initiatives en milieu clinique. Les étudiants estiment que la gestion du changement est un facteur important pour leur réussite en tant que professionnels de la santé. Ce programme peut aisément être reproduit ailleurs.

Design thinking sprints as a facilitation process to enact change in the residency match process and beyond.

Implication Statement: Enacting change in medical education requires effective facilitation processes. Medical education lags behind other fields in systems innovation and radically disruptive approaches to the challenges we encounter. Design thinking "sprints," widely used in many other settings, serve as an opportunity to fill the gap as a facilitation process during periods requiring extensive and/or rapid change. Though resource-intensive, our experience using design thinking sprints for a situation requiring urgent change management with high-stakes implications for Canadian medical education to demonstrate their utility. A more widespread, adoption can contribute to innovation within all aspects of education including curriculum design, policy development, and educational process renewal. Énoncé des implications de la recherche: La mise en œuvre de changements dans la formation médicale exige un processus de facilitation efficace. Comparée à d'autres disciplines, l'éducation médicale est à la traîne en ce qui concerne l'innovation des systèmes et l'adoption d'approches radicalement transformatrices en réponse aux défis rencontrés. Le sprint de conception creative (design thinking sprints), approche largement utilisée dans de nombreux contextes, pourraient permettre de combler le manque de processus de facilitation lorsque des changements importants ou rapides sont à l'œuvre. Notre expérience de l'utilisation de tels sprints dans une situation nécessitant une gestion urgente de changements à enjeux importants pour l'éducation médicale au Canada démontre son utilité, malgré les ressources considérables qui ont dû être mobilisées. Une adoption plus large de cette approche peut contribuer à l'innovation dans tous les aspects de l'éducation, y compris la conception des programmes d'études, l'élaboration de politiques et le renouvellement des processus éducatifs.

Successful Change Management Strategies for Improving Diabetes Care Delivery Among High-Performing Practices.

PURPOSE: To learn how the highest-performing primary care practices manage change when implementing improvements to diabetes care delivery. METHODS: We ranked a total of 330 primary care practices submitting practice management assessments and diabetes reports to the Understanding Infrastructure Transformation Effects on Diabetes study in 2017 and 2019 by Optimal Diabetes Care performance. We ranked practices from the top quartile by greatest annual improvement to capture dynamic change. Starting with the top performers, we interviewed practice leaders to identify their most effective strategies for managing change. Interview transcripts were qualitatively analyzed to identify change management strategies. Saturation occurred when no new strategies were identified over 2 consecutive interviews. RESULTS: Ten of the top 13 practices agreed to interviews. We identified 199 key comments representing 48 key care management concepts. We also categorized concepts into 6 care management themes and 37 strategic approaches. We categorized strategic approaches into 13 distinct change management strategies. The most common strategies identified were (1) standardizing the care process, (2) performance awareness, (3) enhancing care teams, (4) health care organization participation, (5) improving reporting systems, (6) engaging staff and clinicians, (7) accountability for tasks, (8) engaging leadership, and (9) tracking change. Care management themes identified by most practices included proactive care, improving patient relationships, and previsit planning. CONCLUSIONS: Top-performing primary care practices identify a similar group of strategies as important for managing change during quality improvement activities. Practices involved in diabetes improvement activities, and perhaps other chronic conditions, should consider adopting these change management strategies.

Beyond Received Wisdom and Authorised Accounts: What Knowledge Is Needed to Avoid Repeating History? Comment on "'Attending to History' in Major System Change in Healthcare in England: Specialist Cancer Surgery Service Reconfiguration".

Perry and colleagues' study of a programme to reconfigure cancer surgery provision in Greater Manchester highlights the importance of accounting for history in making successful change. In this short commentary, I expand on some of Perry and colleagues' key findings. I note the way in which those leading change in Greater Manchester combined formal expertise in change management with sensitivity to local context, enhancing their approach to change through attention to details around relationships, events and assumptions that might otherwise have derailed the process. I identify lessons for others in how best to account for history in leading change, highlighting in particular the need to attempt to access and understand forms of history that may be suppressed, difficult-to-articulate, or otherwise marginalised.

Using a change management model to develop and implement dental curricula: A case study.

Curriculum transformation is a guiding principle and driving force to continued institutional growth and innovation in oral health education. The transformation process starts from the need and desire for change to achieve the strategic goals of curriculum invocation. The design and implementation process must follow a systematic approach to ensure the oral health curricula are meeting the demands of preparing learners for their future careers and are in line with the institutional strategic goals and processes. The process of curriculum transformation needs to be carefully crafted and implemented to include all constituents and have clear and measurable outcomes to define its path and results. The University of North Carolina at Chapel Hill Adams School of Dentistry is undergoing the journey of oral health curriculum innovation and transformation. The goal of this paper is to describe the change management process using Kotter's organizational model that may apply to other schools aiming to innovate dental curricula.

Change management in higher education: A sequential mixed methods study exploring employees' perception.

BACKGROUND: Higher education institutions need to put change management as a pivotal part of their strategy. The challenge is to effectively contextualize existing change management models to the respective work environment. Failing to properly adapt existing models to match the intricacies of the environment could lead to plenty of setbacks. For such a contextualization to take place, gauging employees' engagement and satisfaction becomes of paramount importance. As such, the overall purpose of the current study is to explore the perception of employees of a medical and health sciences university in Middle East and North Africa (MENA) region, in relation to change management and agility, and to showcase how the captured perspectives can be systemically interpreted to inform decision-making in the context of the study. METHOD: This research study relied on a sequential mixed methods design, which started with an exploration of the perception of Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU) leaders. Qualitative data was collected through a focus group session and was inductively analysed (based on constructivist epistemology). The output of the qualitative analysis contributed to the development of the quantitative data collection tool. The quantitative data was analysed by SPSS-version-27. FINDINGS: The qualitative analysis generated three key themes: Trigger, Execution, and Results, along with a thorough outline of lessons learned and opportunities for improvement. The Cronbach's Alpha reliability score was 92.8%. The percentage of the total average of agreement was 72.3%, and it appeared that 83.2% of the variance can be explained by the instrument (p<0.001). CONCLUSION: The current study generated a novel conceptual framework that can be leveraged by educational leadership and administration to reinforce their decisions and optimize their agility in terms of managing change. The study also introduces a data collection tool which captures the perception of higher education stakeholders regarding the way their respective institutions handle change. This tool proved to be reliable and valid in the context of the study.

Lessons Learned in Change Management in Deploying Novel Informatics Solutions: Experience Implementing a Point-of-Care Patient Photography System with Radiography.

We describe implementation of a point-of-care system for simultaneous acquisition of patient photographs along with portable radiographs at a large academic hospital. During the implementation process, we observed several technical challenges in the areas of (1) hardware-automatic triggering for photograph acquisition, camera hardware enclosure, networking, and system server hardware and (2) software-post-processing of photographs. Additionally, we also faced cultural challenges involving workflow issues, communication with technologists and users, and system maintenance. We describe our solutions to address these challenges. We anticipate that these experiences will provide useful insights into deploying and iterating new technologies in imaging informatics.

Improving service provision through change management.

The change agent role of the family physician is often a daunting task with very little guidance on how to approach change leadership in the current fellowship curriculum. This continuing medical education resource will utilise the theory of change and provide some guidance to taking on this task in the workplace. The approach can be used in healthcare, the community, academia, and research projects. The resource will outline a systematic approach to developing a logic-based strategy for outcomes. The process will be unpacked, the evaluation method outlined, and strategies for ensuring the sustainability of the changing culture will be discussed.

Change Management Strategies Toward Dismantling Race-Based Structural Barriers in Radiology.

Political momentum for antiracist policies grew out of the collective trauma highlighted during the COVID pandemic. This prompted discussions of root cause analyses for differences in health outcomes among historically underserved populations, including racial and ethnic minorities. Dismantling structural racism in medicine is an ambitious goal that requires widespread buy-in and transdisciplinary collaborations across institutions to establish systematic, rigorous approaches that enable sustainable change. Radiology is at the center of medical care and renewed focus on equity, diversity, and inclusion (EDI) provides an opportune window for radiologists to facilitate an open forum to address racialized medicine to catalyze real and lasting change. The framework of change management can help radiology practices create and maintain this change while minimizing disruption. This article discusses how change management principles can be leveraged by radiology to lead EDI interventions that will encourage honest dialogue, serve as a platform to support institutional EDI efforts, and lead to systemic change.

Using Kotter's Change Management Framework to Redesign Departmental GME Recruitment.

Background: In light of the COVID-19 pandemic, dramatic change in the graduate medical education (GME) trainee recruitment process was required. Kotter's 8-Step Change Model is a change management framework that has been successfully applied to a variety of GME initiatives but not for recruitment redesign. Objective: To implement major change in program recruitment during the COVID-19 pandemic while maintaining Match outcomes and a high-quality candidate experience. Methods: In 2020, we applied Kotter's 8 steps to implement major changes to program recruitment for a department of internal medicine including 15 GME programs (1 internal medicine residency and 14 subspecialty fellowships). We collected each program's Match fill rates and used Google Analytics to collect monthly website traffic for the year prior to our change process and the subsequent 2 years. Standardized post-interview survey questions were created, and these results were reviewed for descriptive analysis. Results: We successfully used Kotter's 8 steps to change recruitment to a virtual format. Program fill rates remained high after implementation. Website engagement improved with peak monthly page rates doubling over previous values. During the highest traffic month, the average time on site increased for 7 programs, while the bounce rate decreased by more than half for 10 programs. Candidate descriptive feedback was positive. Conclusions: The application of Kotter's 8 steps guided major changes to GME recruitment for 15 programs and was associated with maintained Match fill rates and increased website engagement.