Research question

RESEARCH STRATEGY

A. SIGNIFICANCE

A.1. COVID-19 created a profound disruption in healthcare: Covid-19 has upended U.S. health care. While most health systems rapidly activated emergency response plans and cancelled all non-urgent procedures and clinic visits, they experienced major negative financial impacts from the pandemic. The nonclinical workforce was often shifted to work-from-home and virtual communication with patients using telehealth exploded. As Slotkin et al. (2020) marveled, “the profound disruption in just 12 weeks of an industry, a century in the making, is astounding.” Health systems around the country have struggled to deal with critical aspects of care delivery, management, decision-making, workforce deployment, communications, and operations in response to the COVID-19 pandemic.

A.2. Lessons need to be learned, disseminated and implemented within a very short timeframe: It is imperative to analyze and evaluate the response of a variety of health systems to the pandemic and derive lessons learned, best practices, guidelines, tools, models, processes, and systems that can and should be disseminated and implemented now and in the future. Specifically, we will study the organizational response of the fourteen hospitals comprising the HCA Healthcare East Florida Division and will study the response at all levels – provider, unit, hospital, division and corporate – along with interactions among and between organizational levels. In accordance with this RFA (RFA-HS-20-003), we have organized our project as “rapid- cycle research” (AcademyHealth, 2020). That is, the proposed project is driven by the questions health system leaders have today; will be conducted in nine months; balances responsiveness with the most rigorous methods possible; and supports learning within a health system as well as broad dissemination of results and learnings to other health systems. It focuses on how decisions and innovations made during the response can best inform operations in the future, during times of normal operations and during public health emergencies.

A.3. There are large variations in health systems response effectiveness: While some health systems, such as HCA Healthcare, Kaiser Permanente, and Geisinger, have been very successful (Slotkin et al., 2020), others have not fared as well (Ramachandran et al., 2020) in their response to the pandemic. It is clear that a number of areas have been problematic for many health systems around the country including, but not limited to: inadequate preparedness, preparation and planning, improper patient transfers, insufficient isolation protocols, inadequate staff planning and training, ineffective communication systems and messaging, insufficient coordination and collaboration within and across systems, procurement planning gaps, incomplete staff protection policies and procedures, overreliance on government sources of equipment and assistance. Thus, a portfolio of health systems, with various degrees of success and differing characteristics need to be studied. We propose to focus on, and learn from, HCA Healthcare, the largest hospital and health system in the United States (Becker Hospital Review, 2019), with a focus on its East Florida division (see rationale below).

A.4. Despite existing guidelines, healthcare preparedness and response capabilities remain very limited: As depicted in Figure 1 (Joint Commission on Accreditation of Healthcare Organizations, 2002), an emergency management plan must address four phases of disaster management: mitigation, preparation, response, and recovery. The model portrays response as the biggest and most visible. It places mitigation and preparation at the base, portraying them both as the driving forces behind a successful response. Recovery is at the top because it is what remains after the response. Various government organizations have established guidelines, standards, or tools designed to help health care organizations manage operations during and after a disastrous event including the Centers for Medicare and Medicaid Services, the National Academy of Medicine, and the Office of the Assistant Secretary for Preparedness and Response. Despite these efforts, healthcare preparedness remains inadequate (Niska and Shimizu, 2011; Goodwin et al., 2016; Ramachandran et al., 2020). In a cross- sectional study of 45 hospitals in Los Angeles County, Kaji and Lewis (2006) found that disaster preparedness and surge capacity were limited by a failure to fully integrate interagency training and planning and a severely limited surge capacity. In a systematic review, Potter et al. (2010) studied the effectiveness of preparedness training materials and found that while topics cover leadership and command structure (18.4%), information and communications (14.1%), organizational systems (78.5%), and others (23.9%), their usefulness for trainers and educators was rated as low.

A.5. While strategies, plans, and guidelines are necessary, they are not sufficient: Keating-Duley (2005) emphasizes four major objectives each state must undertake to assure health care facility preparedness: (1)

Figure 1: Emergency Management

Develop strategies to maximize staffed beds; (2) Develop strategies to cope with the potential staffing shortages; (3) Develop strategies to deal with potential critical equipment shortages; and (4) Implement education, training, and communication strategies for health care workers and the public. While these “capacities” are necessary, health organizations need to build a culture of responsiveness, adaptability, learning, and agility and need to develop, implement and integrate congruent “capabilities” - actions, tools, models, processes, and systems - within the fabric of the organization. For this study, we developed a novel organizational change framework to comprehensively analyze which organizational factors turn capacities into capabilities that quickly enable performance and desirable outcomes in response to an exogenous unexpected external threat. Just as a culture of safety has been shown to be necessary to improve safety (Morello et al., 2013), a culture of responsiveness, adaptability and agility is deemed necessary in this research, and will be investigated.

A.6. We forged a unique affiliation with HCA Healthcare, the largest hospital system in the U.S. (Becker Hospital Review, 2019): With Nova Southeastern University’s (NSU) aggregate investments of over $1.5 billion

in health care, including the most recently accredited Medical School in the U.S., The NSU-HCA relationship is governed by legally-binding affiliation agreements that span the entire continuum of education and research, ensuring that the data sources are secure for project access and reliably available for project purposes. NSU is the largest private institution in the U.S. that meets the U.S. Department of Education’s criteria as a Hispanic- serving Institution. NSU is the largest independent, not-for profit, university in Florida and the Southeastern U.S. NSU will analyze the response of the 14 hospitals comprising the HCA East Florida Division (HCA EFD) as well as collaborate with HCA Healthcare Corporate and the HCA Research Institute (see enclosed letter of commitment/emails speaking to collaboration with HCA personnel). HCA EFD is the largest and most resourced Division of HCA and serves a large, diverse population within the South Florida market.

A.7. The proposed project focuses on a diverse population: The State of Florida has been experiencing dramatic population growth, especially the major tri-county, East coast markets of Palm Beach, Broward, and Miami-Dade Counties. Prior to COVID-19, Florida’s significant population growth reflected a growing business community, low unemployment rates, a broad scope of opportunities, and an influx of immigration from other states and nations. From 2010 to 2017, Florida’s population grew by 11.6%, versus only 2.4% in New York. One of the aspects of Florida that make it so unique is its diversity. Its residents include people from a wide variety of ethnic, racial, national, and religious backgrounds. The state attracts immigrants from other nations, particularly from Latin America. Florida has one of the largest African American populations in the country (including Afro- Caribbean) and has the second highest Latino population on the East Coast outside of New York state. The ethnic Asian population has grown rapidly, the majority are Filipinos, Vietnamese, and ethnic Chinese. The state has several federally recognized American Indian tribes, such as the Seminoles and Miccosukee. These data underscore the immense opportunity we have in South Florida to study health system response to the COVID- 19 pandemic in the context of unique populations of people, many of whom are underserved, understudied and vulnerable. A key aspect of an effective COVID-19 response on behalf of health systems in the State of Florida is cultural competence. Effective and efficient population management in this state requires that the response support cultural differences uniquely present in the diverse South Florida population.

A.8. Over twenty percent (20.5%) of the State of Florida population is age 65 years or older: Another dimension of population vulnerability in the State of Florida is its aging population. With 20.5% Floridians ages 65 and over, the state ranks second in the U.S. only to the State of Maine, which is nearly identical at 20.6% (Himes & Kilduff, 2019). Migration, both internal and international, has had a large impact on the distribution of older adults in Florida as has Florida’s attraction to older retirees. In the COVID-19 pandemic, older adults are at a significantly higher risk for critical illness and mortality, with 93.6% of all COVID-19 deaths in the State of Florida as of June 3, 2020 attributable to people age 55 years or older (CDC, 2020).

A.9. The response to the pandemic in Florida has been effective: As shown in Figure 2, according to Covid Act Now (2020), the current COVID risk level in Florida is medium. Despite dramatic predictions to the contrary, COVID in Florida is spreading in a slow and controlled fashion. In Florida, the infection rate is 1.07%. The positive test rate is 4.6%, and the ICU headroom used is 10%. On average, each person in Florida with COVID is infecting 1.07 other people, which means that COVID is still spreading in Florida, but in a slow and controlled fashion. COVID spread in Florida as of June 11, 2020 is shown in Figure 3. Figure 2: COVID Risk Level in FL

Florida has about 6,059 ICU beds. The State of Florida estimates that 48% are currently occupied by non-COVID patients. Of the remaining 3,151 ICU beds, Florida estimates 327 are occupied by COVID cases, or 10.4% of available beds, as of June 11, 2020 (Covid Act Now, 2020).

A.10. The proposed study will have a large impact: HCA East Florida Division has 14 hospitals, 12 surgery centers and 21 ER locations serving eight counties in Florida that in total account for over a third of the total population in the State. In 2019, The total number of patients treated by HCA East Florida amount to just under 20% of the total population in the eight counties. They also account for 27% of the Medicaid patients and have treated approximately 200,000 uninsured patients. Given the socio-demographic characteristics of the State of Florida population, this project will have a significant direct impact on a large, diverse, and vulnerable population, just through the HCA East Florida Division. In addition, dissemination of results to the national HCA Healthcare system and to other healthcare systems in the U.S. will result in an even larger impact.

B. INNOVATION

This RFA presents an unprecedented opportunity for systematically investigating issues such as workforce deployment, space reallocation, communications between settings, and how decisions affected patient and workforce experience and outcomes in the face of the COVID-19 pandemic. The proposed study is innovative in a number of important ways and has a number of unique distinguishing features (Table 1).

B.1. The study is designed to understand how decisions and innovations made during the response can best inform operations today and in the future, both during normal times and in public health emergencies.

B.2. We have partnered with HCA Healthcare, the largest hospital and health system in the United States (Becker Hospital Review, 2019).

B.3. The evaluation will incorporate considerations of both patient health and safety as well as employee health and safety as the study builds on the healthy organization model (Sainfort et al., 2001).

B.4. This project makes a novel contribution to organizational change theory: The framework proposed in this study adds a new perspective to the current state-of-the-science reflected in the organizational change literature. It will further our understanding of healthcare system preparation and response to significant external threats and disruptions of the magnitude of the COVID-19 pandemic.

B.5. This project will generate new knowledge, practices, tools, processes, models, systems to advance healthcare preparedness, response and outcomes in the face of pandemic and other crisis situations. Beyond the generation of practices and guidelines, though an innovative dissemination and implementation plan, this project will produce a suite of assessment and management tools (e.g., prediction, simulation, staffing allocation, resource allocation, process maps) as well as strategies regarding the role of organizational factors such as the importance of adopting and building a culture of organizational and individual responsiveness and agility. Many of the research products will be immediately available, while others will require additional research and development.

Figure 3: COVID Infection Rate in FL

Table 1: Distinguishing Features of this Proposal

C. APPROACH

C.1. Conceptual Framework

The literature on organizational change and organizational behavior is extremely large, precluding a comprehensive review. The purpose here is to select key models from the literature that address different types of change applicable to health system responsiveness to a major disruptor. Of particular interest are: 1) the organizational factors that drive change within organizations; 2) the factors that influence organizational response to changing environments, especially sudden, unexpected, threats; and 3) the factors that influence the impact of organizational response on outcomes. The goal, then, is to build a theory-based conceptual framework to guide the design and execution of the proposed research.

The conceptual framework derived for this research is shown in Figure 4. It incorporates selected theories of organizational change drawing primarily from the resource-based view of the firm (Miles and Snow, 1978; Barney, 1991), the organizational fitness model (Voelpel SC, et al., 2004), organizational learning and agility (Argyris and Schon, 1995; Jacko et al., 2002; Dyer and Ericksen, 2007), and the healthy organization model (Sainfort et al., 2001). Figure 4 depicts factors that are critical in considering the organizational response (B) to an exogenous shock (A) such as COVID-19 that leads to certain outcomes (C).

This research is being conducted by first conceptually developing and then empirically testing a set of hypotheses that predict interrelatedness between internal resource profiles and organizational responses. It blends two major areas of the strategic management ideology: 1) the influence of the external environment (D in Figure 4) on organizations; and 2) the influence of resources (E in Figure 4) on organizational response to exogenous shock and the external environment.

The resource-based view posits that an organization’s internal resources are a means of organizing processes and obtaining a competitive advantage (Barney, 1991). The resource-based view suggests that organizations must develop unique, firm-specific core competencies and capacities (F in Figure 4) that will enable them to do things differently, adapt to unexpected conditions, and achieve strategic goals that maximize desired outcomes. These capacities include work systems and processes put in place, the structure of the organization, its technologies and equipment, key capacities such as supply chains, logistics, and, most importantly, its human capital, the workforce, the leadership and the culture of the organization (Lawrence, Tworoger, Ruppel, 2014).

Heracleous and Barrett (2001) suggest that deep structures, persistent and stable processes and patterns that influence action, in organizations, shape the change process. Managers, or change agents, with extended knowledge of these deep structures are necessary in the enactment of change. Miles and Snow (1978) propose that an organization's strategic type will influence decisions regarding strategy, structure, and process. They developed a framework for classifying organizations as Defender, Prospector, Analyzer, and Reactor. This framework has been utilized to study response in the hospital industry (Meyer, Brooks, and Goes, 1982). These studies suggest that the strategic “type” of an organization will influence its reaction to regulatory change, technological change, and jolts from the environment. A common theme is that an organization's strategic “type” influences how it receives and perceives information about changes in its environment and therefore, how it

Figure 4: Conceptual Framework

responds to that information. Thus, the resource-based view suggests that resources greatly influence outcomes and organizational success.

However, our conceptual framework also posits that, while resources are critical, organizations are greater than their bundle of resources. Internal practices, knowledge, and managerial decisions about obtaining and utilizing resources may be stronger strategic factors influencing response to shifts in external environments.

The organizational fitness model refers to these as “capabilities” (G in Figure 4). Organizational fitness (Beer and Eisenstat, 2000; Beer and Nohria, 2000; McCarthy and Tan, 2000; Beer, 2003) is defined as an organization’s ability to adapt and survive in the ever-changing business environment, and is achieved through proactive reaction in the face of disruption, natural evolution, and purposeful change. Capabilities are defined as the actual ability of the organization to fully activate its capacities to achieve certain levels of organizational performance (H in Figure 4). Organizational capabilities include coordination, decision making, planning, communication, competence, commitment, creativity, capacity management and use, all of which correspond to redesigned and restructured organizational capacities, which in turn directly influence organizational performance. In studying healthcare systems, which are organizations that 1) require a very high level of knowledge, skills, and technology and 2) deal with very high levels of uncertainty and ambiguity in delivering healthcare services, these capabilities are paramount as is the ability of the organization to incessantly learn and transform. Hence, the feedback loop leading to organizational learning and agility (depicted as I in Figure 4). As pointed out by Prahalad and Hamel (1990) focusing on core organizational competencies creates unique, integrated systems that reinforce fit among the organization’s diverse production and technology skills—a systemic advantage with the ability to immediately respond to change.

The conceptual framework proposed for this study is aligned with the concept of healthy organization (Sainfort et al., 2001), which integrates Donabedian’s well-known structure-process-outcome quality measurement model (1981) with Murphy and Cooper’s human factors model of a “healthy work organization” (2000). It posits that balance between environmental, technological, organizational, and cultural factors is necessary to achieve optimal desired outcomes at the individual, team, and organizational levels. Congruent with stakeholder theory (Freeman, 1984; Phillips, 1997; Arganadona (1998), it also stresses the importance of ethics (Sims and Kramer, 2015) which is highly relevant in healthcare and a critical aspect of culture. More importantly for this particular project, it also emphasizes that both patients’ quality and safety outcomes AND healthcare workers’ work life quality and safety outcomes are intertwined goals and objectives of the organization and are critical to organizational effectiveness and sustained performance. Thus, we posit that outcomes of hospital organizational response to COVID-19 need to include both measures of patients AND healthcare workers outcomes.

C.2. Investigative Team and Expertise

As shown in Table 2, our research team is uniquely qualified to successfully perform this research. Three key personnel (Sainfort, Jacko and Vieweg) have each had continuous funding as PI or co-PI from Federal agencies (NIH, AHRQ, NSF, DOD) for over 25 years and bring tremendous research leadership experience to this project. They also routinely successfully collaborate together on research projects and scientific publications. They all recently joined NSU upon the creation of one of the newest medical schools in the nation and bring complementary expertise to this project. They are joined by talented faculty from the College of Business at NSU with extensive corporate experience in critical domains relevant to this project (Lawrence and Kramer). In addition, key senior personnel

Table 2: Research Team Expertise

at HCA Healthcare Corporate (Fromell) and HCA East Florida Division (Cornehls, Sakano and Whittaker) will lead and coordinate efforts within the HCA system. Finally, a consultant (Mervak) who served as former CFO for HCA Healthcare and currently serves as an adjunct professor at NSU, will assist and advise the research team.

C.3. Preliminary Studies

The PI (Sainfort) and other members of the investigative team (Jacko and Lawrence) have successfully led a number of organizational change studies in healthcare, including:

C.3.1. Radical Change in Primary Care Clinics: Sainfort and Moen (2011) implemented and studied an ambitious and comprehensive clinician-driven process of primary care practice redesign in all primary care clinics at Fairview Health Services in Minnesota. Fairview is one of the largest not-for-profit health care systems in Minnesota, with more than 19,000 employees working in seven hospitals, 38 primary care clinics and 34 specialty clinics throughout the state of Minnesota. Many of the methods proposed in this study were successfully employed in the Fairview project.

C.3.2. Implementation of Quality Improvement Methods into Local Public Health Departments: Riley and Sainfort (2009) studied how QI methods lead to organizational change in health departments in Minnesota.

C.3.3. Comprehensive IT Solution for Quality and Patient Safety: Under AHRQ grant UC1 HS015236, Sainfort (PI), Jacko (I), and their post-doctoral student (Edwards) studied and evaluated the implementation and impact of a suite of new Health Information Technologies on patient safety and quality in a large children’s hospital system in Atlanta. The research included organizational analysis and process mapping of two hospitals (Edwards et al., 2008a, Edwards et al., 2008b, Edwards et al., 2008c; Culler et al., 2009).

C.3.4. Facilitators and Barriers to Organizational Change: Under AHRQ grant R01-HS10246, Gustafson and Sainfort (co-PIs), examined facilitators and barriers to the implementation and adoption of computer-based health support systems in healthcare organizations. As part of the study, they developed and tested a novel decision theoretic model and practical tool to assess and predict the success of organizational change efforts (Gustafson, Sainfort et al. 2003). This is an 18-factor Bayesian model that estimates the probability of successful change and was empirically tested in a comprehensive study of 198 healthcare organizations undergoing organizational changes.

C.3.5. Quality Improvement in Nursing Homes: Under AHRQ grant R01-HS009746, Sainfort (PI) investigated the relationships between quality improvement strategies, organizational characteristics, job factors, and quality of care in 102 nursing homes in Wisconsin. As part of the study, Sainfort and his team conducted interviews, focus groups, observations and surveys (N=12,000) to assess nursing home employee quality of working life and its relationship to a) quality of care (using the resident assessment instrument [RAI] data); b) quality improvement transformational changes; and c) other organizational and structural changes (Sainfort et al., 2005).

C.3.6. Roadmap for Transformational Change in a Hospital Setting: Lawrence (co-Investigator) and her colleagues conducted a longitudinal study of how effective leadership and teamwork strategies can be employed during radical organizational change in a HCA hospital with the goal of developing models for organizational culture change that support better patient care (Lawrence et al., 2014, best paper at Decision Sciences Institute Conference, 2014).

C.4. Health System Partner and Patient Population

C.4.1. Health System Partner: Our hospital partner on this project is HCA Healthcare East Florida Division, which serves the South Florida region as its largest healthcare system, with 18,995 employees. Composed of 14 hospitals spanning eight counites including Miami-Dade, Broward, Palm Beach Counties, and the Treasure Coast, HCA East Florida includes 21 emergency departments and 12 ambulatory surgery centers, five Care Now urgent care centers, three trauma centers, one burn center, one regional laboratory, nine psychiatric programs, 31 teaching programs and 90 physician practice locations. HCA Healthcare is a collaborative healthcare network that extends a knowledge pipeline into every one of its facilities, creating one of the country’s most connected medical environments. HCA produces medical data from approximately 35

Figure 5: HCA EFD Catchment Area

million patient encounters a year. The catchment area for HCA East Florida is Shown in Figure 5. It covers eight counties in the State of Florida. HCA Healthcare is NSU’s preferred clinical partner. HCA Healthcare is constructing a new hospital on the campus of NSU in Davie, Florida. The hospital represents HCA’s single largest investment at $317 million. HCA East Florida already operates a free-standing emergency room facility on the NSU campus.

HCA Healthcare nationally fosters a large, diverse, and inclusive workforce of approximately 280,000 employees, of whom 72% are female, and 47,000 active affiliated physicians (HCA Healthcare, 2020). In addition to gender diversity, as shown in Figure 6, the HCA workforce is very diverse from a race and ethnicity perspective as well as from an age perspective. Thus, the workforce demographics will ensure excellent representation of both women and minority populations among the key informants who will be interviewed during this project.

Nationally, with 184 hospitals, more than 1300 physician practices, 104 freestanding emergency rooms, 230 telehealth facilities and 170

urgent care clinics, in 2019, HCA Healthcare accounted for about 35 million patient encounters and 9.2 million emergency visits (HCA Healthcare, 2020).

As a learning health system, HCA Healthcare collects and analyzes data from our approximately 35 million annual patient encounters to develop technologies and best practices that improve patient care in their facilities.

Three of the investigators on this proposal (Sainfort, Jacko and Vieweg) have been granted data access privileges and will work closely with Yuri Sakano, Division Director, of Nursing Analytics to mine relevant data systems to assist with the project.

C.4.2.: Patient Population: According to the Florida Department of Health (2020), the eight counties covered by HCA East Florida include the three most populous counties in Florida – the tri-county areas of Miami-Dade, Broward and Palm Beach counties - and in total represent more than a third of the total population of the State of Florida with a total population in 2018 of 6.8 million individuals. The tri-county area alone accounts for 88.9% of the 6.8 million people. In 2019, HCA East Florida treated over 1.3 million patients, including 280,000 Medicaid patients and 178,000 uninsured patients. HCA East Florida has a 27% Medicaid market share and serves a highly diverse and vulnerable population (HCA Healthcare East Florida Division, 2019). Indeed, in terms of race

Figure 6: HCA Workforce 2019

Table 3: HCA Catchment Area Race and Ethnicity Table 4: Other Social Determinants

and ethnicity, as shown in Table 3, across the eight counties covered by HCA East Florida, 42% of the population is Hispanic, 19% is non-Hispanic Black, 35% is non-Hispanic White and 4% is other. Table 3 also shows an uneven distribution of race and ethnicity across the eight counites with Miami-Dade having the largest percentage of Hispanics (68.6%) while Broward has the largest percentage of non-Hispanic Blacks (28.2%).

Table 4 further demonstrates that the population in the eight counties covered by HCA East Florida has specific vulnerabilities. The percentage of adults over the age of 65 years is 19% overall and varies from a low 15.6% in Miami-Dade County to a high of 34.8% in Highlands County. The percentage of individuals below the 185% poverty level is 34% overall and varies from 29.1% in Palm Beach County to 49% in Okeechobee County. The percentage of individuals without health insurance is 16% overall and varies from 11.5% in Martin County to 18.1% in Miami-Dade County. Finally, the rate of hospitalization per 100,000 is 12,373 overall and varies from 11,628 in Miami-Dade County to a high of 18,862 in Okeechobee County.

C.5. Methods

The project has the following three specific aims:

Aim 1. Conduct an in-depth retrospective and prospective organizational analysis to fully characterize the

response to the COVID-19 crisis developed and implemented by HCA EFD along with HCA Corporate

in terms of “practices”, including all facilitators, barriers, innovations, activities, plans, interventions,

processes, systems, models, and tools comprising, or affecting, the response.

Aim 2. Evaluate and characterize outcomes – perceived and actual – resulting from the organizational response

on a) the population of patients, with a particular focus on the elderly, b) the healthcare workforce, and

c) the organizational effectiveness, in order to determine, bundle, and prioritize best practices that can

be implemented in the new normal and/or the future, to optimize response to exogenous shocks.

Aim 3. Develop, initiate and implement an innovative multi-faceted dissemination and implementation (D&I)

plan that will optimize scalable and sustainable integration into existing practices. The D&I plan will not

only be comprised of the results of this proposed project but will also constitute a continuous systematic

review and integration of research performed by other grantees and the research community at large.

C.5.1. Aim 1 – Organizational analysis to characterize HCA EFD response to the COVID-19 crisis: HCA Healthcare is a large organization with a well-defined chain of command and matrix organizational structure. Therefore, the organizational analysis will be conducted at all levels – healthcare worker, unit, hospital, division and corporate, as shown in Figure 7. To achieve Aim 1, mixed methods to understand organizational response will be implemented including retrospective qualitative and quantitative methods: semi-structured interviews, focus groups, documents analysis, process analysis and mapping. The data collection efforts are designed to understand the breadth and depth of challenges and enablers to respond to the COVID-19 pandemic. Our strategy will be exploratory and sequentially refined (Devers, 1999), that is, early findings from contextual inquiry, initial interviews, followed by short follow-up questions will inform revision of interview guides and themes for focus groups. As explained in section B. Innovation, we have used mixed methodologies successfully in previous studies. Researchers with organizational change, process engineering, and clinical backgrounds will team up in qualitative data collection.

C.5.1.i. Methods – Environmental Scans. Throughout the duration of the project, we continue to perform environmental scans of the literature, beyond our current knowledge of the fields, to further guide design of interview/focus group questions. We will cover peer reviewed and other “gray” literature (e.g., governmental, professional society) related to hospital preparedness, organizational response, and crisis management.

C.5.1.ii. Methods – In‐depth interviews: We will conduct interviews with key informants among the leadership at the hospital, division and corporate levels. We will include approaches developed in Naturalistic Decision Making (NDM) to understand expertise in complex, real‐world decision making (Klein, 2008). One method developed in NDM research is cognitive task analysis, which uses “tough cases” in interviews to capture how people succeed in spite of significant challenges, and to focus on critical cues, strategies, exceptions, and practical solutions (Crandall et al., 2006; Militello and Hutton, 1998). NDM provides methods to capture the attributes of expertise that are difficult to articulate and often invisible (i.e., mental models, goals, effective motivators) but key to resilience and agility. As shown in Table 5, there are a large number of potential key informants. We plan to recruit all key informants at the corporate and division level and approximately 3 to 5 key informants at each of

Figure 7: Multilevel Analysis

the 14 hospitals. We collected all organizational charts and these individuals will be nominated by the HCA EFD leadership team on this project in conjunction with the CEO and/or COO of each hospital and the research team.

C.5.1.iii. Methods – Focus groups: We will recruit approximately 48 healthcare workers (physicians, nurses, and respiratory therapists – see Table 5) and conduct 4 focus groups at the healthcare worker level. In addition, we will recruit 2 to 3 individuals at the Unit and Hospital levels (see Table 5) from each of the 14 hospitals to conduct 3 additional focus groups. Focus groups will be used to incorporate group activities such as nominal group techniques (Van de Ven and Delbecq, 1972) to prioritize and quality functional deployment (Chaplin et al., 1999) techniques to drill down key factors of productive interactions between levels of organizations. Whenever possible, we will form mixed groups of professionals as opposed to homogeneous professional groups. Research team members with different backgrounds, led by qualitative researchers, will facilitate focus groups.

C.5.1.iv. Methods – Contextual Inquiry: We will, COVID-19 regulations permitting, organize site visits at the hospitals and division level to collect additional information and perform direct observations. Contextual inquiry involves researchers asking questions to the participants while conducting observations for clarification and soliciting more information based on what is observed. Direct observations, sometimes as part of contextual inquiry, are an essential organizational analysis method to look at contextual and other performance shaping factors and to understand how work is actually carried out (Catchpole et al., 2017).

C.5.1.v. Methods – Process Flow Analysis and Process Mapping: Following Shelton et al (2013), we will employ process analysis and process mapping to fully understand the response from the 14 hospitals, division and corporate headquarters to the COVID-19 crisis in East Florida. Process maps (see Figure 8) can reveal the sequence of steps required to generate a specific product or outcome. In this context, we will use them to show the series of activities required to successfully develop and implement elements of the organizational response. Of particular importance is to identify activities that are (1) critical to the success of the system or process, (2) most vulnerable to failure, (3) relevant across a wide range of threat scenarios, (4) readily observable, and (5) under the control or influence of the entity being analyzed.

C.5.1.vi. Methods – Document Analysis: We will collect and analyze all minutes, reports, plans, , tools related to the HCA organizational response to COVID-19 made available to the team by Corporate and the Division.

C.5.1.vii. Methods – Elements/Factors to Be Studied: Questions for semi-structured interviews and focus groups, as well as factors to be uncovered with other methods will be guided by the elements described in the conceptual framework (Figure 4). To ensure completeness, existing lists of questions and topics to be investigated will also be derived from recent reports (AcademyHealth 2020, National Academies, 2020) as well as the list of core elements by Cosgrove et al. (2007) in a report to AHRQ. Communication and teamwork play an important role in the response to COVID-19 at HCA EFD. We will use the TeamSTEPPS™ toolkit (AHRQ, 2019). to guide the inquiry. Sainfort successfully used it to document and team performance in a previous project (Riley et al., 2009).

C.5.1.viii. Methods – Analysis: We will begin analyzing the data during the collection of data and continue throughout the first six months and beyond. All the interviews will be audio/video recorded and transcribed to

Table 5: Aim 1 Key Informants and Methods

Figure 8: Key Elements in Process Mapping

ensure accurate data collection. All qualitative data, including field observations and the transcriptions from the focus groups and interviews, will be entered into Alas.ti, a qualitative data analysis software program, to support the analysis and organization of qualitative data. The mixed methods analysis will merge the qualitative findings by matching qualitatively elicited themes from the observations and interviews. Specifically, we will analyze using a consensual qualitative research approach with codes derived inductively. Any disagreements in coding will be discussed until consensus is reached. Using the constant comparative method, we will formulate the results in terms of a comprehensive list of “organizational practices” – facilitators, barriers, innovations, activities, plans, interventions, processes, systems, models, and tools – and full descriptions of each that, together, comprise or affect, the response. When appropriate, practices will be bundled into subset of distinguishable plans/activities.

C.5.1.ix. Social Distancing Constraints: By the time of notice of award, we anticipate that all aspects of these studies will be feasible assuming COVID-19 guidelines will allow researchers to be physically on-site, observing and interacting with key informants. As a contingency plan, all studies in all three Aims, at the exception of contextual inquiry which requires direct observation, will be successfully (and efficiently) implemented using video conferencing tools such as WebEx (used by HCA) and/or Zoom (used by NSU). We found that the proper use of these technologies have resulted in efficient interviews and effective group discussions in our preliminary interactions with our health system partner. These technologies also provide convenient and transparent recording capabilities.

C.5.2. Aim 2 – Evaluate and characterize outcomes – perceived and actual: The goal of Aim 2 is to evaluate and characterize outcomes – perceived and actual – resulting from the organizational response(s) on a) the population of patients, with a particular focus on the elderly, b) the healthcare workforce, and c) the organizational effectiveness, in order to determine, bundle, and prioritize best practices that can be implemented in the new normal and/or the future, to optimize response to exogenous shocks.

C.5.2.i. Methods – Patient Clinical Data: Data systems from HCA EFD will be queried to perform a pre-post analysis of clinical patient data to characterize potential changes from pre-COVID-19 to current date. HCA has a comprehensive electronic medical record system complemented by in-house data that provides a complete picture of quality of care, morbidity, mortality, safety, recovery for all COVID-19 patients that can be benchmarked against all other hospitals in the HCA system as well as against national benchmarks. Sub-analyses will include analyzing patient data by age and race/ethnicity. Data will be analyzed over time as well as across hospitals and contrasted to the relative number of COVID-19 patients seen in the different hospitals. We expect that a majority of affected patients will be elderly patients, as has been the case in the State of Florida in general, especially regarding mortality rates.

C.5.2.ii. Methods – Complementary Anecdotal Patient Clinical Data: In addition, HCA EFD has kept a comprehensive log of anecdotal data that can be analyzed to complement clinical data. Qualitative analysis will be performed to further document the impact of the organizational response on patients.

C.5.2.iii. Methods – Patient Satisfaction and Employee Satisfaction Data: Similarly, Data systems from HCA EFD will be queried to perform a pre-post analysis of patient satisfaction data and employee satisfaction data to further characterize potential changes pre-COVID-19 to current date. Hospitals in the system, with varying levels of COVID-19 patients, will be compared and contrasted.

C.5.2.iv. Methods – Operations Daily Logs: HCA EFD kept daily logs of all operational functions including supply chain management, utilization, logistics, vertical and horizontal communications, bed management and utilization. All data will be analyzed to characterize the success of the response from an operational perspective.

C.5.2.v. Methods – Human Resources Management: HCA EFD kept daily logs of training of all critical healthcare workers including nurses, respiratory therapists and other clinicians, transfers of healthcare workers across the system, recruitment, deployment and assignment changes, and handoffs. The data will be analyzed and evaluated to produce aggregate measures of the effectiveness of these operations.

Table 6: Sample Barriers

C.5.2.vi. Methods – Evaluation of Organizational Practices identified in Aim 1: We will use the nominal group technique (NGT, Van de Ven and Delbecq, 1972) with three groups of key informants (see Table 5) to rate the effectiveness of all organizational practices identified in Aim 1. We will use two groups of healthcare workers (2 or 3 individuals selected from each of the 14 hospitals) and one group of leaders at the unit and division level. In addition, a third group of healthcare workers will be used to assess potential barriers and obstacles perceived and how well they were mitigated. We will build on Timen et al. (2010) who identified 30 barriers among healthcare workers who had been actively involved in previous crisis situations due to infectious outbreaks. Table 6 shows a sample of the barriers uncovered. We will formulate a similar list for this particular step and employ the NGT technique to obtain consensus ratings.

C.5.2.vii. Analysis of Data: Table 7 depicts a sample of the outcomes and effectiveness measures as well as the sources. All data will be further analyzed and summarized so as to fully depict the extent of the multidimensional success of the organizational response. It will be further disaggregated with the goal of assessing the relative effectiveness of each of the organizational practices uncovered in Aim 1.

C.5.3. Aim 3 –Implement an innovative multi-faceted dissemination and implementation (D&I) plan: The goal of Aim 3 is to develop, initiate and implement an innovative multi- faceted dissemination and implementation (D&I) plan that will optimize scalable and sustainable integration into existing practices. The D&I plan will not only be comprised of the results of this proposed project but will also constitute a continuous systematic review and integration of research performed by other grantees and the research community at large. There is a significant body of literature on best dissemination and implementation strategies (Yuan, 2010; AHRQ, 2012; AHRQ, 2017; Ordoñez and Oliver, 2017; PCORI, 2012). At the simplest level, dissemination is best described as the delivery and receipt of a message, the engagement of an individual in a process, or the transfer of a process or product (Ordoñez and Oliver, 2017). Dissemination should serve three broadly different purposes: awareness, understanding, and action. Indeed, effective dissemination of a knowledge product will most likely require that it satisfies all three in turn: utilization is the goal. Hence, the dissemination process should be interactive, allowing feedback from receiving audiences according to a cyclical model of communications flow as the one shown in Figure 10.

C.5.3.i. Traditional Approaches: Our findings will be disseminated to a broad audience including: 1) frontline clinicians, 2) clinical leadership and managerial decision makers 3) health systems, and 4) policy decision makers at the local, network, and national levels. We will also submit manuscripts to different peer- reviewed medical, informatics, patient safety, public health, and health services journals and present at regional and national conferences. We will leverage our professional membership and participation on national committees to disseminate our work to experts in the field. We will also plan to write blog posts placed on Nova Southeastern University digital outlets.

C.5.3.ii. Integration into Existing Practices, Scalability, and Sustainability: Beyond traditional channels for sharing research results – publications, conferences, design and maintenance of a dedicated web site where information, instrumentation, models, tools, approaches, and data about the study will be posted – designing materials to support what we know to be the most successful mechanism for diffusing knowledge and ensuring implementation success: peer-to-peer, physician-to-physician, educational experiences and programs. One of the most effective channels for adoption of innovation is peer-to-peer education. The KC Patel College of Allopathic Medicine will develop and offer a series of innovative peer-to-peer educational workshops and programs (generating CME units) designed to disseminate successful interventions uncovered and tested in this research. While we will start offering these

Figure 10: Dissemination Elements

Table 7: Sample Outcomes and Effectiveness Measures and Sources

programs in South Florida, we will quickly expand nationally, working with partners. As part of Aim 3, we will develop and create usable guidelines, roadmaps, process flow maps, simulation tools, and other toolkits that can be used by healthcare systems.

C.5.3.iii. Development of a Virtual Consortium for Dissemination: We will not only report results but actually develop assessment tools, training materials, methodologies that can be shared and/or taught. We will work with AHRQ staff to contact all other grantees and their health systems partners, establish a virtual consortium, add their ideas to the mix and bring bundles of practices to bear. The virtual consortium will start during the grant work and will continue to operate after funding. We will continue to review published studies of best practices and lessons learned. We will apply for a conference grant from AHRQ and hold a conference with other grantees. We will publish all best papers as a special issue on best practices in HCA Healthcare Journal of Medicine (Jacko, who is serving on the Editorial Board, will serve as a special editor).

D. HUMAN SUBJECTS INVOLVEMENT, PROTECTION AND PRIORITY POPULATIONS

We will obtain IRB approval to conduct this project. There are no major risks associated with participating in this study and no immediate potential benefits for participants. For Aims 1 and 2, recruitment is voluntary. We will obtain informed consent from key informants. Clinical and organizational data will be completely de-identified and processed by HCA data analytics group. As detailed in the proposal, the South Florida population is highly diverse and vulnerable and thus we will be evaluating the response of a large health system to optimize delivery of health care for priority populations including low-income groups, minority groups, women and the elderly.

E. POTENTIAL PITFALLS AND ALTERNATE STRATEGIES

While we have significant experience with similar projects and methods, we have developed mitigation strategies to prepare for any potential barriers. First, based on our prior experience, we anticipate encountering some difficulties in recruiting providers/facility staff and patients and might encounter some delays. However, having dedicated site champions and site research associates will allow us to overcome these barriers. Second, because of the uniqueness of HCA Healthcare as a partner, some results may not be fully generalizable. However, as part of Aim 1, we will ensure that HCA-specific factors are identified and the research team will derive and articulate more generic alternatives or variations of the organizational practices that can be applicable to other systems, or note that some of these practices my need to be modified to suit a different setting.

F. TIMELINE The timeline is shown in Figure 11. Upon notice of award, all participants will process data use agreements, institutional review board approval, and intellectual property agreements. Hiring logistics will include postdocs. Internal staff are available to ensure timely hiring and onboarding of any additional needed personnel.

Figure 11: Overall Project Timeline