Engineering Resilient Community Pharmacies: Exploring an Integrative Approach to Medication Safety

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Chui, Maria E. Berbakov, Aaron M. Gilson, Jamie A. Stone, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3876998/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction : The increase of people with complex chronic health conditions is stressing the U.S. healthcare delivery system. Community pharmacies play a role in ensuring patients’ safe medication use for chronic care management, but their efforts are undermined by volatile work demands and other system barriers. Methods : This study seeks to conceptualize, design, implement, and test a MedSafeMap TM for the community pharmacy setting to enhance pharmacists’ and technicians’ abilities to either avoid, or to quickly identify and recover from, medication errors before patient safety is endangered. Discussion : The MedSafeMap is an innovative approach that will be used by pharmacists and pharmacy technicians to better navigate the complex tasks in the pharmacy, and to facilitate communication with both patients and clinicians, while safely providing medications to complex patients with chronic health conditions. Medication Safety Community Pharmacies Provider Status Pharmacy Intervention Participatory Design Stakeholder Groups Resilience Safety I/Safety II Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction Over 100 million Americans have multiple chronic conditions[ 1 ] that contribute to more than one million adverse drug events (ADEs) annually, prompting four million people to seek medical care and costing the U.S. healthcare system over $ 8 billion per year.[ 2 , 3 ] Healthcare spending for patients with multiple chronic conditions is up to 20 times higher than for patients with no chronic conditions. That is, Americans with five or more chronic conditions comprise 12% of the population but 41% of total healthcare spending, averaging 20 physician visits per year and using up to 50 times more prescription medications.[ 1 ] Challenges with managing multiple chronic conditions has a direct impact on healthcare utilization with such patients representing a quarter of all hospital admissions annually, with a third of all patients having at least one emergency department visit every year.[ 1 ] Despite these health consequences, efforts to improve medication safety for complex patients in outpatient settings have not been allocated the appropriate resources to be effective. Community pharmacists are recognized as the champions of medication safety, not only through dispensing tasks but also by their expanding role in chronic care management (CCM).[ 4 ] CCM can include managing health problems and goals, medications, other providers, and community services that patients have and need. In many states, CCM also encompasses ordering and interpreting tests for chronic conditions, such as diabetes,[ 4 ] through collaborative practice agreements with providers, and ensuring patients receive appropriate screenings and immunizations. Such expanded practice was facilitated by the COVID-19 pandemic due to pharmacists being one of the few healthcare professionals providing face-to-face care and assuming clinical responsibilities when primary care physicians and nurses were managing COVID-19 emergencies.[ 5 ] Further, community pharmacists play a vital role in medically underserved communities,[ 6 ] such as in locations with too few primary care providers, high poverty or a high elderly population. Patients in these areas face difficulty or delays in getting basic health care because of long travel distances to providers, long wait times for appointments, or no providers who can serve uninsured or underinsured patients. As a result, pharmacists are considered accessible primary care practitioners, seeing patients five to eight times more frequently than do primary care physicians.[ 7 ] Numerous studies have demonstrated the ability of pharmacists to address medication non-adherence,[ 8 ] support naloxone provision and opioid safety counseling,[ 9 ] provide pain management and palliative care,[ 10 ] improve diabetes and cardiovascular outcomes,[ 11 ] and improve vaccination rates in medically underserved communities.[ 12 , 13 ] However, the abilities of community pharmacists to fill this gap are constrained by a work system that is unsustainable and essentially broken.[ 14 ] Pharmacies adhere to product-based reimbursement contracts with pharmacy benefit managers, incentivizing pharmacy staff to fill more prescriptions. As a result, for over a decade, pharmacists have reported high workload and burnout, with opaque corporate performance metrics based on prescription volume and customer service,[ 14 ] rather than on safety or clinical outcomes. COVID-19 exacerbated pharmacists’ workload strain by adding testing and vaccinations to a system that is chronically understaffed and stretched beyond capacity. With pharmacist burnout rates at an all-time high, a call for action to improve pharmacist work systems is critical to prevent a complete collapse in America’s pharmacy system. Pharmacists across the United States have been executing a series of walkouts since September 2023 to improve harsh-working conditions and preventable errors in care.[ 15 ] In Walgreens alone, 600 employees across 20 stores have participated in walkouts, resulting in multi-day disruptions to workflow and patient care.[ 15 ] The purpose of these walkouts is to shed light on the need for a solution to improve the working conditions of pharmacy staff. Juxtaposed to this era of pharmacists’ unmanaged workload, there is a push for them to do more, as evidenced by the introduction of “provider status”.[ 16 ] Provider status will allow pharmacists who provide services such as CCM, comprehensive medication management, and immunizations to receive reimbursement for such clinical services, in addition to product-based dispensing services.[ 17 ] This provides a timely opportunity for pharmacists to envision innovative designs to improve medication safety for their patients. To reimagine community pharmacies as an accessible destination for CCM, we must recognize the increased complexity of the community pharmacy work system. Similar to the increase in pharmacy staff responsibility related to the COVID-19 response, adding additional clinical services with the addition of reimbursement has potential implications for the quality and safety of pharmacist education, business practices, and dispensing. Opening up avenues for reimbursement that is not product based allows for stronger sustainability of expanded services and greater impact in their patient care practices, which can potentially fill a critical gap in Wisconsin, where two-thirds of its counties are medically underserved.[ 12 , 13 ] This opportunity to adopt new services and create coordinated care models can present a significant medication safety challenge. Community pharmacists’ heroic response to COVID-19 demands created work systems that increased stress and negatively impacted their ability to ensure safe use of medications they dispense.[ 18 ] Pharmacist provider status can lead to sustainable and collaborative programs that holistically address complex patients’ chronic care conditions. However, doing so without prospectively considering and testing for unintended consequences may negatively transform the community pharmacy work system, threatening the very medication safety strategies on which pharmacists have come to rely. The consequence of this reality is synergistic: high workload demands contribute to medication errors and ADEs, leading to pharmacists experiencing “learned helplessness” and lack of resiliency (or the ability to adapt to unpredictable work situations) in the face of these ADEs.[ 19 – 22 ] Approaches to Medication Safety Many medication safety studies strive for “zero harm”[ 23 – 25 ] by focusing on “what went wrong” in the face of undesired outcomes, referred to as a Safety-I approach.[ 26 ] The traditional harm-reduction approach has been to conduct root cause analyses of errors and understand the contributing factors that led to the error, in order to reduce their incidence or mitigate their harm. A number of strategies have been encouraged based on this approach, including those developed and tested in our previous studies,[ 27 , 28 ] but the end result is frequently more constraints in a complex system that limits workers’ ability to adapt. Such strategies end up limiting the capacity to adapt to practice demands and make the system more brittle, which can unintentionally lead to other medication safety hazards. Further, stacking isolated interventions does not lead to fundamental changes to the approach to medication safety. It is not surprising that little progress on substantive improvement has occurred in medication safety in the outpatient community pharmacy setting.[ 29 ] Medication safety must be considered in a new way that encompasses Safety-II, the “what went right” approach. Safety-II[ 30 ] is based on resilience engineering, which focuses on understanding how resilient performance is achieved – creating a work system that will attend to unexpected threats while also responding to opportunities.[ 31 ] Instead of framing safety as a linear failure-based model, we need to broaden the scope of inquiry to recognize the complexity and inherent variability in modern systems such as community pharmacies. Further, we need to shift beyond an exclusive consideration of ADEs and failures to also understand and strengthen a work system’s abilities to continuously create safety in everyday practice.[ 32 ] This goal is achieved by focusing on the abilities of a work system to: absorb significant stress before a disruption impacts safety, return to normal operations as quickly as possible and, importantly, adapt to undesirable situations. A system with adaptive capacity can anticipate disruptions and reorganize workflows using alternative paths to maintain successful work and minimize disruptions.[ 33 ] An example of Safety-I and Safety-II approaches can be found in Table 1 . Table 1 Examples of Safety-I and safety-II Approaches Safety-I Example Safety-II Example Checklists can decrease risk by imposing a structured process, but may be counterproductive When a checklist restricts an unexpected situation • A checklist can be completed by rote, rather than thoughtfully • A checklist may install a false sense of security when there is an assumption that all important items are contained in the checklist • Current conditions may be different from the conditions under which the checklist was conceived • The ability for workers to adapt to new conditions is lost • Workers double-check facts against each other • Workers are open and honest about explaining why they wish to deviate from the checklist • There is a healthy skepticism about deviating from the checklist • Workers ask for constructive criticism, ensuring that they are taking the best possible novel approach • Workers embrace team members from other work systems for their “outside the box” thinking The Patient Safety Learning Laboratory: ENRICH Despite numerous calls, there has not been a systematic engineering approach towards outpatient medication safety within community pharmacies. Previous PSLLs have evaluated the physical environment, socio-technological factors, and clinical workflow within inpatient and clinical settings but not within the outpatient community pharmacy settings.[ 34 ] This project, informed by resilience engineering, will address the challenges common in community pharmacies to achieve safe medication use in community-dwelling complex patients with multiple chronic conditions. The goal is to evolve from Safety-I approach to a combined Safety-I and Safety-II approach. The resulting outcome, the Engineering Resilient Community Pharmacies (ENRICH) Patient Safety Learning Laboratory (PSLL), is expected to gain knowledge of strategies for building resilience capacity in community pharmacy work systems in conducting CCM. PSLLs encompass a systematic engineering approach to allow cross-disciplinary professionals to evaluate clinical processes and approaches towards improvements in patient safety.[ 34 ] Our long-term goal is to position the ENRICH PSLL as the premier center for medication and patient safety and CCM in community pharmacies. Despite our prior work, a current gap exists in the systematic application and evaluation of human factors and health systems engineering approaches to improve medication safety and staff work life in community pharmacies. Our PSLL, which is led by experts in human factors and health systems engineering, represents a foundational step towards the creation of a center to promote and normalize a Safety-I/Safety-II approach in pharmacy systems research. Our PSLL will include a focus on the use of the principles of dissemination and implementation research to enhance the potential for sustainability of improvements resulting from patient safety innovations. In addition, this PSLL is designed to generate ideas for future research projects and examine the implications and outcomes related to pharmacist “provider status,” which can serve to expand CCM to support complex patients living in medically underserved areas. The PSLL resulting from this study represents the beginning of a new paradigm, unprecedented in the pharmacy setting, for improving medication safety for community-dwelling patients with complex chronic disease. Methods & Design The methods used for this project have demonstrated success with other healthcare practitioners and in other patient safety studies.[ 27 , 28 ] The Concepts for Applying Resilience Engineering (CARE) model guides our data collection, analysis, and interpretation (Fig. 1 ). Resilience is the ability for the community pharmacy work system to adjust its functioning prior to, during, and following sentinel or unexpected events, and thereby sustain operations under both expected and unexpected conditions.[ 35 ] It assumes that variability in the environment creates the need for adjustment. Work as Imagined (WAI) is conceptualized as the intended, or imagined, alignment between demands of the system (prescription volume, patient acuity) and the capacity to meet those demands. Demand and capacity can never completely align because of the complex nature of the system – there will always be unforeseen demands that require workers to adjust in situ. In addition, workers do not simply comply with protocol but naturally adapt and innovate as part of taking control over their environment. In the CARE model, Work as Done (WAD) refers to the adjustments and the natural variability in how tasks are conducted. Predicting acceptable (what goes right) and unacceptable (what goes wrong) outcomes depends on an understanding of WAD in different demand and capacity circumstances. In this project, we will be using the concepts of WAI and WAD to identify the gap in how pharmacy staff plan their approaches to patient care and how they are able to actually fulfill their responsibilities. Since resilience also applies to the organizational level, and to adaptations in complex systems, it is essential to ensure that characteristics and adaptations of the entire work system are captured. To operationalize the discrete facets of the work system, we have used Systems Engineering Initiative for Patient Safety (SEIPS) 2.0, a human-factors engineering model to improve patient outcomes (Fig. 2 ). The SEIPS model has framed the design and analysis of many safety studies, including research we conducted in community pharmacies.[ 28 , 36 – 38 ] The CARE and SEIPS models work well in tandem because both models contain feedback loops and account for the interconnectedness of work system components. In Fig. 2 , “professional work” references both pharmacists and technicians. Patient work includes the work of the patient and their caregiver, which is essential to CCM. Study Sites To ensure a complete understanding of the problems and implementation strategies of varied community pharmacy work systems, we will partner with three pharmacy organizations. 1. Advocate Health is the 10th largest non-for-profit, integrated health system in the U.S. with 70 community pharmacies that are geographically dispersed throughout urban and rural Wisconsin and Illinois. 2. UW Health is the integrated health system of the University of Wisconsin – Madison, with twelve outpatient pharmacies. 3. Boscobel and Center Pharmacies are located in rural Southwest Wisconsin and are independently owned. Within each of these organizations, two pharmacies will participate that serve ethnically diverse populations and people in medically underserved areas that have high area deprivation indices based on income, education, employment, and housing quality, for a total of six pharmacy sites. In addition, all pharmacies will have at least read-only access to the electronic health records of their patients, which may serve as a tool to facilitate CCM. We will also partner with Fitchburg Family Pharmacy to conduct in-situ simulations, in which we will use simulated complex patient scenarios in a pharmacy itself rather than in training facilities, for the design and development phases (Aim 2) of the project. Fitchburg Family Pharmacy is a medium-sized urban independent pharmacy that provides CCM to a diverse patient population. Project Aims Table 2 describes our project structure: starting with problem analysis (Aim 1), continuing with design and development (Aim 2), which will lead to implementation and evaluation (Aim 3). An expert advisory board, comprised of transdisciplinary stakeholders, will be formed to provide us with high level consultation and content expertise for each of the three project aims. This board includes patients, caregivers, a pharmacy technician researcher, a pharmacy owner, primary care physicians, managers of independent, local, and chain pharmacies, and leaders of pharmacy and medical societies in Wisconsin. Table 2 Project Structure Guided by the AHRQ RFA 5-Step Methodology 5 Step Methodology Problem Analysis Design Development Implementation Evaluation Aims 1: Identify and Prioritize 2: Prototype and Simulate 3: Pilot and Evaluate Methods • Observations & interviews • Information flow diagraming • Artifact analysis • Participatory design • Simulation • Time motion • Pre/post evaluation • Expert evaluation • Surveys and interviews Outputs • Resilience narratives • Functional Resilience Analysis Method diagrams • Prototypes • Ideal interactions • Detailed design specifications • Impact of prototypes on process & outcomes • Tools to assess capacity for resilience • Implementation guide Aim 1: Identify and Define Design Requirements To develop effective and sustainable interventions, an in-depth problem analysis of the work system must be conducted. Thus, the goal of this aim is to understand and map work system resilience, including how WAI differs from WAD, how adjustments are created, and how outcomes are generated. Iterative data collection and analysis will allow continual refinement and clarification of the work system. Observations In-depth ethnographic observations will be conducted over four visits to each of the six pharmacy observation sites (Table 3 ). Study team members will debrief after each observation, as well as in-situ as needed, to adjust observation approaches or focus on specific aspects of the workflow. We will complete 24 hours of observations over four days. Observed artifacts that reflect WAI, such as policies and procedures, memory aids, and cognitive tools, will also be collected and recorded. Full descriptive field notes will be produced immediately after each observational session. Data will be collected concurrently at each setting, and researchers will work across all settings so that comparisons between the settings can inform ongoing data collection strategies. Table 3 Observations at the Pharmacy Sites High-Level Observation Questions 1. What contributes to variability in demand and capacity? 2. What misalignment occurs between demand and capacity, and why? 3. What pressures, problems, or goals are pharmacists and technicians responding to when they create new ways to achieve outcomes? 4. How and under what circumstances do adjustments or adaptations lead to successful and unsuccessful outcomes? Visit 1: Exploratory Evaluation Visits 2–4: Observations • Observe the pharmacy environment holistically • Identify staff roles and responsibilities, processes, and procedures, flows of information and communication, coordinating mechanisms, and supporting tools and technology • Identify interest areas for more precise and targeted observations in subsequent stages • Observe the pharmacy staff • In-depth observations of important processes such as shift change handoffs and medication reconciliation for patients during hospital discharge, as processes critical to providing CCM • Short, structured, discussions and facilitated reflection from staff on aspects of the CARE model and using the SEIPS model components Interviews Semi-structured interviews will be separately conducted with two pharmacists and two technicians from each of the six pharmacy locations to explore and follow up on issues from the prior observation stages to identify processes or areas for additional observation. Questions will focus on how people do their work and how they manage tricky situations, with probes about variability, adaptations, problems, and challenges. Interviews will be audio recorded and transcribed for analysis with participants’ consent. Data Analysis Data Analysis will proceed in three stages. First, a combined deductive-inductive approach will be used to thematically analyze the observation and interview data. A coding scheme will be developed based on elements of the SEIPS model, as well as important themes in the data not captured by the model (see Table 4 ). Categories will be developed by constantly refining the coding scheme, and comparisons will be made between different respondents, different pharmacies, and different processes. Table 4 Aim 1 Observation and Interview Coding Scheme Levels Comparison of WAD and WAI Teams of Pharmacists & Technicians • Interpersonal communication, including verbal and nonverbal • Teamwork skills, including leadership and situation awareness Technology • Usability, flexibility, adjustability, and adaptability Internal Environment • Interruptions and distractions • Lighting • Physical ergonomics of workspace • Crowding and disorganization Tasks • Task demands/workload • Contextual changes, including situation deviations from normal or expected • Production pressure Organization • Complexity, uncertainty, and risk • Information flow, including quantity and pacing • Culture and climate • Policies and procedures • Incentives and disincentives Second, guided by the CARE model, we will expand on the SEIPS coding scheme to construct Functional Resilience Analysis Method (FRAM) models[ 40 , 41 ] to visualize WAD, and to articulate the discrepancies between WAI and WAD. FRAM models allow all activities within selected processes to be visualized to show how they relate to each other and how they interact, based on 6 aspects: (1) input, (2) output, (3) pre-condition, (4) resources, (5) time, and (6) control, demonstrating the system’s complexity.[ 42 ] Each process within the community pharmacy is linked, which allows the study of variability of each process. That variability can produce amplified and unpredicted outcomes (either acceptable or unacceptable).[ 40 , 41 ] Third, the themes generated by the deductive-inductive approach and the FRAM models will be used to create resilience narratives describing trajectories of activity linking misalignments of demand and capacity, adjustments, adaptations, and outcomes. The narratives will focus on how adjustments and adaptations (WAD) mediate between pressures caused by misalignments of demand and capacity, and outcomes. Aim 2: Design and Develop MedSafeMap™ Stakeholder engaged participatory design and simulation-based research will be used in an iterative fashion to design and develop MedSafeMap™, a package of components to optimize pharmacy staff interactions within their work system and with patients and detailed pharmacy design recommendations. Standardized complex patient scenarios will be developed to have both internal validity and fidelity to the real-world pharmacy environment. The goal is to create MedSafeMap components that will ultimately lead to pharmacy staff resilience and optimized patient interactions around CCM. Participatory Design Participatory design is an approach to systems design that actively involves all stakeholders at several stages of the innovation process to help ensure that the result meets their needs and is usable.[ 28 ] Two stakeholder groups will be used: one group consisting of five community pharmacists and one group consisting of five technicians. Stakeholder group meetings will be held six times, approximately every 6–8 weeks. The first four meetings will be held with the pharmacists and technicians separately, since they have different work responsibilities, tasks, and concerns. We also want technicians to fully engage in MedSafeMap development without a pharmacist presence imposing a power differential. The resilience narratives and FRAM diagrams developed in Aim 1, which demonstrate variability and resilience potential, will inform the design and development of the MedSafeMap. We will focus on the processes required to conduct CCM for complex patients, including the possibility of a communication tool to support discussion of alternatives, enhanced instructions for patients, and cognitive aids to support memory. The final two meetings will involve MedSafeMap refinement. To do so, we will bring the pharmacist and technician groups together to work collaboratively. Table 5 provides a list of anticipated or possible MedSafeMap components. Completed MedSafeMap components will be peer reviewed by our advisory board to confirm that they will reproduce the experience in a real-world pharmacy. Scenarios will be piloted in the in-situ simulated setting and refined prior to implementation in Aim 3. Table 5 Current Interactions and potential MedSafeMap Components to Encourage Ideal Interactions Current Interactions Potential MedSafeMap Components • CCM is seen as important but has an impact on workload, which is a barrier to sustained services • Fragmented information across providers • Medication information gap (e.g., multiple pharmacies, no diagnoses or lab values) • Busy retail pharmacies lead to reduced interactions with patients • Coordination gap between pharmacists and caregivers, patients, and providers • Technicians limited by traditional roles • Medication concerns not adequately addressed o Limited support and space for shared decision making • Modeling behaviors o Tactics to overcome communication barriers in pharmacies and engage providers o Patient/family supports to bridge information gap • Information support o Use technology or low-tech strategies to “push” eligible patients into the pharmacy workflow o Create mechanisms to include caregivers prior to, in appointment, and follow up • Cognitive Aids o Physical structures to improve pharmacists’ and technicians’ situation awareness o Supports to address high priority medication needs • Collaborative work support o Facilitate a “huddle” between pharmacist sand technician to create appointment agenda, anticipate patient challenges, review monitoring needs • Role clarity and cross training o Empowering technicians as equal partners and health leaders in the community pharmacy Simulation-Based Research In situ simulation,[ 43 ] or simulation in an actual community pharmacy, will then be conducted to study the ergonomics and physicality of the work setting on performance. In situ simulations also will promote process and MedSafeMap refinement before deployment in actual pharmacies. The final two stakeholder meetings also will involve three rapid adaptive simulation cycles for MedSafeMap refinement (see Fig. 3 ). Each simulation cycle will include 5 different standardized patients (hired for the study). Each patient will represent one of five different complex CCM scenarios that will include at least two chronic conditions and at least one social determinant of health (e.g., low health literacy patient with diabetes and congestive heart failure who is non-adherent to medications). Staffing and equipment, level of complexity, and other critical indicators identified in the participatory design will vary, and allow for comparisons, across the five patient scenarios. Creating robust and standard scenarios is important to mitigate threats to internal validity. Thus, we will devote considerable time to ensuring that the MedSafeMap may be utilized in different patient cases, and in different community pharmacy settings (i.e., are pharmacy agnostic). Ten pharmacist/technician dyads will be recruited to participate in each adaptive simulation cycle. In each adaptive cycle, the pharmacy/technician dyad will complete the simulation five times, once for each standardized patient. The process will be replicated for each of the 10 pharmacy dyads resulting 50 simulations per adaptive cycle. At the completion of each cycle, the study team will then utilize the data collected combined with significant reflection and formative evaluation to refine the MedSafeMap that facilitates resilience and encourages adaption by pharmacy staff. Data Collection Four wide-angle video cameras will be used to record the simulation from locations that best capture how pharmacy staff interact with the physical space, communicate, and share information, and use artifacts within the work system. In addition, two sets of eye tracking glasses (Tobii Pro Glasses)[ 44 – 46 ] – one each for the pharmacist and the technician – will be deployed to track eye movement in the natural world, which will inform the development of prototypes. Specifically, as pharmacy staff navigate the physical pharmacy space, the glasses collect data that will provide an understanding about which artifacts are most instrumental to performing CCM, factors that influence pharmacy staff and patient decision-making, and workflow. Gaze data will be recorded as pharmacy staff read and review information on prescriptions and prescription profiles on the pharmacy electronic health record, and interact and educate patients.[ 47 , 48 ] Aim 2 will be accomplished in three steps, conceptualized in Table 6 . Table 6 Aim 2 Data Collection Procedures Step 1 Step 2 Step 3 Tasks • Record simulations • Document individual and collective behavior • Introduce MedSafeMap and record simulations • Simulate with 10 pharmacist/technician dyads for each of five different standardized patients • Conduct individual debrief interviews with the pharmacists and technicians following completion of each simulated scenario Goal • Identify patterns of interactions and thought processes • Reproduce situations identically to increase confidence in the MedSafeMap’s ability • Gain insight into the thoughts and cognitive processes of pharmacists and technicians Output • Descriptive account of how community pharmacy staff make decisions or share information • Understanding rare events such as sentinel medication errors • Explain variation in the outcome of interest • Understand participants’ perceptions of (1) understanding the problem situation, (2) assessing prototype feasibility, (3) evaluating the effect of the prototype, and (4) optimizing the design and implementation of the prototype Data Analysis Observational checklists will be used to code participant behavior recorded on the videos, thereby assessing MedSafeMap feasibility and effectiveness. The recordings from the wide-angle video cameras and eye tracking glasses will be analyzed for themes between participants and across sites by assessing what areas of interest participants fixate on for extended periods of time. Using gaze duration as a proxy for wearer attention provides insights into which elements of MedSafeMap are influential in shaping pharmacy staff behavior. For example, if one of the components of MedSafeMap includes a technician training to “speak up” when they are concerned that the pharmacist missed a medication related problem, we can respectively code the reactions of the pharmacist and technician based on the videos.[ 49 , 50 ] Qualitative data from pharmacist and technician stakeholder meetings will be subjected to a rigorous analytic approach.[ 36 , 51 – 54 ] We will use deductive content analysis, inductive patterns, themes and categories in our data, guided by our theory-based approach.[ 55 ] A conceptual coding structure will be created and as each interview transcript is added to the analysis, passages will be classified according to existing codes, and codes will be added as needed. Inductive content analysis will also be conducted to determine unanticipated work system characteristics that may facilitate or inhibit resilience. Aim 3: Implement and Pilot Test MedSafeMap Although simulation-based research can have high internal validity by controlling the highly standardized scenarios that will be developed in Aim 2, it is critical to implement and evaluate MedSafeMap “in real life” where WAD diverges from WAI and to address external validity concerning pharmacy work systems relevant to CCM. With this approach, we can determine if changes in performance can be attributed to MedSafeMap rather than other external (e.g., regulatory changes) or internal elements (e.g., updates to electronic health records), and how such elements can affect MedSafeMap performance or impact. The six community pharmacies that participated in Aim 1 observations and interviews will implement MedSafeMap for optimal interactions designed in Aim 2. Implementation and Adaptation A stepped wedge design[ 38 ] will be employed, where the MedSafeMap will be sequentially implemented in two clusters, each cluster comprising of three pharmacies (one pharmacy from each organization) (see Fig. 4 ). The two pharmacies from each organization will be randomized into the two clusters. Each cluster will commence with baseline pre-test data collection and then cross-over from the control condition (pre-implementation) to the intervention condition, where a formative evaluation of MedSafeMap and the strategies from the Implementation Guide will be conducted. This evaluation will be performed for each cluster 4 months into its implementation period to consider “what might be missing, what sociotechnical factors had not been considered and to identify ‘bugs and glitches’ that still need to be addressed.”[ 56 ] The evaluation will include one day of observations by shadowing pharmacy staff and may involve short discussions and facilitated reflection from staff at each of the three pharmacies in Cluster 1. Those observations will be brought back to the research team and advisory board to identify opportunities to improve MedSafeMap. Following the formative evaluation in Cluster 1, we will refine and improve MedSafeMap and implementation strategies to mitigate vulnerabilities or unintended consequences that may expose patients to new harms or further the work burden of pharmacists and technicians. The adapted MedSafeMap and implementation strategies will be deployed for Cluster 2, which will also undergo a similar evaluation. It is possible that minor adaptations will be made, if necessary, before subjecting the cluster to a post-test evaluation.[ 57 ] Evaluation We will use a sequential explanatory design in which the initial data is quantitative (time and motion study, work volume) and complemented by qualitative data (interviews, medication error reporting). This mixed-methods approach will allow the research team to understand variables individually and determine which ones will require further analysis. In line with the CARE and SEIPS 2.0 models, we will collect and analyze data that reflect workflow and care processes, and the perspectives of pharmacists and technicians. Time and Motion Study Our evaluation goal is to examine the impact of MedSafeMap on pharmacists’ and technicians’ ability to be resilient – that is, to successfully attend to unexpected threats while also responding to opportunities,[ 31 ] such as CCM. To do so, we must understand clinical work processes and the way that care is delivered to patients. We anticipate that MedSafeMap will impact the way that pharmacists and technicians perform their work and the ways in which they engage each other and their patients. Time and motion studies have been used to measure clinical workflow related factors, including time task distributions, frequency of multitasking and interruptions, and who completes tasks with a goal of improving efficiency.[ 58 , 59 ] We will conduct observations before and after the adapted MedSafeMap. Using the observational data collected in Aim 1, we will develop a pharmacy work task classification (see Table 7 ). The classifications will be incorporated in the Work Observation Method by Activity Timing (WOMBAT) program to allow for the consistent recording of observational data.[ 60 , 61 ] WOMBAT allows observers to time the start and end of tasks, and to record multiple simultaneous tasks using the multitasking function. If an external factor appears to cause a pharmacist or technician to stop performing one task and start another task, an “interruption” can be recorded. Table 7 Pharmacy Work Task Classifications Work Task Classification Examples What – the task being performed Counseling, communication with prescriber Where – the physical location where the task is undertaken Behind desk, office, front of OTC counter With whom – who the pharmacy staff was with when performing the task Alone, patient, technician, student How – any tools used to complete the task Phone, face to face, computer Observer Training Prior to MedSafeMap implementation and baseline data collection, two observers will be trained to use the WOMBAT program. Data collection will begin when simultaneous but independent observations of the same events, such as those seen in Table 7 , yield an inter-rater reliability score of at least 85%.[ 62 ] Data Collection Observations will be purposely scheduled across a variety of weekday shifts to maximize data variability and capture the full pharmacy workday. One observer will shadow a pharmacist equipped with a tablet with the WOMBAT software installed on it, while, at the same time, a similarly-equipped second observer will shadow a technician. In total, two pharmacists and two technicians will be observed at each pharmacy. Observations will be limited to three, two-hour, sessions per day, each separated by a brief break to reduce participant/observer fatigue. During each break, observers will memo any thoughts for future questions or more in-depth observation. The pharmacists and technicians will be observed for 36 hours both pre- and post-implementation, for a total of 72 hours. We estimate observing tasks across 72 hours in each pharmacy,[ 58 ] yielding a total of 432 hours across the six participating pharmacies.[ 60 , 63 ] Data Analysis To assess changes in pharmacists’ and technicians’ task time distribution post-implementation, we will calculate the proportion of total observed time in each task category by study period (pre- versus post-implementation) for each pharmacy. The proportions of total observed time where pharmacists completed tasks with technicians or alone and using different information tools will also be calculated for each pharmacy. To assess the extent to which the introduction of MedSafeMap increased opportunities for pharmacists and technicians to engage with patients in CCM, we will examine changes to the time pharmacists and technicians spent in (1) discussions with each other on responding to opportunities (i.e., identifying complex patients who would benefit from CCM) and attend to unexpected threats (i.e., personnel absences) and (2) discussions with patients about medications.[ 63 ] Z-tests for proportions will be used to compare the extent of pre- and post-implementation change in the proportion of total observed time for each task category in each pharmacy site. A p < .05 significance level will be used, as well as Holm approaches to account for multiple comparisons, with 95% confidence intervals based on the large sample normal approximation. Pharmacy Reported Data We anticipate that MedSafeMap will support pharmacists’ and technicians’ ability to embed CCM and other clinical services into their workflow, which will improve the quality of patient care, ideally without increasing workload. To assess perceived changes in service provision, pharmacists and technicians will be administered a validated subjective workload survey.[ 64 ] The number and type of documented medication-related problems during CCM services[ 65 ] that are identified and resolved for six months prior to and 12 months following MedSafeMap implementation also will be collected. Pre/post comparisons of services provided and medication-related problems that they averted will be conducted. Pharmacist and Technician Evaluation We also want to gain a more in-depth understanding of how MedSafeMap changed attitudes, behaviors, and performance. It is expected that pharmacists and technicians will feel more resilient after MedSafeMap implementation. That is, they will feel more “capable, facilitated and supported by the organization, to utilize resources to continually adapt and flourish at work, even if/when faced with challenging circumstances.”[ 66 ] This construct will be represented through the Employee Resilience Scale,[ 67 ] a measure of behavioral elements such as learning orientation, proactive posture, positive outlook, network leveraging, and adaptive capacity. Pharmacists and technicians also are likely to eventually feel a greater sense of shared responsibility and teamwork, which would create an environment that enhances the medication safety of their patients. This construct will be represented through the NASA-developed Cockpit Management Attitudes Questionnaire,[ 68 , 69 ] comprising three scales – Communication and Coordination, Command Responsibility, and Recognition of Stressor Effects – which have application to the pharmacy work system. Because we are working with a small number of pharmacists and technicians, and because we want to do an in-depth exploration of pharmacy staff attitudes and behaviors, we will adapt the Employee Resilience and Cockpit Management Attitudes Questionnaire items into an interview guide that will include semi-structured probes. Eight months following MedSafeMap implementation, interviews will be conducted using a retrospective pre-/post-test design approach[ 70 , 71 ] by asking, “Compared to before MedSafeMap was implemented, ...” This approach is appropriate because it is pragmatic, less time-consuming, eliminates the impact of response-shift bias,[ 70 ] and has been used successfully in pharmacy studies.[ 72 , 73 ] Questions will prompt insights into the impact of MedSafeMap on pharmacist and technician resilience, teamwork, and shared responsibility. Interview data will be subjected to the same rigorous qualitative data analysis techniques described in Aim 1. Outcomes Study outcomes are targeted to help populations of medication safety researchers and organizational leaders responsible for implementing proven practices. A summary of the anticipated outcomes can be found in Table 8 . Table 8 Outcomes Aim 1 Aim 2 Aim 3 • Resilience narratives and FRAM models that are context rich and context dependent • Potential to uncover anticipated relationships between variables that can be tested in the subsequent aims to inform the development of the MedSafeMap • Components of MedSafeMap that support CCM in community pharmacies • MedSafeMap that may include designs that re-align currently-existing tasks, coordinate tasks with different pharmacy staff members, or incorporate new practices • MedSafeMap that may include tools to facilitate pharmacist/patient and pharmacist/prescriber collaboration, or tools to provide cognitive support for pharmacists and technicians to anticipate crises or other problems • Quantitative and qualitative evaluation of the impact of MedSafeMap on community pharmacy processes and outcomes • Toolkit to assess capacity and resilience • Implementation Guide Discussion The prevailing Safety-I approach for improving medication safety has emphasized retrospective incident analysis, reactive measures targeted at past problems, human error as an explanation, and control of work through procedural compliance and outcome monitoring.[ 74 ] This approach has proven to be insufficient and frustratingly slow at achieving "zero harm" in outpatient settings, and specifically the community pharmacy.[ 75 ] Such a lack of success stems from investigating medication errors through root cause analysis, which assumes a shortsighted linear cause-and-effect model, rather than a complex model.[ 76 ] Finally, importantly, these approaches create a negative psychological impact on staff by creating a culture of blame.[ 31 , 77 , 78 ] Strengths This study will be the first to operationalize resilience engineering to include a Safety-II approach to medication safety in community pharmacies. The vast majority of safety studies involving community pharmacies assume a linear work process, which limits understanding of community pharmacies as complex work systems. Our research demonstrates that work is not conducted linearly, but rather is comprised of interdependent processes.[ 79 ] The use of the innovative FRAM model will provide a robust model to map multiple processes and their variability, which can inform co-design of potential solutions.[ 40 , 80 , 81 ] This project will prioritize and emphasize the role of pharmacy technicians as critical members of the community pharmacy work system. Expedited during the COVID-19 pandemic, technicians are increasingly being recognized for their willingness to assume new roles and adapt to changing environments.[ 82 ] Technicians have proven themselves effective in collecting patient medication histories,[ 83 ] administrative functions associated with vaccinations, and even providing immunizations to patients.[ 84 ] Provider Status, a new legal designation authorizing Medicaid reimbursement to pharmacists’ services, presents both a timely opportunity to evaluate how increased or broadening responsibilities can be adopted while improving quality of care and medication safety. Legal endorsement to “stretch professional boundaries and envision innovative designs”[ 56 ] is the perfect circumstance in which to move the needle on outpatient medication safety through the design of the next generation of community pharmacies. Pharmacists and technicians, depleted by the unrelenting workload and additional responsibilities from COVID-19, find the Safety-II approach to be attractive.[ 75 ] Safety-II also better represents and supports a culture of safety because it accurately portrays the constant variability of pharmacy work, the need for adjustment, and the importance of flexible adaptation in producing outcomes. Introducing and utilizing a Safety-II approach will provide the test bed, tools, metrics, and frameworks to build the ENRICH PSLL. This new paradigm of approaching CCM with resilience engineering methodologies to improve quality in community pharmacies could then be disseminated to and adopted by medication safety researchers around the country. Limitations Participant bias caused by sensitivity to researcher’s presence is a recognized risk in qualitative observational studies but can be minimized by ensuring that observers have frequent presence in the research setting, which can lead to habituation to their presence, researcher’s sensitivity to and respect for pharmacy staff’ concerns, and their ability to build relationships and trust. Risk of measurement bias will be reduced by having two researchers collecting data only after achieving a satisfactory inter-rater reliability rate, ensuring that differences in interpretation can be identified, discussed, and resolved before full data collection is accomplished. We will use one simulation site, despite being aware that community pharmacies have very different work systems. We also know that using multiple simulation sites would increase the generalizability of findings and enable comparison between sites. However, utilizing simulations to evaluate prototypes that focus on workflow changes related to CCM is unprecedented in community pharmacies, so we want to begin with a single setting to ensure a robust infrastructure to evaluate such simulations. To expand our understanding beyond the single work system exemplified by the simulation site, we will seek input from advisory board members who will provide feedback on the feasibility of implementing MedSafeMap in their diverse community pharmacy settings. Conclusion Community pharmacies have experienced a great deal of change in the last decade alone. With an increase in responsibilities due to the pandemic, as well as changes to the healthcare structure that increases their workload, pharmacy staff are becoming increasingly burnt out. Coupled with high turnover rates and understaffing concerns, there is an unprecedented risk of safety errors and resulting patient harm. To allow staff to take on these responsibilities as CCM providers, we must find a way to manage the workload and optimize resources. We are in a unique position to provide support directly to the pharmacies and give them a voice to influence change in the pharmacy work system. Through this PSLL, we can rethink the current safety approaches and develop an improved work system for medication safety, resulting in improved work conditions for pharmacy staff and increased patient care. Abbreviations Adverse drug event (ADE) Chronic Care Management (CCM) Concepts for Applying Resilience Engineering (CARE) Engineering Resilient Community Pharmacies (ENRICH) Functional Resilience Analysis Method (FRAM) Patient Safety Learning Laboratory (PSLL) Systems Engineering Initiative for Patient Safety (SEIPS) Work as done (WAD) Work as imagined (WAI) Declarations Ethics approval and consent to participate All human subjects research described will be reviewed and approved by the University of Wisconsin – Madison Institutional Review Board. Aim 1 has been approved (study ID: 2023-1100), and all other aims will be reviewed and approved before beginning any human subjects research. Consent for publication Not applicable Availability of data and materials Data is not yet available for this study. Future data will be made available in adherence with the NIH Data Management and Sharing policy. Competing interests MC is a co-owner of Fitchburg Family Pharmacy, which serves as the simulation site for this project. MC will not receive any payment for the use of the pharmacy for this project. The other authors declare no competing interests. Funding support This work was supported by the Agency for Healthcare Research and Quality (grant number R18HS029608). Authors’ contributions MC and JF initiated the project as co-principal investigators of the study and jointly supervised the writing of this protocol. AG, JS, and EL contributed to the conceptualization of the research study. JS managed and coordinated research activity. MC, MB, AG, JS, and JF drafted the initial manuscript. MB collected and organized the relevant data for publication. MB and EH updated proposed models and created new graphics. All authors contributed to the revision process. All authors read and approved the final version of the manuscript. Acknowledgements Not applicable References Buttorff C, Ruder T, Bauman M: Multiple Chronic Conditions in the United States . Santa Monica, CA: RAND Corporation; 2017. Medicine Io: Standardizing Medication Labels: Confusing Patients Less: Workshop Summary . Washington, DC: The National Academies Press; 2008. Medicine Io: Preventing Medication Errors . Washington, DC: The National Academies Press; 2007. Mossialos E, Courtin E, Naci H, Benrimoj S, Bouvy M, Farris K, Noyce P, Sketris I: From "retailers" to health care providers: Transforming the role of community pharmacists in chronic disease management . Health Policy 2015, 119 (5):628-639. Como M, Carter CW, Larose-Pierre M, O'Dare K, Hall CR, Mobley J, Robertson G, Leonard J, Tew L: Pharmacist-Led Chronic Care Management for Medically Underserved Rural Populations in Florida During the COVID-19 Pandemic . Preventing Chronic Disease 2020, 17 :E74. Manolakis PG, Skelton JB: Pharmacists' contributions to primary care in the United States collaborating to address unmet patient care needs: the emerging role for pharmacists to address the shortage of primary care providers . Am J Pharm Educ 2010, 74 (10):S7. Tsuyuki RT, Beahm NP, Okada H, Al Hamarneh YN: Pharmacists as accessible primary health care providers: Review of the evidence . Can Pharm J (Ott) 2018, 151 (1):4-5. Le LD, Paulk IR, Axon DR, Bingham JM: Comprehensive Medication Review Completion in Medically Underserved Areas and Populations . J Health Care Poor Underserved 2021, 32 (3):1301-1311. Bratberg JP: Opioids, naloxone, and beyond: The intersection of medication safety, public health, and pharmacy . Journal of the American Pharmacists Association: JAPhA 2017, 57 (2S):S5-S7. Payne R, Medina E: Delivering Pain Management and Palliative Care in Medically Underserved Communities: Issues and Perspectives . Medicine of the Americas 2001, 2 (1):65-65. Enfinger F, Campbell K, Taylor RJ: Collaboration with pharmacy services in a family practice for the medically underserved . Pharm Pract (Granada) 2009, 7 (4):248-253. Murphy PA, Frazee SG, Cantlin JP, Cohen E, Rosan JR, Harshburger DE: Pharmacy provision of influenza vaccinations in medically underserved communities . Journal of the American Pharmacists Association: JAPhA 2012, 52 (1):67-70. Mc Namara KP, Dunbar JA, Philpot B, Marriott JL, Reddy P, Janus ED: Potential of pharmacists to help reduce the burden of poorly managed cardiovascular risk . Aust J Rural Health 2012, 20 (2):67-73. Fadare OO, Doucette WR, Gaither CA, Schommer JC, Arya V, Bakken BK, Kreling DH, Mott DA, Witry MJ: Exploring the moderating role of job resources in how job demands influence burnout and professional fulfillment among U.S. pharmacists . Research in social & administrative pharmacy: RSAP 2022, 18 (10):3821-3830. Goodkind NR, E.: CVS and Walgreens pharmacy staff begin 3-day walkout . In: CNN. waow.com; 2023. Wisconsin Legislature: 2021 Wisconsin Act 98 . 2023. Schommer JC, Olson AW, Isetts BJ: Transforming community-based pharmacy practice through financially sustainable centers for health and personal care . Journal of the American Pharmacists Association: JAPhA 2019, 59 (3):306-309. Schommer JC, Lee S, Gaither CA, Alvarez NA, Shaughnessy AM: Improving the Experience of Providing Care in Community-Based Pharmacies . Pharmacy (Basel, Switzerland) 2022, 10 (4):67. Malone DC, Abarca J, Skrepnek GH, Murphy JE, Armstrong EP, Grizzle AJ, Rehfeld RA, Woosley RL: Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions . Med Care 2007, 45 (5):456-462. Hassell K, Seston EM, Schafheutle EI, Wagner A, Eden M: Workload in community pharmacies in the UK and its impact on patient safety and pharmacists' well-being: a review of the evidence . Health Soc Care Community 2011, 19 (6):561-575. Holden RJ, Patel NR, Scanlon MC, Shalaby TM, Arnold JM, Karsh B-T: Effects of mental demands during dispensing on perceived medication safety and employee well being: A study of workload in pediatric hospital pharmacies . Research in social & administrative pharmacy : RSAP 2010, 6 (4):293-306. Langran C, Mantzourani E, Hughes L, Hall K, Willis S: “I'm at breaking point”; Exploring pharmacists' resilience, coping and burnout during the COVID-19 pandemic . Exploratory Research in Clinical and Social Pharmacy 2022, 5 :100104. Gandhi TK, Feeley D, Schummers D: Zero Harm in Health Care . NEJM Catalyst Innovations in Care Delivery 2020, 1 (2). Leading the Way to Zero Resources | The Joint Commission . 2023. Stockwell DC, Kayes DC, Thomas EJ: Patient Safety: Where to Aim When Zero Harm Is Not the Target-A Case for Learning and Resilience . J Patient Saf 2022, 18 (5):e877-e882. Patterson M, Deutsch ES: Safety-I, Safety-II and Resilience Engineering . Curr Probl Pediatr Adolesc Health Care 2015, 45 (12):382-389. Chui MA, Stone JA, Holden RJ: Improving over-the-counter medication safety for older adults: A study protocol for a demonstration and dissemination study . Res Social Adm Pharm 2017, 13 (5):930-937. Chui MA, Berbakov ME, Gilson AM, Morris AO, Stone JA: Effectiveness and sustainment of a tailored over-the-counter medication safety intervention in community pharmacies: A randomized controlled trial . Research in Social and Administrative Pharmacy 2022. Wears R: Still Not Safe: Patient Safety and the Middle-Managing of American Medicine : Oxford University Press; 2019. Merandi J, Vannatta K, Davis JT, McClead RE, Brilli R, Bartman T: Safety II Behavior in a Pediatric Intensive Care Unit . Pediatrics 2018, 141 (6):e20180018. Plunkett A, Plunkett E: Positive approaches to safety: Learning from what we do well . Paediatr Anaesth 2022, 32 (11):1223-1229. Verhagen MJ, de Vos MS, Sujan M, Hamming JF: The problem with making Safety-II work in healthcare . BMJ quality & safety 2022, 31 (5):402-408. Hickford AJ, Blainey SP, Ortega Hortelano A, Pant R: Resilience engineering: theory and practice in interdependent infrastructure systems . Environ Syst Decis 2018, 38 (3):278-291. Overview of Patient Safety Learning Laboratory (PSLL) Projects [https://www.ahrq.gov/patient-safety/resources/learning-lab/index.html] Resilience Engineering: Concepts and Precepts , 1st Edition edn. London: CRC Press; 2006. Odukoya OK, Stone JA, Chui MA: Barriers and facilitators to recovering from e-prescribing errors in community pharmacies . Journal of the American Pharmacists Association: JAPhA 2015, 55 (1):52-58. Chui MA, Mott DA, Maxwell L: A qualitative assessment of a community pharmacy cognitive pharmaceutical services program, using a work system approach . Research in social & administrative pharmacy: RSAP 2012, 8 (3):206-216. Morris AO, Gilson A, Chui MA, Xiong K: Utilizing a cognitive engineering approach to conduct a hierarchical task analysis to understand complex older adult decision-making during over-the-counter medication selection . Research in social & administrative pharmacy: RSAP 2021, 17 (12):2116-2126. Holden RJ, Carayon P, Gurses AP, Hoonakker P, Hundt AS, Ozok AA, Rivera-Rodriguez AJ: SEIPS 2.0: a human factors framework for studying and improving the work of healthcare professionals and patients . Ergonomics 2013, 56 (11):1669-1686. McNab D, Freestone J, Black C, Carson-Stevens A, Bowie P: Participatory design of an improvement intervention for the primary care management of possible sepsis using the Functional Resonance Analysis Method . BMC Med 2018, 16 (1):174. van Dijk LM, Meulman MD, van Eikenhorst L, Merten H, Schutijser BCFM, Wagner C: Can using the functional resonance analysis method, as an intervention, improve patient safety in hospitals?: a stepped wedge design protocol . BMC Health Serv Res 2021, 21 (1):1228. The FRAM Model Visualiser . 2023. LeBlanc VR, Manser T, Weinger MB, Musson D, Kutzin J, Howard SK: The study of factors affecting human and systems performance in healthcare using simulation . Simul Healthc 2011, 6 Suppl :S24-29. Tórtora G, Machín L, Ares G: Influence of nutritional warnings and other label features on consumers' choice: Results from an eye-tracking study . Food Res Int 2019, 119 :605-611. van Renswoude DR, Raijmakers MEJ, Koornneef A, Johnson SP, Hunnius S, Visser I: Gazepath: An eye-tracking analysis tool that accounts for individual differences and data quality . Behav Res Methods 2018, 50 (2):834-852. Wilkinson KM, Mitchell T: Eye tracking research to answer questions about augmentative and alternative communication assessment and intervention . Augment Altern Commun 2014, 30 (2):106-119. Moon J, Berbakov ME, Morris AO, Gilson AM, Stone JA, Watterson TL, Chui MA: Eyetracking for macroergonomics in the wild: Exploring its use for understanding older adults’ over-the-counter medication selection behavior in community pharmacies and its implications for other health care settings . In: International Symposium on Human Factors and Ergonomics in Health Care: 2022/03/20/23 2022 ; 2022. Morris AO, Berbakov ME, Moon J, Stone JA, Gilson AM, Watterson TL, Chui MA: Senior Section 2.0: Intersecting Implementation Science and Human Factors to Adapt Our Community Pharmacy Intervention to Improve Over-the-Counter Medication Safety Among Older Adults . In: International Symposium on Human Factors and Ergonomics in Health Care: 2022/03/20/23 2022 ; 2022. Cook DA: One drop at a time: research to advance the science of simulation . Simul Healthc 2010, 5 (1):1-4. Lamé G, Dixon-Woods M: Using clinical simulation to study how to improve quality and safety in healthcare . BMJ Simul Technol Enhanc Learn 2020, 6 (2):87-94. Maxwell L, Odukoya OK, Stone JA, Chui MA: Using a conflict conceptual framework to describe challenges to coordinated patient care from the physicians' and pharmacists' perspective . Research in social & administrative pharmacy: RSAP 2014, 10 (6):824-836. Odukoya OK, Stone JA, Chui MA: How do community pharmacies recover from e-prescription errors? Research in social & administrative pharmacy: RSAP 2014, 10 (6):837-852. Chui MA, Stone JA, Martin BA, Croes KD, Thorpe JM: Safeguarding older adults from inappropriate over-the-counter medications: the role of community pharmacists . Gerontologist 2014, 54 (6):989-1000. Chui MA, Stone JA, Thorpe JM, Martin BA: Work System Barriers to Providing Safe Over-the-Counter (OTC) Medication Recommendations for Older Adults . Proceedings of the Human Factors and Ergonomics Society Annual Meeting 2013, 57 (1):1098-1102. Patton MQ: Qualitative Research & Evaluation Methods: Integrating Theory and Practice , 4th Edition edn; 2014. PA-21-266: Patient Safety Learning Laboratories: Advancing Patient Safety through Design, Systems Engineering, and Health Services Research (R18 Clinical Trial Optional) . 2023. Dreischulte T, Grant A, Donnan P, Guthrie B: Pro’s and con’s of the stepped wedge design in cluster randomised trials of quality improvement interventions: two current examples . Trials 2013, 14 (1):O87. Karia A, Norman R, Robinson S, Lehnbom E, Laba T-L, Durakovic I, Balane C, Joshi R, Webster R: Pharmacist's time spent: Space for Pharmacy-based Interventions and Consultation TimE (SPICE)-an observational time and motion study . BMJ Open 2022, 12 (3):e055597. Havnes K, Lehnbom EC, Walter SR, Garcia BH, Halvorsen KH: Time distribution for pharmacists conducting a randomized controlled trial-An observational time and motion study . PLoS One 2021, 16 (4):e0250898. Westbrook JI, Li L, Hooper TD, Raban MZ, Middleton S, Lehnbom EC: Effectiveness of a 'Do not interrupt' bundled intervention to reduce interruptions during medication administration: a cluster randomised controlled feasibility study . BMJ quality & safety 2017, 26 (9):734-742. Ballermann MA, Shaw NT, Mayes DC, Gibney RTN, Westbrook JI: Validation of the Work Observation Method By Activity Timing (WOMBAT) method of conducting time-motion observations in critical care settings: an observational study . BMC Med Inform Decis Mak 2011, 11 :32. Gwet KL: Handbook of Inter-Rater Reliability, 4th Edition: The Definitive Guide to Measuring The Extent of Agreement Among Raters , 4th Edition edn: Advanced Analytics, LLC; 2014. Westbrook JI, Li L, Shah S, Lehnbom EC, Prgomet M, Schofield B, Cresswell K, Slee A, Coleman JJ, McCloughan L et al : A cross-country time and motion study to measure the impact of electronic medication management systems on the work of hospital pharmacists in Australia and England . Int J Med Inform 2019, 129 :253-259. Chui MA, Look KA, Mott DA: The association of subjective workload dimensions on quality of care and pharmacist quality of work life . Research in social & administrative pharmacy: RSAP 2014, 10 (2):328-340. Simonson W, Feinberg JL: Medication-related problems in the elderly : defining the issues and identifying solutions . Drugs & Aging 2005, 22 (7):559-569. Luthans F: The need for and meaning of positive organizational behavior . Journal of Organizational Behavior 2002, 23 (6):695-706. Näswall K, Kuntz J, Malinen S: Employee Resilience Scale (EmpRes) Measurement Properties . In . ; 2015. Gregorich SE, Helmreich RL, Wilhelm JA: The structure of cockpit management attitudes . J Appl Psychol 1990, 75 (6):682-690. Helmreich RL, Foushee HC, Benson R, Russini W: Cockpit resource management: exploring the attitude-performance linkage . Aviat Space Environ Med 1986, 57 (12 Pt 1):1198-1200. Geldhof GJ, Warner DA, Finders JK, Thogmartin AA, Clark A, Longway KA: Revisiting the utility of retrospective pre-post designs: The need for mixed-method pilot data . Eval Program Plann 2018, 70 :83-89. Bhanji F, Gottesman R, de Grave W, Steinert Y, Winer LR: The retrospective pre-post: a practical method to evaluate learning from an educational program . Acad Emerg Med 2012, 19 (2):189-194. Stuhec M, Lah L: Clinical pharmacist interventions in elderly patients with mental disorders in primary care focused on psychotropics: a retrospective pre-post observational study . Ther Adv Psychopharmacol 2021, 11 :20451253211011007. Almulhim AS, Aldayyen A, Yenina K, Chiappini A, Khan TM: Optimization of antibiotic selection in the emergency department for urine culture follow ups, a retrospective pre-post intervention study: clinical pharmacist efforts . J Pharm Policy Pract 2019, 12 :8. Hollnagel E, Braithwaite J, Wears RL: Preface: On the Need for Resilience in Health Care . In: Resilient Health Care. 1st Edition edn.: CRC Press; 2013: ix-xxvi. Hollnagel E, Braithwaite J: Resilient Health Care : CRC Press; 2019. Braithwaite J, Churruca K, Ellis LA, Long J, Clay-Williams R, Damen N, Herkes J, Pomare C, Ludlow K: Complexity science in healthcare: aspirations, approaches, applications and accomplishments: a white paper . Sydney: Macquarie University; 2017. Boyle TA, Bishop A, Morrison B, Murphy A, Barker J, Ashcroft DM, Phipps D, Mahaffey T, MacKinnon NJ: Pharmacist work stress and learning from quality related events . Research in social & administrative pharmacy: RSAP 2016, 12 (5):772-783. Parker J, Davies B: No Blame No Gain? From a No Blame Culture to a Responsibility Culture in Medicine . J Appl Philos 2020, 37 (4):646-660. Lester CA, Chui MA: Using link analysis to explore the impact of the physical environment on pharmacist tasks . Research in social & administrative pharmacy: RSAP 2016, 12 (4):627-632. Gulpen AJW, van Dijk JK, Damen NL, Ten Cate H, Schalla S, Ten Cate-Hoek AJ: Organisation of care for patients using direct oral anticoagulants . Neth Heart J 2020, 28 (9):452-456. Pickup L, Atkinson S, Hollnagel E, Bowie P, Gray S, Rawlinson S, Forrester K: Blood sampling - Two sides to the story . Appl Ergon 2017, 59 (Pt A):234-242. Draime JA, Wicker EC, Krauss ZJ, Sweeney JL, Anderson DC: Description of Position Ads for Pharmacy Technicians . Pharmacy (Basel, Switzerland) 2020, 8 (2):88. Jobin J, Irwin AN, Pimentel J, Tanner MC: Accuracy of medication histories collected by pharmacy technicians during hospital admission . Research in social & administrative pharmacy: RSAP 2018, 14 (7):695-699. McKeirnan K, Sarchet G: Implementing Immunizing Pharmacy Technicians in a Federal Healthcare Facility . Pharmacy (Basel, Switzerland) 2019, 7 (4):152. Additional Declarations Competing interest reported. Michelle Chui is a co-owner of Fitchburg Family Pharmacy, which serves as the simulation site for this project. Michelle Chui will not receive any payment for the use of the pharmacy for this project. The other authors declare no competing interests or any issues related to journal policies. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3876998","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":268041971,"identity":"97379bce-ddf2-4455-8ea5-93cc80fe92ef","order_by":0,"name":"Michelle A. 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Berbakov","email":"","orcid":"","institution":"University of Wisconsin-Madison School of Pharmacy","correspondingAuthor":false,"prefix":"","firstName":"Maria","middleName":"E.","lastName":"Berbakov","suffix":""},{"id":268041973,"identity":"c71c41c8-9320-470b-a4d9-89091d81cfe4","order_by":2,"name":"Aaron M. Gilson","email":"","orcid":"","institution":"University of Wisconsin-Madison School of Pharmacy","correspondingAuthor":false,"prefix":"","firstName":"Aaron","middleName":"M.","lastName":"Gilson","suffix":""},{"id":268041974,"identity":"5bda402f-b986-477b-abf2-5c1719a6bd27","order_by":3,"name":"Jamie A. Stone","email":"","orcid":"","institution":"University of Wisconsin-Madison School of Pharmacy","correspondingAuthor":false,"prefix":"","firstName":"Jamie","middleName":"A.","lastName":"Stone","suffix":""},{"id":268041975,"identity":"91cf0428-b23a-4f29-821b-b9b476842893","order_by":4,"name":"Elin C. 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Ford","lastName":"II","suffix":""}],"badges":[],"createdAt":"2024-01-18 22:14:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3876998/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3876998/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":49992755,"identity":"8873c874-c234-486f-a016-e9c5e5bf523c","added_by":"auto","created_at":"2024-01-22 18:58:51","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":49553,"visible":true,"origin":"","legend":"\u003cp\u003eConcepts for Applying Resilience Engineering (CARE) model\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3876998/v1/b4b671b953dfabecedda17cd.jpg"},{"id":49992768,"identity":"06dac093-00e6-4385-a02c-777471481a1d","added_by":"auto","created_at":"2024-01-22 18:58:54","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":69026,"visible":true,"origin":"","legend":"\u003cp\u003eSEIPS 2.0 model[39] adapted for community pharmacy work system\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3876998/v1/70c22d0df33e2ab2ccf68c1d.jpg"},{"id":49992767,"identity":"98c5c024-3c45-46e6-bdfd-791aa267b5d3","added_by":"auto","created_at":"2024-01-22 18:58:53","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":31093,"visible":true,"origin":"","legend":"\u003cp\u003eSimulation Cycles\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3876998/v1/9bc9a50ffa53c1179148ff70.jpg"},{"id":49992766,"identity":"f27a2b76-beb5-44b4-8c9b-d87e01eda99f","added_by":"auto","created_at":"2024-01-22 18:58:53","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":30569,"visible":true,"origin":"","legend":"\u003cp\u003eStepped Wedge Design and Data Collection Methods\u003c/p\u003e","description":"","filename":"4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3876998/v1/a2a4d68dc38bfd9d22bc4deb.jpg"},{"id":53402971,"identity":"0d62bb62-5ae9-47e3-ba9a-12c5c9adb5a1","added_by":"auto","created_at":"2024-03-25 14:56:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2353108,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3876998/v1/1954ce40-4615-4696-a3bd-1fd713ec640f.pdf"}],"financialInterests":"Competing interest reported. Michelle Chui is a co-owner of Fitchburg Family Pharmacy, which serves as the simulation site for this project. Michelle Chui will not receive any payment for the use of the pharmacy for this project. The other authors declare no competing interests or any issues related to journal policies.","formattedTitle":"Engineering Resilient Community Pharmacies: Exploring an Integrative Approach to Medication Safety","fulltext":[{"header":"Introduction","content":"\u003cp\u003eOver 100\u0026nbsp;million Americans have multiple chronic conditions[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] that contribute to more than one million adverse drug events (ADEs) annually, prompting four million people to seek medical care and costing the U.S. healthcare system over \u003cspan\u003e$\u003c/span\u003e8\u0026nbsp;billion per year.[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] Healthcare spending for patients with multiple chronic conditions is up to 20 times higher than for patients with no chronic conditions. That is, Americans with five or more chronic conditions comprise 12% of the population but 41% of total healthcare spending, averaging 20 physician visits per year and using up to 50 times more prescription medications.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] Challenges with managing multiple chronic conditions has a direct impact on healthcare utilization with such patients representing a quarter of all hospital admissions annually, with a third of all patients having at least one emergency department visit every year.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] Despite these health consequences, efforts to improve medication safety for complex patients in outpatient settings have not been allocated the appropriate resources to be effective.\u003c/p\u003e \u003cp\u003eCommunity pharmacists are recognized as the champions of medication safety, not only through dispensing tasks but also by their expanding role in chronic care management (CCM).[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] CCM can include managing health problems and goals, medications, other providers, and community services that patients have and need. In many states, CCM also encompasses ordering and interpreting tests for chronic conditions, such as diabetes,[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] through collaborative practice agreements with providers, and ensuring patients receive appropriate screenings and immunizations. Such expanded practice was facilitated by the COVID-19 pandemic due to pharmacists being one of the few healthcare professionals providing face-to-face care and assuming clinical responsibilities when primary care physicians and nurses were managing COVID-19 emergencies.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eFurther, community pharmacists play a vital role in medically underserved communities,[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] such as in locations with too few primary care providers, high poverty or a high elderly population. Patients in these areas face difficulty or delays in getting basic health care because of long travel distances to providers, long wait times for appointments, or no providers who can serve uninsured or underinsured patients. As a result, pharmacists are considered accessible primary care practitioners, seeing patients five to eight times more frequently than do primary care physicians.[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] Numerous studies have demonstrated the ability of pharmacists to address medication non-adherence,[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] support naloxone provision and opioid safety counseling,[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] provide pain management and palliative care,[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] improve diabetes and cardiovascular outcomes,[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] and improve vaccination rates in medically underserved communities.[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eHowever, the abilities of community pharmacists to fill this gap are constrained by a work system that is unsustainable and essentially broken.[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] Pharmacies adhere to product-based reimbursement contracts with pharmacy benefit managers, incentivizing pharmacy staff to fill more prescriptions. As a result, for over a decade, pharmacists have reported high workload and burnout, with opaque corporate performance metrics based on prescription volume and customer service,[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] rather than on safety or clinical outcomes. COVID-19 exacerbated pharmacists\u0026rsquo; workload strain by adding testing and vaccinations to a system that is chronically understaffed and stretched beyond capacity. With pharmacist burnout rates at an all-time high, a call for action to improve pharmacist work systems is critical to prevent a complete collapse in America\u0026rsquo;s pharmacy system. Pharmacists across the United States have been executing a series of walkouts since September 2023 to improve harsh-working conditions and preventable errors in care.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] In Walgreens alone, 600 employees across 20 stores have participated in walkouts, resulting in multi-day disruptions to workflow and patient care.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] The purpose of these walkouts is to shed light on the need for a solution to improve the working conditions of pharmacy staff.\u003c/p\u003e \u003cp\u003eJuxtaposed to this era of pharmacists\u0026rsquo; unmanaged workload, there is a push for them to do more, as evidenced by the introduction of \u0026ldquo;provider status\u0026rdquo;.[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] Provider status will allow pharmacists who provide services such as CCM, comprehensive medication management, and immunizations to receive reimbursement for such clinical services, in addition to product-based dispensing services.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] This provides a timely opportunity for pharmacists to envision innovative designs to improve medication safety for their patients. To reimagine community pharmacies as an accessible destination for CCM, we must recognize the increased complexity of the community pharmacy work system. Similar to the increase in pharmacy staff responsibility related to the COVID-19 response, adding additional clinical services with the addition of reimbursement has potential implications for the quality and safety of pharmacist education, business practices, and dispensing. Opening up avenues for reimbursement that is not product based allows for stronger sustainability of expanded services and greater impact in their patient care practices, which can potentially fill a critical gap in Wisconsin, where two-thirds of its counties are medically underserved.[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThis opportunity to adopt new services and create coordinated care models can present a significant medication safety challenge. Community pharmacists\u0026rsquo; heroic response to COVID-19 demands created work systems that increased stress and negatively impacted their ability to ensure safe use of medications they dispense.[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] Pharmacist provider status can lead to sustainable and collaborative programs that holistically address complex patients\u0026rsquo; chronic care conditions. However, doing so without prospectively considering and testing for unintended consequences may negatively transform the community pharmacy work system, threatening the very medication safety strategies on which pharmacists have come to rely. The consequence of this reality is synergistic: high workload demands contribute to medication errors and ADEs, leading to pharmacists experiencing \u0026ldquo;learned helplessness\u0026rdquo; and lack of resiliency (or the ability to adapt to unpredictable work situations) in the face of these ADEs.[\u003cspan additionalcitationids=\"CR20 CR21\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/p\u003e\n\u003ch3\u003eApproaches to Medication Safety\u003c/h3\u003e\n\u003cp\u003eMany medication safety studies strive for \u0026ldquo;zero harm\u0026rdquo;[\u003cspan additionalcitationids=\"CR24\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] by focusing on \u0026ldquo;what went wrong\u0026rdquo; in the face of undesired outcomes, referred to as a Safety-I approach.[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] The traditional harm-reduction approach has been to conduct root cause analyses of errors and understand the contributing factors that led to the error, in order to reduce their incidence or mitigate their harm. A number of strategies have been encouraged based on this approach, including those developed and tested in our previous studies,[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] but the end result is frequently more constraints in a complex system that limits workers\u0026rsquo; ability to adapt. Such strategies end up limiting the capacity to adapt to practice demands and make the system more brittle, which can unintentionally lead to other medication safety hazards. Further, stacking isolated interventions does not lead to fundamental changes to the approach to medication safety. It is not surprising that little progress on substantive improvement has occurred in medication safety in the outpatient community pharmacy setting.[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eMedication safety must be considered in a new way that encompasses Safety-II, the \u0026ldquo;what went right\u0026rdquo; approach. Safety-II[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e] is based on resilience engineering, which focuses on understanding how resilient performance is achieved \u0026ndash; creating a work system that will attend to unexpected threats while also responding to opportunities.[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] Instead of framing safety as a linear failure-based model, we need to broaden the scope of inquiry to recognize the complexity and inherent variability in modern systems such as community pharmacies. Further, we need to shift beyond an exclusive consideration of ADEs and failures to also understand and strengthen a work system\u0026rsquo;s abilities to continuously create safety in everyday practice.[\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e] This goal is achieved by focusing on the abilities of a work system to: absorb significant stress before a disruption impacts safety, return to normal operations as quickly as possible and, importantly, adapt to undesirable situations. A system with adaptive capacity can anticipate disruptions and reorganize workflows using alternative paths to maintain successful work and minimize disruptions.[\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] An example of Safety-I and Safety-II approaches can be found in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eExamples of Safety-I and safety-II Approaches\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSafety-I Example\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSafety-II Example\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChecklists can decrease risk by imposing a\u003c/p\u003e \u003cp\u003estructured process, but may be\u003c/p\u003e \u003cp\u003ecounterproductive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhen a checklist restricts an unexpected\u003c/p\u003e \u003cp\u003esituation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; A checklist can be completed by rote, rather than thoughtfully\u003c/p\u003e \u003cp\u003e\u0026bull; A checklist may install a false sense of security when there is an assumption that all important items are contained in the checklist\u003c/p\u003e \u003cp\u003e\u0026bull; Current conditions may be different from the conditions under which the checklist was conceived\u003c/p\u003e \u003cp\u003e\u0026bull; The ability for workers to adapt to new conditions is lost\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Workers double-check facts against each other\u003c/p\u003e \u003cp\u003e\u0026bull; Workers are open and honest about explaining why they wish to deviate from the checklist\u003c/p\u003e \u003cp\u003e\u0026bull; There is a healthy skepticism about deviating from the checklist\u003c/p\u003e \u003cp\u003e\u0026bull; Workers ask for constructive criticism, ensuring that they are taking the best possible novel approach\u003c/p\u003e \u003cp\u003e\u0026bull; Workers embrace team members from other work systems for their \u0026ldquo;outside the box\u0026rdquo; thinking\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003eThe Patient Safety Learning Laboratory: ENRICH\u003c/h3\u003e\n\u003cp\u003eDespite numerous calls, there has not been a systematic engineering approach towards outpatient medication safety within community pharmacies. Previous PSLLs have evaluated the physical environment, socio-technological factors, and clinical workflow within inpatient and clinical settings but not within the outpatient community pharmacy settings.[\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e] This project, informed by resilience engineering, will address the challenges common in community pharmacies to achieve safe medication use in community-dwelling complex patients with multiple chronic conditions. The goal is to evolve from Safety-I approach to a combined Safety-I and Safety-II approach. The resulting outcome, the Engineering Resilient Community Pharmacies (ENRICH) Patient Safety Learning Laboratory (PSLL), is expected to gain knowledge of strategies for building resilience capacity in community pharmacy work systems in conducting CCM. PSLLs encompass a systematic engineering approach to allow cross-disciplinary professionals to evaluate clinical processes and approaches towards improvements in patient safety.[\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eOur long-term goal is to position the ENRICH PSLL as the premier center for medication and patient safety and CCM in community pharmacies. Despite our prior work, a current gap exists in the systematic application and evaluation of human factors and health systems engineering approaches to improve medication safety and staff work life in community pharmacies. Our PSLL, which is led by experts in human factors and health systems engineering, represents a foundational step towards the creation of a center to promote and normalize a Safety-I/Safety-II approach in pharmacy systems research. Our PSLL will include a focus on the use of the principles of dissemination and implementation research to enhance the potential for sustainability of improvements resulting from patient safety innovations. In addition, this PSLL is designed to generate ideas for future research projects and examine the implications and outcomes related to pharmacist \u0026ldquo;provider status,\u0026rdquo; which can serve to expand CCM to support complex patients living in medically underserved areas. The PSLL resulting from this study represents the beginning of a new paradigm, unprecedented in the pharmacy setting, for improving medication safety for community-dwelling patients with complex chronic disease.\u003c/p\u003e"},{"header":"Methods \u0026 Design","content":"\u003cp\u003eThe methods used for this project have demonstrated success with other healthcare practitioners and in other patient safety studies.[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] The Concepts for Applying Resilience Engineering (CARE) model guides our data collection, analysis, and interpretation (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Resilience is the ability for the community pharmacy work system to adjust its functioning prior to, during, and following sentinel or unexpected events, and thereby sustain operations under both expected and unexpected conditions.[\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e] It assumes that variability in the environment creates the need for adjustment. Work as Imagined (WAI) is conceptualized as the intended, or imagined, alignment between demands of the system (prescription volume, patient acuity) and the capacity to meet those demands. Demand and capacity can never completely align because of the complex nature of the system \u0026ndash; there will always be unforeseen demands that require workers to adjust in situ. In addition, workers do not simply comply with protocol but naturally adapt and innovate as part of taking control over their environment. In the CARE model, Work as Done (WAD) refers to the adjustments and the natural variability in how tasks are conducted. Predicting acceptable (what goes right) and unacceptable (what goes wrong) outcomes depends on an understanding of WAD in different demand and capacity circumstances. In this project, we will be using the concepts of WAI and WAD to identify the gap in how pharmacy staff plan their approaches to patient care and how they are able to actually fulfill their responsibilities.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eSince resilience also applies to the organizational level, and to adaptations in complex systems, it is essential to ensure that characteristics and adaptations of the entire work system are captured. To operationalize the discrete facets of the work system, we have used Systems Engineering Initiative for Patient Safety (SEIPS) 2.0, a human-factors engineering model to improve patient outcomes (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The SEIPS model has framed the design and analysis of many safety studies, including research we conducted in community pharmacies.[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan additionalcitationids=\"CR37\" citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e] The CARE and SEIPS models work well in tandem because both models contain feedback loops and account for the interconnectedness of work system components. In Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, \u0026ldquo;professional work\u0026rdquo; references both pharmacists and technicians. Patient work includes the work of the patient and their caregiver, which is essential to CCM.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy Sites\u003c/h2\u003e \u003cp\u003eTo ensure a complete understanding of the problems and implementation strategies of varied community pharmacy work systems, we will partner with three pharmacy organizations.\u003c/p\u003e \u003cp\u003e1. Advocate Health is the 10th largest non-for-profit, integrated health system in the U.S. with 70 community pharmacies that are geographically dispersed throughout urban and rural Wisconsin and Illinois.\u003c/p\u003e \u003cp\u003e2. UW Health is the integrated health system of the University of Wisconsin \u0026ndash; Madison, with twelve outpatient pharmacies.\u003c/p\u003e \u003cp\u003e3. Boscobel and Center Pharmacies are located in rural Southwest Wisconsin and are independently owned.\u003c/p\u003e \u003cp\u003eWithin each of these organizations, two pharmacies will participate that serve ethnically diverse populations and people in medically underserved areas that have high area deprivation indices based on income, education, employment, and housing quality, for a total of six pharmacy sites. In addition, all pharmacies will have at least read-only access to the electronic health records of their patients, which may serve as a tool to facilitate CCM.\u003c/p\u003e \u003cp\u003eWe will also partner with Fitchburg Family Pharmacy to conduct in-situ simulations, in which we will use simulated complex patient scenarios in a pharmacy itself rather than in training facilities, for the design and development phases (Aim 2) of the project. Fitchburg Family Pharmacy is a medium-sized urban independent pharmacy that provides CCM to a diverse patient population.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eProject Aims\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e describes our project structure: starting with problem analysis (Aim 1), continuing with design and development (Aim 2), which will lead to implementation and evaluation (Aim 3). An expert advisory board, comprised of transdisciplinary stakeholders, will be formed to provide us with high level consultation and content expertise for each of the three project aims. This board includes patients, caregivers, a pharmacy technician researcher, a pharmacy owner, primary care physicians, managers of independent, local, and chain pharmacies, and leaders of pharmacy and medical societies in Wisconsin.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eProject Structure Guided by the AHRQ RFA 5-Step Methodology\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5 Step Methodology\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eProblem Analysis\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDesign\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDevelopment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eImplementation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eEvaluation\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAims\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003e1: Identify and Prioritize\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e\u003cem\u003e2: Prototype and Simulate\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e\u003cem\u003e3: Pilot and Evaluate\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Observations \u0026amp; interviews\u003c/p\u003e \u003cp\u003e\u0026bull; Information flow diagraming\u003c/p\u003e \u003cp\u003e\u0026bull; Artifact analysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e\u0026bull; Participatory design\u003c/p\u003e \u003cp\u003e\u0026bull; Simulation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e\u0026bull; Time motion\u003c/p\u003e \u003cp\u003e\u0026bull; Pre/post evaluation\u003c/p\u003e \u003cp\u003e\u0026bull; Expert evaluation\u003c/p\u003e \u003cp\u003e\u0026bull; Surveys and interviews\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eOutputs\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Resilience narratives\u003c/p\u003e \u003cp\u003e\u0026bull; Functional Resilience Analysis Method diagrams\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e\u0026bull; Prototypes\u003c/p\u003e \u003cp\u003e\u0026bull; Ideal interactions\u003c/p\u003e \u003cp\u003e\u0026bull; Detailed design specifications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e\u0026bull; Impact of prototypes on process \u0026amp; outcomes\u003c/p\u003e \u003cp\u003e\u0026bull; Tools to assess capacity for resilience\u003c/p\u003e \u003cp\u003e\u0026bull; Implementation guide\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eAim 1: Identify and Define Design Requirements\u003c/h2\u003e \u003cp\u003eTo develop effective and sustainable interventions, an in-depth problem analysis of the work system must be conducted. Thus, the goal of this aim is to understand and map work system resilience, including how WAI differs from WAD, how adjustments are created, and how outcomes are generated. Iterative data collection and analysis will allow continual refinement and clarification of the work system.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eObservations\u003c/h2\u003e \u003cp\u003eIn-depth ethnographic observations will be conducted over four visits to each of the six pharmacy observation sites (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Study team members will debrief after each observation, as well as in-situ as needed, to adjust observation approaches or focus on specific aspects of the workflow. We will complete 24 hours of observations over four days. Observed artifacts that reflect WAI, such as policies and procedures, memory aids, and cognitive tools, will also be collected and recorded. Full descriptive field notes will be produced immediately after each observational session. Data will be collected concurrently at each setting, and researchers will work across all settings so that comparisons between the settings can inform ongoing data collection strategies.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eObservations at the Pharmacy Sites\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eHigh-Level Observation Questions\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e1. What contributes to variability in demand and capacity?\u003c/p\u003e \u003cp\u003e2. What misalignment occurs between demand and capacity, and why?\u003c/p\u003e \u003cp\u003e3. What pressures, problems, or goals are pharmacists and technicians responding to when they create new ways to achieve outcomes?\u003c/p\u003e \u003cp\u003e4. How and under what circumstances do adjustments or adaptations lead to successful and unsuccessful outcomes?\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVisit 1: Exploratory Evaluation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eVisits 2\u0026ndash;4: Observations\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Observe the pharmacy environment holistically\u003c/p\u003e \u003cp\u003e\u0026bull; Identify staff roles and responsibilities, processes, and procedures, flows of information and communication, coordinating mechanisms, and supporting tools and technology\u003c/p\u003e \u003cp\u003e\u0026bull; Identify interest areas for more precise and targeted observations in subsequent stages\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Observe the pharmacy staff\u003c/p\u003e \u003cp\u003e\u0026bull; In-depth observations of important processes such as shift change handoffs and medication reconciliation for patients during hospital discharge, as processes critical to providing CCM\u003c/p\u003e \u003cp\u003e\u0026bull; Short, structured, discussions and facilitated reflection from staff on aspects of the CARE model and using the SEIPS model components\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eInterviews\u003c/h2\u003e \u003cp\u003eSemi-structured interviews will be separately conducted with two pharmacists and two technicians from each of the six pharmacy locations to explore and follow up on issues from the prior observation stages to identify processes or areas for additional observation. Questions will focus on how people do their work and how they manage tricky situations, with probes about variability, adaptations, problems, and challenges. Interviews will be audio recorded and transcribed for analysis with participants\u0026rsquo; consent.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eData Analysis\u003c/h2\u003e \u003cp\u003eData Analysis will proceed in three stages. First, a combined deductive-inductive approach will be used to thematically analyze the observation and interview data. A coding scheme will be developed based on elements of the SEIPS model, as well as important themes in the data not captured by the model (see Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Categories will be developed by constantly refining the coding scheme, and comparisons will be made between different respondents, different pharmacies, and different processes.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAim 1 Observation and Interview Coding Scheme\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLevels\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eComparison of WAD and WAI\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTeams of Pharmacists \u0026amp; Technicians\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Interpersonal communication, including verbal and nonverbal\u003c/p\u003e \u003cp\u003e\u0026bull; Teamwork skills, including leadership and situation awareness\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Usability, flexibility, adjustability, and adaptability\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInternal Environment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Interruptions and distractions\u003c/p\u003e \u003cp\u003e\u0026bull; Lighting\u003c/p\u003e \u003cp\u003e\u0026bull; Physical ergonomics of workspace\u003c/p\u003e \u003cp\u003e\u0026bull; Crowding and disorganization\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTasks\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Task demands/workload\u003c/p\u003e \u003cp\u003e\u0026bull; Contextual changes, including situation deviations from normal or expected\u003c/p\u003e \u003cp\u003e\u0026bull; Production pressure\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOrganization\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Complexity, uncertainty, and risk\u003c/p\u003e \u003cp\u003e\u0026bull; Information flow, including quantity and pacing\u003c/p\u003e \u003cp\u003e\u0026bull; Culture and climate\u003c/p\u003e \u003cp\u003e\u0026bull; Policies and procedures\u003c/p\u003e \u003cp\u003e\u0026bull; Incentives and disincentives\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eSecond, guided by the CARE model, we will expand on the SEIPS coding scheme to construct Functional Resilience Analysis Method (FRAM) models[\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e] to visualize WAD, and to articulate the discrepancies between WAI and WAD. FRAM models allow all activities within selected processes to be visualized to show how they relate to each other and how they interact, based on 6 aspects: (1) input, (2) output, (3) pre-condition, (4) resources, (5) time, and (6) control, demonstrating the system\u0026rsquo;s complexity.[\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e] Each process within the community pharmacy is linked, which allows the study of variability of each process. That variability can produce amplified and unpredicted outcomes (either acceptable or unacceptable).[\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThird, the themes generated by the deductive-inductive approach and the FRAM models will be used to create resilience narratives describing trajectories of activity linking misalignments of demand and capacity, adjustments, adaptations, and outcomes. The narratives will focus on how adjustments and adaptations (WAD) mediate between pressures caused by misalignments of demand and capacity, and outcomes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eAim 2: Design and Develop MedSafeMap\u0026trade;\u003c/h2\u003e \u003cp\u003eStakeholder engaged participatory design and simulation-based research will be used in an iterative fashion to design and develop MedSafeMap\u0026trade;, a package of components to optimize pharmacy staff interactions within their work system and with patients and detailed pharmacy design recommendations. Standardized complex patient scenarios will be developed to have both internal validity and fidelity to the real-world pharmacy environment. The goal is to create MedSafeMap components that will ultimately lead to pharmacy staff resilience and optimized patient interactions around CCM.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eParticipatory Design\u003c/h2\u003e \u003cp\u003eParticipatory design is an approach to systems design that actively involves all stakeholders at several stages of the innovation process to help ensure that the result meets their needs and is usable.[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] Two stakeholder groups will be used: one group consisting of five community pharmacists and one group consisting of five technicians.\u003c/p\u003e \u003cp\u003eStakeholder group meetings will be held six times, approximately every 6\u0026ndash;8 weeks. The first four meetings will be held with the pharmacists and technicians separately, since they have different work responsibilities, tasks, and concerns. We also want technicians to fully engage in MedSafeMap development without a pharmacist presence imposing a power differential. The resilience narratives and FRAM diagrams developed in Aim 1, which demonstrate variability and resilience potential, will inform the design and development of the MedSafeMap. We will focus on the processes required to conduct CCM for complex patients, including the possibility of a communication tool to support discussion of alternatives, enhanced instructions for patients, and cognitive aids to support memory. The final two meetings will involve MedSafeMap refinement. To do so, we will bring the pharmacist and technician groups together to work collaboratively. Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e provides a list of anticipated or possible MedSafeMap components. Completed MedSafeMap components will be peer reviewed by our advisory board to confirm that they will reproduce the experience in a real-world pharmacy. Scenarios will be piloted in the in-situ simulated setting and refined prior to implementation in Aim 3.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCurrent Interactions and potential MedSafeMap Components to Encourage Ideal Interactions\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCurrent Interactions\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePotential MedSafeMap Components\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; CCM is seen as important but has an impact on workload, which is a barrier to sustained services\u003c/p\u003e \u003cp\u003e\u0026bull; Fragmented information across providers\u003c/p\u003e \u003cp\u003e\u0026bull; Medication information gap (e.g., multiple pharmacies, no diagnoses or lab values)\u003c/p\u003e \u003cp\u003e\u0026bull; Busy retail pharmacies lead to reduced interactions with patients\u003c/p\u003e \u003cp\u003e\u0026bull; Coordination gap between pharmacists and caregivers, patients, and providers\u003c/p\u003e \u003cp\u003e\u0026bull; Technicians limited by traditional roles\u003c/p\u003e \u003cp\u003e\u0026bull; Medication concerns not adequately addressed\u003c/p\u003e \u003cp\u003eo Limited support and space for shared decision making\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; \u003cb\u003eModeling behaviors\u003c/b\u003e\u003c/p\u003e \u003cp\u003eo Tactics to overcome communication barriers in pharmacies and engage providers\u003c/p\u003e \u003cp\u003eo Patient/family supports to bridge information gap\u003c/p\u003e \u003cp\u003e\u0026bull; \u003cb\u003eInformation support\u003c/b\u003e\u003c/p\u003e \u003cp\u003eo Use technology or low-tech strategies to \u0026ldquo;push\u0026rdquo; eligible patients into the pharmacy workflow\u003c/p\u003e \u003cp\u003eo Create mechanisms to include caregivers prior to, in appointment, and follow up\u003c/p\u003e \u003cp\u003e\u0026bull; \u003cb\u003eCognitive Aids\u003c/b\u003e\u003c/p\u003e \u003cp\u003eo Physical structures to improve pharmacists\u0026rsquo; and technicians\u0026rsquo; situation awareness\u003c/p\u003e \u003cp\u003eo Supports to address high priority medication needs\u003c/p\u003e \u003cp\u003e\u0026bull; \u003cb\u003eCollaborative work support\u003c/b\u003e\u003c/p\u003e \u003cp\u003eo Facilitate a \u0026ldquo;huddle\u0026rdquo; between pharmacist sand technician to create appointment agenda, anticipate patient challenges, review monitoring needs\u003c/p\u003e \u003cp\u003e\u0026bull; \u003cb\u003eRole clarity and cross training\u003c/b\u003e\u003c/p\u003e \u003cp\u003eo Empowering technicians as equal partners and health leaders in the community pharmacy\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSimulation-Based Research\u003c/h2\u003e \u003cp\u003eIn situ simulation,[\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e] or simulation in an actual community pharmacy, will then be conducted to study the ergonomics and physicality of the work setting on performance. In situ simulations also will promote process and MedSafeMap refinement before deployment in actual pharmacies.\u003c/p\u003e \u003cp\u003eThe final two stakeholder meetings also will involve three rapid adaptive simulation cycles for MedSafeMap refinement (see Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Each simulation cycle will include 5 different standardized patients (hired for the study). Each patient will represent one of five different complex CCM scenarios that will include at least two chronic conditions and at least one social determinant of health (e.g., low health literacy patient with diabetes and congestive heart failure who is non-adherent to medications). Staffing and equipment, level of complexity, and other critical indicators identified in the participatory design will vary, and allow for comparisons, across the five patient scenarios. Creating robust and standard scenarios is important to mitigate threats to internal validity. Thus, we will devote considerable time to ensuring that the MedSafeMap may be utilized in different patient cases, and in different community pharmacy settings (i.e., are pharmacy agnostic).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eTen pharmacist/technician dyads will be recruited to participate in each adaptive simulation cycle. In each adaptive cycle, the pharmacy/technician dyad will complete the simulation five times, once for each standardized patient. The process will be replicated for each of the 10 pharmacy dyads resulting 50 simulations per adaptive cycle. At the completion of each cycle, the study team will then utilize the data collected combined with significant reflection and formative evaluation to refine the MedSafeMap that facilitates resilience and encourages adaption by pharmacy staff.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eData Collection\u003c/h2\u003e \u003cp\u003eFour wide-angle video cameras will be used to record the simulation from locations that best capture how pharmacy staff interact with the physical space, communicate, and share information, and use artifacts within the work system. In addition, two sets of eye tracking glasses (Tobii Pro Glasses)[\u003cspan additionalcitationids=\"CR45\" citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e] \u0026ndash; one each for the pharmacist and the technician \u0026ndash; will be deployed to track eye movement in the natural world, which will inform the development of prototypes. Specifically, as pharmacy staff navigate the physical pharmacy space, the glasses collect data that will provide an understanding about which artifacts are most instrumental to performing CCM, factors that influence pharmacy staff and patient decision-making, and workflow. Gaze data will be recorded as pharmacy staff read and review information on prescriptions and prescription profiles on the pharmacy electronic health record, and interact and educate patients.[\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e, \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e] Aim 2 will be accomplished in three steps, conceptualized in Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAim 2 Data Collection Procedures\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStep 1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStep 2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStep 3\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTasks\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Record simulations\u003c/p\u003e \u003cp\u003e\u0026bull; Document individual and collective behavior\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; Introduce MedSafeMap and record simulations\u003c/p\u003e \u003cp\u003e\u0026bull; Simulate with 10 pharmacist/technician dyads for each of five different standardized patients\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026bull; Conduct individual debrief interviews with the pharmacists and technicians following completion of each simulated scenario\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGoal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Identify patterns of interactions and thought processes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; Reproduce situations identically to increase confidence in the MedSafeMap\u0026rsquo;s ability\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026bull; Gain insight into the thoughts and cognitive processes of pharmacists and technicians\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eOutput\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Descriptive account of how community pharmacy staff make decisions or share information\u003c/p\u003e \u003cp\u003e\u0026bull; Understanding rare events such as sentinel medication errors\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; Explain variation in the outcome of interest\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026bull; Understand participants\u0026rsquo; perceptions of (1) understanding the problem situation, (2) assessing prototype feasibility, (3) evaluating the effect of the prototype, and (4) optimizing the design and implementation of the prototype\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eData Analysis\u003c/h2\u003e \u003cp\u003eObservational checklists will be used to code participant behavior recorded on the videos, thereby assessing MedSafeMap feasibility and effectiveness. The recordings from the wide-angle video cameras and eye tracking glasses will be analyzed for themes between participants and across sites by assessing what areas of interest participants fixate on for extended periods of time. Using gaze duration as a proxy for wearer attention provides insights into which elements of MedSafeMap are influential in shaping pharmacy staff behavior. For example, if one of the components of MedSafeMap includes a technician training to \u0026ldquo;speak up\u0026rdquo; when they are concerned that the pharmacist missed a medication related problem, we can respectively code the reactions of the pharmacist and technician based on the videos.[\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eQualitative data from pharmacist and technician stakeholder meetings will be subjected to a rigorous analytic approach.[\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan additionalcitationids=\"CR52 CR53\" citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e] We will use deductive content analysis, inductive patterns, themes and categories in our data, guided by our theory-based approach.[\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e] A conceptual coding structure will be created and as each interview transcript is added to the analysis, passages will be classified according to existing codes, and codes will be added as needed. Inductive content analysis will also be conducted to determine unanticipated work system characteristics that may facilitate or inhibit resilience.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eAim 3: Implement and Pilot Test MedSafeMap\u003c/h2\u003e \u003cp\u003eAlthough simulation-based research can have high internal validity by controlling the highly standardized scenarios that will be developed in Aim 2, it is critical to implement and evaluate MedSafeMap \u0026ldquo;in real life\u0026rdquo; where WAD diverges from WAI and to address external validity concerning pharmacy work systems relevant to CCM. With this approach, we can determine if changes in performance can be attributed to MedSafeMap rather than other external (e.g., regulatory changes) or internal elements (e.g., updates to electronic health records), and how such elements can affect MedSafeMap performance or impact. The six community pharmacies that participated in Aim 1 observations and interviews will implement MedSafeMap for optimal interactions designed in Aim 2.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eImplementation and Adaptation\u003c/h2\u003e \u003cp\u003eA stepped wedge design[\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e] will be employed, where the MedSafeMap will be sequentially implemented in two clusters, each cluster comprising of three pharmacies (one pharmacy from each organization) (see Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). The two pharmacies from each organization will be randomized into the two clusters. Each cluster will commence with baseline pre-test data collection and then cross-over from the control condition (pre-implementation) to the intervention condition, where a formative evaluation of MedSafeMap and the strategies from the Implementation Guide will be conducted. This evaluation will be performed for each cluster 4 months into its implementation period to consider \u0026ldquo;what might be missing, what sociotechnical factors had not been considered and to identify \u0026lsquo;bugs and glitches\u0026rsquo; that still need to be addressed.\u0026rdquo;[\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e] The evaluation will include one day of observations by shadowing pharmacy staff and may involve short discussions and facilitated reflection from staff at each of the three pharmacies in Cluster 1. Those observations will be brought back to the research team and advisory board to identify opportunities to improve MedSafeMap. Following the formative evaluation in Cluster 1, we will refine and improve MedSafeMap and implementation strategies to mitigate vulnerabilities or unintended consequences that may expose patients to new harms or further the work burden of pharmacists and technicians. The adapted MedSafeMap and implementation strategies will be deployed for Cluster 2, which will also undergo a similar evaluation. It is possible that minor adaptations will be made, if necessary, before subjecting the cluster to a post-test evaluation.[\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e]\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eEvaluation\u003c/h2\u003e \u003cp\u003eWe will use a sequential explanatory design in which the initial data is quantitative (time and motion study, work volume) and complemented by qualitative data (interviews, medication error reporting). This mixed-methods approach will allow the research team to understand variables individually and determine which ones will require further analysis. In line with the CARE and SEIPS 2.0 models, we will collect and analyze data that reflect workflow and care processes, and the perspectives of pharmacists and technicians.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eTime and Motion Study\u003c/h2\u003e \u003cp\u003eOur evaluation goal is to examine the impact of MedSafeMap on pharmacists\u0026rsquo; and technicians\u0026rsquo; ability to be resilient \u0026ndash; that is, to successfully attend to unexpected threats while also responding to opportunities,[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] such as CCM. To do so, we must understand clinical work processes and the way that care is delivered to patients. We anticipate that MedSafeMap will impact the way that pharmacists and technicians perform their work and the ways in which they engage each other and their patients. Time and motion studies have been used to measure clinical workflow related factors, including time task distributions, frequency of multitasking and interruptions, and who completes tasks with a goal of improving efficiency.[\u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e, \u003cspan citationid=\"CR59\" class=\"CitationRef\"\u003e59\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eWe will conduct observations before and after the adapted MedSafeMap. Using the observational data collected in Aim 1, we will develop a pharmacy work task classification (see Table\u0026nbsp;\u003cspan refid=\"Tab7\" class=\"InternalRef\"\u003e7\u003c/span\u003e). The classifications will be incorporated in the Work Observation Method by Activity Timing (WOMBAT) program to allow for the consistent recording of observational data.[\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e, \u003cspan citationid=\"CR61\" class=\"CitationRef\"\u003e61\u003c/span\u003e] WOMBAT allows observers to time the start and end of tasks, and to record multiple simultaneous tasks using the multitasking function. If an external factor appears to cause a pharmacist or technician to stop performing one task and start another task, an \u0026ldquo;interruption\u0026rdquo; can be recorded.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab7\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 7\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePharmacy Work Task Classifications\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWork Task Classification\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExamples\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhat \u0026ndash; the task being performed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCounseling, communication with prescriber\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhere \u0026ndash; the physical location where the task is undertaken\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBehind desk, office, front of OTC counter\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWith whom \u0026ndash; who the pharmacy staff was with when performing the task\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAlone, patient, technician, student\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHow \u0026ndash; any tools used to complete the task\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePhone, face to face, computer\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eObserver Training\u003c/h2\u003e \u003cp\u003ePrior to MedSafeMap implementation and baseline data collection, two observers will be trained to use the WOMBAT program. Data collection will begin when simultaneous but independent observations of the same events, such as those seen in Table\u0026nbsp;\u003cspan refid=\"Tab7\" class=\"InternalRef\"\u003e7\u003c/span\u003e, yield an inter-rater reliability score of at least 85%.[\u003cspan citationid=\"CR62\" class=\"CitationRef\"\u003e62\u003c/span\u003e]\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eData Collection\u003c/h2\u003e \u003cp\u003eObservations will be purposely scheduled across a variety of weekday shifts to maximize data variability and capture the full pharmacy workday. One observer will shadow a pharmacist equipped with a tablet with the WOMBAT software installed on it, while, at the same time, a similarly-equipped second observer will shadow a technician. In total, two pharmacists and two technicians will be observed at each pharmacy. Observations will be limited to three, two-hour, sessions per day, each separated by a brief break to reduce participant/observer fatigue. During each break, observers will memo any thoughts for future questions or more in-depth observation. The pharmacists and technicians will be observed for 36 hours both pre- and post-implementation, for a total of 72 hours. We estimate observing tasks across 72 hours in each pharmacy,[\u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e] yielding a total of 432 hours across the six participating pharmacies.[\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e, \u003cspan citationid=\"CR63\" class=\"CitationRef\"\u003e63\u003c/span\u003e]\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eData Analysis\u003c/h2\u003e \u003cp\u003eTo assess changes in pharmacists\u0026rsquo; and technicians\u0026rsquo; task time distribution post-implementation, we will calculate the proportion of total observed time in each task category by study period (pre- versus post-implementation) for each pharmacy. The proportions of total observed time where pharmacists completed tasks with technicians or alone and using different information tools will also be calculated for each pharmacy. To assess the extent to which the introduction of MedSafeMap increased opportunities for pharmacists and technicians to engage with patients in CCM, we will examine changes to the time pharmacists and technicians spent in (1) discussions with each other on responding to opportunities (i.e., identifying complex patients who would benefit from CCM) and attend to unexpected threats (i.e., personnel absences) and (2) discussions with patients about medications.[\u003cspan citationid=\"CR63\" class=\"CitationRef\"\u003e63\u003c/span\u003e] Z-tests for proportions will be used to compare the extent of pre- and post-implementation change in the proportion of total observed time for each task category in each pharmacy site. A p\u0026thinsp;\u0026lt;\u0026thinsp;.05 significance level will be used, as well as Holm approaches to account for multiple comparisons, with 95% confidence intervals based on the large sample normal approximation.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003ePharmacy Reported Data\u003c/h2\u003e \u003cp\u003eWe anticipate that MedSafeMap will support pharmacists\u0026rsquo; and technicians\u0026rsquo; ability to embed CCM and other clinical services into their workflow, which will improve the quality of patient care, ideally without increasing workload. To assess perceived changes in service provision, pharmacists and technicians will be administered a validated subjective workload survey.[\u003cspan citationid=\"CR64\" class=\"CitationRef\"\u003e64\u003c/span\u003e] The number and type of documented medication-related problems during CCM services[\u003cspan citationid=\"CR65\" class=\"CitationRef\"\u003e65\u003c/span\u003e] that are identified and resolved for six months prior to and 12 months following MedSafeMap implementation also will be collected. Pre/post comparisons of services provided and medication-related problems that they averted will be conducted.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003ePharmacist and Technician Evaluation\u003c/h2\u003e \u003cp\u003eWe also want to gain a more in-depth understanding of how MedSafeMap changed attitudes, behaviors, and performance. It is expected that pharmacists and technicians will feel more resilient after MedSafeMap implementation. That is, they will feel more \u0026ldquo;capable, facilitated and supported by the organization, to utilize resources to continually adapt and flourish at work, even if/when faced with challenging circumstances.\u0026rdquo;[\u003cspan citationid=\"CR66\" class=\"CitationRef\"\u003e66\u003c/span\u003e] This construct will be represented through the Employee Resilience Scale,[\u003cspan citationid=\"CR67\" class=\"CitationRef\"\u003e67\u003c/span\u003e] a measure of behavioral elements such as learning orientation, proactive posture, positive outlook, network leveraging, and adaptive capacity.\u003c/p\u003e \u003cp\u003ePharmacists and technicians also are likely to eventually feel a greater sense of shared responsibility and teamwork, which would create an environment that enhances the medication safety of their patients. This construct will be represented through the NASA-developed Cockpit Management Attitudes Questionnaire,[\u003cspan citationid=\"CR68\" class=\"CitationRef\"\u003e68\u003c/span\u003e, \u003cspan citationid=\"CR69\" class=\"CitationRef\"\u003e69\u003c/span\u003e] comprising three scales \u0026ndash; Communication and Coordination, Command Responsibility, and Recognition of Stressor Effects \u0026ndash; which have application to the pharmacy work system.\u003c/p\u003e \u003cp\u003eBecause we are working with a small number of pharmacists and technicians, and because we want to do an in-depth exploration of pharmacy staff attitudes and behaviors, we will adapt the Employee Resilience and Cockpit Management Attitudes Questionnaire items into an interview guide that will include semi-structured probes. Eight months following MedSafeMap implementation, interviews will be conducted using a retrospective pre-/post-test design approach[\u003cspan citationid=\"CR70\" class=\"CitationRef\"\u003e70\u003c/span\u003e, \u003cspan citationid=\"CR71\" class=\"CitationRef\"\u003e71\u003c/span\u003e] by asking, \u0026ldquo;Compared to before MedSafeMap was implemented, ...\u0026rdquo; This approach is appropriate because it is pragmatic, less time-consuming, eliminates the impact of response-shift bias,[\u003cspan citationid=\"CR70\" class=\"CitationRef\"\u003e70\u003c/span\u003e] and has been used successfully in pharmacy studies.[\u003cspan citationid=\"CR72\" class=\"CitationRef\"\u003e72\u003c/span\u003e, \u003cspan citationid=\"CR73\" class=\"CitationRef\"\u003e73\u003c/span\u003e] Questions will prompt insights into the impact of MedSafeMap on pharmacist and technician resilience, teamwork, and shared responsibility. Interview data will be subjected to the same rigorous qualitative data analysis techniques described in Aim 1.\u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eOutcomes\u003c/h2\u003e \u003cp\u003eStudy outcomes are targeted to help populations of medication safety researchers and organizational leaders responsible for implementing proven practices. A summary of the anticipated outcomes can be found in Table\u0026nbsp;\u003cspan refid=\"Tab8\" class=\"InternalRef\"\u003e8\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab8\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 8\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAim 1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAim 2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAim 3\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Resilience narratives and FRAM models that are context rich and context dependent\u003c/p\u003e \u003cp\u003e\u0026bull; Potential to uncover anticipated relationships between variables that can be tested in the subsequent aims to inform the development of the MedSafeMap\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Components of MedSafeMap that support CCM in community pharmacies\u003c/p\u003e \u003cp\u003e\u0026bull; MedSafeMap that may include designs that re-align currently-existing tasks, coordinate tasks with different pharmacy staff members, or incorporate new practices\u003c/p\u003e \u003cp\u003e\u0026bull; MedSafeMap that may include tools to facilitate pharmacist/patient and pharmacist/prescriber collaboration, or tools to provide cognitive support for pharmacists and technicians to anticipate crises or other problems\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; Quantitative and qualitative evaluation of the impact of MedSafeMap on community pharmacy processes and outcomes\u003c/p\u003e \u003cp\u003e\u0026bull; Toolkit to assess capacity and resilience\u003c/p\u003e \u003cp\u003e\u0026bull; Implementation Guide\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe prevailing Safety-I approach for improving medication safety has emphasized retrospective incident analysis, reactive measures targeted at past problems, human error as an explanation, and control of work through procedural compliance and outcome monitoring.[\u003cspan citationid=\"CR74\" class=\"CitationRef\"\u003e74\u003c/span\u003e] This approach has proven to be insufficient and frustratingly slow at achieving \"zero harm\" in outpatient settings, and specifically the community pharmacy.[\u003cspan citationid=\"CR75\" class=\"CitationRef\"\u003e75\u003c/span\u003e] Such a lack of success stems from investigating medication errors through root cause analysis, which assumes a shortsighted linear cause-and-effect model, rather than a complex model.[\u003cspan citationid=\"CR76\" class=\"CitationRef\"\u003e76\u003c/span\u003e] Finally, importantly, these approaches create a negative psychological impact on staff by creating a culture of blame.[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR77\" class=\"CitationRef\"\u003e77\u003c/span\u003e, \u003cspan citationid=\"CR78\" class=\"CitationRef\"\u003e78\u003c/span\u003e]\u003c/p\u003e \u003cdiv id=\"Sec27\" class=\"Section2\"\u003e \u003ch2\u003eStrengths\u003c/h2\u003e \u003cp\u003eThis study will be the first to operationalize resilience engineering to include a Safety-II approach to medication safety in community pharmacies. The vast majority of safety studies involving community pharmacies assume a linear work process, which limits understanding of community pharmacies as complex work systems. Our research demonstrates that work is not conducted linearly, but rather is comprised of interdependent processes.[\u003cspan citationid=\"CR79\" class=\"CitationRef\"\u003e79\u003c/span\u003e] The use of the innovative FRAM model will provide a robust model to map multiple processes and their variability, which can inform co-design of potential solutions.[\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e, \u003cspan citationid=\"CR80\" class=\"CitationRef\"\u003e80\u003c/span\u003e, \u003cspan citationid=\"CR81\" class=\"CitationRef\"\u003e81\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThis project will prioritize and emphasize the role of pharmacy technicians as critical members of the community pharmacy work system. Expedited during the COVID-19 pandemic, technicians are increasingly being recognized for their willingness to assume new roles and adapt to changing environments.[\u003cspan citationid=\"CR82\" class=\"CitationRef\"\u003e82\u003c/span\u003e] Technicians have proven themselves effective in collecting patient medication histories,[\u003cspan citationid=\"CR83\" class=\"CitationRef\"\u003e83\u003c/span\u003e] administrative functions associated with vaccinations, and even providing immunizations to patients.[\u003cspan citationid=\"CR84\" class=\"CitationRef\"\u003e84\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eProvider Status, a new legal designation authorizing Medicaid reimbursement to pharmacists\u0026rsquo; services, presents both a timely opportunity to evaluate how increased or broadening responsibilities can be adopted while improving quality of care and medication safety. Legal endorsement to \u0026ldquo;stretch professional boundaries and envision innovative designs\u0026rdquo;[\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e] is the perfect circumstance in which to move the needle on outpatient medication safety through the design of the next generation of community pharmacies. Pharmacists and technicians, depleted by the unrelenting workload and additional responsibilities from COVID-19, find the Safety-II approach to be attractive.[\u003cspan citationid=\"CR75\" class=\"CitationRef\"\u003e75\u003c/span\u003e] Safety-II also better represents and supports a culture of safety because it accurately portrays the constant variability of pharmacy work, the need for adjustment, and the importance of flexible adaptation in producing outcomes.\u003c/p\u003e \u003cp\u003eIntroducing and utilizing a Safety-II approach will provide the test bed, tools, metrics, and frameworks to build the ENRICH PSLL. This new paradigm of approaching CCM with resilience engineering methodologies to improve quality in community pharmacies could then be disseminated to and adopted by medication safety researchers around the country.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eParticipant bias caused by sensitivity to researcher\u0026rsquo;s presence is a recognized risk in qualitative observational studies but can be minimized by ensuring that observers have frequent presence in the research setting, which can lead to habituation to their presence, researcher\u0026rsquo;s sensitivity to and respect for pharmacy staff\u0026rsquo; concerns, and their ability to build relationships and trust. Risk of measurement bias will be reduced by having two researchers collecting data only after achieving a satisfactory inter-rater reliability rate, ensuring that differences in interpretation can be identified, discussed, and resolved before full data collection is accomplished.\u003c/p\u003e \u003cp\u003eWe will use one simulation site, despite being aware that community pharmacies have very different work systems. We also know that using multiple simulation sites would increase the generalizability of findings and enable comparison between sites. However, utilizing simulations to evaluate prototypes that focus on workflow changes related to CCM is unprecedented in community pharmacies, so we want to begin with a single setting to ensure a robust infrastructure to evaluate such simulations. To expand our understanding beyond the single work system exemplified by the simulation site, we will seek input from advisory board members who will provide feedback on the feasibility of implementing MedSafeMap in their diverse community pharmacy settings.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eCommunity pharmacies have experienced a great deal of change in the last decade alone. With an increase in responsibilities due to the pandemic, as well as changes to the healthcare structure that increases their workload, pharmacy staff are becoming increasingly burnt out. Coupled with high turnover rates and understaffing concerns, there is an unprecedented risk of safety errors and resulting patient harm. To allow staff to take on these responsibilities as CCM providers, we must find a way to manage the workload and optimize resources. We are in a unique position to provide support directly to the pharmacies and give them a voice to influence change in the pharmacy work system. Through this PSLL, we can rethink the current safety approaches and develop an improved work system for medication safety, resulting in improved work conditions for pharmacy staff and increased patient care.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cul\u003e\n \u003cli\u003eAdverse drug event (ADE)\u003c/li\u003e\n \u003cli\u003eChronic Care Management (CCM)\u003c/li\u003e\n \u003cli\u003eConcepts for Applying Resilience Engineering (CARE)\u003c/li\u003e\n \u003cli\u003eEngineering Resilient Community Pharmacies (ENRICH)\u003c/li\u003e\n \u003cli\u003eFunctional Resilience Analysis Method (FRAM)\u003c/li\u003e\n \u003cli\u003ePatient Safety Learning Laboratory (PSLL)\u003c/li\u003e\n \u003cli\u003eSystems Engineering Initiative for Patient Safety (SEIPS)\u003c/li\u003e\n \u003cli\u003eWork as done (WAD)\u003c/li\u003e\n \u003cli\u003eWork as imagined (WAI)\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cu\u003eEthics approval and consent to participate\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll human subjects research described will be reviewed and approved by the University of Wisconsin \u0026ndash; Madison Institutional Review Board. Aim 1 has been approved (study ID: 2023-1100), and all other aims will be reviewed and approved before beginning any human subjects research.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eConsent for publication\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAvailability of data and materials\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData is not yet available for this study. Future data will be made available in adherence with the NIH Data Management and Sharing policy.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eCompeting interests\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMC is a co-owner of Fitchburg Family Pharmacy, which serves as the simulation site for this project. MC will not receive any payment for the use of the pharmacy for this project. The other authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eFunding support\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported by the\u0026nbsp;Agency for Healthcare Research and Quality\u0026nbsp;(grant number\u0026nbsp;R18HS029608).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAuthors\u0026rsquo; contributions\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMC and JF initiated the project as co-principal investigators of the study and jointly supervised the writing of this protocol. AG, JS, and EL contributed to the conceptualization of the research study. JS managed and coordinated research activity. MC, MB, AG, JS, and JF drafted the initial manuscript. MB collected and organized the relevant data for publication. MB and EH updated proposed models and created new graphics. All authors contributed to the revision process. All authors read and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAcknowledgements\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eButtorff C, Ruder T, Bauman M: \u003cstrong\u003eMultiple Chronic Conditions in the United States\u003c/strong\u003e. Santa Monica, CA: RAND Corporation; 2017.\u003c/li\u003e\n\u003cli\u003eMedicine Io: \u003cstrong\u003eStandardizing Medication Labels: Confusing Patients Less: Workshop Summary\u003c/strong\u003e. Washington, DC: The National Academies Press; 2008.\u003c/li\u003e\n\u003cli\u003eMedicine Io: \u003cstrong\u003ePreventing Medication Errors\u003c/strong\u003e. Washington, DC: The National Academies Press; 2007.\u003c/li\u003e\n\u003cli\u003eMossialos E, Courtin E, Naci H, Benrimoj S, Bouvy M, Farris K, Noyce P, Sketris I: \u003cstrong\u003eFrom \u0026quot;retailers\u0026quot; to health care providers: Transforming the role of community pharmacists in chronic disease management\u003c/strong\u003e. \u003cem\u003eHealth Policy \u003c/em\u003e2015, \u003cstrong\u003e119\u003c/strong\u003e(5):628-639.\u003c/li\u003e\n\u003cli\u003eComo M, Carter CW, Larose-Pierre M, O\u0026apos;Dare K, Hall CR, Mobley J, Robertson G, Leonard J, Tew L: \u003cstrong\u003ePharmacist-Led Chronic Care Management for Medically Underserved Rural Populations in Florida During the COVID-19 Pandemic\u003c/strong\u003e. \u003cem\u003ePreventing Chronic Disease \u003c/em\u003e2020, \u003cstrong\u003e17\u003c/strong\u003e:E74.\u003c/li\u003e\n\u003cli\u003eManolakis PG, Skelton JB: \u003cstrong\u003ePharmacists\u0026apos; contributions to primary care in the United States collaborating to address unmet patient care needs: the emerging role for pharmacists to address the shortage of primary care providers\u003c/strong\u003e. \u003cem\u003eAm J Pharm Educ \u003c/em\u003e2010, \u003cstrong\u003e74\u003c/strong\u003e(10):S7.\u003c/li\u003e\n\u003cli\u003eTsuyuki RT, Beahm NP, Okada H, Al Hamarneh YN: \u003cstrong\u003ePharmacists as accessible primary health care providers: Review of the evidence\u003c/strong\u003e. \u003cem\u003eCan Pharm J (Ott) \u003c/em\u003e2018, \u003cstrong\u003e151\u003c/strong\u003e(1):4-5.\u003c/li\u003e\n\u003cli\u003eLe LD, Paulk IR, Axon DR, Bingham JM: \u003cstrong\u003eComprehensive Medication Review Completion in Medically Underserved Areas and Populations\u003c/strong\u003e. \u003cem\u003eJ Health Care Poor Underserved \u003c/em\u003e2021, \u003cstrong\u003e32\u003c/strong\u003e(3):1301-1311.\u003c/li\u003e\n\u003cli\u003eBratberg JP: \u003cstrong\u003eOpioids, naloxone, and beyond: The intersection of medication safety, public health, and pharmacy\u003c/strong\u003e. \u003cem\u003eJournal of the American Pharmacists Association: JAPhA \u003c/em\u003e2017, \u003cstrong\u003e57\u003c/strong\u003e(2S):S5-S7.\u003c/li\u003e\n\u003cli\u003ePayne R, Medina E: \u003cstrong\u003eDelivering Pain Management and Palliative Care in Medically Underserved Communities: Issues and Perspectives\u003c/strong\u003e. \u003cem\u003eMedicine of the Americas \u003c/em\u003e2001, \u003cstrong\u003e2\u003c/strong\u003e(1):65-65.\u003c/li\u003e\n\u003cli\u003eEnfinger F, Campbell K, Taylor RJ: \u003cstrong\u003eCollaboration with pharmacy services in a family practice for the medically underserved\u003c/strong\u003e. \u003cem\u003ePharm Pract (Granada) \u003c/em\u003e2009, \u003cstrong\u003e7\u003c/strong\u003e(4):248-253.\u003c/li\u003e\n\u003cli\u003eMurphy PA, Frazee SG, Cantlin JP, Cohen E, Rosan JR, Harshburger DE: \u003cstrong\u003ePharmacy provision of influenza vaccinations in medically underserved communities\u003c/strong\u003e. \u003cem\u003eJournal of the American Pharmacists Association: JAPhA \u003c/em\u003e2012, \u003cstrong\u003e52\u003c/strong\u003e(1):67-70.\u003c/li\u003e\n\u003cli\u003eMc Namara KP, Dunbar JA, Philpot B, Marriott JL, Reddy P, Janus ED: \u003cstrong\u003ePotential of pharmacists to help reduce the burden of poorly managed cardiovascular risk\u003c/strong\u003e. \u003cem\u003eAust J Rural Health \u003c/em\u003e2012, \u003cstrong\u003e20\u003c/strong\u003e(2):67-73.\u003c/li\u003e\n\u003cli\u003eFadare OO, Doucette WR, Gaither CA, Schommer JC, Arya V, Bakken BK, Kreling DH, Mott DA, Witry MJ: \u003cstrong\u003eExploring the moderating role of job resources in how job demands influence burnout and professional fulfillment among U.S. pharmacists\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2022, \u003cstrong\u003e18\u003c/strong\u003e(10):3821-3830.\u003c/li\u003e\n\u003cli\u003eGoodkind NR, E.: \u003cstrong\u003eCVS and Walgreens pharmacy staff begin 3-day walkout\u003c/strong\u003e. In: \u003cem\u003eCNN.\u003c/em\u003e waow.com; 2023.\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eWisconsin Legislature: 2021 Wisconsin Act 98\u003c/strong\u003e. 2023.\u003c/li\u003e\n\u003cli\u003eSchommer JC, Olson AW, Isetts BJ: \u003cstrong\u003eTransforming community-based pharmacy practice through financially sustainable centers for health and personal care\u003c/strong\u003e. \u003cem\u003eJournal of the American Pharmacists Association: JAPhA \u003c/em\u003e2019, \u003cstrong\u003e59\u003c/strong\u003e(3):306-309.\u003c/li\u003e\n\u003cli\u003eSchommer JC, Lee S, Gaither CA, Alvarez NA, Shaughnessy AM: \u003cstrong\u003eImproving the Experience of Providing Care in Community-Based Pharmacies\u003c/strong\u003e. \u003cem\u003ePharmacy (Basel, Switzerland) \u003c/em\u003e2022, \u003cstrong\u003e10\u003c/strong\u003e(4):67.\u003c/li\u003e\n\u003cli\u003eMalone DC, Abarca J, Skrepnek GH, Murphy JE, Armstrong EP, Grizzle AJ, Rehfeld RA, Woosley RL: \u003cstrong\u003ePharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions\u003c/strong\u003e. \u003cem\u003eMed Care \u003c/em\u003e2007, \u003cstrong\u003e45\u003c/strong\u003e(5):456-462.\u003c/li\u003e\n\u003cli\u003eHassell K, Seston EM, Schafheutle EI, Wagner A, Eden M: \u003cstrong\u003eWorkload in community pharmacies in the UK and its impact on patient safety and pharmacists\u0026apos; well-being: a review of the evidence\u003c/strong\u003e. \u003cem\u003eHealth Soc Care Community \u003c/em\u003e2011, \u003cstrong\u003e19\u003c/strong\u003e(6):561-575.\u003c/li\u003e\n\u003cli\u003eHolden RJ, Patel NR, Scanlon MC, Shalaby TM, Arnold JM, Karsh B-T: \u003cstrong\u003eEffects of mental demands during dispensing on perceived medication safety and employee well being: A study of workload in pediatric hospital pharmacies\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy : RSAP \u003c/em\u003e2010, \u003cstrong\u003e6\u003c/strong\u003e(4):293-306.\u003c/li\u003e\n\u003cli\u003eLangran C, Mantzourani E, Hughes L, Hall K, Willis S: \u003cstrong\u003e\u0026ldquo;I\u0026apos;m at breaking point\u0026rdquo;; Exploring pharmacists\u0026apos; resilience, coping and burnout during the COVID-19 pandemic\u003c/strong\u003e. \u003cem\u003eExploratory Research in Clinical and Social Pharmacy \u003c/em\u003e2022, \u003cstrong\u003e5\u003c/strong\u003e:100104.\u003c/li\u003e\n\u003cli\u003eGandhi TK, Feeley D, Schummers D: \u003cstrong\u003eZero Harm in Health Care\u003c/strong\u003e. \u003cem\u003eNEJM Catalyst Innovations in Care Delivery \u003c/em\u003e2020, \u003cstrong\u003e1\u003c/strong\u003e(2).\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eLeading the Way to Zero Resources | The Joint Commission\u003c/strong\u003e. 2023.\u003c/li\u003e\n\u003cli\u003eStockwell DC, Kayes DC, Thomas EJ: \u003cstrong\u003ePatient Safety: Where to Aim When Zero Harm Is Not the Target-A Case for Learning and Resilience\u003c/strong\u003e. \u003cem\u003eJ Patient Saf \u003c/em\u003e2022, \u003cstrong\u003e18\u003c/strong\u003e(5):e877-e882.\u003c/li\u003e\n\u003cli\u003ePatterson M, Deutsch ES: \u003cstrong\u003eSafety-I, Safety-II and Resilience Engineering\u003c/strong\u003e. \u003cem\u003eCurr Probl Pediatr Adolesc Health Care \u003c/em\u003e2015, \u003cstrong\u003e45\u003c/strong\u003e(12):382-389.\u003c/li\u003e\n\u003cli\u003eChui MA, Stone JA, Holden RJ: \u003cstrong\u003eImproving over-the-counter medication safety for older adults: A study protocol for a demonstration and dissemination study\u003c/strong\u003e. \u003cem\u003eRes Social Adm Pharm \u003c/em\u003e2017, \u003cstrong\u003e13\u003c/strong\u003e(5):930-937.\u003c/li\u003e\n\u003cli\u003eChui MA, Berbakov ME, Gilson AM, Morris AO, Stone JA: \u003cstrong\u003eEffectiveness and sustainment of a tailored over-the-counter medication safety intervention in community pharmacies: A randomized controlled trial\u003c/strong\u003e. \u003cem\u003eResearch in Social and Administrative Pharmacy \u003c/em\u003e2022.\u003c/li\u003e\n\u003cli\u003eWears R: \u003cstrong\u003eStill Not Safe: Patient Safety and the Middle-Managing of American Medicine\u003c/strong\u003e: Oxford University Press; 2019.\u003c/li\u003e\n\u003cli\u003eMerandi J, Vannatta K, Davis JT, McClead RE, Brilli R, Bartman T: \u003cstrong\u003eSafety II Behavior in a Pediatric Intensive Care Unit\u003c/strong\u003e. \u003cem\u003ePediatrics \u003c/em\u003e2018, \u003cstrong\u003e141\u003c/strong\u003e(6):e20180018.\u003c/li\u003e\n\u003cli\u003ePlunkett A, Plunkett E: \u003cstrong\u003ePositive approaches to safety: Learning from what we do well\u003c/strong\u003e. \u003cem\u003ePaediatr Anaesth \u003c/em\u003e2022, \u003cstrong\u003e32\u003c/strong\u003e(11):1223-1229.\u003c/li\u003e\n\u003cli\u003eVerhagen MJ, de Vos MS, Sujan M, Hamming JF: \u003cstrong\u003eThe problem with making Safety-II work in healthcare\u003c/strong\u003e. \u003cem\u003eBMJ quality \u0026amp; safety \u003c/em\u003e2022, \u003cstrong\u003e31\u003c/strong\u003e(5):402-408.\u003c/li\u003e\n\u003cli\u003eHickford AJ, Blainey SP, Ortega Hortelano A, Pant R: \u003cstrong\u003eResilience engineering: theory and practice in interdependent infrastructure systems\u003c/strong\u003e. \u003cem\u003eEnviron Syst Decis \u003c/em\u003e2018, \u003cstrong\u003e38\u003c/strong\u003e(3):278-291.\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eOverview of Patient Safety Learning Laboratory (PSLL) Projects \u003c/strong\u003e[https://www.ahrq.gov/patient-safety/resources/learning-lab/index.html]\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eResilience Engineering: Concepts and Precepts\u003c/strong\u003e, 1st Edition edn. London: CRC Press; 2006.\u003c/li\u003e\n\u003cli\u003eOdukoya OK, Stone JA, Chui MA: \u003cstrong\u003eBarriers and facilitators to recovering from e-prescribing errors in community pharmacies\u003c/strong\u003e. \u003cem\u003eJournal of the American Pharmacists Association: JAPhA \u003c/em\u003e2015, \u003cstrong\u003e55\u003c/strong\u003e(1):52-58.\u003c/li\u003e\n\u003cli\u003eChui MA, Mott DA, Maxwell L: \u003cstrong\u003eA qualitative assessment of a community pharmacy cognitive pharmaceutical services program, using a work system approach\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2012, \u003cstrong\u003e8\u003c/strong\u003e(3):206-216.\u003c/li\u003e\n\u003cli\u003eMorris AO, Gilson A, Chui MA, Xiong K: \u003cstrong\u003eUtilizing a cognitive engineering approach to conduct a hierarchical task analysis to understand complex older adult decision-making during over-the-counter medication selection\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2021, \u003cstrong\u003e17\u003c/strong\u003e(12):2116-2126.\u003c/li\u003e\n\u003cli\u003eHolden RJ, Carayon P, Gurses AP, Hoonakker P, Hundt AS, Ozok AA, Rivera-Rodriguez AJ: \u003cstrong\u003eSEIPS 2.0: a human factors framework for studying and improving the work of healthcare professionals and patients\u003c/strong\u003e. \u003cem\u003eErgonomics \u003c/em\u003e2013, \u003cstrong\u003e56\u003c/strong\u003e(11):1669-1686.\u003c/li\u003e\n\u003cli\u003eMcNab D, Freestone J, Black C, Carson-Stevens A, Bowie P: \u003cstrong\u003eParticipatory design of an improvement intervention for the primary care management of possible sepsis using the Functional Resonance Analysis Method\u003c/strong\u003e. \u003cem\u003eBMC Med \u003c/em\u003e2018, \u003cstrong\u003e16\u003c/strong\u003e(1):174.\u003c/li\u003e\n\u003cli\u003evan Dijk LM, Meulman MD, van Eikenhorst L, Merten H, Schutijser BCFM, Wagner C: \u003cstrong\u003eCan using the functional resonance analysis method, as an intervention, improve patient safety in hospitals?: a stepped wedge design protocol\u003c/strong\u003e. \u003cem\u003eBMC Health Serv Res \u003c/em\u003e2021, \u003cstrong\u003e21\u003c/strong\u003e(1):1228.\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eThe FRAM Model Visualiser\u003c/strong\u003e. 2023.\u003c/li\u003e\n\u003cli\u003eLeBlanc VR, Manser T, Weinger MB, Musson D, Kutzin J, Howard SK: \u003cstrong\u003eThe study of factors affecting human and systems performance in healthcare using simulation\u003c/strong\u003e. \u003cem\u003eSimul Healthc \u003c/em\u003e2011, \u003cstrong\u003e6 Suppl\u003c/strong\u003e:S24-29.\u003c/li\u003e\n\u003cli\u003eT\u0026oacute;rtora G, Mach\u0026iacute;n L, Ares G: \u003cstrong\u003eInfluence of nutritional warnings and other label features on consumers\u0026apos; choice: Results from an eye-tracking study\u003c/strong\u003e. \u003cem\u003eFood Res Int \u003c/em\u003e2019, \u003cstrong\u003e119\u003c/strong\u003e:605-611.\u003c/li\u003e\n\u003cli\u003evan Renswoude DR, Raijmakers MEJ, Koornneef A, Johnson SP, Hunnius S, Visser I: \u003cstrong\u003eGazepath: An eye-tracking analysis tool that accounts for individual differences and data quality\u003c/strong\u003e. \u003cem\u003eBehav Res Methods \u003c/em\u003e2018, \u003cstrong\u003e50\u003c/strong\u003e(2):834-852.\u003c/li\u003e\n\u003cli\u003eWilkinson KM, Mitchell T: \u003cstrong\u003eEye tracking research to answer questions about augmentative and alternative communication assessment and intervention\u003c/strong\u003e. \u003cem\u003eAugment Altern Commun \u003c/em\u003e2014, \u003cstrong\u003e30\u003c/strong\u003e(2):106-119.\u003c/li\u003e\n\u003cli\u003eMoon J, Berbakov ME, Morris AO, Gilson AM, Stone JA, Watterson TL, Chui MA: \u003cstrong\u003eEyetracking for macroergonomics in the wild: Exploring its use for understanding older adults\u0026rsquo; over-the-counter medication selection behavior in community pharmacies and its implications for other health care settings\u003c/strong\u003e. In: \u003cem\u003eInternational Symposium on Human Factors and Ergonomics in Health Care: 2022/03/20/23 2022\u003c/em\u003e; 2022.\u003c/li\u003e\n\u003cli\u003eMorris AO, Berbakov ME, Moon J, Stone JA, Gilson AM, Watterson TL, Chui MA: \u003cstrong\u003eSenior Section 2.0: Intersecting Implementation Science and Human Factors to Adapt Our Community Pharmacy Intervention to Improve Over-the-Counter Medication Safety Among Older Adults\u003c/strong\u003e. In: \u003cem\u003eInternational Symposium on Human Factors and Ergonomics in Health Care: 2022/03/20/23 2022\u003c/em\u003e; 2022.\u003c/li\u003e\n\u003cli\u003eCook DA: \u003cstrong\u003eOne drop at a time: research to advance the science of simulation\u003c/strong\u003e. \u003cem\u003eSimul Healthc \u003c/em\u003e2010, \u003cstrong\u003e5\u003c/strong\u003e(1):1-4.\u003c/li\u003e\n\u003cli\u003eLam\u0026eacute; G, Dixon-Woods M: \u003cstrong\u003eUsing clinical simulation to study how to improve quality and safety in healthcare\u003c/strong\u003e. \u003cem\u003eBMJ Simul Technol Enhanc Learn \u003c/em\u003e2020, \u003cstrong\u003e6\u003c/strong\u003e(2):87-94.\u003c/li\u003e\n\u003cli\u003eMaxwell L, Odukoya OK, Stone JA, Chui MA: \u003cstrong\u003eUsing a conflict conceptual framework to describe challenges to coordinated patient care from the physicians\u0026apos; and pharmacists\u0026apos; perspective\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2014, \u003cstrong\u003e10\u003c/strong\u003e(6):824-836.\u003c/li\u003e\n\u003cli\u003eOdukoya OK, Stone JA, Chui MA: \u003cstrong\u003eHow do community pharmacies recover from e-prescription errors?\u003c/strong\u003e \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2014, \u003cstrong\u003e10\u003c/strong\u003e(6):837-852.\u003c/li\u003e\n\u003cli\u003eChui MA, Stone JA, Martin BA, Croes KD, Thorpe JM: \u003cstrong\u003eSafeguarding older adults from inappropriate over-the-counter medications: the role of community pharmacists\u003c/strong\u003e. \u003cem\u003eGerontologist \u003c/em\u003e2014, \u003cstrong\u003e54\u003c/strong\u003e(6):989-1000.\u003c/li\u003e\n\u003cli\u003eChui MA, Stone JA, Thorpe JM, Martin BA: \u003cstrong\u003eWork System Barriers to Providing Safe Over-the-Counter (OTC) Medication Recommendations for Older Adults\u003c/strong\u003e. \u003cem\u003eProceedings of the Human Factors and Ergonomics Society Annual Meeting \u003c/em\u003e2013, \u003cstrong\u003e57\u003c/strong\u003e(1):1098-1102.\u003c/li\u003e\n\u003cli\u003ePatton MQ: \u003cstrong\u003eQualitative Research \u0026amp; Evaluation Methods: Integrating Theory and Practice\u003c/strong\u003e, 4th Edition edn; 2014.\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003ePA-21-266: Patient Safety Learning Laboratories: Advancing Patient Safety through Design, Systems Engineering, and Health Services Research (R18 Clinical Trial Optional)\u003c/strong\u003e. 2023.\u003c/li\u003e\n\u003cli\u003eDreischulte T, Grant A, Donnan P, Guthrie B: \u003cstrong\u003ePro\u0026rsquo;s and con\u0026rsquo;s of the stepped wedge design in cluster randomised trials of quality improvement interventions: two current examples\u003c/strong\u003e. \u003cem\u003eTrials \u003c/em\u003e2013, \u003cstrong\u003e14\u003c/strong\u003e(1):O87.\u003c/li\u003e\n\u003cli\u003eKaria A, Norman R, Robinson S, Lehnbom E, Laba T-L, Durakovic I, Balane C, Joshi R, Webster R: \u003cstrong\u003ePharmacist\u0026apos;s time spent: Space for Pharmacy-based Interventions and Consultation TimE (SPICE)-an observational time and motion study\u003c/strong\u003e. \u003cem\u003eBMJ Open \u003c/em\u003e2022, \u003cstrong\u003e12\u003c/strong\u003e(3):e055597.\u003c/li\u003e\n\u003cli\u003eHavnes K, Lehnbom EC, Walter SR, Garcia BH, Halvorsen KH: \u003cstrong\u003eTime distribution for pharmacists conducting a randomized controlled trial-An observational time and motion study\u003c/strong\u003e. \u003cem\u003ePLoS One \u003c/em\u003e2021, \u003cstrong\u003e16\u003c/strong\u003e(4):e0250898.\u003c/li\u003e\n\u003cli\u003eWestbrook JI, Li L, Hooper TD, Raban MZ, Middleton S, Lehnbom EC: \u003cstrong\u003eEffectiveness of a \u0026apos;Do not interrupt\u0026apos; bundled intervention to reduce interruptions during medication administration: a cluster randomised controlled feasibility study\u003c/strong\u003e. \u003cem\u003eBMJ quality \u0026amp; safety \u003c/em\u003e2017, \u003cstrong\u003e26\u003c/strong\u003e(9):734-742.\u003c/li\u003e\n\u003cli\u003eBallermann MA, Shaw NT, Mayes DC, Gibney RTN, Westbrook JI: \u003cstrong\u003eValidation of the Work Observation Method By Activity Timing (WOMBAT) method of conducting time-motion observations in critical care settings: an observational study\u003c/strong\u003e. \u003cem\u003eBMC Med Inform Decis Mak \u003c/em\u003e2011, \u003cstrong\u003e11\u003c/strong\u003e:32.\u003c/li\u003e\n\u003cli\u003eGwet KL: \u003cstrong\u003eHandbook of Inter-Rater Reliability, 4th Edition: The Definitive Guide to Measuring The Extent of Agreement Among Raters\u003c/strong\u003e, 4th Edition edn: Advanced Analytics, LLC; 2014.\u003c/li\u003e\n\u003cli\u003eWestbrook JI, Li L, Shah S, Lehnbom EC, Prgomet M, Schofield B, Cresswell K, Slee A, Coleman JJ, McCloughan L\u003cem\u003e et al\u003c/em\u003e: \u003cstrong\u003eA cross-country time and motion study to measure the impact of electronic medication management systems on the work of hospital pharmacists in Australia and England\u003c/strong\u003e. \u003cem\u003eInt J Med Inform \u003c/em\u003e2019, \u003cstrong\u003e129\u003c/strong\u003e:253-259.\u003c/li\u003e\n\u003cli\u003eChui MA, Look KA, Mott DA: \u003cstrong\u003eThe association of subjective workload dimensions on quality of care and pharmacist quality of work life\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2014, \u003cstrong\u003e10\u003c/strong\u003e(2):328-340.\u003c/li\u003e\n\u003cli\u003eSimonson W, Feinberg JL: \u003cstrong\u003eMedication-related problems in the elderly : defining the issues and identifying solutions\u003c/strong\u003e. \u003cem\u003eDrugs \u0026amp; Aging \u003c/em\u003e2005, \u003cstrong\u003e22\u003c/strong\u003e(7):559-569.\u003c/li\u003e\n\u003cli\u003eLuthans F: \u003cstrong\u003eThe need for and meaning of positive organizational behavior\u003c/strong\u003e. \u003cem\u003eJournal of Organizational Behavior \u003c/em\u003e2002, \u003cstrong\u003e23\u003c/strong\u003e(6):695-706.\u003c/li\u003e\n\u003cli\u003eN\u0026auml;swall K, Kuntz J, Malinen S: \u003cstrong\u003eEmployee Resilience Scale (EmpRes) Measurement Properties\u003c/strong\u003e. In\u003cem\u003e.\u003c/em\u003e; 2015.\u003c/li\u003e\n\u003cli\u003eGregorich SE, Helmreich RL, Wilhelm JA: \u003cstrong\u003eThe structure of cockpit management attitudes\u003c/strong\u003e. \u003cem\u003eJ Appl Psychol \u003c/em\u003e1990, \u003cstrong\u003e75\u003c/strong\u003e(6):682-690.\u003c/li\u003e\n\u003cli\u003eHelmreich RL, Foushee HC, Benson R, Russini W: \u003cstrong\u003eCockpit resource management: exploring the attitude-performance linkage\u003c/strong\u003e. \u003cem\u003eAviat Space Environ Med \u003c/em\u003e1986, \u003cstrong\u003e57\u003c/strong\u003e(12 Pt 1):1198-1200.\u003c/li\u003e\n\u003cli\u003eGeldhof GJ, Warner DA, Finders JK, Thogmartin AA, Clark A, Longway KA: \u003cstrong\u003eRevisiting the utility of retrospective pre-post designs: The need for mixed-method pilot data\u003c/strong\u003e. \u003cem\u003eEval Program Plann \u003c/em\u003e2018, \u003cstrong\u003e70\u003c/strong\u003e:83-89.\u003c/li\u003e\n\u003cli\u003eBhanji F, Gottesman R, de Grave W, Steinert Y, Winer LR: \u003cstrong\u003eThe retrospective pre-post: a practical method to evaluate learning from an educational program\u003c/strong\u003e. \u003cem\u003eAcad Emerg Med \u003c/em\u003e2012, \u003cstrong\u003e19\u003c/strong\u003e(2):189-194.\u003c/li\u003e\n\u003cli\u003eStuhec M, Lah L: \u003cstrong\u003eClinical pharmacist interventions in elderly patients with mental disorders in primary care focused on psychotropics: a retrospective pre-post observational study\u003c/strong\u003e. \u003cem\u003eTher Adv Psychopharmacol \u003c/em\u003e2021, \u003cstrong\u003e11\u003c/strong\u003e:20451253211011007.\u003c/li\u003e\n\u003cli\u003eAlmulhim AS, Aldayyen A, Yenina K, Chiappini A, Khan TM: \u003cstrong\u003eOptimization of antibiotic selection in the emergency department for urine culture follow ups, a retrospective pre-post intervention study: clinical pharmacist efforts\u003c/strong\u003e. \u003cem\u003eJ Pharm Policy Pract \u003c/em\u003e2019, \u003cstrong\u003e12\u003c/strong\u003e:8.\u003c/li\u003e\n\u003cli\u003eHollnagel E, Braithwaite J, Wears RL: \u003cstrong\u003ePreface: On the Need for Resilience in Health Care\u003c/strong\u003e. In: \u003cem\u003eResilient Health Care.\u003c/em\u003e 1st Edition edn.: CRC Press; 2013: ix-xxvi.\u003c/li\u003e\n\u003cli\u003eHollnagel E, Braithwaite J: \u003cstrong\u003eResilient Health Care\u003c/strong\u003e: CRC Press; 2019.\u003c/li\u003e\n\u003cli\u003eBraithwaite J, Churruca K, Ellis LA, Long J, Clay-Williams R, Damen N, Herkes J, Pomare C, Ludlow K: \u003cstrong\u003eComplexity science in healthcare: aspirations, approaches, applications and accomplishments: a white paper\u003c/strong\u003e. Sydney: Macquarie University; 2017.\u003c/li\u003e\n\u003cli\u003eBoyle TA, Bishop A, Morrison B, Murphy A, Barker J, Ashcroft DM, Phipps D, Mahaffey T, MacKinnon NJ: \u003cstrong\u003ePharmacist work stress and learning from quality related events\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2016, \u003cstrong\u003e12\u003c/strong\u003e(5):772-783.\u003c/li\u003e\n\u003cli\u003eParker J, Davies B: \u003cstrong\u003eNo Blame No Gain? From a No Blame Culture to a Responsibility Culture in Medicine\u003c/strong\u003e. \u003cem\u003eJ Appl Philos \u003c/em\u003e2020, \u003cstrong\u003e37\u003c/strong\u003e(4):646-660.\u003c/li\u003e\n\u003cli\u003eLester CA, Chui MA: \u003cstrong\u003eUsing link analysis to explore the impact of the physical environment on pharmacist tasks\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2016, \u003cstrong\u003e12\u003c/strong\u003e(4):627-632.\u003c/li\u003e\n\u003cli\u003eGulpen AJW, van Dijk JK, Damen NL, Ten Cate H, Schalla S, Ten Cate-Hoek AJ: \u003cstrong\u003eOrganisation of care for patients using direct oral anticoagulants\u003c/strong\u003e. \u003cem\u003eNeth Heart J \u003c/em\u003e2020, \u003cstrong\u003e28\u003c/strong\u003e(9):452-456.\u003c/li\u003e\n\u003cli\u003ePickup L, Atkinson S, Hollnagel E, Bowie P, Gray S, Rawlinson S, Forrester K: \u003cstrong\u003eBlood sampling - Two sides to the story\u003c/strong\u003e. \u003cem\u003eAppl Ergon \u003c/em\u003e2017, \u003cstrong\u003e59\u003c/strong\u003e(Pt A):234-242.\u003c/li\u003e\n\u003cli\u003eDraime JA, Wicker EC, Krauss ZJ, Sweeney JL, Anderson DC: \u003cstrong\u003eDescription of Position Ads for Pharmacy Technicians\u003c/strong\u003e. \u003cem\u003ePharmacy (Basel, Switzerland) \u003c/em\u003e2020, \u003cstrong\u003e8\u003c/strong\u003e(2):88.\u003c/li\u003e\n\u003cli\u003eJobin J, Irwin AN, Pimentel J, Tanner MC: \u003cstrong\u003eAccuracy of medication histories collected by pharmacy technicians during hospital admission\u003c/strong\u003e. \u003cem\u003eResearch in social \u0026amp; administrative pharmacy: RSAP \u003c/em\u003e2018, \u003cstrong\u003e14\u003c/strong\u003e(7):695-699.\u003c/li\u003e\n\u003cli\u003eMcKeirnan K, Sarchet G: \u003cstrong\u003eImplementing Immunizing Pharmacy Technicians in a Federal Healthcare Facility\u003c/strong\u003e. \u003cem\u003ePharmacy (Basel, Switzerland) \u003c/em\u003e2019, \u003cstrong\u003e7\u003c/strong\u003e(4):152.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Medication Safety, Community Pharmacies, Provider Status, Pharmacy Intervention, Participatory Design, Stakeholder Groups, Resilience, Safety I/Safety II","lastPublishedDoi":"10.21203/rs.3.rs-3876998/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3876998/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cu\u003eIntroduction\u003c/u\u003e: The increase of people with complex chronic health conditions is stressing the U.S. healthcare delivery system. Community pharmacies play a role in ensuring patients’ safe medication use for chronic care management, but their efforts are undermined by volatile work demands and other system barriers.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eMethods\u003c/u\u003e: This study seeks to conceptualize, design, implement, and test a MedSafeMap\u003csup\u003eTM\u003c/sup\u003e for the community pharmacy setting to enhance pharmacists’ and technicians’ abilities to either avoid, or to quickly identify and recover from, medication errors before patient safety is endangered.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eDiscussion\u003c/u\u003e: The MedSafeMap is an innovative approach that will be used by pharmacists and pharmacy technicians to better navigate the complex tasks in the pharmacy, and to facilitate communication with both patients and clinicians, while safely providing medications to complex patients with chronic health conditions.\u003c/p\u003e","manuscriptTitle":"Engineering Resilient Community Pharmacies: Exploring an Integrative Approach to Medication Safety","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-22 18:57:20","doi":"10.21203/rs.3.rs-3876998/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"bd26ced0-d6ef-405e-aef3-e1c539baf9ac","owner":[],"postedDate":"January 22nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-03-25T14:48:43+00:00","versionOfRecord":[],"versionCreatedAt":"2024-01-22 18:57:20","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3876998","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3876998","identity":"rs-3876998","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}