Designing a new clinical environment provides a unique opportunity to rethink the relationship between physical spaces, equipment, patient care processes, and patient outcomes. Good design enhances care, whereas poor design can undermine patient outcomes.1 Simply transferring existing processes and workflows directly to a new clinical environment may cause unanticipated problems for healthcare providers, manifest inefficiencies in care delivery, contribute to errors, or may just be infeasible within the new space.2,3 Latent safety threats (LSTs), for example, are unanticipated, system-based design or organization issues that, if not detected and rectified in planning, can emerge in practice, causing harm to patients or clinicians.3,4 Accordingly, transitioning to new clinical spaces requires careful planning during both the design and testing phases to ensure that patient care is not compromised.
Managing the relationship between design, workflows, and patient outcomes requires a robust approach to ensure that newly designed spaces serve the needs of both patients and clinicians. Although existing operational readiness frameworks provide high-level strategies to manage transitions, they do not specify processes for designing and testing new clinical systems, workflows, or training-related issues.5,6 In contrast, human-centered approaches, such as participatory ergonomics, directly involve people in the planning of their own work, aiming to improve productivity and work system design.6,7 Recent case studies on participatory ergonomics have used simulation for assembly line and healthcare systems design,8,9 suggesting value in using different modalities (eg, mock-ups, table-top simulation) to imitate real-world processes and systems in support of human-centered design.
Despite these benefits of participatory ergonomics, our thorough literature search did not yield any framework, in human factors, healthcare, or elsewhere, that accounts for integrating existing workflows, for innovating to generate new opportunities, and for making iterative modifications based on LSTs, particularly when emergent changes disrupt the original, intended design. Recognizing this need, we were drawn to the principles of design thinking, another human-centered, iterative process that shares the end-user focus of participatory ergonomics and provides a more holistic approach for understanding issues and testing solutions. We also saw the potential for design thinking to be used well given the physical resources, equipment, and simulation training modalities available at our institution.
As a solutions-based and human-centered approach to innovation, design thinking has been applied in numerous industries to guide the design and testing of new products.10 Translating a design thinking approach to healthcare may address the limitations of existing operational readiness and human factors frameworks, given its focus on the full timescale of change and on end users (eg, clinicians, teams, patients, and their families).11 To date, design thinking has been widely used in healthcare for innovating new technologies and for solving healthcare challenges (eg, improved nursing handoff communication, treatment of posttraumatic stress disorder using virtual reality exposure therapy).12,13 Although design thinking seems to be a natural fit to inform the construction of new clinical infrastructure, there is a lack of literature to describe this specific application of its principles.
To enact design thinking, we used simulation given its successful track record for testing work systems and new clinical spaces and because the iterative prototype testing central to design thinking aligns with well-established simulation-based methodologies,2,14,15 where events can be repeated, and design adjustments made based on the healthcare team's feedback. In particular, in situ simulation (ISS) has become an effective modality for identifying LSTs before patient exposure.2,3 We define ISS as simulation in the clinical environment, aimed at studying how employees, equipment, and systems respond in their “natural state.”16 Existing approaches to using simulation for operational readiness focus on the unitary use of either center based or ISS, which we judged as incomplete for navigating such high-stakes changes. Conducting ISS scenarios requires most construction to be completed, and thus, any design flaws identified during the simulation may not be easily resolved. Hence, rather than using any single simulation modality, we chose multiple modalities to pre-emptively identify and address issues that manifest during the early design stages through the building phase and ultimately opening day for patient care.2,14 Furthermore, simulation scenarios can be used to test various permutations of clinical scenarios in a predictable timeframe, including low-frequency, high-risk situations.17 Our proposed approach contrasts with the use of observations of actual clinical tasks, which functions well to design predictable workflows or existing workspaces, but is not always actionable for new clinical spaces.18
Although recommendations and notable practices for healthcare design elements exist, these are often integrated within construction blueprints before testing among end users.1 The resulting integrative strategy may not generalize to all end users across an institution. For example, although most guidelines recommend single-bed rooms to reduce transmissible infections, they do not prescribe where each room should be located within variably sized floor plans, to ensure adequate sightlines to the patient, or the optimal location of hand sanitizer dispensers in the hallways surrounding each room. Existing healthcare design frameworks lack the flexibility to inform more granular and specific aspects of care at an institution, such as the transport of a patient from triage to their room in the emergency department (ED). Our proposed context- and institution-specific application of design thinking using simulation aims to holistically design workplace practices, technologies and tools, physical space, and how all facets are organized optimally within a healthcare facility.8 By combining principles from existing healthcare and human factors approaches, we may incrementally improve the design and testing of new clinical infrastructure.
To navigate our transition to a new ED, we leveraged the principles from design thinking coupled with a multimodal simulation-based approach, and aimed to develop and apply a practical and comprehensive framework that healthcare organizations and stakeholders can use to navigate complex and high-risk infrastructure transitions during the design, evaluation, and modification of new clinical spaces. Although the outcomes and findings from our experience may be context and institution specific, the simulations and design principles we applied will inform other institutions designing new clinical spaces.
We assembled a multidisciplinary team 8 months before opening day to conduct simulation-based testing (Fig. 1). Institutional authorities judged our initiative as not requiring research ethics Board approval. Team members included staff emergency physicians, nurses, respiratory therapists, clinical assistants, clericals, and members of our organization's operational readiness and planning departments. The project architects were not part of the team as the blueprints had been finalized before this process beginning. The team served as the planning committee, simulation implementation team, and a point of contact within the hospital administration. Members were selected based on 2 criteria: (a) a leadership or education role within their clinical domain and (b) experience with simulation. Early in the planning process, we applied the following 5 steps of design thinking to revise our objectives and assume an end user–focused process (Fig. 2). The first 2 steps comprise the problem space, where the focus is developing a complete understanding of the user and their needs. To promote a human-centered focus, we used several human factors methods during this phase, including ethnographic observations, focus groups, and interviews. The final 3 steps comprise the solution space where the focus shifts to developing and evaluating solutions. Hereinafter, we outline each step and how we applied it within our context.
Step 1: Empathize
Empathizing establishes the problems requiring design solutions. To accomplish this step, we combined both simulation and nonsimulation strategies. First, we used data from a previous ISS study at our organization, which identified LSTs in our ED related to equipment usability, protocol integration within the clinical space, and team positioning during resuscitations.19,20 For example, we repeatedly observed clinicians placing resuscitation equipment during a procedure on the patient because of inadequate table-top spaces. This adaptation resulting from poor design went unrecognized by clinicians as they had become accustomed to it. Simulation served a critical role during this step, allowing us to customize cases that otherwise may not occur frequently, to rerun the same scenario to confirm observations, and to preplan how we focused observations on certain behaviors, practices, or equipment.
Next, we used those results to guide informal interviews and focus groups with clinicians aimed at better understanding their current workflows, challenges in the existing space, and how care delivery might be imagined within a larger space. We conducted these for a 1-month period with 20 to 30 nurses, 10 to 15 physicians, and several of our other staff members. Participants were provided with a blueprint of the new space to help inform this discussion. We coupled the interviews with direct observation of clinicians during this period. We collected notes throughout this process to generate a list of problems that required attention.
Step 2: Define
A multidisciplinary team (C.H., A.P., L.B., D.G., K.W.) synthesized the data from step 1, defined current issues in the old ED, and predicted which issues might manifest in the new ED. We categorized them into the following 7 themes, which we shared with clinicians to ensure accuracy: staff communication, patient triage, patient transport, resuscitations, equipment usability and supplies, physical space utilization, and security.
Step 3: Ideate
We held 5 small (4–6 people) and 3 larger group (15–20 people) brainstorming sessions to develop solutions for identified problems. Participants included members of the hospital planning department, and all relevant clinical faculty. These occurred approximately twice per month during the first 4 months of the initiative.
Step 4: Prototype
Prototyping used 2 simulation modalities: (a) table-top simulation and (b) simulations within a mock-up ED room. Mock-ups enable users to test the space and provide important feedback before design plans are finalized, whereas table-top simulations facilitate larger-scale process evaluation.8,21 We created the table-top simulations using a laminated blueprint of the entire ED and colored cotton balls to represent various ED personnel, their movements, and positions (Fig. 3A). We met with our ED staff and leadership to generate a list of ED workflows to test using table-top simulations. We developed multiple scenarios and cross-referenced each to ensure that all workflows were represented in at least one scenario (Table 1). Scenarios included a patient with chest pain, dyspnea, sepsis, and cardiac arrest. These scenarios began at triage and continued until the patient left the ED with multiple permutations evaluated (eg, the dyspnea patient who requires noninvasive ventilation vs. intubation). As we cross-referenced these scenarios with our list of workflows, we discovered that we lacked testing for the acutely agitated patient, and as such, we added this scenario. Because the renovation only affected “acute” patients, minor issues seen in our ambulatory care section were not tested. These table-top simulations allowed our team to rapidly prototype ideas before investing significant resource in ISS testing. These sessions consisted of 5 to 10 multidisciplinary participants.
Concurrently, we built 3 “mock-up” patient care rooms (Fig. 3B) where we conducted simulation scenarios using low-technology manikins and simulated patients to visualize, in real time, how the precise location of equipment within a room impacted workflows. The 2 mock-up rooms represented exact replicas of the 36 newly constructed standard ED patient rooms. Although the mock-up rooms lacked an active gas and oxygen supply, we represented each of these with temporary wall mounts, allowing feedback on optimal placement of these wall mounted units. We mounted other elements, such as the patient monitor, garbage bins, and sharps containers, with the intent that their proposed position could change based on the user experience. Our data collection processes included completing a structured feedback form, notetakers who captured verbal feedback, and video recordings. The video recordings were reviewed by the study team to clarify feedback and to review granular details of each workflow. We used these findings iteratively to adjust and finalize our ED design.
To model care within our new ED, we developed 4 simulation scenarios that could be run during both the prototype and testing phases (steps 4 and 5). Three team members (A.P., C.H., K.W.), each with at least 5 years of simulation education experience, developed 4 scenarios aimed at capturing all necessary elements from our problem list from step 2. Our team met to list and cross-reference ED-based workflows, processes, and procedures with the proposed scenarios.
We designed scenarios to be easily modifiable and flexible when using either manikins (3G SimMan, Laerdal) or standardized patients. One to 2 teams participated in each scenario. We selected 4 case presentations common to our ED, all described in Table 1.
Step 5: Test
We conducted 3 nonsequential days of video-recorded multidisciplinary ISS scenarios for 2 weeks (Fig. 3C). We began our first ISS session without full communication capabilities or central monitoring, as the technology had not yet been installed. By day 3, our ED was fully operational and we completed final testing 2 days before opening to the public. Simulation participants consisted of volunteer ED personnel. A discipline-matched observer (ie, nurse observing nurse participants) provided feedback during the postscenario debriefing. On day 1, we conducted all scenarios exclusively within the patient room to identify design and workflow issues. On day 2, scenarios began at ED triage with the simulated patient's arrival to evaluate the triage and registration process, as well as patient transport and general team communication throughout the ED. On day 3, we evaluated any implemented changes from previous days, as well as more specialized workflows including the violent patient protocol and trauma care of the critically injured. An MD and RN co-led the debriefing and sought feedback about the workspace and workflows. We encouraged all participants to write ideas, comments, and concerns on several whiteboards.
Three main design changes from old to new ED dominated our focus during this process: (a) a fourfold increase in physical space; (b) a substantial increase in the distance from triage to patient care rooms; and (c) significant changes to the model of care based on a new physical layout. The latter consisted of 12 to 14 beds in 1 of 3 sections or “pods,” with patients triaged and assigned to each pod. The impetus for the pod-based design was, in part, to allow each pod to function independently should an infectious agent outbreak occur requiring immediate quarantine processes.
Our findings in applying all design thinking steps are described in Table 2. During the empathy step, clinicians repeatedly expressed concern with the transition to a larger space and with workflows in the pod-based system. We contextualized these design changes into 7 themes (Table 3), used them to define specific issues, and addressed each one through brainstorming sessions with our design team and invited clinical representatives. Brainstorming sessions were often coupled with table-top simulations to pilot new or modified processes. Examples for each theme are outlined in Table 3 where the issue or potential LST is noted, alongside how we applied simulation in the solution space.
An example of this process occurred after we observed and heard from clinicians about issues related to equipment usability and supplies. Confirming previous results,22 our interviews showed that clinicians could not quickly obtain equipment for critical care procedures, resulting in delayed patient care (step 1, empathize). We observed that procedural equipment was scattered and stocked in unpredictable locations, and anticipating this problem would be exacerbated by the new space being 4 times larger (step 2, define). During small group meetings, clinicians brainstormed bundled packages stocked within a resuscitation tower (step 3, ideate). During table-top simulations, we identified optimal locations for the towers. During mock-ups, usability testing ensured tower functionality and the ordering of necessary equipment (step 4, prototype). In ISS scenarios, we piloted the resuscitation towers (Fig. 4) and solicited user feedback regarding equipment and usability. Iterative design changes included modifying the equipment, assigning stocking personnel, and developing an equipment repository to facilitate stocking (step 5, test).
In May 2017, our ED opened successfully with changes integrated from our testing and evaluation process. Our systematic approach also led to our establishing informed, ongoing monitoring procedures. For example, after the issues with our portable phone connectivity, the hospital information technology department assigned a team to monitor phone functionality during the first week after opening day. Deliberate testing before opening day engaged institutional leadership, and as a result, additional monitoring resources were in place for several weeks after our ED opened.
We applied a design thinking framework integrated with multimodal simulation to assist our transition to a new clinical space. Most reports on using simulation, most often only ISS, to test new clinical infrastructure apply the process upon completion of the construction and just before opening for clinical care.2,3,14 We have shown that simulation affords prototyping and iterative modification to the clinical design process before final testing. With hospital leaders, we developed and deployed simulation-based human-centered design and focused on the following 3 areas: (a) systems (eg, integration of computer order entry within the ED); (b) processes (eg, staff-staff communication); and (c) physical space (eg, layout for wall mounted equipment in patient rooms).
Originally, we planned to conduct only a 3-day testing period using ISS within the new ED before opening day. We learned quickly that moving to a larger remodeled space required more than ISS testing alone. We needed to redesign processes and systems that functioned within a completely different physical space. We were surprised that current published approaches to healthcare design lacked adequate end-user input throughout the design and testing process.23,24 By contrast, scholars in participatory ergonomics prioritize end-user input, although they typically focus on interviewing workers to understand how to improve workplace practices and reduce work-related injuries.25 In addition, although researchers in participatory ergonomics have more recently applied simulation in healthcare and other domains,8,26 we found that reviews of evidence-based healthcare design made no mention of applying simulation as a method to inform further designs.1,24 Hence, we saw an opportunity to leverage our team's expertise in using multiple simulation modalities to prioritize the perspective of our end users, who are central to design thinking.
Using the design thinking framework, our team innovatively applied multiple simulation modalities to efficiently and iteratively prototype options with multiple end users before constructing the ED. Applying the concept of functional task alignment (ie, ensuring session objectives align with each simulator's functional properties) allowed us to choose simulation modalities wisely.27 Table-top simulations solicited high-level participant feedback without invoking significant costs or resources. Mock-up simulations facilitated room design changes, whereas ISS scenarios permitted “final tests” of all systems and technology integrated within the workspace. These findings align with previous work that sought to compare table-top and mock-up simulation methodologies for healthcare infrastructure design.8 The authors concluded that table-top simulations afford high-level views of the organizational processes, whereas mock-up simulations facilitated study of the technologies, tools, and smaller scale room issues. Our findings align with their conclusion that one simulation modality cannot support the “identification and evaluation of all types of ergonomic conditions.” Instead, the selection of an appropriate simulation modality for healthcare design should be made with the intended outcome in mind. Furthermore, we believe that using our holistic framework to link these modalities can optimize these outcomes.
By seeking end-user feedback through simulation testing, we consistently learned that we could mitigate potential problems in advance of the ED opening day. Another by-product is that our staff remained well-informed of the construction process. In addition, although it may seem odd that some problems we identified were not recognized during the early blueprint design phases, we believe that those early processes, largely relying on clinician feedback, may not fully support user-centered design because of the following: (a) the same clinicians may not remain engaged throughout the process resulting in inconsistent end-user representation; (b) clinicians may only spend a short period reviewing blueprints without significant thought into the implications of each design proposal; and (c) opportunities for mock-up spaces and usability testing with simulation are rare. As an example, a communication plan for clinicians working in a larger space was planned before the transition; however, our design process showed that it remained to be finalized. Decisions could have been left to nonclinicians within the communications department. Our table-top simulations identified that we required reliable handheld devices for all clinical personnel (not required in our previous smaller space). Our design team's advocacy led to our institutional leadership prioritizing this issue. We tested the selected product, which initially proved inadequate because of poor connectivity. Fortunately, our information technology department was present during ISS scenarios to observe these issues and adjusted network connections to ensure that the devices were usable by opening day. Though seemingly common sense, our team was surprised by how frequently these small but important issues arose and how well we could address them. Only by prototyping and testing can lasting solutions be reached.
We note that the resources required to undertake a design thinking project are substantial. In our case, multidisciplinary team members and their time were the primary resources invested. Institutions without existing simulation programs, manikins, or simulation equipment may face substantial hurdles in implementing our approach. A cost-benefit analysis may be important for institutions to objectively establish how best to allocate their unique resources when undertaking projects of this magnitude. We also faced instances when proposed changes could not be tested and/or implemented because of architectural and construction limitations. For example, we discovered a considerable issue relating to poor sightlines to several patient rooms only during the ISS sessions, at which time we could not change the configuration of our ED as construction was nearly finished. Although we note this to be a limitation in our experience, we believe that early engagement longitudinally between architects and a clinician-led design team would help overcome such challenges. Robust and systematic table-top and room mock-up simulations are feasible approaches to ensure that the entire team is informed before finalizing blueprints, which may aid in identifying LSTs related to room and department configuration. In a later project, we engaged early with our architects in the design of our trauma bay, using data from mock-up simulations to reconfigure the location of walls and number of beds.
In this project, we focused on smaller scale design solutions within each patient room and on integrating systems and protocols within the physical space. We cannot be certain that the issues we identified were the most important ones. Design thinking is iterative and a dynamic process, meaning ongoing application of an end-user focus may continue to capture new or otherwise unidentified issues. Since opening nearly 2 years ago, our reflections suggest that we identified the main issues related to the transition.
Despite early challenges, our institution's leadership team welcomed the design thinking–informed, systematic approach. Guided by this approach, we innovatively used multimodal simulation to modify, test, and evaluate the construction of a new ED. Building on this project's successes, we implemented an institution-wide program to guide the design and testing of future construction of clinical spaces. Looking forward, we propose that institutions must consider an integrative approach with a clinician-led simulation team to support the design and testing of new clinical infrastructure as early in their construction process as possible. Healthcare administrators must move beyond using ISS exclusively, toward using rigorously selected simulation modalities that serve functional and cost-effective purposes for human-centered clinical design.
The authors thank the staff from the Allan Waters Family Simulation Centre for their support in conducting each simulation and the staff from St. Michael's Hospital who participated in the simulations.
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