In-situ medical simulation for pre-implementation testing of clinical service in a regional hospital in Hong Kong

Abstract

The implementation of a new clinical service is associated with anxiety and challenges that may prevent smooth and safe execution of the service. Unexpected issues may not be apparent until the actual clinical service commences. We present a novel approach to test the new clinical setting before actual implementation of our endovascular aortic repair service. In-situ simulation at the new clinical location would enable identification of potential process and system issues prior to implementation of the service. After preliminary planning, a simulation test utilising a case scenario with actual simulation of the entire care process was carried out to identify any logistic, equipment, settings or clinical workflow issues, and to trial a contingency plan for a surgical complication. All patient care including anaesthetic, surgical, and nursing procedures and processes were simulated and tested. Overall, 17 vital process and system issues were identified during the simulation as potential clinical concerns. They included difficult patient positioning, draping pattern, unsatisfactory equipment setup, inadequate critical surgical instruments, blood products logistics, and inadequate nursing support during crisis. In-situ simulation provides an innovative method to identify critical deficiencies and unexpected issues before implementation of a new clinical service. Life-threatening and serious practical issues can be identified and corrected before formal service commences. This article describes our experience with the use of simulation in pre-implementation testing of a clinical process or service. We found the method useful and would recommend it to others.

Introduction

The implementation of clinical service in a new hospital facility or location is associated with challenges that may prevent a smooth and safe execution of the service.¹ New equipment, unfamiliar surroundings and setup, untested emergency care support, alarm systems and logistics, and new interdisciplinary staff mix may contribute to unexpected negative outcomes. Anticipated and actual practices may differ significantly and need to be modified to adapt to the new environment. In addition, some unexpected issues may not be apparent until the actual clinical service commences. Such concerns may lead to significant anxiety and stress in both administrative and clinical staff involved in the planning of the new service.

Clinical simulation is commonly employed in education and patient safety training of frontline health care professionals.² It is now becoming increasingly common that simulation is also used in assessment, credentialing, and even in health care system integration and feasibility testing of clinical process and equipment.^{3 4} Advanced simulation methods have previously been adopted to assess and optimise workflow and setup at new facility prior to clinical operation.^{5 6} Usability testing of new equipment with simulation techniques may enhance medical safety before clinical application. In-situ simulation at a new clinical location offers a unique opportunity to identify potential process and system issues prior to implementation of a new service. This type of simulation method is valuable to assess, troubleshoot, or develop new system processes.⁷

Our hospital is a local district hospital with about 480 beds. A new endovascular aortic repair (EVAR) service was planned in the angiography suite located in the Department of Radiology on the hospital ground floor. No elective surgical procedure under anaesthesia had previously been performed at this location. This location is remote from the operating theatre suite and intensive care unit that are located on the second floor of the same building. We conducted an in-situ simulation of a clinical case 2 weeks before the first procedure in a real patient to assess the readiness of our preparation for the clinical service.

Definitions

Simulation is defined as a technique that creates a situation or environment that allows a person to experience a representation of a real event for the purpose of practice, learning, evaluation and testing, or to gain an understanding of systems or human actions.⁷ In-situ simulation refers to simulation exercises that take place in the actual patient care setting/environment in an effort to achieve a high level of fidelity and realism.⁷

Planning a new service

Effective and safe planning of a new service is not only challenging but often a tedious and fretful procedure. In our case, key stakeholders including the operating theatre nursing team, anaesthesiologists, surgeons, and angiography suite staff met on four occasions over 2 months to discuss the logistics of patient flow, clinical service needs, and setup. Patient selection criteria, preparation, transfer logistics, location setup, equipment, drugs and consumables stocks, and postoperative care were discussed. Workflow logistics; clinical care plans; detailed emergency and contingency plans; and lists of essential surgical, anaesthetic, and nursing consumables and equipment were worked out and agreed by all parties. Several visits to the angiography suites were held to assess the site and familiarise staff. The position of patient and health care staff, equipment, and overall setup were tried out.

At the last planning session, a simulated case was proposed to be performed at the new clinical location to test our preparation before the first real patient case was conducted.

Research approval and informed consent

Clinical research ethics committee approval was not required as this was a simulated site-testing exercise with no study participant or data involved. All parties involved consented to participate voluntarily, and the project was supported and approved by the Hospital's Chief Executive and the Hospital's Working Group on EVAR service.

Clinical scenario

In order to facilitate the simulation test, a clinical case scenario was developed by two co-authors (TTK and WCW) who are simulation education[-]trained instructors and were the main coordinators of the exercise. The scenario was of a routine case scheduled for EVAR procedure under general anaesthesia in the angiography suite. The case background involved a 78-year-old man with multiple stable medical conditions including hypertension, history of congestive cardiac failure, chronic renal impairment, and a 7-cm infrarenal abdominal aortic aneurysm scheduled for endovascular aortic surgery. He was on aspirin, metoprolol, lisinopril, amlodipine, and isosorbide dinitrate. Echocardiography assessment had reported a left ventricular ejection fraction of 35%. Blood type and screen, and a postoperative bed in intensive care unit were available before the operation. Premedication with oral N-acetylcysteine, midazolam, and his usual medications was prescribed and administered in the ward prior to transfer to the angiography suite.

The scenario began with patient transferring to the angiography suite by ward staff and on arrival, checking by the angiography suite nurse. Timeout was then performed with the anaesthesiologists, surgeon, and nurse in the angiography suite before the anaesthetic procedure commenced. Invasive arterial pressure monitoring was set up, and the patient was anaesthetised on the transfer trolley before being moved onto the angiography table. An anaesthetic workstation (Primus; Drägerwerk AG [and] Co. KGaA, Germany) with Infinity C700 physiological monitor (Drägerwerk AG [and] Co. KGaA, Germany) was used for the general anaesthesia. The anaesthesiologist simulated the induction of general anaesthesia on a training simulator with full virtual physiological monitoring. The anaesthetic procedure tested the setup at the head of the ‘operating table' and the logistics of delivering anaesthesia to the patient in the small and compact room.

Following general anaesthesia, the surgeon cleaned and draped the surgical field, and commenced the surgical procedure according to his usual practice at another hospital. One nurse scrubbed in and another two circulating nurses assisted the procedure. All required surgical instruments and equipment were laid out on sterile trolleys. The surgical team performed each step of the procedure as in a real clinical case including imitating the femoral arterial puncture and insertion of the guidewire and aortic stent to test the surgical setup, equipment locations, and the positions of staff and patient. No EVAR simulator or manikin was used for the surgical procedure part as we did not intend to assess the technical aspects of the surgical procedure.

When the surgical part of the exercise was completed, the scenario proceeded to evaluate the contingency plan in case of a surgical complication resulting in haemorrhagic shock. The patient would need to be transferred to the operating theatre for open surgery to stop the bleeding, instead of directly to the intensive care unit from the angiography suite after completion of the procedure as per preoperative plan. The surgeon was able to test the availability of surgical instruments for haemostasis while the anaesthesiology team was able to test the logistics, clinical support, and treatment protocols for fluid and blood resuscitation, and urgent arrangements for transferring to the main operating theatre. The site of surgical complication was not specified and the surgeon went through a mental exercise with the surgical team of different surgical management requirements during the crisis.

Simulation exercise

Two co-authors were responsible for coordinating, directing, and running the exercise. Frontline representatives from the anaesthetic, vascular surgery, operating theatre nursing, and angiography suite teams who will be involved in the new future clinical service were nominated by their heads of department to participate in the simulation exercise. An actor who was a ward nurse played the role of the patient during transfer from the ward to the angiography suite as it facilitated the checking procedure. The patient checking part of the scenario also involved a participant nurse from the surgical ward who accompanied the patient from the ward. The participants involved are shown in Table 1.

Table 1. Resources involved in the simulation exercise

A high-fidelity simulator (SimMan 3G; Laerdal, Stavanger, Norway) was used during the perioperative phase from timeout procedure onwards. The SimMan 3G can be controlled by a wireless laptop, and is able to generate virtual vital signs on a monitor. This simulator has peripheral pulses, chest expansion, pupillary responses, and can simulate normal and abnormal breath sounds, heart sounds, pupil size, and normal and difficult airway, among other functions. The entire induction of anaesthesia including tracheal intubation was performed on the simulator. The technical part of the simulation was supported by two staff from the Simulation and Training Centre.

The simulation exercise took place in the afternoon of a normal working day. The area of simulation exercise was an isolated part of the Department of Radiology with minimal patient traffic. A half-hour briefing of involved parties was conducted prior to the commencement of the exercise. The objective of the exercise to test the workflow logistics, setup, and care plans of the new service was explained. All participants were instructed to play their professional role during the simulated exercise, as they would in the real clinical situation (Fig 1). The exercise was carried out in four phases: a pre-anaesthetic phase, anaesthesia induction phase, operative phase, and postoperative phase.

Figure 1. Surgeon ready to start

Data collection and evaluation

Three observers who were nurse managers from the operating theatre and surgical wards evaluated the scenario and made comments independently. An evaluation checklist was designed by the exercise coordinators together with members of the planning team for observers to identify any deficiency and safety issues associated with the event at each phase (Table 2). The checklist followed the anticipated flow of events during the case. The evaluation began with pre-medication and sending of the patient to the angiography suite. Positioning, surgical draping, range of X-ray table, and blood ordering logistics were tested. After the scenario, all participants were debriefed, and observers were invited to share their observations. Areas of improvement were noted and required alterations made by relevant team members before scheduling first real patient for the EVAR procedure in the angiography suite.

Table 2. Observer evaluation checklist

Issues identified

The in-situ simulation took place in the angiography suite over four phases in 3 hours. During the simulation, 17 vital process and system issues were identified, including anaesthetic and surgical issues such as poor patient positioning, draping pattern, unsatisfactory equipment setup, inadequate critical surgical instruments, blood products requesting logistics, and inadequate nursing support during the crisis (Table 3). Some of these deficiencies were corrected immediately during the simulation exercise. During the post-exercise, observer checklist deficiencies and participant experience were reviewed and discussed, and solutions devised.

Table 3. Issues identified (critical issues in italics)

Benefits of simulation testing

This is the first reported use of simulation for the purpose of testing a new service in Hong Kong. Previous publications have reported the effectiveness of simulation-based methodology to identify process gaps before major institutional change.^{5 6}Kobayashi et al⁵ found the utility of simulated patient encounters in testing a new emergency department functions and operational capabilities useful. The trial run also helped in the design of an optimal clinical care environment. In their experience, most issues that arose were not apparent with traditional preparation efforts. Staff also felt more comfortable and confident attending to critical patients in the new facility after participating in simulated scenarios. Bender et al⁶ evaluated the function of a new neonatal intensive care unit using simulation-based technology and methodology. The exercise involved multidisciplinary stakeholders in two simulated clinical scenarios. They identified 164 latent safety hazards in communication, facilities, supplies, staffing, and training with over 90% of them resolved at transition to the new facility. They concluded that it provided valuable benefits for system refinement and patient safety.⁶

Issues such as inadequate electrical sockets and equipment electrical cables, breathing circuit too short, and various positioning difficulties were encountered in our simulation exercise despite earlier planning and preparation (Fig 2). One may attribute such deficiencies to poor planning in some situations, but simulation testing is in fact a most suitable method to identify and iron out these unanticipated problems, regardless of whether or not they were the result of poor planning. Some issues that may appear trivial and simple to correct were identified as potential patient safety concerns in real life. It was critical that these life-threatening problems and other serious practical issues were identified during the in-situ simulation as this enabled us to make improvements to facilitate a more efficient and safe service. Another example was related to the management of a surgical complication during the procedure, resulting in some urgency for the surgeon to control the bleeding, a sudden and urgent blood request for resuscitation by the anaesthesiologists, and immediate need for emergency surgery in the main theatre suite, all happening simultaneously. An essential surgical vascular clip was found lacking while there was confusion about the logistics of getting blood products requested urgently. Other concerns and difficulties were identified during the crisis and were eventually rectified.

Figure 2. Patient head-end

We did not repeat the simulation testing after correcting the deficiencies identified at the initial exercise because of lack of time. We did not feel that it was necessary to repeat the simulation although a second test may still have produced some unexpected results. The first real case therefore became an assessment of the final preparation. The case was conducted 3 weeks after the simulation testing. The procedures at each stage went as anticipated without any problem. The first patient did not require any blood transfusion and we were not able to test the transfusion logistics in real life after simulation testing. In a further subsequent patient (real case) blood transfusion was required, and the logistics of ordering and obtaining blood products urgently were carried out smoothly and uneventfully, indicating successful correction of the initial problems with the blood collection procedure.

Challenges

A significant amount of time was spent in planning the exercise so that it resembled closely the actual workflow and procedures. As the clinical activity involved several different specialties, it was challenging to organise a multispecialty group to plan and participate in the exercise. The number of participants depends on the usual staffing need of the clinical activity. The two coordinators who were experienced medical simulation trainers were the key persons who devised the scenario and coordinated and executed the simulation exercise. Most participants were required to attend the briefing and simulation exercise only on the day. Some discussions were conducted by email. Although different specialty teams could have conducted their own individual exercise separately, the cross-specialty interactions and benefits may not have been apparent.

The leadership of the exercise and the hospital's support were vital for the smooth conduct of the simulation testing. All the heads of department involved in the new service, and our Hospital Chief Executive supported the exercise making it easy to organise the participants and observers.

It is important to test out the actual clinical location. The setting up of the venue required some time prior to the simulation exercise. In our case, the availability of the angiography suite was a challenge as we needed to find an unused session when all stakeholders were also available. This will be especially difficult in a busy hospital where the clinical area may not be available during office hours. In such cases, running the simulation exercise after hours may be considered.

Although in-situ simulation remains an effective method to test out a new location and service, the organiser should ensure that the exercise is not confused with a real clinical case. Special attention should be given to the use of training equipment, drugs, and consumables in the clinical area, so that they are not inadvertently used in a real patient. Staff and other patients in the clinical area should also be aware that the simulation exercise is in progress. It was helpful in our case that the angiography suite was located in an area where patient traffic flow was easily controlled in the afternoon.

In this exercise, we borrowed a high-fidelity human patient simulator from our Simulation and Training Centre. The manikin came with physiological features and computer-controlled virtual vital signs. It was a bonus to have access to this simulator although a successful simulation test such as ours may also be performed with a lower-fidelity manikin such as that used for cardiopulmonary resuscitation training. The advantage for us with this exercise was that the high-fidelity simulator provided real-time temporal changes in vital signs of the patient during the surgical complication, thereby creating a sense of urgency and crisis to the situation. This facilitated the testing of contingency plans during the emergency. The most important aspect of the exercise, however, was not the simulator but the actual role play of the scenario script and evaluation of the settings, workflows logistics, and clinical processes. We were fortunate that technical support from the Centre was also available. In a hospital where such expertise and resources may not be available, this should not be a barrier to simulation-based testing as there is the option to consult a simulation training centre for assistance.

The procedure and results of simulation testing should be clearly documented. One limitation of this study was that we did not document the exercise with video recordings. Photographs were taken but their quality was modest. These would have been helpful in the discussion and sharing process.

Conclusion

It is advantageous to identify critical deficiencies and unexpected issues that may not be apparent prior to implementation of a new service. The testing of a new clinical service, facility, or environment with simulation technology requires considerable time, effort, and expense. Very often traditional checks and testing will only evaluate individual aspects of a new facility in isolation and separately. Exposing the new environment and critical services to a simulated clinical event allows actual experience of the settings, workflow, and clinical management to reveal issues not apparent with the usual manual checks.

Acknowledgements

The authors would like to express their appreciation to staff at the Department of Radiology, Department of Anaesthesiology and Operating Services, Department of Surgery, and New Territories East Cluster Simulation and Training Centre for their support and contributions.

References

1. Berwick DM. A primer on leading the improvement of systems. BMJ 1996;312:619-22.

2. Okuda Y, Bryson EO, DeMaria S Jr, et al. The utility of simulation in medical education: what is the evidence? Mt Sinai J Med 2009;76:330-43.

3. Holmboe E, Rizzolo MA, Sachdeva AK, Rosenberg M, Ziv A. Simulation-based assessment and the regulation of healthcare professionals. Simul Healthc 2011;6 Suppl:S58-62.

4. Landman AB, Redden L, Neri P, et al. Using a medical simulation center as an electronic health record usability laboratory. J Am Med Inform Assoc 2014;21:558-63.

5. Kobayashi L, Shapiro MJ, Sucov A, et al. Portable advanced medical simulation for new emergency department testing and orientation. Acad Emerg Med 2006;13:691-5.

6. Bender J, Shields R, Kennally K. Transportable enhanced simulation technologies for pre-implementation limited operations testing: neonatal intensive care unit. Simul Healthc 2011;6:204-12.

7. Healthcare simulation dictionary. Society for Simulation in Healthcare. June 2016. Available from: http://www.ssih.org/dictionary. Accessed Dec 2016.