Sudden cardiac arrest is the leading cause of death in the United States, accounting for approximately 568,400 deaths per year.1 Despite new drugs and therapies, progress in this area has been slow, and outcomes remain poor. In the hospital setting, where providers, drugs, and devices are readily available, only 1 in 4 adult patients who experience cardiac arrest survive to hospital discharge, and one third of them are left with significant neurologic disability.1
One factor contributing to poor outcomes for patients who experience cardiac arrest is the inconsistency of resuscitation practices and overall low adherence to international resuscitation guidelines.2,3 Although many training programs focus on provider skills and knowledge as a way of improving the quality of the resuscitation,4 less attention is paid to other organizational factors that create the conditions for reduced quality of care.5 Systems problems such as deficiencies in the physical space or equipment design, hospital-level policies, work culture, and poor leadership and teamwork are now known to contribute significantly to the quality of care provided, yet there are only a few small scale reports of programs designed to address these system-level vulnerabilities for in-hospital patients who experience cardiac arrest.6–9 Systems engineering tools have been used successfully in other large-scale complex industries, such as telecommunications and manufacturing, to improve the quality and performance of those systems.10 Although some disciplines such as cardiac surgery have been successful at this, the application of engineering concepts and methods to health care systems redesign for in-hospital cardiac arrest is lacking.11,12
Simulation can be broadly defined as the “artificial replication of sufficient elements of a real world domain to achieve a stated goal—and typically includes training individuals and teams to deal with the domain or testing the capacity of personnel to work in the domain.”13 Several groups have demonstrated the effectiveness of simulation-based cardiac arrest programs in improving provider confidence,14 teamwork behaviors,15 and decision making.16 Staff training using high-fidelity medical simulation has also been shown to improve patient outcomes in one study of pediatric cardiac arrest simulations at a large academic medical center.17 The use of simulation in the real work setting (in situ simulation) is particularly valuable to elicit, study, and correct latent systems problems because it brings together all the elements of the care team and the environment. In situ simulation allows observations of the process of care as it happens and not as we might speculate might happen or as it “should” happen. Although resource intensive and costly, in situ simulation is an invaluable tool for identifying and mitigating these clinical and systems hazards and defects related to the resuscitation response.8 In fact, in situ simulation is now a well-established educational and quality improvement tool. Several groups have reported on the use of in situ simulation of cardiac arrest events to improve nontechnical skills among resuscitation team members,9,18 assess different aspects of the technical conduct of resuscitation such as the quality of chest compressions8 or the use of defibrillation devices,19 and to detect latent system failures in the hospital setting.7–9,18,20,21
Here, we describe a large-scale in situ simulation-based quality improvement program that was designed to continuously monitor the cardiac arrest response process for hazards and defects and to detect opportunities for system optimization. A hazard is “any event that could harm the patient.”22 A defect is defined as “any clinical or operational occurrence that should not be repeated.”23 We applied a systems engineering model to categorize and understand the structure, processes, and outcomes related to in-hospital resuscitations.24
The Durham VA Medical Center is a 274-bed tertiary referral center that provides service to more than 200,000 veterans living in a 26-county area of central and eastern North Carolina. A formal quality improvement program proposal was approved by the medical center chief of staff, and the local institutional review board deemed this work to be exempt from ethics review.
The quality improvement initiative had 3 primary goals as follows:
- To improve the safety and quality of care for patients admitted to the Durham VA Medical Center by identifying and mitigating hazards and defects related to processes of care for cardiopulmonary resuscitation (CPR)
- To enhance the educational experience of resident physicians and other providers in CPR and other urgent or emergent care situations
- To foster an institutional culture of learning and continuous quality improvement
Funding for this program was provided by a grant from the VA National Center for Patient Safety.
Code Documentation Review and Interviews with Stakeholders
To understand current practices and to identify opportunities for improvement in the way the hospital responded to cardiac arrests, we conducted a review of the code documentation for the previous year, interviewed key stakeholders, performed direct observations of code responses, and reviewed the hospital policies on resuscitation. Hospital “code sheets” were reviewed, and any deficiencies documented there were recorded. A total of 11 interviews were conducted by one of the investigators (A.Ba.) with residents in training, intensive care unit staff, members of the critical care committee and hospital leadership, critical care unit nurses and nursing aids, and other personnel. The interviews were semistructured and included open-ended questions such as “what do you like the most about the way codes are conducted currently?” and “what needs improvement?” “Code blue” responses were observed by attending real team responses to in-hospital cardiac arrest events at different times of the day and on different hospital locations, and notes were made regarding opportunities for improvement.
The following 5 key themes emerged from the interviews with key stakeholders:
- There was frequently a lack of leadership and role clarity during CPR events.
- There were no standardized processes for training and conduct of CPR other than periodic advanced cardiovascular life support certification.
- There was significant variation in the quality of the resuscitation efforts among different code response teams.
- Residents would value hands-on training using high-fidelity simulation.
- Staff would generally welcome periodic comparative feedback reports on the performance of the CPR team (CRT), where process measures (such as average time to defibrillation) and outcome measures (such as survival to hospital discharge) are reported back to the team and compared with other medical centers with similar characteristics.
With the program goals in mind and using the information gathered through review of the code documentation, interviews, and observations, we designed a new program using in situ high-fidelity simulation to probe and address system vulnerabilities and to improve leadership and teamwork among members of the CRT.
Clarification of Team Structure and Function
The first step in the system redesign consisted of summarizing and simplifying the structure and processes related to the CRT. As part of the orientation material that is provided at the beginning of the month, residents rotating through all 3 intensive care units now receive a 1-page (front and back) handout that contains basic information on the structure and function of the CRT and a description of the respective roles and responsibilities of team members. The handout summarizes key information from our hospital policy on the CRT incorporating tables and figures (Fig. 1). It concludes with a list of basic teamwork and communication concepts that provide the framework for postsimulation debriefing sessions (Fig. 2). Staff nurses and respiratory therapists who participate in resuscitation efforts as permanent staff at the facility receive a similar handout. This material aims to create a shared mental model among the resuscitation team members before the simulated exercises.
Cardiopulmonary Resuscitation Team Simulation Sessions
The simulator is deployed at different hospital locations to recreate cardiac arrest scenarios. The simulation team consists of 2 simulation nurse educators and an anesthesiologist and an intensivist who is well versed in resuscitation medicine. The program uses a high-fidelity simulator (Laerdal SimMan 3G, Laerdal Medical, Stavanger, Norway). One or more webcams with portable microphones are installed at strategic vantage points to capture the activities of CRT members. Other equipment includes a standard hospital code cart stocked with mock drugs, medical supplies (central line and airway kits), and a Lifepak 12 defibrillator (Medtronic, Redmond, WA). A central line task trainer (Simulab Corporation, Seattle, WA) was initially used for all codes at our institution, but after we converted to intraosseous lines for all in-hospital resuscitations, an intraosseous line insertion kit (EZ-IO Intraosseous Infusion System, Vidacare Corporation, San Antonio, TX) became part of our standard training equipment. Two-way VHF radios with discrete headsets allow instructors to communicate and coordinate efforts during the scenario. A video projector, external speakers, compact screen, and teaching aids are used for video-assisted debriefing sessions. The equipment is stored and transported in a dedicated case designed for this purpose (Fig. 3).
The clinical details of the cardiac arrest scenarios are arranged with unit personnel before activating the emergency response system. This varies somewhat by location and allows supervisory personnel critical input in choosing a specific clinical scenario or testing a particular aspect of the system they believe to be especially vulnerable.
Between 2 and 6 simulated CRT practice sessions (“mock codes”) are conducted each month. Although the sessions are unannounced, instructors monitor hospital emergencies and unit workload before the exercises to ensure that the simulation does not conflict with real emergencies or periods of intense clinical workload. Each 30-minute session is divided into the following segments: resuscitation (8 minutes), program introduction (for newcomers) and brief review of nontechnical skills concepts (5 minutes), video-assisted debrief (12 minutes), and “roll-up” (5 minutes).
During the resuscitation, the activated CRT encounters the manikin in either pulseless electrical activity or ventricular fibrillation and must manage the scenario as they would an actual patient in cardiac arrest. Task and contextual fidelity is preserved as much as possible by providing a realistic case stem and by using equipment normally located in the specific clinical environment. Realism is further enhanced by blending simulation modes such as a femoral line trainer (for central line placement), an intraosseous line insertion kit, and medical actors (who represent family members or other medical personnel). The simulation proceeds undisturbed with the instructors only observing and recording the event. They interact with the participants only to prevent hazardous situations or to help with nonstandard clinical tasks, for example, applying modified defibrillation pads or inserting a central venous catheter using the task trainer.
The resuscitation is followed by a 5-minute introduction to the program. During this introduction, the simulation team prepares the recording, software, and audiovisual equipment for the video-assisted debrief.
The facilitator begins the debrief with a statement emphasizing the blame-free, safe, and solution-focused nature of the event. Posters are used to facilitate review of the CRT structure, provider roles, and responsibilities and to illustrate some basic nontechnical skills concepts (Figs. 1 and 2). A video of the event is then projected on the wall (or portable screen). Using the video as an aide, the simulation team leads the CRT in a discussion focusing mainly on leadership and teamwork behaviors, eliciting or offering suggestions for improvement. Technical concepts that are absolutely critical to resuscitation such as rapid identification of rhythm and quality of CPR are also discussed. Hazards and system problems identified by the CRT members are also addressed during the debrief to further understand the needs and barriers. The session concludes with an open discussion, during which each participant and observer is asked in turn to share one “take-home” point or comment.
After each exercise, the training team meets to debrief. First, an internal review of the conduct of the exercise is performed, highlighting positive and negative occurrences. Notes are taken and later on incorporated into the simulation log, an electronic file that is used to document every event, the resources used, the participants involved, and the lessons learned. Suggestions for improvement are incorporated into future exercises. In addition, any systems problems related to the resuscitation effort that are detected during the scenario are documented in the same simulation log. The Systems Engineering Initiative for Patient Safety (SEIPS) model is used to classify the observations and understand the relationship among the different components of the system. Structural hazards such as unsuitable equipment or physical space at a particular location or process redesign needs are discussed among the respective stakeholder groups, and solutions are deployed as needed. Typically, a deficiency identified during the conduct of the event is discussed during the debrief. The simulation team later follows up with the responsible party (eg, unit manager, engineering department, or pharmacy department), and a solution is crafted, which is then implemented during the following event and refined. Once deemed adequate and stable, the tool or redesigned process is finally implemented in real cardiac arrest responses. Other structural or process deficiencies that are detected through these exercises are discussed among the critical care committee members, and solutions are crafted with multidisciplinary involvement. For example, proposed changes to the configuration of the code cart were first vetted by this committee and later implemented and iteratively refined.
A total of 72 simulated unannounced cardiac arrest sessions were conducted between October 2010 and September 2013 at various locations throughout the medical center and at different times of the day, including the late evening. More than 300 providers participated in these sessions, including 87 physicians, 100 nurses, 21 respiratory therapists, and 10 administrative staff. A total of 335 hours were devoted to the program, including preparation, process improvement, and didactic activities.
We detected several environmental, teamwork, human-machine interface, culture, and policy hazards and defects. Some of the problems that were addressed through the program were well-known to providers, and the program simply created a formal mechanism by which solutions could be implemented. For example, several experienced nurse managers who routinely respond to codes had raised concerns about occasional delays in establishing intravenous access during resuscitations. After implementation of this program, the suggestion to introduce intraosseous devices was presented to the critical care committee, then tested and further refined during the simulated exercises, and finally implemented in real codes. Other hazards were latent, and the program served to uncover them before any real harm occurred. For example, a simulated event at a newly opened gastrointestinal endoscopy unit revealed that the wall oxygen outlet in one of the procedure rooms was far away from the head of the bed, making it impossible for the bag-mask-valve device to reach the patient. The room layout was reconfigured as a result of this exercise. Other examples of problems detected and their solutions are presented in Table 1.
We describe a large-scale program that uses simulation to improve the quality of CPR in the hospital setting. With the conduct of more than 70 unannounced in situ simulated cardiac arrest events, we have identified and mitigated latent hazards and defects in the hospital emergency response system.
Most studies aimed at improving CRT performance have focused on proficiency with advanced cardiovascular life support treatment protocols. However, our interviews indicated that the greatest barriers to delivering safe and effective care were systems vulnerabilities and ineffective teamwork rather than specific knowledge or skill deficits.
As stated in the US Institute of Medicine report “To Err Is Human,” most errors in patient care are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them.25 Our program brings many components of the system together and tests the processes (care and noncare related) needed to achieve the desired outcome. Through these exercises, we are able to systematically study the linkages among the different components of the system, the processes, and the outcomes, to design, implement, and evaluate solutions. As such, the program constitutes a robust quality improvement tool.
Traditional approaches to quality measurement and improvement often rely on the model conceptualized by Avedis Donabedian, in which the system (structure) is linked to the outcomes through the process of care.26 Efforts to improve the quality of care have traditionally focused heavily on the provider and on tools and technologies, all components of the structure, and to some extent, on the processes of care. For example, there are numerous studies that evaluate the efficacy of different drug dosing regimens for CPR and on different resuscitation devices.27,28 Even the American Heart Association’s Basic and Advanced Life Support courses focus heavily on the individual provider’s knowledge of resuscitation algorithms and on technical skills such as bag-mask ventilation, chest compressions, and the use of the defibrillator.4 Unfortunately, this approach ignores other components of the health care delivery system such as the physical space, hospital policies, and non–patient care processes, all of which are important in providing safe and high-quality resuscitation.
The SEIPS model may be used to complement and expand the Donabedian framework by further characterizing structure into 5 categories.24 According to this model, the person (or team) performs a range of tasks using various tools and technologies. The performance of these tasks occurs within a certain physical environment and under specific organizational conditions. It also recognizes the importance of other processes beyond the actual health care delivery process, such as equipment maintenance, supply chain, cleaning, and information flow. Finally, it adds employee and organizational outcomes to the list of important outcomes to consider (Fig. 4). The SEIPS model is useful because it encourages an appreciation of the entire system of care and the interactions among the different components, as opposed to focusing on one aspect of the system at a time.24
Using this framework, we identified several relationships among the different components of the structure (called “work system” in the SEIPS model) and among these components and other processes and outcomes. For example, in the case of our resuscitation team, a long and difficult-to-read hospital policy regarding the CRT provided an organizational barrier to a well-conducted resuscitation because team members rarely knew which providers needed to respond or what their roles and responsibilities were. This forced them to spend the critical initial minutes of the resuscitation organizing the team and distributing tasks. In fact, teams that are assembled ad hoc perform worse than teams that are structured before the resuscitation event.29 By summarizing and clarifying the hospital policy before the crisis occurs, our program provides a structure to the team with tasks and responsibilities defined, thus allowing team members to focus on the resuscitation as soon as they arrive on the scene. Similarly, our program has identified certain factors in the physical environment that constituted barriers to effective and efficient care, such as areas of the hospital that were inaccessible to members of the CRT or signs and maps that were outdated.
An example of a care-related process that we redesigned is communication with the laboratory during codes. Under the previous system, each laboratory test required an individual computerized order by the team leader. There was significant variability in the tests ordered, how samples were collected and labeled, sent to the laboratory, and results reported. Under the redesigned system, a preassembled code laboratory package is included in every code cart. The “laboratory pack” contains all necessary supplies, including tubes, a needleless transfer device, and labels. The samples are hand delivered by designated personnel. A standard set of studies (“code labs”) is now automatically run by the laboratory when the package is received, and the results are called back to the unit. This process was initially tested during simulated codes and, after several iterations, has been implemented in real codes. Other systems issues detected and addressed by this program include the procurement and widespread use of step stools for CPR and the incorporation of intraosseous vascular access into clinical care.
As stated by Carayon et al,24 by making it “easy to do things right and hard to do things wrong,” a systems redesign approach may be more successful at changing provider behavior because the focus is shifted away from the provider and therefore goes against a “culture of blame” and moves toward a “culture of continuous quality improvement.” Our program requires the direct involvement of all providers and ancillary staff in a quality improvement activity, in this case, CPR. The different participants are allowed and even encouraged to participate and become invested in the process of organizational change without risking loss of control or autonomy, an issue especially relevant to medical professionals.24
Finally, our program has allowed us to collect resuscitation process data (performance data) that are generally not otherwise available or difficult to access. For example, by conducting unannounced codes at different times of the day, we have been able to assess the paging system and CRT response times. Such granular data are important when redesigning processes of care but very difficult to capture during day-to-day clinical activities.
The disadvantages of our program should be acknowledged. The fact that the sessions occur in the middle of a working day poses a challenge because participants may find themselves torn between attending to their clinical duties and participating in this learning simulation experience. Being cognizant of this, we strive to keep the sessions short and focused and create an atmosphere that is nonthreatening and perceived to be valuable for all who participate. This has allowed us to achieve and sustain adequate engagement from the majority of providers. In addition, we do not objectively measure the educational benefit to learners. Rather than burden the participants with questionnaires or surveys, we opted to focus on assessing the impact of the program by monitoring longitudinal patient outcomes and other consequences of process changes. An example of the latter is a decreased incidence of laboratory order entry errors after the implementation of the new code cart laboratory pack. Lastly, the impact of this program on team performance during real codes and on patient outcomes has not been studied. In-hospital cardiac arrests are rare events, and the number of events that must be analyzed to demonstrate significant differences is beyond the scope of this project.
In summary, we describe here an ongoing program that uses in situ simulation to identify and mitigate latent hazards and defects in the hospital emergency response system. The SEIPS model provides a framework for describing and analyzing the structure, processes, and outcomes related to these events.
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