Patient Safety in the Critical Care Setting: Common Risks and Review of Evidence-Based Mitigation Strategies

Abstract

The Intensive Care Unit (ICU) has evolved in the last 50 years. This evolution’s main drivers include equipment and software improvements, the patient safety movement, and a better pathophysiological understanding of critical illness. There is mounting pressure from accreditation agencies, governmental regulation, financial challenges, operational dynamics, staffing changes, and increased acuity affecting-ICU care delivery and impacting patient safety. There are higher than ever expectations to improve clinical outcomes after an intensive care stay, to enhance patient safety, to increase family involvement in decision making, and merge the multidisciplinary medical experience into an effective teamwork. Leadership focus is directed towards increasing diversity and inclusion in the workforce while enhancing psychological safety. This review addresses the common risks for patient safety in the intensive care setting and describes the changes in mindset and application of evidence-based mitigation strategies.

1. Introduction

“First, do no harm”, the Hippocratic oath dating back over 2000 years remains the basic philosophy of all healthcare providers caring for patients. Preventing harm in the care of patients has led to a safety culture transformation in the critical care setting [1]. Early studies in adverse events highlighted the role of human factors and organizational systems [2, 3]. The report from the National Academy of Medicine (NAM, formerly Institute of Medicine IOM) “To Err is Human: Building a Safer Health System” [4], described 44,000–98,000 deaths related to medical errors. This report revolutionized the medical system in the United States and shifted the attention towards patient safety. In the general population’s mindset, the concept of patient safety has been influenced by the depiction of medical errors in medical television shows [5] and the news media [6, 7]. Intensive care is an area where safe practice is of paramount importance. Errors have been reported in intensive care units (ICUs) worldwide commonly associated with medication related events, indwelling lines, airway specific, and equipment failure [8]. Patients with organ failure or with a requirement for a higher intensity of care have elevated odds for exposure to a significant event [9].

The Agency for Healthcare Research and Quality (AHRQ), an official website of the Department of Health and Human Services in the Unites States, defines errors as “acts of commission or omission leading to an undesirable outcome or significant potential for such an outcome” [10]. Adverse events are defined as “any injury caused by medical care” and do not imply negligence, poor quality care, or error [10]. An adverse event can be associated with an unfavorable clinical outcome related to any part of a diagnosis or therapy (known complications), or not related to the disease process (e.g., pneumothorax after a central line placement). Medical errors are considered the third leading cause of death in the US [11]. After 20 years of effort in improving patient safety, there is a better foundation to address potential solutions using evidence-based approaches across institutions involving multiple work units. Evolving health care to become a High-Reliability Organization (HRO) is a constant journey to excellence. It requires a transformation where leadership is committed to engaging in patient safety solutions at the work unit level, to evolve into a culture of safety, and support advanced performance improvement methodology [12].

The objective of this review is to (1) summarize the current view of patient safety in the critically ill patient setting and (2) highlight novel approaches to improve safety in critical care.

1.1 Method

1.1.1 Search strategy

The information included in this review was obtained from a search conducted using PubMed, MEDLINE, and Google to access government publications and industry related websites. Single and paired combination of terms included patient safety, critical care, intensive care, simulation, telemedicine, medical error, adverse events, psychological safety, post intensive care syndrome, leadership, technology, education, culture of safety, teamwork, COVID-19, shared-decision making, artificial intelligence, communication, interprofessional collaboration, checklist, and bundle of care. The themes extracted from this process were discussed between the authors and with professional colleagues with expertise in patient safety and served as the foundation for important topics related to patient safety and critical care.

1.2 Critical care safety events

From the number of events reported by the Office of Inspector General (OIG) in 2010, a global 27% of Medicare patients experienced harm events [13]; while 25% experienced harm in 2018 (with 13.1% experiencing an adverse event that resulted in patient harm, defined as an event that requires intervention but does not result in permanent harm) [14]. These two reports also demonstrated that after a physician review of these events, 44% of them were deemed clearly or likely preventable in 2010, compared to the most recent report in 2022 where 43% were determined to be preventable.

The critical care setting holds a number of patient safety challenges related to the complexity and intensity of care [9], the high-risk decision making in clinically unstable patients [15], and the LOS in an ICU setting [16, 17]. Adverse drug events (ADEs) result in more than half a million injuries or deaths in U.S. hospitalized patients in intensive care units [18]. The adult critical care literature has reported significant variability of adverse events in the intensive care unit (ICU), ranging from 0.8 adverse events and 1.5 serious errors for a 10-bed critical care unit [19] to 1.7 error per patient per day in a medical-surgical of a university hospital [20]. A more recent systematic review and meta-analysis demonstrated a significant increase in ICU and hospital length of stay (LOS) in patients who suffered an adverse event [21]. In this systematic review, the authors were not able to establish a strong relationship between safety events and mortality, possibly related to patient heterogeneity. However, in a prospective clinical study performed in 70 French ICUs, it was reported that having more than two adverse events increased the risk of death [22]. This group was able to determine that those patients with more severe illness were at higher risk for an adverse event.

The pediatric population in ICU is not precluded from suffering adverse events. Medication errors are frequent, particularly in the younger group [17] and are considered preventable adverse events. Dosing errors are reported as the most common subtype. Pediatric medications are calculated based on weight or BMI and usually include a fraction of an adult dose, augmenting the potential for a 10-fold dosing errors [23]. A more recent study addressed human factors as contributing to prescription errors in pediatric intensive care units (PICUs) and found that cognitive burden, both physical (fatigue, distraction) and psychological (workload change, inexperience) were the most common latent factors associated to these findings [24].

Capturing and measuring adverse events challenges the incidence and mortality statistics related to unintentional medical errors. The development and implementation of incident reporting systems in healthcare has become a fundamental strategy aiming at improving patient safety [25]. Despite the success of reporting “near misses” or “close calls” in the aviation and nuclear plant industry, underreporting has become a factor undermining incident reporting within the medical system [26]. Several factors affecting incident reporting in healthcare include fear of adverse consequences and ineffective processes/systems of reporting [27]. In critical care, both adult and pediatric, factors associated to increased reporting include anonymity, regular feedback about errors reported and solution implementation, and a healthy culture of safety [28]. Other efforts to collect reliable data within the medical system include the development of a group of quality indicators by the Agency for Healthcare Research and Quality (AHRQ) [29] in an attempt to nationally provide a measure to monitor performance overtime and apply the information collected to the development of solutions targeting error prevention. The institution of global triggers became available through the Institute for Healthcare Improvement (IHI) [30] and was designed to provide a method for accurate identification of adverse events and rate measurement of these events overtime. A hospitalized standardized mortality ratio (HSMR) was implemented in the United Kingdom in 2001 [31].

1.3 Socioeconomic impact

For any given year, the cost of adverse events to the American health system can be measured in the billions of dollars. In 2008, an OIG report stated the cost was $324 million for the single month of October 2008 [13]. In the 2022 OIG report, an extra Medicare cost was incurred for all preventable and nonpreventable events. This report calculated hundreds of millions of dollars for October 2018 [14]. In 2006, Jain et al. demonstrated that the use of quality improvement initiatives directed to enhance the culture of safety and teamwork, with the specific goal to decrease hospital acquired infections, led to a 21% reduction in cost per ICU discharge [32]. Adopting bundles of care, the authors demonstrated a decline in ventilator associated pneumonia, bloodstream infection, and urinary tract infection, and the number of adverse events decreased from an average of 25 events per day to less than 5. The creation and adoption of ICU bundles of care for adults [33] and pediatric populations [34] have provided a new practice model for liberating critically ill patients from the ICU environment. The strategic implementation of bundles of care leads to a reduction in hospital cost [35].

The indirect cost related to ICU events is considered of significant magnitude. Intensive care survivors reported suffering from physical, cognitive, or mental health symptoms long after dismissal from their ICU stay [36]. Evidence recognizes that longer ICU delirium is associated with increased cognitive deficits [37]. As a result, the Society of Critical Care Medicine coined the term post-intensive care syndrome (PICS) and addressed strategies to mitigate unfavorable outcomes [38]. Compelling research notes that this phenomenon is pertinent to all ages, children included. The pediatric recovery trajectory affects the patient and the family nucleus in the long-term and has not been fully elucidated [39]. Further, families of ICU survivors also demonstrate psychiatric diagnoses, including depression, posttraumatic stress disorder, anxiety, and complicated grief [38]. The cognitive impairment and psychiatric diagnosis lead to an economic impact because of loss of income from the patient or the caregiver [40]. The future of critical care is shifting towards the ICU survivorship and their successful rehabilitation [41].

The human impact of adverse events directly affects the well-being of patients (first victim). Similarly, healthcare providers (second victim) are negatively affected [42, 43] eliciting emotional distress characterized by guilt, anxiety, remorse, depression, burnout, and physical symptoms ranging from fatigue to sleep disturbances [44]. A high rate of adverse medication events occur in the critical care setting [18] with greater harm to the patient when compared to non-ICU populations [45]. The consequences on the well-being of the healthcare provider in the critical care setting after a medical error occurs result in personal blame and guilt [46].

2. Causality

The patient safety movement has significantly shifted from attempting to prevent errors to decreasing harm to the patient [47]. Focusing on minimizing or preventing harm draws attention to the environment and processes. A systematic approach to assessing the quality of care includes defining the objectives for review and the processes within the organization that interact with the human factors. In approaching quality of care assessment, the Donabedian triad [48] classifies three categories: Structure-Process-Outcome (Figure 1) as an effort to improve the quality of care provided. In this model, harm can be seen as an outcome, while errors are approached with a magnifying lens. This approach avoids focusing on the provider’s responsibility for harm, and advocates orienting towards the system involved in the error, knowing that errors and harm are not always linked. A mature culture of safety leads to injury prevention by asking “why” during every step of the root cause analysis and by supporting the development of an injury prevention model [49]. It also provides a more constructive follow-up to families and patients, as evidenced by a decrease in the number of claims by half, associated reductions in legal fees, less cost per claim and decreased settlement amount when changes in the response to harm with a communication and optimal resolution approach is implemented [50, 51, 52]. A mature culture of safety focuses on the system and the impact on people, elevating psychological safety, concentrating on why the event occurred within that environment; and why the established redundancies within the system were not effective in aborting the event. Changing the culture of safety where the outcome (harm) is not the center of the investigation to one where the investigative questions move away from what happened and who was involved, increases the trust in the evaluation process and decreases the fear of participating in the event assessment [53]. Emphasizing on the individual participants and not the system assessment results in further degradation of the culture, prevents people from speaking up, and leads to more cover-ups due to concerns of being labeled as incompetent as well as enhances the fear of retaliation.

Figure 1.

Relationship between Donabedian’s quality assessment model and culture. Donabedian’s Quality Assessment integrated with the Culture of Safety. The beginning of a cultural model of quality improvement assessment can shift between focusing on an outcome to focusing on the structure within an ecosystem. The elements that Donabedian labeled in this quality assessment model are described along with a culture of safety stage of development. As the culture evolves, the attention is re-directed towards the process of care and common improvement activities are directed to reduce variation. At a mature level, the culture of safety focuses the solutions to system re-engineering and psychological safety (Figure based on Donabedian A. The Quality of Care. How can it be assessed? Jama 1988;12:1743).

2.1 Intensive care and teamwork

An effective and efficient workload involves a highly specialized workforce where teamwork is the central process [54]. The intensive care unit is a highly complex system where the most acute and severe medical cases are cared for in the acute and chronic phases. The complexity includes the highly technological support with continuous assessment and integration of multiple disciplines in the decision-making process [55]. Collaboration, coordination, and networking between disciplines aim to achieve the same goal, patient care, and better patient outcomes [54]. The type of teamwork described in the intensive care unit is commonly characterized as multidisciplinary, although other terms such as interdisciplinary, multi-professional, and interprofessional have also been used [56]. For this chapter, we will use the term interprofessional collaboration [57]. In addition, when the patient and family members are included in the decision-making process, the effects of stressful decisions among parents are mitigated, the sense of remorse is lessened [58] and the levels of dissatisfaction among family members is reduced [59].

2.2 Common errors

Non-diagnostic medical errors and adverse events have been well described in the intensive care setting, impacting hospital LOS and ICU days [21]. The common categories include medication errors, communication and handoff errors, teamwork errors, healthcare-associated infections, and surgical errors. All these areas can be easily reported, investigated, and have been the focus of quality improvement approaches to prevent and minimize harm.

Unlike non-diagnostic errors that are easier to investigate, diagnostic errors require a different strategy. In an exploratory study delving into diagnostic errors, Barwise et al. found that the most cited errors across different ICU stakeholder groups include: a) difficulties associated with organizational factors, such as availability and relevance of the information within the electronic health record (EHR), workflow problems and capacity issues; b) difficulties related to interpersonal factors, e.g., poor communication, failed handoff, and suboptimal teamwork; and c) difficulties related to the individual clinician or patient factors [60].

A systematic review in Pediatric Critical Care found that up to 67% of diagnostic errors in the pediatric critical care setting are related to system factors, while up to 30% included cognitive factors. Notably, 40% of the diagnostic errors combined cognitive and system factors [61].

As the field of patient safety has evolved through the years, diagnostic errors have become an important area of investigation. A superficial view of this topic might target only the provider who, based on skill and experience, reached a medical decision [62]. However, considering our current scope and development of evidence in patient safety, a deeper understanding of decision-making leads to scrutinizing the institutional structure and processes available, including technical and human factors, policies and procedures, and a culture of harm prevention [63]. Whether building safety checks into the healthcare system will suffice to prevent diagnostic errors is yet to be determined.

2.3 Taxonomy

The Agency for Healthcare Research and Quality (AHRQ) and the Patient Safety Network (PSNET) define near-miss events as “errors that occur in the process of providing medical care that are detected and corrected before a patient is harmed.” They have also been called “close calls” [10]. In the current complex ICU environment, identifying and correcting events before they reach the patient is paramount as healthcare organizations engage in the care delivery process in critical care environments. To help us understand this undertaking, James Reasons’s Swiss cheese model illustrates how small but multiple systems’ failures lead to safety events which are often harmful to patients [30]. Within the glossary of patient safety terminology relevant to this review, we include “sentinel events” and “never events”. The AHRQ notes that “sentinel events”, a term utilized by The Joint Commission, can also be viewed as “never events” and it further defines sentinel events as “an unexpected occurrence involving death or serious physiological or psychological injury, or the risk thereof” [64] which highlights the interchangeable aspect of this important terminology [65]. A common taxonomy for event classification widely used in publications and at institutional levels was designed by the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). In this index, errors are graded in categories A through I, depending on the level of harm (Figure 2) [66].

Figure 2.

Coordination between quality improvement, patient safety and risk management using culture of safety principles to predict, prevent and manage harm. A quality oversight team must organize the response to all events being reported, independently of the level. The most serious events will require risk management to engage and deploy resources to perform a Root-Cause-Analysis. Less severe events, such as near-misses, can be managed by the Patient Safety and Quality office, ultimately responsible for developing standards of optimal care, new gold standards, ensuring compliance with established policies and procedures. It is everyone’s responsibility to create a culture of safety and to generate the educational tools to predict, prevent and manage harm.(*Permission is hereby granted to reproduce information contained herein provided that such reproduction shall not modify the text and shall include the copyright notice).

Severe error investigations commonly involve the root cause analysis (RCA) process developed by the Joint Commission on Accreditation of Healthcare Organizations. A widely used approach to categorizing the root cause of errors was published by Charles Vincent [67] and continues to be helpful in event investigations. It follows a similar logic as the Swiss cheese model created after James Reason’s publication on latent human failures [68], emphasizing that the analyses of medical errors should anchor on diving into root causes that explain decision making, not on the whom and how, but in the why. The goal is to identify the gaps within the ecosystem using root cause analyses to address the system’s failures. This recommendation aligns with The Joint Commission’s® goal of zero harm. Ideally, investigating near misses can identify gaps requiring proactive intervention. Near miss reporting is weak unless it is closely associated to a negative outcome [69]. These types of events are rarely reported as they are time-consuming and require additional evaluative effort. Furthermore, it is challenging to measure their results. As we move towards a preventative rather than reactive approach healthcare, exploring the near-miss events should be a gold standard.

2.4 Staffing impact, coronavirus disease 2019 (COVID-19) era and current challenges

The COVID 19 pandemic spurred on a mass workforce exodus from healthcare and increasing emotional distress, impacting all levels of care across the healthcare continuum, including the critical care environment [70]. Considering this new phenomenon, organizations were forced to reimagine innovative ICU care models [71], recognizing that the ICU of the future will have a different team composition with varied operational strategies [72]. The ongoing challenge healthcare institutions encounter is the increasing number of patients with life-threatening conditions in critical care settings. A decreased supply of critical care staff created from a “deficit status quo” [73] and the additional COVID-19 pandemic burden have exacerbated the current systems, putting patient safety at risk. Evidence demonstrates that nursing staffing and workload in the ICU have a direct impact on mortality rates, nosocomial infections, increased length of hospital stay (LOS) and overall inferior nursing performance [74]. The COVID 19 pandemic prompted older generations to retire, mothers decided to stay at home and care for their children due to a lack of available childcare, while others decided to leave healthcare altogether and pursue other careers. There is increasing evidence that nurses plan to leave the workforce at a faster rate when compared with the past decade [75]. As a result, the Great Resignation shifted the predominant workforce characteristics towards younger and less experienced staff compared to the pre-pandemic workforce. Research suggests that novice nurses are more prone to make medical errors, impacting the quality of care provided to their patients and driving the healthcare community to search for innovative approaches in education and clinical practice [76]. Younger generations prefer collaboration over competition and mentorship relationships with their bosses over the standard hierarchical structures in healthcare organizations [77]. This preference can be harnessed to drive patient safety initiatives in critical care while helping co-create new collaboration models.

This technology-savvy workforce also demands more sophisticated hardware and software that enables their professional responsibilities. Modernizing, enhancing, and automating processes and integrating systems that improve the ICU workflows will be crucial to retaining the current workforce.

Understanding the needs of the current workforce will help organizations develop retention strategies, create an enjoyable work environment, and subsequently improve patient safety. Intangibles such as job structures that can maintain a better work-life balance, burnout prevention, and joy creation will be non-negotiable.

3. Mitigation strategies and proposed solutions

3.1 Culture of safety

Institutional Core Values: At an institutional level, the quality oversight team must create a cultural shift by coordinating that each department addresses safety, process improvement, professional outcome assessment, and patient satisfaction. This cultural shift should be focused on personal responsibility and behaviors consistent with institutional core values [1, 32, 78].

3.2 Decision making

All healthcare providers who attend to patients in the medical system are highly motivated, highly trained individuals whose professional goal is to support others in their most vulnerable moments. It is therefore of the utmost importance to approach medical errors from a systems perspective, understanding that human decision-making is anchored in an evolving medical system where ideally, patient safety should depend on error anticipation and prevention [47]. HROs e.g., nuclear power industry, commercial aviation, aeronautics, base their safety on organized algorithms. Humans are placed in an environment where decision-making is anticipated, and the appropriate tools exist to minimize risk (e.g., checklists).

Little attention has been given to a type of medical error that is difficult to measure and rarely reported: diagnostic errors. This group of errors have been recognized as a significant patient safety threat, involving intra- and inter-professional teamwork [79, 80]. In 2015, the National Academies of Sciences (NAM) released a landmark report addressing this concern: Improving Diagnosis in Health Care [81]. Decision-making and subsequent actions for diagnostic and treatment purposes occur in an ecosystem that involves structure, processes, policies, and an accepted culture within an institution. It is imperative to understand diagnostic reasoning and critical thinking to improve diagnostic performance and reduce error.

Daniel Kahneman won a Nobel Prize in 1982 for the systematic identification and characterization of human decision behaviors which were not previously described. His book, Thinking, Fast and Slow, describes two cognitive systems of thinking and decision making: System 1 or Type 1 (automatic, emotional, stereotypic, unconscious), and System 2 or Type 2 (slow, effortful, infrequent, logical, calculating, conscious) [82]. He theorized that System 1 uses cognitive “shortcuts” (heuristics) to reduce the cognitive cost of decision-making. In this area, cognitive biases can preclude the bayesian approach to medical decisions. Cognitive psychologists have explored medical reasoning, the use of these mental systems, and cognitive self-monitoring strategies (metacognition, debiasing) that allow for a mental pause to recognize and shift between these processes [83, 84]. Understanding cognitive decision-making processes that influence medical decision behavior will impact cognitive errors. Education in cognitive science and critical thinking, associated with metacognitive skill training [85] using curricula can provide practitioners with the tools to understand and recognize cognitive biases, particularly in high-paced, high-risk specialties such as Anesthesiology, Critical Care, and Emergency Medicine [86].

4. Leadership

4.1 Leading with humility

Leading with humility is an attribute sought after in healthcare, mainly because most subject matter experts undergo rigorous training and become highly skilled before being able to treat and manage critically ill patients. Bringing these experts together and capturing the collective genius requires humble leadership, collaboration, and a shared purpose: to produce safety outcomes. Owens et al. proposed several characteristics of leader humility: “(a) a manifested willingness to view oneself accurately, (b) an appreciation of others’ strengths and contributions, and (c) teachability or openness to new ideas and feedback” [87]. Leading with humility is a signature trait [88] of inclusive leadership characterized by humble inquiry. Considering the fast-paced environment of our current ICUs and the commitment to patient safety, servant leadership is key to being open to asking the questions to which we do not know the answers. Centering the message around the patient, we recognize the importance of leading with humility.

4.2 Inclusion

The current volatile, unpredictable, complex, and ambiguous healthcare environment suggests that everyone’s voice can be mission-critical [89]. This can be accomplished if we cultivate inclusive and agile leadership. In this climate, inclusive leadership is crucial to collaboration and the avoidance of preventable failures. ICU teams’ structure involves physician attendings, residents, nurses, respiratory therapists, advanced practice providers and many other roles from diverse backgrounds.

Empirical evidence continues to grow about the importance of inclusive leadership and its influence on culture in healthcare. The Leadership Saves Lives study demonstrated that organizational culture and performance improvement significantly influence mortality rates for patients experiencing acute myocardial infarction [90]. Inclusive leadership crosses hierarchies and invites distinct perspectives and authentic participation. This helps build trust among peers, psychological safety, and situational humility. For example, when physician leaders of intensive care units invite dialog on “what else can we do; how can we tackle this opportunity together,” they demonstrate openness to other ideas and foster collaborative problem-solving. Inclusion leads to greater engagement, team performance, and improved patient outcomes [91]. The care for our critically ill patients has become increasingly complex, and teams rely on each other to save lives.

4.3 Psychological safety

Psychological safety is foundational to healthcare organizations and the conduit through which patient safety occurs. This phenomenon and its related antecedent concepts have been studied since the 1990s, with much progress made in recent years. It has been linked to team performance [92], ethical conduct [93], team diversity [94, 95], incivility [96], reporting of medical errors [94], innovation [97], and has been identified as a predictor for turnover intent [98]. A great problem occurs when medical errors are not reported due to lower psychological safety. The organization and patients suffer as a result, either through direct harm or missed opportunities to prevent latent failures.

Compelling evidence shows that when team members speak up, they are willing and able to talk about mistakes, collectively tackle improvement, and are more likely to innovate and drive solutions [91]. Nembhard and Edmondson discovered that intensive care units which foster high levels of psychological safety spontaneously decreased morbidity and mortality without additional interventions such as training or education. Despite growing evidence, psychological safety in healthcare organizations remains an untapped opportunity. Some factors include unmitigated and unapologetic hierarchies, fear of endangering someone’s life, and old authoritarian leadership models. Fostering psychological safety in the current complex environment is crucial for catching near misses [69], addressing medical errors, and continuously learning from them.

High psychological safety is a prerequisite to advancing patient safety. Over the years, research in social psychology has identified humble inquiry as the avenue to build psychological safety. Recent data shows that leaders can effectively build it not only through seeking feedback from team members, but also by sharing criticism they previously received, and by being openly vulnerable. Grant and Coutifaris randomly assigned leaders to criticize themselves as opposed to asking for criticism. Just inviting them to do that once, it increased psychological safety in their teams for at least a year [99]. This led teams to organize monthly vulnerability meetings and reserve time for “check-ins” on what needs to improve. Other structured practices that enable and support psychological safety include time outs, huddles, debriefs, listening and communication as agreed upon competencies, understood method to raise a concern or question, and escalation protocols.

5. Technology

Unfortunately, even in modern medicine, with some of the most advanced medical equipment in the world, it is not an easy task to be able to remove noise, recognize a deteriorating patient in early stages, initiate timely resuscitation maneuvers, correctly identify a differential diagnosis, and orchestrate highly complex multidisciplinary teams to focus on critical short term goals while maintaining a strategic plan to allow the “person-in-the-bed” to recover to a high functioning level, as close as possible to the pre-morbid state and prevent a possible PICS.

Because the ICU is only one segment in the patient’s journey, we must be comfortable stepping outside the physical boundaries and create operating conditions that include electronic outreach and monitoring in a control tower fashion, proactive ICU nursing rounding, and rapid response, preventing complications of medical care, enhanced rehabilitation pathways, avoiding transition of care gaps, preparing survivor clinics, readmission prevention with advance care at home, and others yet to be invented.

5.1 Smart alerts

Changing the ICU framework towards early identification and protocolized management of critically ill patients is perhaps one of the most significant contributions developed in recent years [100]. ICU and Quality Improvement teams participate in local, national, and international research teams to develop processes and decision support tools deployed at the point of care in critically ill patients [101, 102]. Evidence supports that smart alerts improve the care provided in the ICU, some examples include: (a) adherence to basic critical care processes such as the sepsis bundle [103], (b) ventilator bundle with sedation holiday compliance [100, 101], and (c) enhanced risk stratification utilizing severity of disease score calculators [104].

When smart alerts are deliberately deployed using implementation science tools, they can lead to better outcomes such as decreased in ICU, hospital, and 28 days mortality rates from sepsis [103] and alleviated cognitive workload with more accessible navigation through the EMR [105]. Smart alerts also have the potential to add value in intensive care units by lowering cost, decreasing ICU and Hospital LOS, improving disability-adjusted life years, quality-adjusted life years, and incremental cost-effectiveness ratio [106].

To juxtapose the attributes smart alerts have, they can potentiate negative consequences if the alerts are missed or delayed due to technical difficulties, which might translate into delays in care. Some examples include technical failures, firewall blocking, and security issues with smartphone/tablet alert delivery which may present a barrier to optimal alert delivery in the ICU setting [100].

End-user fatigue contributes to disengagement with the alerting mechanisms; it increases human error, information overload, as well as alerts with higher false positive (noise) rates. This can derive from user preferences for specific alert delivery methods, which can affect compliance [107].

5.2 Decision support systems and artificial intelligence

Artificial Intelligence (AI) tools intended for practice enhancement will have to address these challenges. Based on insights gained from studies of human error [60], understanding of information needs [108], and both cognitive and organizational ergonomics [109], we need to establish an infrastructure to develop and test advanced analytics centered on clinician’s needs and ICU decision support tools applicable both at the bedside and across the hospital of the future. AI applications in critical care are in the early stages of development. Some of the initially published studies showcase applications to predict LOS, ICU readmission, mortality rates, and early identification of complications and risk stratification [110]. The promise of AI enhancing safety in the ICU depends on its successful application to common ICU problems such as point-of-care ultrasound, volume assessment, medication titration, ventilator management, and other smart devices [111]. An essential element to consider when evaluating the role of AI is that scientific evidence still needs to catch up with machine learning algorithms. For example, the FDA has approved 130 AI devices, of which 126 were based only on retrospective research [112]. Also, we must ensure that measures are taken to avoid algorithmic biases such as race, gender, and other social determinants of health. As such, algorithm developers should transparently report the steps taken for the algorithm to be equitable and representative of the entire population or at least report the specific input data sources, population composition, bias assessment validation, and training data location and period [112].

The role of AI-based technologies in critical care is expanding exponentially. Much of the work utilizing AI in intensive care has been around predictive analytics for early identification of deteriorating/at risk patients and machine learning models to predict patient’s clinical trajectory [111]. Solutions such as using predictive analytics to provide early insights on whether a patient will develop delirium [113], pressure injuries [114] from prolonged ICU stay, sepsis [115], or have unattended bed exits triggering falls, have the potential to become the gold standard for the healthcare industry. They augment the decision support process, enhance reliability, and accelerate much-needed agility in critical care. These tools are crucial to optimizing the care our patients receive and achieving the goal of zero harm. Halamka and Cerrato describe in The Digital Reconstruction of Healthcare that the future belongs to advanced data analytics. Supporting human skills with Big Data and AI-based algorithms can be equated to “giving the best artists the best analytic tools” [116]. It will elevate the potential for decreased ICU stay, and fewer hospital-acquired infections, among many other healthcare-associated conditions. This vision advances the frontiers of patient safety into an ultra-safe space. Another promising feature of AI-based solutions is solidifying healthcare in the high-reliability space where there is less dependence on human behavior and more reliance on systems and structures. Minimizing patient harm while delivering care includes high-reliability practices which lead to a “more integrated picture of operations at the moment and earlier detection of potential threats to safety” [117]. Empirical evidence suggests that advanced predictive analytics must be part of the solution to improve the patient’s safety journey in critical care environments.

5.3 Electronic medical record (EMR)

The transition from handwritten records to EMR has improved efficiency, revenue capture, and billing. Evidence supports using EMRs to enhance patient safety and improve outcomes [118]. Reports exist promoting that EMR saves time during documentation [119]. If critical elements of EMR design and implementation are overlooked, then the positive or negative impact on patient safety and quality could potentially be amplified [108]. To appropriately design and implement an EMR in the ICU, crucial elements must be considered, including information overload, clinical setting, rule development, controlled environment testing, field testing, and implementation science. As an example, Pickering et al. have demonstrated that after following these steps for introducing a novel Ambient Warning Response and Evaluation (AWARE), EMR was associated with improved efficiency of data access and decreased cognitive overload due to improved presentation format [120].

5.4 Dashboards and feedback

The amount of information and metrics being tracked by ICU providers and leaders can be overwhelming. It is paramount that critical priorities are distilled at the unit, team, and provider levels. Priorities need to be divided into metrics to induce improvements that can be tracked in dashboards and transparently published and accessed. To sustain the gains, providers should be given factual and non-judgmental feedback as close to real-time as possible. Utilizing this methodology with the sepsis care bundle compliance, for example, some ICUs have been able to improve compliance, [121] sustain gains, and translate them into improved patient outcomes [103, 122].

6. Education

The critical care setting is a highly technical, fast-pacing, high-risk clinical area where medical knowledge advancement requires frequent up-to-date resources, and skill mastering involves the confidence and expertise of team members at different levels. Novice healthcare providers need the experience in critical thinking and skill mastering commonly provided within the practice, arguably impinging on patient safety principles. The balance between autonomy and supervision in all disciplines is an ever-changing part of daily practice in the intensive care unit. The challenges in an increased demand on training hours, limited patient encounters, and the focus on patient safety have led to relying more on innovation and technology to provide an effective curriculum.

Recognizing the degree of safety within the critical care practice can set the stage to determine the priorities needed in education. Education is frequently embedded within practice to maintain a high level of patient safety and minimize harm. Figure 3 describes the functional levels frequently found in this setting, including the unique nature of the ICU, where teams often move within a spectrum of an ultra-safe activity to an ultra-adaptive activity, setting the stage for a higher risk for errors [123].

Figure 3.

Approaches to safety education and practice in the intensive care unit. Successful Critical Care practices feel comfortable with fast changes in pace and complexity. These changes come with an increase in risk, translating into variations in safety levels for decisions and procedures executed. ICU conditions can change very quickly ranging between an ultra-safe environment as in bedside rounds, a highly reliable as in central line placement, a reliable as in difficult airways or an ultra-adaptive in multiorgan failure/code situations. With this construct in mind, education should be directed to arm providers with the tools to think fast and slow between: routine operations/focus on prevention, applying known procedures in emergencies/focus on protocols, being flexible/focus on adaptative team strategies and professional expertise/focus on stabilization followed by recovery. *(Vincent, C and R. Amalberti, Strategies for the Real World 2015, Chapter 3, pg 31. Ref. 123).

Medical simulation has been introduced as an effective methodology in medical education in general [124]; and within the critical care practice to impart critical care principles, particularly in skill acquisition and competence [125]. This technology has had a widely positive educational impact on all health-related professional groups [126]. It provides significant results when combined with reflective debriefing, considered the most crucial component in healthcare simulation [127]. The interactive, bidirectional, and reflective conversation at the end of a simulation exercise cements the basis of adult learning strategies using experiential learning. Several methodologies have been described in the literature, including debrief timing, methodology, structure alternatives, and process elements. The facilitator-guided debrief is the most common methodology and improves individual and team performance [128]. Recently, a more positive approach to debrief, learning from success (LFS), has been endorsed where adaptation is the focus of the exercise with a scenario that includes unanticipated and problematic disruptions that are presented to the learners [129]. Faculty members using the LFS approach require a deeper understanding of human factor science, patient safety, implementation science, and organizational psychology.

Can the use of medical simulation improve the goals of patient safety and decrease harm to patients? The current body of literature describes enhanced skills and knowledge, competence, better outcomes, and lower error rates using procedural simulation training [130]. The use of simulation has also been applied to hospital design to identify latent conditions and mitigate safety concerns in a systematic process [131].

6.1 Skills development and assessment

The skill set required for the ICU healthcare providers is unique and differentiated from other work units within the hospital. Some of these skills include high risk airway management, conscious sedation, management of mechanical ventilatory and circulatory support, among others. There are several ways to ensure providers who join the ICU have the necessary skill set for critical decision-making and advanced procedures. Standard credentialing processes and certification have been established to ensure providers complete a certain number of procedures. It is essential to recognize the limitations of relying narrowly on procedural skills when ICU leadership makes hiring decisions. Having mechanisms to evaluate soft skills and decision-making prior to hiring can enhance safety by elevating the starting skillset. One tool to consider is using simulation scenarios that mimic typical decompensation events to evaluate and optimize performance. Utilizing simulation center-based interviews for nurse practitioners and physician assistants at one institution improved retention. It also decreased actions for practice deficiencies compared to a conventional interview method [132].

6.1.1 Cultural values

When new employees join, they only have a basic understanding of the organization based on small bits of information gathered during the interview process. During their onboarding, we need to establish a memorable experience that helps them internalize the expectations, including service values, cultural components, [78] shared understanding of how we work, how we interact, fair and just culture, and how we respond to safety events and improvement culture.

6.1.2 Defining successful ICU outcomes

Meaningful outcomes must be concordant with the patient’s wishes. From the patient’s perspective, the quality of life, independence, and quality of death and dying are often more important than survival per se. We also must prevent catastrophic long-term consequences for patients and their families, many of which are iatrogenic.

6.2 Shared-decision making

Informed Medical Decisions Foundation defines shared decision-making as “Shared decision-making is a collaborative process that allows patients, or their surrogates, and clinicians to make health care decisions together, taking into account the best scientific evidence available, as well as the patient’s values, goals, and preferences” [133]. Subsequently, effective communication with patients and families is the pillar of shared decision-making and patient-centered care [134]. The availability of health information technology (HIT) allows for increased connectivity between patients and providers. A systematic review of the current literature addressing patient access to their EMR, reported increased patient engagement with the medical system, increased communication with their health care teams, increased discovery of medical errors, and improved adherence to medication [135]. Furhermore, vast research conducted in the shared decisiom-making space, clarified the opportunities related to patient’s preferences, goals and values, especially in the ICU setting where requests for futile interventions often arise [136]. From the patient and family’s perspective, effective communication enhances trust in their healthcare providers and improves the perception of their care within a system [137, 138, 139].

7. Professional development

Patient safety science continues to be an ever-changing field in health care. Continuous professional development in all disciplines and lifelong learning are essential to meeting patients’ expectations, regulatory requirements, personal growth, and job satisfaction. An integral part of the development and organization of a safety program within an institution is continuing professional development. This requires a well-developed systematic approach to individual and team growth, in conjunction with technology implementation and invariably uses principles of human-engineering science. Enhancing communication between professionals, various services, and with patients requires leadership involvement in creating an environment of excellence [55].

8. Team dynamics

The relevance of team training is evident in the critical care setting. On any given day, various disciplines and providers from different professions interact to provide the best care to critically ill patients. This fluid interaction is significantly highlighted during acute clinical situations where dynamic changes in personnel occur frequently. The Joint Commission® lists communication error among the most common causality related to sentinel events [140]. Several barriers can compromise effective communication within the medical system, including behavioral, cognitive, linguistic, environmental, and technological sources. Identifying and analyzing communication obstacles can allow for implementation of specific evidence-based solutions [134, 141].

Failures in communication and teamwork are contributors to many adverse events. For the past 10 years, emphasis has been given to team training and multiple strategies have been described [142]. Desirable teamwork behaviors include situational monitoring, communication, leadership, mutual respect, trust, role participation, and shared mental models [143]. Effective response in interdisciplinary and interprofessional collaboration is enhanced during team training. Several training programs have been created including crew resource management (CRM), which originated from the aviation industry, medical team training (MTT) at the Veteran’s Health Hospitals, and the Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) from the AHRQ. A 2020 systematic review supported the effectiveness of team training in knowledge, skills, and attitudes (KSAs) after 30 days of training [144]. This systematic review collectively described improved patient outcomes, enhanced communication, and handoff tool implementation. It has been recommended to include team-training concepts throughout the career development of all healthcare professionals [142].

8.1 Interprofessional collaboration

To optimize the patient’s journey in the ICU, genuine integration of multidisciplinary coordination must be the new norm. Given the fast-paced performance pressures applied to allied health personnel (pharmacists, RT, Nutrition support, OT, PT), their current roles will evolve to participant-consultant experts for the entire unit [54].

Teaming on the fly is progressively common in critical care, especially when patients are experiencing hemodynamic instability and require emergent mechanical support. Extracorporeal membrane oxygenation can be used as a lifesaving strategy [145]. By default, this intervention requires a remarkably elevated level of interprofessional collaboration between perfusionists, respiratory therapists, physicians, physical therapists, and nurses, among many other roles.

8.2 Collective intelligence

The critical care environment is non-linear, complex, and characterized by stable and unstable equilibria. Operating as an adaptive system requires agility and a deep understanding of our interdependencies. As a result, we rely on each other’s expertise to deliver the best and safest care during these critical moments of our patient’s lives [146].

Every patient in the ICU is likely to benefit from the focused attention of multiple disciplines [54]. For this model to succeed, it will be essential to leverage synchronous and asynchronous communication technologies to elevate the collective intelligence. This construct is more critical than ever as we navigate diverse disciplines, engage experts from various backgrounds and generations, and integrate numerous technology-based solutions to augment the decision-making process. An example of this approach includes bedside rounds. In this activity, multiple disciplines organize daily to discuss the patient’s condition, utilize various technologies such as the EMR and dashboards, and co-create the care plan.

Healthcare is moving away from the reductionist undertakings of individual performance to collective intelligence, improving the patient safety journey. We propose that there should be a deliberate institutional framework that maximizes collective intelligence, coordinating between quality improvement, patient safety, and risk management utilizing culture of safety principles to predict, prevent, and manage harm (Figure 2) [147].

8.3 Checklists and the checklist for early recognition and treatment of acute illness (CERTAIN) project

Checklists have been recommended as decision support tools to decrease the number of cognitive errors [148] and to encourage reflective practice [79] and metacognition [149]. Using checklists within the acute care setting and the surgical suite has led to discovering latent threats to patient safety. Medical crisis checklists have been tested in a simulated environment, demonstrating improved management during a critical medical emergency [150].

CERTAIN has been implemented across more than 55 hospitals worldwide (https://www.icertain.org/partners). Physicians, nurses, and other allied health staff from these institutions use bedside decision support tools and web-based remote simulation and coaching. Utilizing quality improvement methodology, CERTAIN implementation has demonstrated feasibility and better adherence to critical care processes in a timely manner while decreasing complications, decreasing ICU LOS, decreasing hospital LOS, and lowering mortality [151]. Another advantage of CERTAIN is the ability to provide tele-education and coaching that leads to improved costs while also improving care and outcomes in resource-limited ICUs [152].

8.4 Bundles of care and the ICU liberation project (ABCDEF)

Healthcare has shifted from the concept of caring for a critically ill patient from “ICU resuscitation and prolonged ICU stay” to an “ICU liberation” approach. The patient’s outcome after an ICU stay has become a significant area of investigation, still requiring further understanding. In 2013, the Society of Critical Care Medicine and the American College of Critical Care Medicine joined forces to update the Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in the ICU adult (ICU PAD Guidelines) published in Critical Care Medicine [153], and soon after adopted the ABDCEF Bundle of Care for the ICU setting. This bundle includes: Assess, prevent, and manage pain; B consists of both spontaneous breathing trials and spontaneous awakening trials (SAT); Choice of analgesia and sedation; Delirium: Assess, prevent, and manage; Early mobility and exercise; and Family engagement and empowerment [154] and has been named the ICU Liberation ABCDEF Bundle.

In 2018, the implementation of the ABCDEF bundle of care in 68 adult hospitals resulted in decreased mechanical ventilation days, hospital deaths, incidence of delirium, and ICU readmissions. Collectively, using all the elements of this bundle, led to a significant dose-related improvement in the outcomes measured [155]. It is noteworthy that despite these improvements, ICU providers encounter challenges implementing all the elements of the bundle reliably and consistently [156] and questions remain unanswered, which will lead to further research [157].

9. Conclusion

The initial enthusiasm to address and nullify adverse events in the health care system has clashed with the reality of a complex and ever-changing medical system prone to adverse events and medical errors. Fortunately, by approaching these complexities with the same mindset we approach complex ICU patients, we better understand the type and complexity of adverse events in medicine. This perspective has allowed the ICU community to refocus energy on quality improvement activities.

There will always be a potential for an adverse event in the intensive care practice. This understanding guides our efforts to re-engineer the healthcare delivery system in a way that minimizes risk and creates continuous learning loops for every near miss and medical error. In this review, we have proposed evidence-based mitigation strategies and solutions to develop a more robust safety culture, increase psychological safety, and encourage a more humble and inclusive leadership (Figure 4).

Figure 4.

Understanding risks, focusing on improvement and testing evidence based mitigation strategies and solutions. Mind-map describing how to achieve better understanding of the variables affecting safety in a patient’s journey through the ICU. We also describe evidence-based mitigation strategies and possible solutions when looking at the ICU from a broader perspective including cultural aspects, leadership styles, and technological solutions. Description of retention strategies based on impactful education, stimulating professional development, and promoting team dynamics celebrating interprofessional collaboration and collective intelligence as described within the text. (Arteaga, Bacu, Moreno Franco 2022).

Innovation strategies with more intelligent alerts that leverage AI, and decision support tools that maximize the utility of ergonomics, human engineering, and cognitive thinking, are becoming routine. These tools will prepare the medical system to promptly recognize, triage, and intervene in high-risk situations, minimizing harm. Anticipation is a crucial element of preparation. Creating dashboards and feedback loops allow intensive care teams to respond better when facing similar clinical situations.

Most importantly, there must be an investment in the human element beyond appropriate staffing-to-acuity levels. Over and above, constant investment is needed to support the workforce using an impactful onboarding experience, a series of challenging simulation scenarios, relevant debriefing routines, stimulating professional development curricula, and promoting team dynamics. The patients and their families are becoming an integral part of the ICU team. Together, patient safety in the ICU is fast moving towards integration and futuristic models of care.

Acknowledgments

Support from our institution, the Mayo Clinic, made possible the content and publication of this chapter. It is the Mayo Clinic’s shared goal and vision that inspired the content in this chapter.

Conflict of interest

The authors declare no conflict of interest.

Notes/thanks/other declarations

We want to thank our mentors, colleagues, and learners who planted the curiosity and the desire to seek ways to improve our current medical system. Most importantly, we are grateful to our patients from whom we have learnt how to become better health care professionals and best serve their needs. Without this collaboration, the content of this chapter would have been incomplete.