A Patient Safety Problem

Clinical deterioration on the general hospital wards is common and all too often results in patients progressing to cardiopulmonary arrest, which carries significant morbidity and mortality.^1-5 Occasionally, this progression is not witnessed or perhaps even worse, observed but unrecognized,^1,6 resulting in an unmonitored/unwitnessed arrest. These events are currently categorized as a serious adverse event (AE) by several reporting metrics including the American Heart Association’s Get with the Guidelines®⁷ and the Agency for Healthcare Research and Quality’s (AHRQ) Patient Safety Indicators (PSIs).⁸ Surgical patients may be prone to cardiopulmonary arrest due to their underlying diseases (especially conditions such as obstructive sleep apnea and cardiac disease), the surgical procedure, and the administration of opioids coupled with residual anesthesia.^9,10 This is a major concern for anesthesia professionals who help determine if the patient is safe to go to an unmonitored floor or should request a monitored bed which may be a limited resource.

The Rapid Response System as a Patient Safety Intervention

In the mid-1990s, Rapid Response Systems (RRS) were implemented to address this patient safety problem.^4,11,12 RRSs are composed of two main elements. The most visible element is the team that responds to the call for help for the deteriorating patient. These teams are often, though not always, made up of intensive care unit providers and are referred to as the “efferent limb” of the response. The “afferent limb” refers to the process and criteria by which clinical deterioration is recognized and a rapid response team is activated. The afferent limb uses activation criteria, education programs, and policy changes to encourage providers to activate the efferent limb whenever a patient’s condition appears to be deteriorating. Understanding and developing effective and valid activation criteria is perhaps the most crucial component of the RRS², even though the rapid response team (efferent limb) is essential to the success of these systems. Therefore, these activation criteria have evolved over time into a wide range of Early Warning Scores (EWS).

Beginning in the early 1990s, common predictors of clinical deterioration were identified from the medical records of patients that had arrested on the general ward.^2,5,6 The predictors identified were primarily physiological changes (elevated heart rate, low blood pressure, or mental status change) and were often found to be present for many hours prior to the arrest event. The ability to identify these changes indicated potential opportunities for early intervention. Presumably, the earlier warning signs are recognized, the more effective the intervention could be. Even though RRS have been successful in reducing in-hospital mortality and unanticipated cardiopulmonary arrest, they have failed to achieve their full potential.^4,9,10 Failure of health care professionals to recognize the deteriorating patient and the inability of existing data systems to trigger an appropriate response in a timely manner remain pervasive.

Addressing Afferent Limb Failure using Early Warning Scores

Efforts to address deficiencies in early identification of clinical deterioration (i.e., afferent limb failure) have taken several approaches including education programs, nurse empowerment initiatives, and increasingly the use of data-driven systems to improve clinical response. Initially, hospitals used single vital sign parameter thresholds in combination with “clinical concern” about the patient by the bedside nursing staff as activation criteria and many still do. Many hospitals subsequently developed and implemented “early warning scores” (EWSs) that attempt to integrate vital signs and laboratory data (e.g., lactic acid) to improve the sensitivity and specificity for earlier detection. Some studies of EWSs have shown improvement in patient outcomes compared with single parameter vital signs systems while others have shown little difference in outcomes.^3,13-36 These differences in study findings may result from use of overly strict or loose criteria for signaling a deterioration (e.g., extreme heart-rate cutoffs), use of nonequivalent outcomes (such as total cardiac arrest rate vs. non-ICU cardiac arrest rate), ineffective education programs to encourage appropriate RRS activation, lack of policies to support the intervention, poor project implementation, and variable acceptance in the medical care culture, among others.

A number of EWSs are worth focusing on. One of the earliest published in the literature was by Subbe et al. in 2003.¹³ This group developed a manual multiparameter scoring system, which assigned points based on the degree of abnormality of each parameter. Their EWS included mental status in addition to physiologic vital signs. When patients exceeded a threshold score (> 4), they were referred for clinical evaluation. Unfortunately, its initial implementation did not show an improvement in outcomes. In 2006, Green and Williams reported the results of an “Early Warning Clinical Marker Referral Tool,” which incorporated single parameter vital signs. While the authors were unable to demonstrate improved outcomes with the EWS, it did result in patients being referred for ICU admission with fewer markers of instability and illness suggesting that such a score could lead to earlier recognition of deterioration. In another study, Rothschild et al.¹⁸ implemented a single parameter EWS for patients on general medical wards. They found that while early warning conditions used to activate RRS teams were only fair predictors of acute deterioration, early signs of respiratory failure during routine monitoring were strongly associated with future life-threatening adverse events. In that same year, Prytherch et al. described an EWS called ViEWS (VitalPAC™ EWS, Sussex Place, London).¹⁷ This data-aggregated and weighted “track and trigger” system was developed to potentially become a national standard in the United Kingdom’s National Health Service. When ViEWS was applied to previously collected datasets, its ability to predict cardiac arrest and death was superior to other existing EWSs.^17,19 A simplified version of ViEWS was then validated in a Canadian regional hospital on actual patients where it was found to be effective for general ward medical and surgical patients.¹⁶ Table 1 includes a list of several clinically evaluated EWSs.

Table 1. Table of Selected Early Warning Scores

A 2014 systematic review of the EWS literature for use on general ward patients included 1 randomized controlled trial and 20 observational studies that evaluated 13 different EWS systems. Some EWSs used in the studies consisted of single parameters systems while others used integrated scoring systems. Some sought to identify specific clinical conditions such as sepsis. Eight studies (all observational) examined the ability of an EWS to predict death or cardiopulmonary arrest. Collectively, these studies showed that EWSs perform well for prediction of cardiac arrest and death within 48 hours. Thirteen studies examined the impact of EWS on health outcomes and resource utilization with mixed results.³⁷ This suggests that EWSs’ impact on outcome is uncertain, but they may be able to identify deteriorating patients.

More recently, predictive algorithms using machine learning and big data have been proposed and developed, with improved ability to predict clinical deterioration.³⁸ Machine learning is an artificial intelligence process whereby computer algorithms “self-learn” and improve their performance through training on datasets without the need for reprogramming. While conceptually appealing, EWSs need to demonstrate that their implementation can improve clinical outcomes.

Several explanations have been proposed to explain the failure of existing EWSs in improving clinical outcomes. First, the frequency of vital sign acquisition on the wards may be insufficient to allow detection of clinical deterioration.⁶ A second possible explanation is that vital sign values may have inaccuracies and audits of vital sign data confirm this.³⁹ Electronic health records (EHRs) do little to improve this situation as their performance is dependent on the intermittently and sometimes inaccurately collected data points. Third, recognition, response, and communication to the clinical team may not be timely enough. Therefore, it is not surprising that EWSs and the afferent limb of RRS don’t necessarily live up to their presumed potential.

Surveillance monitoring may be a better way to collect and act on clinical data for a patient who is deteriorating on a general ward.^40,41 Surveillance monitoring is distinguished from “condition monitoring,” which is employed in ICUs where the patients are unstable or are at risk for instability and the staff-to-patient ratio is adjusted accordingly. In contrast, general ward patients are generally at low risk for instability and the staff-to-patient ratio is much lower. Surveillance monitoring seeks to identify the infrequent occurrence of clinical deterioration in otherwise low-risk patients. General medical patients and especially postsurgical patients on the wards are at risk of a variety of complications including arrhythmias, myocardial ischemia, sepsis, respiratory insufficiency, and bleeding complications. Surveillance monitoring offers the possibility of improving upon many of the limiting features of existing EWSs that are thought to be at the core of afferent limb failure; it is continuous, relies less on fallible humans, is potentially more accurate,and, if automatically linked to an activation hierarchy such as a pager or mobile phone escalation protocol, may be able to circumvent the continued lack of appreciation of the patient’s developing deterioration.

Surveillance monitoring still needs to overcome several hurdles that may be challenging. First, it needs to be mobile and wireless since general ward patients are usually ambulatory as compared to monitoring of ICU patients, who are much less so. Wireless technology has advanced tremendously in the last decade, and wireless systems now exist that may meet this need.⁴² Embedded in the use of this technology is the need to meet ever-changing and more stringent security standards to protect not only patients’ information, but also hospitals’ health information technology systems. A second requirement is the need for the mobile surveillance monitor to have adequate battery life. The need for frequent battery changes/recharges would make such a system impractical. A third requirement is the need for the monitor to be comfortable and relatively unobtrusive. Ambulatory general ward patients will not likely tolerate wearing heavy or uncomfortable monitoring equipment. Fourth, the vital-sign data collection should be continuous, since use of intermittently collected data may miss early signs of deterioration. Fifth, it needs to have an acceptable accuracy and a manageable false alarm rate. Condition monitoring in the ICU (e.g., certain ECG alarms) has a high false alarm rate. These high false alarm rates may lead to alarm fatigue, which is a widely recognized patient safety issue in which alarms are ignored or there is a delayed response.⁴³ An acceptable false alarm rate for clinical monitoring of ward patients is uncertain. However, the need to control alarm fatigue must be balanced against the potential benefit that may be derived by obtaining continuous higher fidelity data.

Studies of surveillance monitoring are still limited but the results are encouraging. Several studies have demonstrated success using primarily pulse oximetry surveillance monitoring in post-surgical patients.^44-49 A recent study⁴² examined a multiparameter wireless surveillance monitoring system on a neurological/neurosurgical ward and found that the average alarm rate for all alarms (SpO₂, HR, RR, NIBP) was 2.3 alarms/patient/day and the RRS activation rate was reduced. Other measured outcomes, such as readmission to the ICU, did not show a statistically significant improvement though there was a positive trend in the right direction. We have tested a similar system on a general postsurgical ward and found similar trends.⁵⁰

Conclusion

Unrecognized and unattended clinical deterioration on general hospital wards must be avoided. The implementation of RRSs has reduced the occurrence of such events but better methods to predict early deterioration and to link this to interventions are needed to further improve outcomes. Despite improvements in EWS and surveillance monitoring, it will still be necessary for providers to act in a timely manner, develop an appropriate differential diagnosis quickly, gather additional relevant data as needed, and institute effective evidence-based therapies including necessary triage to a higher level of care to improve patient outcomes.

 

Dr. Winters is the division director for Critical Care Medicine in the Johns Hopkins Dept. of Anesthesiology and Critical Care Medicine and co-director of the Surgical Intensive Care Units at the Johns Hopkins University School of Medicine.

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He reports no conflicts of interest pertaining to this article.

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