Still recent, it is easy to recall the strain exerted by the pandemic triggered by SARS-CoV-2 virus on the health care systems everywhere.1 Long before, in Intensive Care Medicine, there was already a strong association between high care pressure and a lack of adherence to clinical practice guidelines, which secondarily led to a worsening prognosis, including increased mortality.2–4

From a safety perspective, the pandemic imposed atypical work dynamics that caused gaps in clinical safety at all levels of health care.5 Specifically, significant changes in the perception of safety culture were described, associated with structural, leadership, and communication deficits.6 Other authors highlighted inefficiencies in the system due to a lack of process standardization.7

In the ICU setting, incidents related to patient safety (IRSP) during the pandemic led to an increase in primary bacteremia,8 central venous catheter-associated bacteremia,9 ventilator-associated pneumonia, catheter-associated urinary tract infections, renal failure, and thromboembolic and vascular events, all of which were associated with increased mortality.10,11 In response to these IRSPs, health care professionals were further strained as they were forced to adapt to new safety standards.12 Simultaneously, during this period, IRSP reporting systems were underutilized.13–15

Our group has developed a proactive safety tool called Real-Time Random Safety Audits (AASTRE), which has been associated with improvements in structure, process, and outcome quality indicators. AASTRE has proven particularly useful in situations of high care pressure and for the more severe critically ill patients.16,17 This tool is based on a set of evidence-based measures that are considered mandatory during ICU care activities. Randomization refers to the fact that neither the measures nor the patients audited can be known in advance of the safety rounds, as both are randomized on the day of the audit.

Emphasizing the importance of clinical safety and considering the paradox of its neglect during the pandemic, the objectives of this study are: 1) To describe the adaptation of AASTRE to the pandemic work dynamic; 2) To demonstrate that AASTRE is feasible and useful in a real pandemic scenario; 3) To build a web platform that makes the results visible in a simple, continuous, and intuitive way for clinicians.

During the study period, a total of 390 patient-days were analyzed, 179 of whom were non-COVID patients and 49, COVID patients (Table 1). The latter were significantly younger [61 vs 66 years (p = 0.011)] than the non-COVID ones. Additionally, COVID patients had significantly longer lengths of stay, higher SAPS 3 scores, and higher ICU mortality rates vs non-COVID patients [18.5 vs 10.97 days (p < 0.001); 52 vs 49 (p = 0.039); and 34.7% vs 15.2% (p = 0.004), respectively]. Moreover, COVID patients remained many more days on mechanical ventilation and with a urinary catheter than no-COVID patients [14.94 vs 4.45 days (p < 0.001); 17.87 vs 8.6 days (p = 0.001), respectively]. No significant differences were found between the 3 groups in the outcome indicators under consideration (Table 2).

This is the first study ever conducted during the pandemic that evaluated the effect of a safety intervention that allowed converting unsafe situations into safe ones in real-time. Its feasibility and utility were demonstrated for both COVID and non-COVID patients.

The lack of studies on clinical safety during the pandemic is notable.24 Some authors describe patient safety incidents (PSIs) associated with treatment delays or the performance of inappropriate procedures, suggesting that proactive safety tools could have been useful in that context.25 Concurrently, the safety gap has been explained by the need to reallocate personal resources: many safety experts returned to purely clinical activities, preventing many functional units from maintaining or promoting their activities.26

Of note that AASTRE is a tool deeply embedded in the culture of our organization. This fact likely relates to the feasibility described in this study. AASTRE is based on the interaction between health care professionals (some responsible for patient care and others facilitating measure verification – prompters)16. This moves away from the idea of safety rounds led by managers or safety experts. In fact, in our own experience, the presence of trainees and nursing staff during audits makes interaction a space for organizational learning17 focused on processes. It has been reported that the one factor that significantly improves audit acceptance is building a shared sense of the results.27

A particularly striking result was the high utility of the tool during the analyzed period (PMR-AASTRE-G of 11.8%), which is significantly higher than the results obtained by AASTRE in previous pre-pandemic periods (5.4% and 6.7%).16,17 The utility of AASTRE is directly associated with real-time improvements in safety since the evaluated measures, if not performed at the time of the audit (omission errors), were taken immediately (real-time). Former studies17 associated AASTRE's utility with times of higher clinical workload. In this study, the health care team managed both COVID and non-COVID patients, so the clinical workload was evenly distributed among all professionals. During the pandemic, this sustained workload—translated into physical and cognitive fatigue—has been associated with omission errors through its influence on decision-making and task prioritization.28,29 In relation to utility, Arabi et al.30 concluded that, in situations like those experienced during the pandemic, a fundamental lesson that needed to be learnt was the need to prioritize the use of measures exclusively based on scientific evidence, an aspect guaranteed by AASTRE.

Reportedly, high clinical workload (high nursing and physician-to-patient ratios) has been associated with lower quality of care, a higher number of adverse events, longer lengths of stays, and higher mortality.31,32 Margadant et al.33 showed that a high NAS was associated with in-hospital mortality. Consequently, our study demonstrated that avoiding nursing workload overload (defined by NAS34) was associated with proper adherence to evidence-based measures and, therefore, fewer omission errors.

Consistent with what Ilan et al.35 described and what has been shown in former studies,16,17 our study found that patient severity was associated with significant tool utility. This is explained by the fact that high patient severity makes many medical care efforts to be focused on measures necessary for prompt patient resuscitation, while other less urgent but also important evidence-based measures are sidetracked.

It is of note that despite the COVID group being a more severe group, with longer lengths of stay, days on mechanical ventilation, and days with a urinary catheter, there were no significant differences in outcome indicators, such as rates of NAVM, tracheobronchitis, BRC, and catheter-associated urinary tract infections, as described by other authors.8–10

The goal of any health care system is to strive for excellence while prioritizing the patients’ best interests. For this reason, health care professionals should first aim to understand how they perform their roles, regardless of contextual complexity. In this regard, AASTRE has become a solid support for quality of care, not only because of its utility (as discussed) but also because it provides a form of quantitative feedback that has proven essential for driving any improvement in care quality.36

This study has several limitations: 1) It was conducted at a single center; 2) The study took place during the 6th wave of the pandemic, when clinical pressure was still high, though lower compared with other periods during the pandemic (although still far from normal clinical conditions, Moreno-Mulet et al.37). In any case, the reduced clinical pressure undoubtedly favored the implementation of AASTRE. 3) The study was conducted at a time when there was no longer collaboration with other specialties (Cardiology, Pediatrics, Emergency Medicine, Anesthesia) as had been the case in previous waves. This aspect would have been interesting to analyze as, under those circumstances, the use of AASTRE creates an interaction between the prompter and the trainee physician that allows for the formation of a learning space,20 which would have probably had more repercussions as a tool for information transmission and learning. 4) Finally, reactive tools, such as adverse event notifications were not considered, which would have helped analyze the safety situation of our ICU during the study period.

AASTRE proved to be a feasible and useful tool during the last phase of the pandemic (characterized by moderate clinical pressure) with only 2 weekly interventions of approximately 30 min each. The clinical complexity in an environment of COVID and non-COVID patients may explain the utility of AASTRE in both patient groups, with a notable increase in PMR-AASTRE-G compared with previously analyzed periods.

MB, GS, MS, and AR contributed to the study design. MB, GS, and MS conducted the safety rounds. JB and JC contributed to the configuration of the SIC and the calculation of metrics for indicators and process measures. JC, AR, and JB contributed to data analysis and statistical analysis. JC and MB developed and implemented the process indicators platform. All authors contributed to the drafting of the manuscript. All authors read and approved the final manuscript.

This study was approved by the Ethics and Clinical Research Committee (CEIC) of Institut d’Investigació Sanitària Pere Virgili. Reference: 3/2021. Given the nature of the study and the anonymity of the data, obtaining informed consent was deemed unnecessary.

This study was funded by Instituto de Salud Carlos III (ISCIII) through the project "FIS PI20/01674" and co-financed by the European Union and the Ricardo Barri Casanovas Foundation grant.