Problem Addressed

The COVID-19 pandemic resulted in a time of unprecedented patient volume, rapidly changing or uncertain clinical guidance, and a need for organizations to respond rapidly to patient safety issues. Healthcare organizations sought ways to expedite processes to update protocols that were traditionally revised in response to the introduction of clear new practice-changing evidence.² Additionally, organizations needed ways to rapidly disseminate and implement updated protocols.^3,4

Description of the Innovative Activity

The I-READI framework is based on the steps taken by a multidisciplinary team at the University of Pennsylvania to rapidly respond to a concerning number of incidents of both endotracheal tube obstruction and failed extubations among ventilated patients during the early days of the COVID-19 pandemic. The team responded and addressed these problems within weeks and created the I-READI framework as a guide for other health systems to follow during times of crisis. I-READI stands for Integration, Root-cause Analysis, Evidence, Adaptation, Dissemination, and Integration.

The foundation and starting point for the steps taken by the innovation team was vertical and horizontal integration of quality and safety teams. The innovation team addressed a safety crisis quickly by rapidly elevating frontline clinicians’ concerns and efficiently coordinating and disseminating collaborative solutions via existing lines of communication that were expanded and streamlined in anticipation of the first wave of COVID-19 cases. The communication channels crossed units, specialties, and facilities, and included frontline clinical staff and administrative staff. Thanks to this preparative integration, by the time of the first surge, University of Pennsylvania Health System administrators, the health system’s Critical Care Committee, and the pulmonary and intensive care unit (ICU) teams were gathering at regular safety huddles, poised to identify and address new problems as they arose. These meetings enabled clinicians and administrators across hospitals to be immediately aware of concerning cases of endotracheal tube obstruction and reintubation among ventilated patients with COVID-19.

After frontline clinicians raised concerns about the events to safety leaders during the daily safety huddle, critical care staff and administrators began to analyze the problem using aggregate root-cause analysis, examining multiple cases with the same complication. Individual team members gathered and synthesized the latest research findings and consulted colleagues around the world for insight. In the case of endotracheal tube obstruction for ventilated patients, after collecting available information, the team discussed and determined solutions and then adapted their ventilation protocols accordingly. In this example, to improve detection, the team decided to increase the frequency and improve standardization of airway resistance monitoring. To prevent this complication, the organization augmented airway humidification by switching from passive heat and moisture exchangers, deployed initially because of their infection control properties, to active heated humidification systems. The team distributed new protocols through multiple channels, including a publicly accessible COVID-19 learning website, pulmonary and critical care division faculty meetings, fellow-led educational conferences, and weekly operations and clinical update meetings. New guidelines were operationalized through easy-to-follow one-page clinical guides and integration into patient safety checklists guided by ICU dashboard data monitoring.

Context of the Innovation

With the COVID-19 pandemic, clinical practices as well as best practices for patient and healthcare worker safety have been rapidly evolving. At the start of the pandemic, hospitals and systems faced the challenge of providing care for patients with less understood conditions in the context of a rapid influx of new information. Clinical protocols and practices were revised to prioritize infection control for healthcare workers. Systems had to adjust to a high volume of critically ill and highly contagious patients. Healthcare staff were frequently reassigned from their usual roles to help in high-volume and high-need units. Often, those on the frontlines were working outside of their specialty areas, and there was an increased need for training and quality assurance. In general, to provide high-quality care and ensure patient and healthcare worker safety, it was important to distribute information rapidly and effectively to those on the frontlines. It was critical that frontline staff could communicate concerns they were seeing with patients back to hospital leaders.

During the earlier weeks of the COVID-19 pandemic, frontline workers in the University of Pennsylvania Health System noted that in mechanically ventilated COVID-19 patients, there was a concerning trend in the number of reported cases of both endotracheal tube obstruction and, after extubation, reintubations related to obstruction of the upper native airway. Endotracheal tube obstruction due to mucus and debris is typically rare. However, in the health system’s facilities, 9.2% of intubated patients during a roughly two-week period had an obstructed endotracheal tube.¹ Such obstructions can cause complications and be life-threatening.^5,6 Also a cause for concern during the same period, 36% of patients required reintubation within 48 hours of extubation, which is several times higher than the typical rate of 10% in that timeframe.¹ Of particular concern, mortality rates for patients requiring reintubation are high, at roughly 30% to 40%.⁷

Results

In the two weeks after implementation of the new protocols, the rate of endotracheal tube obstruction among mechanically ventilated patients with COVID-19 decreased from 9.2% to less than 1%.¹ During the same period, reintubation rates decreased from 36% to 9%.¹ The improved rates are in line with prepandemic rates and have been sustained.

Resources Used and Skills Needed

To implement the I-READI framework, healthcare systems require established multidisciplinary safety and quality teams that allow for vertical communication (i.e., from frontline workers to unit leaders and hospital administrators) and horizontal communication (i.e., bridging specialties and facilities across a healthcare system). The innovation team stressed the importance of having communications and reporting platforms in place such as real time patient monitoring dashboards and safety huddles.

The innovation also requires that team members have skills and experience with aggregate root-cause analysis to review multiple cases of common adverse events. Team members should be able to assess how other sites are approaching similar issues by accessing their external peer networks. Technical resources such as real-time data monitoring capabilities and conducting remote tele-consults are also helpful. However, the innovation team emphasizes that material resources are less important than the ability of staff to come together for a common cause, communicate directly and efficiently across hierarchy and discipline, and commit their time to finding solutions.

Funding Sources

No outside funding sources contributed to the creation or implementation of the innovation.

Getting Started with This Innovation

For the pre-implementation planning phase, according to the innovation team, focus should be on ensuring that units, facilities, and the health system have the foundational components that allow for quick implementation of the I-READI framework even under rapidly changing conditions. These components are as follows:

• Streamlined communication pathways for real-time horizontal and vertical updates that are bidirectional (i.e., to and from frontline clinicians) and within units, hospitals, and across the health system
• Daily efficient virtual safety huddles during times of crisis that include frontline providers and clinical and hospital leaders
• Data collection systems to monitor care delivery, quality, and safety metrics in real time
• Daily board rounds with review of real-time patient data and systematic patient safety checklists
• Ability to convene emergency meetings within hours of sentinel events
• Ability to reorganize and repurpose existing groups and committees
• Standardized, centrally located, and accessible policies and protocols
• Remote clinical support
• Safety staff and standing safety committees
• Dissemination channels online, via standing conferences, and through regular meetings
• A culture of trust, commitment, teamwork, and flexibility
• Processes for gathering and synthesizing multidisciplinary expert input and resolving differing opinions
• Contingency plans (e.g., if supplies run out)

Sustaining This Innovation

Sustainability requires ongoing maintenance of committees, protocols, and channels for reliable communication and dissemination of accurate and up-to-date recommendations, as described in the sections above. The innovation team notes that it is important that clinical leaders and administrators maintain direct channels of communication with frontline clinicians to be aware of real-time safety issues and to be able to respond to problems as they arise. The team stresses that implementing organizations require commitment and flexibility to initiate and sustain the innovation; organizations must be able to react to the changing needs of a situation by, for example, repurposing and reconfiguring existing committees. Finally, the team reports that convening key stakeholders when deliberating practice changes helps to support the sustainability of those changes.

References/Related Articles

Ginestra JC, Atkins J, Mikkelsen M, et al. The I-READI quality and safety framework: a health system’s response to airway complications in mechanically ventilated patients with COVID-19. NEJM Catalyst Innov Care Deliv. 2021;2(1).

Pierce M, Gudowski SW, Roberts KJ, et al. The rapid implementation of ad hoc tele-critical care respiratory therapy (eRT) service in the wake of the COVID-19 surge. J Clin Med. 2022;11(3):718.

Stark N, Kerrissey M, Grade M, et al. Streamlining care in crisis: rapid creation and implementation of a digital support tool for COVID-19. West J Emerg Med. 2020;21(5):1095-1101.

Footnotes

1. Ginestra JC, Atkins J, Mikkelsen M, et al. The I-READI quality and safety framework: a health system’s response to airway complications in mechanically ventilated patients with COVID-19. NEJM Catalyst Innov Care Deliv. 2021;2(1).
2. Martínez García L, Arévalo-Rodríguez I, Solà I, et al. Strategies for monitoring and updating clinical practice guidelines: a systematic review. Implementation Sci. 2012;7(article 109).
3. Reeves JJ, Hollandsworth HM, Torriani FJ, et al. Rapid response to COVID-19: health informatics support for outbreak management in an academic health system. J Am Med Inform Assoc. 2020;27(6):853-859.
4. Salvador-Carulla L, Rosenberg S, Mendoza J, et al. Rapid response to crisis: health system lessons from the active period of COVID-19. Health Policy Tech. 2020;9(4):578-586.
5. Karim HM, Yunus M, Bhattacharyya P. A retrospective study of endotracheal or tracheostomy tube blockage and their impact on the patients in an intensive care unit. J Mahatma Gandhi Institute Med Sci. 2017;22(1):12-17.
6. Shah C, Kollef MH. Endotracheal tube intraluminal volume loss among mechanically ventilated patients. Crit Care Med. 2004;32(1):120-125.
7. Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998;158(2):489-493.