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Crisis Standards of Care in a Pandemic: Navigating the Ethical, Clinical, Psychological, and Policy-making Maelstrom

Authors:

Abstract

The COVID-19 pandemic has caused clinicians at the frontlines to confront difficult decisions regarding resource allocation, treatment options, and ultimately the life-saving measures that must be taken at the point of care. This article addresses the importance of enacting Crisis Standards of Care (CSC) as a policy mechanism to facilitate the shift to population-based medicine. In times of emergencies and crises such as this pandemic, the enactment of CSC enables concrete decisions to be made by governments relating to supply chains, resource allocation, and provision of care to maximize societal benefit. This shift from an individual to a population-based societal focus has profound consequences on how clinical decisions are made at the point of care. Failing to enact CSC may have psychological impacts for healthcare providers particularly related to moral distress, through an inability to fully enact individual beliefs (individually-focused clinical decisions) which form their moral compass.
© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for
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Crisis Standards of Care in a Pandemic: Navigating the Ethical, Clinical,
Psychological, and Policy-making Maelstrom
Attila J. Hertelendy, Ph.D*1 Gregory R. Ciottone, MD2, Cheryl L. Mitchell, Ph.D,3, Jennifer
Gutberg, MSc., 4Frederick M. Burkle, MD, MPH, DTM5
*Co-First Authors
1 Department of Information Systems and Business Analytics, College of Business, Florida
International University, Miami, Florida
2 Beth Israel Deaconess Medical Center, Disaster Medicine Fellowship Program, Boston, MA
3 Faculty & MBA Academic Director, Gustavson School of Business, University of Victoria,
Victoria, British Columbia, Canada
4 PhD Candidate, Institute of Health Policy, Management and Evaluation, University of
Toronto, Toronto, Ontario, Canada
5 Senior Fellow and Scientist, Harvard Humanitarian Initiative, Harvard University and T.H.
Chan School of Public Health, Cambridge, MA
Correspondence:
Attila J. Hertelendy,PhD
Department of Information Systems and Business Analytics
College of Business
Florida International University
11200 S.W. 8th Street, Room RB 250
Miami, FL 33199
Email: ahertele@fiu.edu
Keywords:; Crisis Standards of Care; COVID-19; Pandemics; Global Public Health; Moral
Alignment, Ethics
Running Title: Crisis Standards of Care in a Pandemic
Abstract:
The COVID-19 pandemic has caused clinicians at the frontlines to confront difficult decisions regarding
resource allocation, treatment options, and ultimately the life-saving measures that must be taken at
the point of care. This article addresses the importance of enacting Crisis Standards of Care (CSC) as a
policy mechanism to facilitate the shift to population-based medicine. In times of emergencies and
crises such as this pandemic, the enactment of CSC enables concrete decisions to be made by
governments relating to supply chains, resource allocation, and provision of care to maximize societal
benefit. This shift from an individual to a population-based societal focus has profound consequences on
how clinical decisions are made at the point of care. Failing to enact CSC may have psychological impacts
for healthcare providers particularly related to moral distress, through an inability to fully enact
individual beliefs (individually-focused clinical decisions) which form their moral compass.
Keywords: Coronavirus; Crisis Standards of Care; COVID-19; Pandemics; Global Public Health;
Population-based management; Moral Alignment, Ethics
Background
On January 30, 2020, the World Health Organization (WHO) declared the SARS-CoV-2 outbreak a Public
Health Emergency of International Concern.1 Forty-one days later, the WHO issued a statement that the
coronavirus, now known as COVID-19, could be characterized as a Pandemic. The WHO pandemic
announcement triggered immediate and sweeping emergency protocols and contingency plans across
the globe. In the healthcare sector, a key emergency policy initiative would have involved a triggering of
Crisis Standards of Care (CSC), which are defined as a substantial change in usual healthcare operations
and the level of care it is possible to deliver, which is made necessary by a pervasive (e.g., pandemic
influenza) or catastrophic (e.g., earthquake, hurricane) disaster.2 However, a clear announcement or
trigger for the shift to CSC has not been articulated publicly to date. As of July, 2020, the pandemic still
shows no signs of abatement. Globally there are 10,897,074 cases with over 521,874 fatalities. The
United States currently has the most cases with over 2.7 million and more than 100,000 fatalities.3
United States CSC Implementation
While numerous reports have outlined guidelines pertinent to CSC and when to trigger, in the United
States actual declaration and implementation are left to state jurisdiction, which has resulted in fifty
different policies and variable triggers.4-7 For example, the Minnesota CSC Framework does not explicitly
state that a pandemic event should trigger a CSC, rather that the “Minnesota Department of Health
might consider the following indicators and triggers to activate a CSC response for a Pandemic phase/
impact.”8
This contradicts the guidance provided in 2009 by the Institute of Medicine (IOM) where the authors
unanimously agreed that waiting for a hard “trigger” as evidence of a crisis was deemed inappropriate.5
Absent in government policies and the disaster literature is an explicit trigger that mandates a shift to a
systems framework for the enactment and implementation of CSC plans that outline the legal, ethical,
palliative care, and mental health issues that agencies and organizations at each level of a disaster
response must address. The change in the delivery to CSC is formally declared by a state government,
which provides the legal and regulatory framework to authorize care to be provided in non-traditional
locations and to provide guidance for triage of life-sustaining interventions. 5-6
International CSC Implementation
For the global community, the WHO has not released guidance on CSC.9 The American Medical
Association has provided guidance related to the Code of Ethics related to CSC but does not articulate
clinical protocols.10 Guidance is focused primarily on decision-making related to the allocation of scarce
resources. To our knowledge, no studies have focused on the international implementation of CSC. The
development of CSC guidelines should ideally be led by the WHO, however each country should enact its
own distinct mechanisms to clearly identify triggers for when CSC should be implemented. Early and
decisive action in this regard will contribute to reducing moral distress for frontline healthcare workers
and contribute to a coordinated and more effective response to the current and future pandemics.
CSC and Population-based Medicine
In absence of CSC declaration, clinicians have been forced into ongoing ethically- and morally-
ambiguous scenarios at the point of care, that should instead have been addressed at the policy level.
The root of the dilemma inherent in these scenarios is not merely a failure to enact a national CSC.
Rather, the enactment of CSC is meant to signal to frontline providers a fundamental shift “from
optimizing individual care to maximizing population health outcomes”.11 With this shift should come an
understanding that the goals of care during a pandemic are fundamentally different, and that point of
care decisions must be made in light of limited resources and efforts to limit further spread of the
disease.12 Under CSC, medical care during a pandemic event, such as COVID-19, would shift from an
individual focus to the promotion of thoughtful stewardship of limited resources intended to result in
the best possible outcome for society as a whole.5 This defines population-based medicine or
management which most individual healthcare providers have neither trained in, nor have experience in
implementing. For most, education, training, and their daily work have been focused on individual one-
on-one patient care and decision-making strategies. The shift, therefore, to population-based medicine
is one that requires active and ongoing guidance from governments to frame in explicit terms the
approach to clinical care that is expected in this crisis.
Levin et al. (2009) discussed the need for altered standards of care during an influenza pandemic as
early as 2009.13 Subsequent IOM reports followed in 2009 and 2012 that provided frameworks,
guidelines, and a toolkit for CSC.4-6- Leider et al. (2017) argue that ethical guidance provided in many of
the frameworks for CSC should be both theoretically sound and practically useful.14 One of the
challenges associated with the implementation of CSC is that these have not seen wide-scale
implementation globally, other than some aspects related to triage management of large populations
which has become a crucial challenge for Italy where the category of non-survivability based on lack of
life-saving resources had to be implemented.15,16
Moral Distress and Other CSC consequences on the Frontlines
The enactment of CSC allows healthcare providers, organizations, and systems alike to set off a domino
effect of actionable policies. These policies dictate concrete decisions relating to supply chains, resource
allocation, and provision of care to maximize societal benefit.5 This shift from an individual to a
population-based societal focus has profound consequences on how clinical decisions are made at the
point of care. The practical implications of enacting CSC have been elaborated. However, there are
also important psychological impacts for healthcare providers. The provision of care in a population-
based medicine approach may have direct or indirect consequences from a patient safety lens. In
particular, clinicians who provide what they perceive as sub-par or even inappropriate care may suffer
from the well-known second victim phenomenon that occurs within professional caregivers following an
adverse event.17,18 Clinicians may “move on” from the events of COVID-19, in one of three possible
manners: merely “surviving”; “thriving” and making the best of the lessons learned; or “dropping out”,
whether of their role, organization, or profession.19 The second victim phenomenon has been linked to
patient safety culture, where non-punitive responses to error have been associated with reduced
distress caused by the second victim phenomenon.20 The risk of a negative safety culture impacting
clinicians’ well-being and increasing the likelihood of experiencing second victim phenomenon is
substantial: open communication and blame-free environments are a critical underpinning of patient
safety culture.21 However, in the midst of a pandemic, dynamics of blame, shame, and deferral to
hierarchy are likely to be rampant. For instance, how should clinicians be blamed or penalized for
adverse events that occur as a result of limited resources? Similarly, clinicians must be able to openly
acknowledge their concerns, fears, and traumas. A culture that shames honesty and does not allow for
sharing of emotional trauma is one that will result in long-term harm to providers everywhere.20
In particular, the experience of moral distress is one that is likely to be directly exacerbated by the
enactment, or lack thereof, of CSC. Moral distress describes psychological issues that arise from knowing
what the ‘right thing’ to do is, but being constrained from doing the ‘right thing’ by external factors.
Frontline providers can experience moral distress through an inability to fully enact individual beliefs
(clinical decisions) which form their moral compass. 22
Mental health consequences of working in crisis conditions that have health system impacts, such as
burnout, absenteeism, and sick leave related to moral distress, have been well documented in the
literature, including studies on SARS and Ebola.23,24 In the COVID-19 pandemic, stressful environments,
changing expectations, and ambiguous policies create conditions where moral distress is inevitable.25
Clinicians are asked to dramatically shift to crisis-level practice, however, there is limited support and
guidance on how to navigate that transition. The early enactment of overarching broad CSC guidelines
that could be modified to suit regional needs would allow for moral alignment of beliefs and actions
nationwide, allowing professional caregivers time to mitigate the impact of moral distress.
We recognize that any degree of CSC will still carry some element of psychological burden and cognitive
dissonance for healthcare providers, who are asked to operate in an environment where evidence is
limited, and decisions may have to be made in direct contrast to what evidence is available. 26 Early
national declaration and enactment of CSC will not fundamentally stop this from occurring, however, it
could allow providers the opportunity to reframe and make sense of their upcoming actions, preparing
them to make rapid decisions while reducing the psychological burden of ongoing moral distress.
Buffering Moral Distress through CSC
“Sensemaking” refers to the process of cognitively “constructing” a plausible meaning for surprising
events or even ambiguous situations that occur. 27 In a very real sense, frontline providers across the
globe are engaging in sensemaking around the severity of COVID-19, but are forced to do so while in the
heat of the crisis. Evidence from the H1N1 pandemic suggests the critical role that sensemaking plays in
aligning perspectives and recognizing the presence and impact of a pandemic in a highly uncertain
environment. 28
In absence of early, nationally enacted CSC we are asking providers to work within their existing
frameworks, developed through best clinical judgment yet differing region to region, and quickly apply
them in a highly volatile, uncertain, and high-risk situation. This is likely to cause providers moral
distress, particularly those who travel to different regions due to healthcare worker shortages, as it is
such a rapid and dramatic deviation from their typical practice. However, enacting early national CSC
can give providers a universal standard to engage in revised sensemaking around their clinical actions.
26,29 This would create a clear external trigger, allowing providers to better understand the shift from
“best standards of care for an individual” to “best standards of care for a population”, prior to having to
implement them in their personal practice. Failure to give providers this opportunity to update their
sensemaking of CSC is only adding an unnecessary psychological burden.
While sensemaking is fundamentally retroactive, it is also ongoing and a major contributor to the
psychological well-being of healthcare providers. As the COVID-19 pandemic unfolds, providers will
continue to construct their response to COVID-19. The sooner a national CSC declaration is enacted, the
more time providers who are not currently in the hot zone will have to reflect on and align themselves
to the clinical decisions that may be required.
Lastly, before the COVID-19 pandemic, medicine and health care in general were working more and
more toward the acceptance of multidisciplinary and transdisciplinary decision-making of complex
health issues. Several academic disciplines and professional specializations draw from each other to
redefine problems and solutions outside normal boundaries. This has increasingly been adapted to
coronavirus treatment and triage options allowing both multiple health experts and multidisciplinary
expertise to better adapt and share more optimal care plans and spread the burden of decision-making
across the demands of anticipated population-based care and CSC.30,4
Future Considerations for Research
There is a paucity of research related to how the enactment and implementation of CSC impacts the
wellbeing of healthcare providers and patients alike. Important question remain to be explored related
to the timing of CSC. As guidelines are developed by international stakeholders, national governments
and local health authorities these should be evaluated to determine how early implementation of CSC
affects the overall quality of care and patient safety.
Conclusion
One major problem remains. Healthcare providers define public health crises along prevention,
preparedness, and epidemiological dictums, that inform, educate, and empower the individual
management options available to healthcare providers combined with the larger source of population-
based management aggregated data.31 From this combined analysis comes single actionable clinical
approaches to save the most lives within a population-based overarching system. Unfortunately, history
will show that what remains the most compelling impediment to CSC policy implementation is that
governmental powers still define public health through political and economic imperatives.32 This must
change.
Data Availability
No new data were generated or analyzed in support of this review
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Background: The COVID-19 pandemic has highlighted health care systems’ vulnerabilities. Hospitals face increasing risk of periods of scarcity of life-sustaining resources such as ventilators for mechanical respiratory support, as has been the case in Italy as of March, 2020. The National Academy of Medicine has provided guidance on crisis standards of care, which call for the reallocation of scarce medical resources to those who will benefit most during extreme situations. Given that this will require a departure from the usual fiduciary duty of the bedside clinician, we determined and mapped potential barriers to the implementation of the guidelines from stakeholders using an implementation science framework. Methods: A protocol was created to operationalize national and state guidelines for triaging ventilators during crisis conditions. Focus groups and key informant interviews were conducted from July-September 2018 with clinicians at three acute care hospitals of an urban academic medical center. Respiratory therapists, intensivists, nursing leadership and the palliative care interdisciplinary team participated in focus groups. Key informant interviews were conducted with emergency management, respiratory therapy and emergency medicine. Subjects were presented the protocol and their reflections were elicited using a semi-structured interview guide. Data from transcripts and notes were categorized using a coding strategy based on the Theoretical Domains Framework. Results: Participants anticipated that implementing this protocol would challenge their roles and identities as clinicians including both their fiduciary duty to the patient and their decision-making autonomy. Despite this, many participants acknowledged the need for such a protocol to standardize care and minimize bias as well as to mitigate potential consequences for individual clinicians. Participants identified the question of considering patient quality of life in triage decisions as an important and unresolved ethical issue in disaster triage. Conclusion: Clinicians’ discomfort with shifting roles and obligations could pose implementation barriers for crisis standards of care.
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Introduction Current research of moral distress is mainly derived from challenges within high-resource health care settings, and there is lack of clarity among the different definitions. Disaster responders are prone to a range of moral challenges during the work, which may give rise to moral distress. Further, organizations have considered increased drop-out rates and sick leaves among disaster responders as consequences of moral distress. Therefore, initiatives have been taken to address and understand the impacts of moral distress and its consequences for responders. Since there is unclarity among the different definitions, a first step is to understand the concept of moral distress and its interlinkages within the literature related to disaster responders. Hypothesis/Problem To examine how disaster responders are affected by moral challenges, systematic knowledge is needed about the concepts related to moral distress. This paper aims to elucidate how the concept of moral distress in disaster response is defined and explained in the literature. Methods The paper opted to systematically map the existing literature through the methods of a scoping review. The searches derived documents which were screened regarding specific inclusion criteria. The included 16 documents were analyzed and collated according to their definitions of moral distress or according to their descriptions of moral distress. Results The paper provides clarity among the different concepts and definitions of moral distress within disaster response. Several concepts exist that describe the outcomes of morally challenging situations, centering on situations when individuals are prevented from acting in accordance with their moral values. Their specific differences suggest that to achieve greater clarity in future work, moral stress and moral distress should be distinguished. Conclusion Based on the findings, a conceptual model of the development of moral distress was developed, which displays a manifestation of moral distress with the interplay between the responder and the context. The overview of the different concepts in this model can facilitate future research and be used to illuminate how the concepts are interrelated.
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Background: Terrorism, disease outbreaks, and other natural disasters and mass casualty events have pushed health care and public health systems to identify and refine emergency preparedness protocols for disaster response. Ethical guidance, alongside legal and medical frameworks, are increasingly common components of disaster response plans. Objectives: To systematically review the prevalence and content of ethical guidance offered for disaster response, specifically around crisis standards of care (CSCs). Search methods: We systematically indexed academic literature from PubMed, Google Scholar, and ISI Web of Science from 2012 to 2016. Selection criteria: We searched for peer-reviewed articles that substantively engaged in discussion of ethical guidance for CSCs. Data collection and analysis: Researchers screened potential articles for identification and discussion of ethical issues in CSC planning. We categorized and cataloged ethical concepts and principles. Main results: Of 580 peer-reviewed articles mentioning ethics and CSCs or disaster planning, 38 (6%) met selection criteria. The systematic review of the CSC ethics literature since 2012 showed that authors were primarily focused on the ethical justifications for CSC (n = 20) as well as a need for ethics guidelines for implementing CSCs; the ethical justifications for triage (n = 19), both as to which criteria to use and the appropriate processes by which to employ triage; and international issues (n = 17). In addition to these areas of focus, the scholarly literature included discussion of a number of other ethical issues, including duty to care (n = 11), concepts of a duty to plan (n = 8), utilitarianism (n = 5), moral distress (n = 4), professional norms (n = 3), reciprocity (n = 2), allocation criteria (n = 4), equity (n = 4), research ethics (n = 2), duty to steward resources (n = 2), social utility and social worth (n = 2), and a number of others (n = 20). Although public health preparedness efforts have paid increasing attention to CSCs in recent years, CSC plans have rarely been implemented within the United States to date, although some components are common (e.g., triage is used in US emergency departments regularly). Conversely, countries outside the United States more commonly implement CSCs within a natural disaster or humanitarian crisis response, and may offer significant insight into ethics and disaster response for US-based practitioners. Conclusions: This systematic review identifies the most oft-used and -discussed ethical concepts and principles used in disaster planning around CSCs. Although discussion of more nuanced issues (e.g., health equity) are present, the majority of items substantively engaging in ethical discussion around disaster planning do so regarding triage and why ethics is needed in disaster response generally. Public health implications. A significant evolution in disaster planning has occurred within the past decade; ethical theories and frameworks have been put to work. For ethical guidance to be useful, it must be practical and implementable. Although high-level, abstract frameworks were once prevalent in disaster planning-especially in the early days of pandemic planning-concerns about the ethically difficult concept of CSCs pervade scholarly articles. Ethical norms must be clearly stated and justified and practical guidelines ought to follow from them. Ethical frameworks should guide clinical protocols, but this requires that ethical analysis clarifies what strategies to use to honor ethical commitments and achieve ethical objectives. Such implementation issues must be considered well ahead of a disaster. As governments and health care systems plan for mass casualty events, ethical guidance that is theoretically sound and practically useful can-and should-form an important foundation from which to build practical guidance for responding to disasters with morally appropriate means. (Am J Public Health. Published online ahead of print July 20, 2017: e1-e9. doi:10.2105/AJPH.2017.303882).
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Long before the 2014 Ebola outbreak in West Africa, the United States was already experiencing a failure of confidence between politicians and scientists, primarily focused on differences of opinion on climate extremes. This ongoing clash has culminated in an environment where politicians most often no longer listen to scientists. Importation of Ebola virus to the United States prompted an immediate political fervor over travel bans, sealing off borders and disputes over the reliability of both quarantine and treatment protocol. This demonstrated that evidenced­ based scientific discourse risks taking a back seat to political hyperbole and fear. The role of public health and medical expertise should be to ensure that cogent response strategies, based upon good science and accumulated knowledge and experience, are put in place to help inform the development of sound public policy. But in times of crisis, such reasoned expertise and experience are too often overlooked in favor of the partisan press " sound bite " , where fear and insecurity have proved to be severely counterproductive. While scientists recognize that science cannot be entirely apolitical, the lessons from the impact of Ebola on political discourse shows that there is need for stronger engagement of the scientific community in crafting messages required for response to such events. This includes the creation of moral and ethical standards for the press, politicians and scientists, a partnership of confidence between the three that does not now exist and an " elected officials " toolbox that helps to translate scientific evidence and experience into readily acceptable policy and public communication.
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Disasters and public health emergencies can stress health care systems to the breaking point and disrupt delivery of vital medical services. During such crises, hospitals and long-term care facilities may be without power; trained staff, ambulances, medical supplies and beds could be in short supply; and alternate care facilities may need to be used. Planning for these situations is necessary to provide the best possible health care during a crisis and, if needed, equitably allocate scarce resources. Crisis Standards of Care: A Toolkit for Indicators and Triggers examines indicators and triggers that guide the implementation of crisis standards of care and provides a discussion toolkit to help stakeholders establish indicators and triggers for their own communities. Together, indicators and triggers help guide operational decision making about providing care during public health and medical emergencies and disasters. Indicators and triggers represent the information and actions taken at specific thresholds that guide incident recognition, response, and recovery. This report discusses indicators and triggers for both a slow onset scenario, such as pandemic influenza, and a no-notice scenario, such as an earthquake. Crisis Standards of Care features discussion toolkits customized to help various stakeholders develop indicators and triggers for their own organizations, agencies, and jurisdictions. The toolkit contains scenarios, key questions, and examples of indicators, triggers, and tactics to help promote discussion. In addition to common elements designed to facilitate integrated planning, the toolkit contains chapters specifically customized for emergency management, public health, emergency medical services, hospital and acute care, and out-of-hospital care. © 2013 by the National Academy of Sciences. All rights reserved.
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Background: Second victim experiences can affect the wellbeing of health care providers and compromise patient safety. Many factors associated with improved coping after patient safety event involvement are also components of a strong patient safety culture, so that supportive patient safety cultures may reduce second victim–related trauma. A cross-sectional survey study was conducted to assess the influence of patient safety culture on second victim–related distress. Methods: The Agency for Healthcare Research and Quality (AHRQ) Hospital Survey on Patient Safety Culture (HSOPSC) and the Second Victim Experience and Support Tool (SVEST), which was developed to assess organizational support and personal and professional distress after involvement in a patient safety event, were administered to nurses involved in direct patient care. Results: Of 358 nurses at a specialized pediatric hospital, 169 (47.2%) completed both surveys. Hierarchical linear regres sion demonstrated that the patient safety culture survey dimension nonpunitive response to error was significantly associated with reductions in the second victim survey dimensions psychological, physical, and professional distress (p < 0.001). As a mediator, organizational support fully explained the nonpunitive response to error–physical distress and nonpunitive response to error–professional distress relationships and partially explained the nonpunitive response to error–psychological distress relationship. Conclusions: The results suggest that punitive safety cultures may contribute to self-reported perceptions of second victim–related psychological, physical, and professional distress, which could reflect a lack of organizational support. Reducing punitive response to error and encouraging supportive coworker, supervisor, and institutional interactions may be useful strategies to manage the severity of second victim experiences.