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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3793_Библиотеки_им_академика_М_И_Перельмана
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Evolution of the Coronary Care Unit:
Past, Present, and Future
Jason N. Katz, Richard C. Becker
OUTLINE
Origins of the Coronary Care Unit, 2
Early Days of Resuscitation, 2
A Paradigm Shift—Prevention of Cardiac Arrest, 3
Validating the Benefit of the Coronary Care Unit, 4
Economic Impact of the Cardiac Intensive Care Unit, 4
Patient Selection in the Cardiac Intensive Care Unit, 4
Defining the Contemporary Cardiac Intensive Care
Unit, 4
Ongoing Evolution of Cardiac Intensive Care Units, 5
Multidisciplinary Clinical Integration and the Cardiac
Intensive Care Unit Model, 5
Management Algorithms, 7
Education and Training in the Cardiac Intensive Care
Unit, 7
Technology Needs in Contemporary Cardiac Intensive
Care Units, 8
Research in the Cardiac Intensive Care Unit, 8
Research Processes, 9
Informed Consent, 10
Developing an On-site Research Program, 10
Conclusion, 10
Originating during a time of recognized unmet medical need
and advances in medicine, the coronary care unit (CCU) emerged
as one of the most important advances in the care of patients
with life-threatening cardiovascular conditions. It has evolved
further with technology, including mechanical circulatory support,
to become a portal of entry for critically ill patients requiring a
high level of support and vast resources. The emergence of
contemporary cardiac intensive care units (CICUs) has introduced
paradigm shifs in staffing, necessary skill sets, training, and cost
for hospitals and health systems. This chapter offers a historical
perspective of CCUs and their journey to the contemporary era
of CICUs that provide high-acuity tertiary and quaternary care
in the United States (Fig. 1.1). Also discussed are several pertinent
constructs for academic medical centers with busy CICUs,
including education, training of physician and nonphysician
providers, and the importance of research as a vehicle to drive
discovery and advanced care.
ORIGINS OF THE CORONARY CARE UNIT
Several seminal descriptions of acute myocardial infarction
(MI)—a frequently fatal event at the time—underscored a clear
medical unmet need.
measures, there were very few options to effectively manage
patients with acute MI.
Early Days of Resuscitation
The first impactful therapy to attenuate the most common and
life-threatening complications of MI, ventricular tachycardia and
1,2
Other than morphine and supportive
3,4
ventricular fibrillation, emerged with open-chest
closed-chest defibrillation.
tions,7 the overall construct of a CCU designed with specific
goals to detect and treat fatal ventricular arrhythmias rapidly
evolved.
Desmond Julian was the first to articulate the general construct
of a CCU. In his original 1961 presentation to the Royal Thoracic
Society,8 he described five cases of cardiac massage with the goal
to resuscitate patients with acute MI. He came to the profound
conclusion that “many cases of cardiac arrest associated with
acute myocardial ischaemia could be treated successfully if all
medical, nursing, and auxiliary staff were trained in closed-chest
massage, and if the cardiac rhythm of patients…was monitored
by an electrocardiographic link to an alarm system.” His vision
for the CCU was founded on the following four basic principles:
• Continuouselectrocardiogrammonitoringwitharrhythmia
alarms
• Cardiopulmonary resuscitation with external debrillator
capabilities
• Admissionof patientswithacuteMItoa single unitofthe
hospital where trained personnel, cardiac medications, and
specialized equipment were readily available
• Theabilityoftrainednursestoinitiateresuscitationattempts
in the absence of physicians
Approximately 3 years later, the first CCU was established at
the Royal Infirmary of Edinburgh. Soon thereafter, several clinicians in North America developed specialized units devoted
exclusively to the treatment of patients with suspected MI. Meltzer9
created a two-room research unit with an aperture in the wall
5,6
Soon after these original descrip-
and, later,
2
CHAPTER 1 Evolution of the Coronary Care Unit: Past, Present, and Future 2.e1
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Keywords
Coronary Care Unit
Cardiovascular Intensive Care Unit
Resuscitation
CHAPTER 1 Evolution of the Coronary Care Unit: Past, Present, and Future 3
patients with
in CCU
and implementation
1961
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First concept of CCU
1923
First case
series of 19
acute MI
published
1947
Open chest
defibrillation
performed
articulated to British
Thoracic Society
1960
Efficacy
of CPR
established
1968
IABP used to
treat AMI and
its complications
1920s
1928
100 patient
case series of
patients
presenting
with AMI
Fig. 1.1 Evolution of the coronary care unit over time. AMI, Acute myocardial infarction; CCU,
coronary care unit; CPR, cardiopulmonary resuscitation; IABP, intraaortic balloon pump; MI,
myocardial infarction.
1930s 1940s 1950s 1960s 1970s
1956
Successful
external
direct current
defibrillation
through which defibrillator paddles could be passed from one
patient to the other. Brown and associates10 established a four-bed
unit with an adjacent nursing station and arrhythmia surveillance
provided using a converted electroencephalogram unit with
electrocardiogram amplifiers.
Day,11 a contemporary of Meltzer, Brown, and Julian, built
mobile “crash carts” in an attempt to resuscitate patients with
acute MI who were admitted to general medical wards. He
recognized that delays in arrhythmia detection significantly limited
the success of subsequent resuscitation attempts. As a result of
his observations, an 11-bed unit was established at Bethany
Hospital in New York staffed by “specially trained nurses who
could provide expert bedside attention, interpret signs of impending decompensation and quickly institute CPR.” Day is largely
credited with introducing the term code blue to describe resuscitation efforts for cyanotic patients following cardiac arrest and
the term coronary care unit.
A Paradigm Shift—Prevention of Cardiac Arrest
Julian12 described the “second phase” of CCUs as an expansion
from a sole focus on resuscitation to prevention of lethal
arrhythmias and advanced care. Killip and Kimball13 published
their experience of 250 patients with acute MI treated in a fourbed CCU at New York Hospital–Cornell Medical Center and
reported that aggressive medical therapy reduced in-hospital
mortality from 26% to 7%. This led Killip and Kimball to conclude
that “the development of the coronary care unit represents one
of the most significant advances in the hospital practice of
1962
First CCUs
established
in North
America
1967
Killip and
Kimball
report on
experience
with 250 CCU
patients;
mortality rate
decreased
from 26% to 7%
1970
Development
of Swan-Ganz
catheter
medicine.”13 Not only did it seem that patients with acute MI
had improved survival if treated in a CCU, but also all in-hospital
cardiac arrest patients seemed more likely to survive if geographically located in the CCU. “Although frequently sudden, and hence
often ‘unexpected,’ the cessation of adequate circulatory function
is usually preceded by warning signals.”13 Thus began the era of
CCUs throughout the world, with a categorical focus on the
prevention of cardiac arrest.
Lown and colleagues14 detailed the key components of the CCU
at the Peter Bent Brigham Hospital in Boston. The foundation
of their CCU centered on assembling a “vigilant group of nurses
properly indoctrinated in electrocardiographic pattern recognition and qualified to intervene skillfully with a prerehearsed and
well-disciplined repertoire of activities in the event of a cardiac
14
arrest.”
With a CCU mortality of 11.5% and an in-hospital
mortality of 16.9%, these clinician-investigators hypothesized that
an aggressive protocol for arrhythmia suppression after MI could
virtually eradicate sudden, unexpected death. While cumulative
data did not support routine preventive antiarrhythmic therapy
15
in MI,
the fundamental construct of advanced care for patients
at risk for post-MI complications established a foundation for
contemporary CCUs.
Additional developments in the care of patients with acute
MI—including the use of intraaortic balloon counterpulsation,16
the implementation of flow-directed catheters for hemodynamic
monitoring,17 and either pharmacologic or mechanical myocardial
reperfusion therapy18—contributed to the advance and wide-scale
availability of CCUs.
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VALIDATING THE BENEFIT OF THE CORONARY
CARE UNIT
With the advent of CCUs and recognition that intensive care
rendered on a “24-7” basis required substantial resources with
resulting cost, the medical community posed fundamental
questions about outcomes. Early comparisons of CCUs and
general medical wards suffered from their observational nature
and lack of analytic rigor. For example, the previously described
study performed by Killip and Kimball13 attributed a near 20%
decline in mortality to the successful implementation of the
CCU environment. Other observational studies conducted in
the United States19 and Scandinavia
20,21
drew similar conclusions,
with lower mortality rates and greater resuscitation success in
patients with acute MI treated in a CCU setting.
Several investigators22 attributed the decline in mortality rates
from ischemic heart disease in the United States to the presence
of CCUs. From 1968 to 1976, estimates suggested a decline in
mortality of approximately 21%. This, in turn, translated to
saving 85,000 lives over the observation period.
23,24
The key to
improved outcomes was likely the specialized care received in the
CCU setting. This theme continued to play out during the era of
reperfusion for acute MI.25 Few would challenge the importance
of specialized resources and care in the management of patients
with complex cardiovascular disease.
26
Economic Impact of the Cardiac Intensive
Care Unit
Intensive care units (ICUs) are places of high resource use and
high expenditure. Accordingly, they contribute significantly to
the economic burden of health care.27 While ICUs constitute
less than 10% of hospital beds in the United States, estimates
suggest that they consume more than 20% of total hospital costs
and nearly 1% of the US gross domestic product.
reported that ICU costs have increased by nearly 200% in the
years 1985 to 2000.30 These observations underscore the importance of patient selection and resource utilization. Contemporary
data support similarities in resource use, morbidity and mortality,
and in-hospital length of stay for ICUs and CICUs.
28,29
It has been
31–34
PATIENT SELECTION IN THE CARDIAC
INTENSIVE CARE UNIT
This is particularly important within an ICU where changes in
patient status occur suddenly and require immediate recognition
and action. While medical ICUs and CICUs may seem more
similar than dissimilar, it is the responsibility of all institutions
to recognize specific needs and staff their units accordingly36
(Fig. 1.2).
The CCU landscape has evolved substantially over the
past several decades to a unit better described as a CICU. As a
result of diagnostic platforms, advanced pharmacotherapeutics,
mechanical circulatory assist devices, and novel interventional
techniques, cardiologists have impacted the natural history of
MI significantly. Consequently, the mortality rates for acute
MI have steadily declined.
37,38
At the same time, however, the
care of patients with other complex cardiovascular diseases and
noncardiac critical illness is steadily increasing in the CICU. An
aging US population, acute and chronic sequelae of nonfatal MI,
comorbid medical conditions, and complications of implantable
devices all result in increased susceptibility to critical illness in
high-risk patients. Many, if not all, of these patients are likely
to be admitted to the modern-day CICU. What were previously
purely resuscitative and preventive units for patients with MI have
now arguably transformed into critical care units for patients
with cardiovascular disease. In fact, many institutions now refer,
either formally or informally, to their CCU as the CICU.
In a descriptive analysis of US critical care units, Groeger and
colleagues39 highlighted mortality statistics, resource use data,
and patient characteristics of modern CICUs; their results were
remarkably comparable to composite data from contemporary
medical ICUs.
33,34
The severity of illness, quantified by a classic
measure of critical illness (the APACHE [Acute Physiology, Age,
and Chronic Health Evaluation] II score), was the greatest
independent predictor of in-hospital mortality in a CICU cohort
of patients—suggesting that risk stratification in the CICU could
be conducted in a manner similar to other ICUs, where the
APACHE II score is well established.
If the contemporary CICU has become an ICU for patients
with complex cardiovascular disease, reassessment of patient
selection, resources, cost, and required training for faculty, nurses,
and support staff must be undertaken. A growing body of evidence
supports the ability of critical care specialists to improve the
care of ICU patients,
the CICU would derive similar benefit.
40–42
and it is anticipated that patients in
39
The current cost of health care in the United States dictates
utilization of services that are carefully aligned with patient needs.
The $3 trillion of health care expenditures suggests that this
tenet is not being followed optimally. While CCUs were developed
initially to manage arrhythmias among patients with acute MI,
it is becoming increasingly clear that monitoring capabilities,
staffing, and expertise can be provided on dedicated cardiology
floors for many patients. Accordingly, each institution must
establish metrics of acuity and complex care that take full
advantage of CICUs and the resources therein.
The appropriate organizational structure is of great importance
in contemporary CICUs. We believe that whether an open- or
closed-unit model is employed, the key to delivering optimal
care is aligning provider skill set with specific patient needs.
DEFINING THE CONTEMPORARY CARDIAC
INTENSIVE CARE UNIT
Several contemporary databases have been used to illustrate the
demographic, clinical, and operational characteristics of ICUs
in the United States.
to establish practice guidelines, generate hypotheses for clinical
research undertakings, and accelerate quality improvement
initiatives in critical care medicine. Our longitudinal assessment
35
of Duke University Hospital provided an early glimpse of a sea
change in academic CCUs.
We created a single-center, administrative database containing
2 decades of diagnostic, procedural, demographic, and outcomerelated variables from the Duke CCU and clearly demonstrated
39,43,44
In turn, these datasets have been used
CHAPTER 1 Evolution of the Coronary Care Unit: Past, Present, and Future 5
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Fig. 1.2 Similarities and differences between the medical intensive care unit (MICU) and coronary
intensive care unit (CICU). LVAD, Left ventricular assist device; MCS, mechanical circulatory
support. (From Katz JN, Minder M, Olenchock B, et al. The genesis, maturation, and future of
Critical Care Cardiology. J Am Coll Cardiol. 2016;68:67-79.)
a growing critical care burden and increased implementation of
critical care resources over time (Figs. 1.3 and 1.4).
Ongoing Evolution of Cardiac Intensive Care Units
Multiple nonrandomized studies offer general support for the
beneficial role of the CCU in the management of patients with
acute MI. As a result, there has been a rapid proliferation of
these specialized units in the United States and worldwide since
their introduction into the medical vernacular more than 4
decades ago. At the same time, data support significant evolutionary changes within contemporary CICUs. Observational studies
suggest that although the mortality for acute MI has steadily
declined, there is a greater burden of noncoronary cardiovascular
disease and critical illness. For these patients, the role and impact
of CICU care are uncertain. This uncertainty has numerous
implications related to patient outcomes, resource use, and costs
of care. As we continue to work toward better defining the
changing landscape of the CICU and its place within the current
health care system, several key topics need to be addressed.
Multidisciplinary Clinical Integration and the
Cardiac Intensive Care Unit Model
Because of the multiplicity and complexity of critical care delivery,
and the advancing critical care burden in the contemporary
CICU, the development of practice models for efficient and
effective patient care will be an important part of the continued
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16
14
12
10
8
6
4
2
evolution of the CCU. At the same time, landmark documents
from the National Academy of Medicine (formerly the Institute
of Medicine) have attacked several “dysfunctional” processes of
past and current health care systems, with particular attention
focused on the elimination of “isolationist decision-making and
ineffective team dynamics” that may put patient care at risk.
A careful appraisal of the role of multidisciplinary care in the
CICU will therefore be essential moving forward.
in ICUs; they include the open model, closed model, and hybrid
models. Each of these critical care platforms have distinct
advantages and disadvantages from patient-care and systems-based
perspectives. In a closed ICU model, all patients are cared for by
an intensivist-led team that is primarily responsible for making
clinical decisions. In a contemporary CICU, this leader might
be a general cardiologist, a cardiologist with critical care expertise,
or an intensivist adept in the care of patients with complex
cardiovascular illness. In an open ICU model, the patient’s primary
physician determines the need for ICU admission and discharge
0
1992–19961987–1991 1997–2001 2002–2006
Acute respiratory failure
Pneumonia/pneumonitis
Acute renal failure
Acute liver failure
Sepsis/septic shock
Cardiogenic shock
Fig. 1.3 Unadjusted trends in selected high activity illnesses in the Duke University Hospital
coronary care unit (unpublished data 1987–2006).
45,46
Currently, several models of health care delivery are employed
and makes all management decisions. A hybrid ICU model
represents a blend of the two more traditional critical care delivery
models. The available evidence increasingly supports a closed
or hybrid ICU format for delivering high-quality, cost-effective
care compared with the open model.
Governing bodies for the major critical care medicine organiza-
47,48
tions universally espouse the benefits of multidisciplinary critical
49,50
care.
It is believed that shared responsibility for ICU team
leadership is a fundamental component for providing optimal
medical care for critically ill patients. A multidisciplinary approach
to CICU management seems equally reasonable in light of growing
patient complexity. Potential members of CICU teams, all of
whom would be intimately involved in the day-to-day care of
patients, might include a cardiologist, intensivist, pharmacist,
respiratory therapist, critical care nurse, and social worker or
case manager. The goal of this integrated team is to provide the
highest quality care, while limiting adverse events, curbing ineffective resource use and associated cost, and providing an efficient
patient transition out of the intensive care setting.
CHAPTER 1 Evolution of the Coronary Care Unit: Past, Present, and Future 7
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15
10
5
Management Algorithms
Best practice in patient care is achieved by following the best
available evidence and standardizing processes and procedures
within a working environment. We believe that standard operating
procedures are particularly important in CICUs and even more
so in those within an academic medical center experiencing a
near constant turnover of residents, fellows, and students from
nursing, pharmacy, physical therapy, respiratory therapy, and
other trainees. Protocols that would have previously been attributable to MICUs are now quite relevant to CICUs.
are shown in Fig. 1.5.
EDUCATION AND TRAINING IN THE CARDIAC
INTENSIVE CARE UNIT
Most CICUs employ nurses with critical care backgrounds. With
a growing number of patients with complex cardiovascular disease
admitted to the CICU, there is a significant need for training
0
1987-1991 1992-1996 1997-2001 2002-2006
Prolonged mechanical ventilation
Endotracheal intubation
Central venous catheter
Hemodialysis
Bronchoscopy
Swan-Ganz catheter
Fig. 1.4 Unadjusted trends in selected critical care procedures performed in the Duke University
Hospital coronary care unit (unpublished date 1987–2006).
more nurses skilled in cardiovascular critical care. At the same
time, an existing nursing shortage52 raises a potential barrier to
growth and, more important, achieving excellence in patient
care in the CICU.
As discussed previously, the diversity of critical illness in today’s
CICU poses many challenges to general cardiologists who have
traditionally staffed these units. To achieve optimal alignment of
physician skills and patient needs, there are several fundamental
options: providing cardiologists with requisite skills in critical
51
Several examples
care delivery (in the form of continuing medical education),
training cardiologists with advanced specialization in critical
care medicine, introducing a cardiology-critical track during
fellowship training, or including an intensivist on the CICU
41,42,53
team.
The American College of Cardiology Core Cardiovascular
Training (COCATS) Statement revised four requirements in 2015
to reflect the evolution and complexity of the CICU.54 Moreover,
for the first time, critical care cardiology was seen as a vital and
requisite component of cardiology fellowship programs.
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Fig. 1.5 Examples for processes, procedures, and management algorithms in a contemporary
coronary care unit. CVC, Central venous catheter. (From van Diepen S, Sligl WI, Washam JB,
et al. Prevention of critical care complications in the coronary intensive care unit: protocols,
bundles, and insights from intensive care studies. Can J Cardiol. 2017;33:10.)
The new training guidelines outline the essentials of critical
care cardiology that should be taught to all fellows. Critical care
training should be integrated into the fellowship program and
include the evaluation and management of patients with acute,
life-threatening cardiovascular illnesses, exposure to noninvasive
and invasive diagnostic modalities commonly used in the evaluation of such patients, familiarity with both temporary and
long-term mechanical circulatory support devices, and understanding of the management of the critically ill patient.
The advent of critical care fellowships, including those for
cardiologists,
complex illness among hospitalized patients, including those
within a CICU (Fig. 1.6). Hill and colleagues56 assessed preparedness among critical care fellowship trainees in the United States.
In a 19-item survey, they assessed trainee confidence in the
management of cardiac critical care illnesses and the performance
of cardiac-specific critical care interventions as suggested by the
Accreditation Council for Graduate Medical Education. Respondents reported lower confidence in managing cardiovascular as
compared with noncardiovascular diseases in the ICU setting.
In addition, they reported lower competence in performing
cardiovascular procedures specific to the ICU. While this survey
represents a relatively modest number of trainees (n = 134), it
should raise awareness and a thorough evaluation of curricula,
training methods, and assessment tools in current cardiology
critical care training programs.
55
specifically addresses the heightened burden of
Technology Needs in Contemporary Cardiac
Intensive Care Units
Beyond the continuous telemetry monitoring and defibrillator
capabilities that represent the foundation and origins of CCU
care, contemporary needs include the ability to provide noninvasive and invasive hemodynamic monitoring, mechanical
ventilation, fluoroscopic guidance for bedside procedures, continuous renal replacement therapy, methods for circulatory support
(e.g., intraaortic balloon counterpulsation, percutaneous and
implantable ventricular-assist devices, extracorporeal circulatory
assist circuits), and portable echocardiography. Additionally,
clinical information systems for standardization of care, monitoring outcomes, and tracking quality are vital. These clinical
information systems often include electronic clinician order entry
and real-time nursing data entry as well.
Finally, there has been a growing enthusiasm for telemedicine,
especially for more rural health care facilities with limited
resources for critical care. This technology has also been advocated
as a way to navigate the impending crisis of insufficient critical
care specialists to meet the growing demands for their skills57
and has a potentially viable role in the operation of many CICUs
in the United States and other countries.
RESEARCH IN THE CARDIAC INTENSIVE
CARE UNIT
The evolution of the CICU also provides a fertile environment
from which to conduct novel research. Existing platforms for
CICU-based critical care investigation have included the ongoing
development and implementation of mechanical circulatory
support devices, the creation of models for the study of sepsisassociated myocardial dysfunction, and the execution of clinical
analyses to study the impact of bleeding and transfusion on
patient outcomes. The potential for future platforms in basic,
translational, genomic, and clinical study is seemingly limitless.
The generation of knowledge culminating from such research will
inevitably lead to improvements in patient care, including more
efficient CICU operational models, standardization of cardiac
critical care delivery, creation of physician decision-support
tools, and advanced personnel training. Key components for
developing a successful, translatable, and reproducible platform
of CICU-based critical care research include the creation of
uniform computerized databases for efficient data abstraction,
the organization of dedicated cardiac acute care research teams,
and the establishment of focused multicenter and international
CHAPTER 1 Evolution of the Coronary Care Unit: Past, Present, and Future 9
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Fig. 1.6 Proposed levels of competency and training models for achieving board eligibility in
critical care cardiology. (From Katz JN, Minder M, Olenchock B, et al. The genesis, maturation,
and future of Critical Care Cardiology. J Am Coll Cardiol. 2016;68:67-79.)
research networks with the necessary tools for implementing
novel research constructs. Additionally, contributions from
academic organizations, government agencies, philanthropic
groups, and industry to provide funding and other resources
for project support and investigator career development in the
field of cardiovascular critical care will be crucial. Box 1.1 lists
potential research areas for future study.
Research Processes
A successful acute care research program must have an infrastructure that is dynamic and scalable to varying environments
and conditions, including prehospital identification and processing
of potential study subjects. Essential components for operationalizing clinical trials conducted or initiated in the prehospital setting
include an experienced steering committee, an in-depth assessment of feasibility, specifically trained research coordinators
either in the field or readily available employing a teleresearch
platform, a tailored recruitment strategy, a facile and experienced
institutional review board (IRB), and a mechanism for electronic
informed consent (e-consent, see below) employing individuals
or family members.
The acute care research team should develop training materials,
including an operations manual, quick reference guide (pocket
size) for both the on-site technicians and research personnel,
BOX 1.1 Potential Topics for Acute Care
Research in the Coronary Care Unit (CCU)
Systems-of-care, operations, and organizational models
Predictive models of clinical decompensation and intervention
Circulating biomarkers of cardiovascular critical illness
Device development (e.g., smart beds and risk integration)
Escalation of care algorithms
Economic analyses of CICU-based critical care delivery
Practice patterns for pharmacotherapy in the CICU and new drug development
for cardiovascular critical illness
Genomic studies of critical illness susceptibility in CICU patients
Optimal mechanical ventilation strategies for cardiac patients and optimal
weaning protocols
Role of telemedicine, medical informatics, and other electronic innovations in
the CICU
Development and implementation of training and learning models to improve
cardiac critical care delivery
Effectiveness of multidisciplinary clinical integration in the CICU
Informed consent for research participation in a critical care setting
Application of current critical care quality metrics for CICU quality-of-care
initiatives
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and certification documents. All training materials should be
available through an acute care research-dedicated website. A
communications team consisting of the following is essential:
writers, editors, graphic designers, and production personnel
who specialize in developing customized materials for clinical
studies—including paper and electronic data forms, e-consent
platform (developed with the study team and IRB), in-service
manuals, posters, pocket cards, and project websites. These
trial-specific aids have been shown repeatedly to speed enrollment,
reduce queries, and enhance project workflows.
Clinical trial coordinators, technicians, and other research
personnel should be required to log in to a secure acute care
research website to view training modules that carefully and
thoroughly summarize prehospital processes, policies, and
procedures. Annual retraining should be required for continued
participation with notices for renewal sent at least 1 month in
advance of certification expiration. Additional supportive training
materials—such as streaming videos, an operations manual, and
quick reference guide—should be available through the website to
allow for “any time” review and reference by all staff members. A
web-based training method is advantageous over the traditional
in-person training paradigm primarily due to the scalability
of this approach. Regardless of the number of new personnel
or sites that need to be trained, there should be no additional
costs, preparation time, travel, or coordination time—making
training efficient, effective, and seamless. Anyone, anywhere and
any time, can be trained on the process. It is critical to have
processes firmly in place from the outset of conducting acute care
research.
Informed Consent
The informed consent process in acute care research can be
challenging. In nonacute care settings, patients and their families
have time to consider whether the research best benefits the
patient’s interest and can voluntarily choose to participate or
decline participation in the research study. Due to the nature of
research in acute care settings, obtaining informed consent is
time sensitive and it can be problematic when patients are
physically or mentally unable to provide consent for themselves
and there is a delay in identifying the legally authorized representative (LAR) or next of kin.
Some of the informed consent barriers identified in clinical
research in acute care settings are improper communication with
the acute care population, inability to identify LAR or next of
kin in timely manner and patients’ incapacity to understand
informed consent (study procedure, risk and benefits, and so
on). Communication with culturally diverse populations (e.g.,
non–English speaking) needs to be considered.
The research team working in acute care research settings
should be trained professionals with the ability to make educated,
time-sensitive decisions. There should be a properly distributed
workload. The study team should be comfortable with properly
communicating and explaining the risks and benefits of research
to patients and their families.
Developing an On-site Research Program
A successful acute care research program requires a dedicated
group of investigators, coordinators, and administrators. The
University of Cincinnati Medical Center established an acute
care research program under the auspices of our Center for
Clinical and Translational Science and Training (CCTST) and
includes individuals from varying backgrounds with extensive
research experience. Our collaborative approach utilizes a learning
development model of analysis, design, development, implementation, and evaluation (an ADDIE model). The goal is to establish
a strong foundation for education, training, and design to be
used specifically for acute care research.
CONCLUSION
The CCU revolutionized the care of patients with acute MI, and
the CICU now offers an environment of highly skilled professionals working as teams to improve the care of patients with a
broad range of complex cardiovascular conditions that are life
threatening or potentially life altering. Patient selection, appropriate resource utilization, and standardized processes of care
collectively represent the key to achieve optimal outcomes at a
cost that is justifiable in an era of affordable care. Education,
training, and research must be a priority moving forward.
Acknowledgment
We thank Tim Smith, MD, for reviewing the manuscript.
The full reference list for this chapter is available at
ExpertConsult.com.
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