12 PART 1: An O ver view of the Approach to and Organization of Critical Care

QUALIT Y INDICATORS IN review of the available evidence A meta-analysis, including data

from 10 studies and more than staffing model the addition of a
demonstrates 30% lower hospital
CRITICAL C ARE and 40% lower ICU mortalities, 100,000 patients, could not nighttime intensivist did not

■ demonstrate a higher mortality provide benefits; however, in

as well as decreased length of
due to nighttime admissions, low-intensity staffing ICUs, the
stay, in high-intensity staffing
even when stratified by presence of a night- time
model ICUs.51 High-intensity
subgroups according to intensivist was associated with
intensivist staffing models are
intensiv- ist coverage. The lower mortality.113 Clearly this
currently a major quality
authors could demonstrate an field is a current and exciting
recommendation of several
S organizations.109 However, there association between weekend topic, still open for discussion,
admissions and mortality, with authors debating whether
are several issues to consider in
which may reflect the 24-hour intensivist staffing
T this quality metric. First, with the
should114,115 or not116,117 be
exception of the United States, possibility that it is not only the
availability of intensivists that adopted. Given the costs of
most large ICUs are run under
R what would be considered a makes a difference, but that a staffing ICUs 24 hours a day,
more complex organizational the unavail- ability of
high-intensity model; therefore,
behavior on weekends, which intensivists to staff ICUs even
U the open ICU model is primarily
during daytime, and the lack of
an issue for one country. might include limited access to
other hospital services, may be evidence beyond reasonable
Second, the available literature
C on this quality metric addresses the most important factor.112 doubt, it would be premature to
More recent data, from suggest that 24-hour intensivist
how the ICU is organized, not
administrative databases staffing model should be
T whether an individual patient
universally adopted, although it
has an intensivist as their including 49 ICUs,
demonstrated that in ICUs with seems reasonable that some
physician. At least one
U publication has demonstrated a high-intensity organizations may benefit from
it, especially those with a low-
that, in a select group of
intensity staffing model.
R critically ill patients, ICUs that
The most expensive part of
have no access to inten- sivists
intensive care is labor. There is
can have good outcomes.54 This
E a con- siderable body of
study supports the complexities
literature trying to identify the
Several structural characteristics of organizations and indicates
of ICUs have been linked to ideal nursing staffing ratios and
the challenges of implementing
better out- a more limited set of studies
system changes on the basis of
comes. Although it is unlikely looking at other clinician staff-
population studies; some ICUs
that there will be randomized ing. Not unexpectedly, an
may achieve equally good
controlled trials comparing association between higher
outcomes with different models.
different models of ICU care,44-57 patient to nurse ratio and
Although it seems reason- able to
nighttime availability of mortality has been
suggest the closed ICU model as
intensivists,7,58-68 staffing ratios,69- demonstrated. Administrative
a policy, health care institutions
86
volume of admissions,87-94 data from general surgery,
could benefit from learning why
special- ized units,95,96 shift vascular and orthopedics
these individual ICUs perform so
models,97 availability of patients in 168 hospitals in
well, in spite of not having a
technology,98-101 provider Pennsylvania showed that there
closed model.110
experience,102 teamwork,103,104 or is an OR for mortality of 1.07
Nighttime availability of
organizational climate,105-108 the per each extra patient per nurse.
intensivists is another area
asso- ciation between some of This represents five excess
where the lit-
these structural features and deaths per 1000 patients if the
erature uses confusing terms. It
outcome is quite strong. patient to nurse ratio goes from
may refer to on-site 24 hours
However, it must be kept in mind 4:1 to 8:1.72 Stemming from this
coverage by intensivists, to open
that organizational behavior is important information from
ICUs where the evening is
more complex than the ward care, several authors have
covered by intensiv- ists, or to
individual structural factors and investigated this issue in more
availability of consultants over
many organi- zations may detail in the ICU. A meta-
the phone or via computer.
actually perform quite well in analysis of the current literature
Interest in the subject was raised
spite of not being compliant with supports a decrease of 30% in
by reports of an association
policy recommendations. nosocomial pneumonia,
between weekend hospital
ICUs can use many different 50% in unplanned extubations,
admissions and mortality for
models of care, and the literature and 9% in mortality per increase
several acute diagnoses, such as
has confusing terminology for in one registered nurse per
abdominal aortic aneurysm,
these different models. An ICU patient per day.69,83 Interestingly,
acute epiglottitis, and pulmonary
model usu- ally refers to there seemed to be a dose
embolism.111 Several
intensivists’ degree of response effect, consistent with
investigators pursued the
responsibility over patient care causality, when the data were
question whether ICU
taken. In “closed” models, only analyzed by quartiles of patients
admissions at night or on the
intensivists have admitting per nurse in the ICU: Models
weekend were associated with
privileges to the ICU and work in with 1.6 to 2 patients per nurse
mortality, which led to
collaboration with the patient’s per shift were consistently better
heterogeneous results.7,60-68 There
primary physician. “Open” units than models with 3 and even
is speculation that the
allow the patient’s primary larger effects could be seen on
heterogeneity of results may be
physician to retain full the comparison with models
due to different models of care:
responsibility over clinical with 4. It seems reasonable to
Units that have on-site
decisions and consultation with recommend models where nurses
intensivists may show no
an intensive care physi- cian is do not take responsibility over
differences in mortality between
optional. The term high- more than 2 critically ill patients
daytime and nighttime
intensity staffing model refers to per shift. Obviously,
admissions,60,61 while units
either a closed ICU or an open organizations may choose a more
without on- site coverage may
ICU with mandatory intensivist fluid regimen, where nurses
have worse outcomes for
consultation. A systematic share responsibility over 4
nighttime admissions.7,65,67
patients, but one nurse may be that “boarding”
dedi- cated to a more acute
patient when needed, while the
other takes over 3 less intense
patients.
Unfortunately there are scarce
data on the appropriateness of
inten- sivist staffing ratios. A
single center study, where the
expansions of the ICU led to
varying staffing rations over
time (from 1:7.5 beds to 1:15
beds), provides the only evidence
available: There was no effect on
mor- tality with varying staff
ratios, but length of stay seemed
to be higher in the model with 1
intensivist caring for 15 beds.80
There currently are no data to
support recommendations
regarding the most appropriate
intensivist staffing ratio.
Constant training is one of the
hallmarks of highly reliable
organiza- tions.118 Much of the
training in health care
organizations is performed on
the job. Therefore, it is intuitive
to consider the possibility that
insti- tutions that have higher
volumes of specific conditions
should perform better. Higher
volumes of specific conditions
may also lead to better
outcomes by decreasing
variability in diagnosis and
focusing nursing expertise. In
fact, there is a large amount of
evidence linking hospital
volumes to better outcomes in
several clinical conditions,89
including AIDS,119
cardiology,92,120 vascular
surgery,121 cancer,122
orthopedics,123 urology,124
neurosurgery,125 and critical
care.87,90 This is important for
two reasons: (1) policy makers
may choose to combine units to
increase the volumes and (2)
given the lack of adequate
outcomes and process quality
indicators for benchmarking,
health care consumers may
choose hospitals with higher
volume as a surrogate of better
outcomes.
Similar reasoning led to the
concept of specialty ICUs in
transplant, trauma,
neurosurgery, and other areas.
Some evidence points toward
better outcomes in units with
lower diagnostic diversity99,106
and in neu- rocritical care units
for intracerebral hemorrhage.96
However, analyzing data from
almost 100,000 patients in 124
ICUs across the United States,
investigators could not
demonstrate any benefit of
specialty ICUs for six medical
conditions, including acute
coronary syndrome, ischemic
stroke, intracranial hemorrhage,
pneumonia, abdominal and
cardiotho- racic surgery.95 In fact
their data support the possibility
CHAPTER 2: Measuring Quality 13
patients, those with specific conditions being cared for in a specialty Table 2-3 contains a list of selected processes of care indicators,
ICU outside of the needs of the patient, may actually be harmed by with validated outcomes summarized to guide in understanding
these models. expected benefits from these processes. The last column contains a

■
description of the suggested quality indicator to be measured. The
definitions are intentionally broad to allow for local needs in defining
eligible patients. Given the state of evidence, it is entirely possible that
some of these evidence-based process measures will be under debate
PROCES as you review this table.

S ■
Given the limitations in studying outcomes or structure as measures
of OUTCOM
quality, process of care seems like an appealing option. Process
measures have intuitive appeal to clinicians who may find data
showing that they are not doing something they believe they should E
be more compelling than recommendations about structure of the Mortality, despite its limitations, will always remain high on the list
ICU or risk-adjusted mortality. It also seems a clearer way to address of
a clinical behavior than other quality reports. Finally, for statistical quality measures stakeholders request when discussing quality. For
reasons it is easier to moni- tor changes in more common processes obvi- ous reasons, crude mortality is inadequate to assess this
than in rare events like death or VAP. Selecting process measures, outcome, and intensive care has led the field of risk adjustment for
particularly in critical care, presents some challenges. Ideally process decades.132-134 Scoring systems have helped us simplify our
measures should be linked with com- pelling, usually randomized epidemiological description of criti- cally ill patients and adjust for
trial, evidence of a direct effect on outcome. These evidence-based confounding due to severity of illness in research; however, they have
process indicators may be referred to as outcome validated and not been validated to be used for (1) bench- marking40 or (2)
represent direct measures of quality.126 Unfortunately, there is scarce identification of low performing units.34 One important question
availability of indicators that have been robustly validated in critical remains to be answered: Is it useful to monitor mortality over time as
care. Even processes of care based on large randomized clini- cal trials, a quality improvement strategy in individual units? Intensivists
such as low tidal volume ventilation for acute lung injury,127 have been advocate for several different methods of longitudinal follow-up,
disputed in the literature.128 This is the very nature of science and to including serial standardized mortality ratios (SMRs), risk-adjusted p
expect 100% agreement would break the safeguard against col- lective charts, risk- adjusted CUSUM charts, and other approaches.135
error that derives from differences in opinion.129 Although not unique However, to date there are no data to validate the use of longitudinal
to critical care, developing strict process measures of quality of care SMRs to monitor quality.
will always be difficult as the evidence base is modest and evolving. What makes risk-adjusted mortality unsuitable to be used as a
Glucose control and renal dose dopamine are just a few of the quality indicator?
treatments that might have made excellent process measures of
quality until they were shown to be ineffective or harmful. 1. SMRs can change due to factors unrelated to the quality of care,
There is a bit of confusion in the literature regarding what processes such as the way laboratory values and vital signs are recorded. In
of care means. Examples of processes of care include deep venous an elegant study, patients had laboratory values and vital signs
throm- bosis prophylaxis, sedation interruption strategies, daily recorded at ICU admission and then as per clinical indication
assessment of readiness to wean, head of bed elevation, assessment for (standard mea- surement), concomitantly, the authors measured
early enteral nutrition, compliance with evidence-based protocols, use laboratory values every 2 hours and vitals whenever they were
of continu- ous subglottic aspiration, stress ulcer prophylaxis, and low abnormal (intensive measurement). The intensive measurements
tidal volume ventilation. Practices that are frequently cited as led to absolute SMRs
processes of care, but that we do not consider as such, include length 10% lower than the standard measurements, in both APACHE II
of ICU stay, proportion of occupied beds, duration of mechanical and SAPS II.136 An ICU using more intensive measurement will look
ventilation,130 plateau airway better than one that uses standard measurement, even when no real
differences exist because the more intensive monitoring yields
more
pressures below 30 cm H2O,131 and central venous saturation above extreme values for severity of illness variables.
70%.131 The reason for not considering these as processes of care risk adjust the results to the patient population.
indica-
tors is that they are confounded by patients’ characteristics and are not
under the exclusive control of providers. It is easy to understand
this concept when we discuss ICU length of stay or duration of
mechanical ventilation. These end points are clearly influenced by more
than just our clinical processes of care and cannot be compared across
patients and/ or centers without appropriate risk adjustment.
However, it is harder to understand why physiologic targets of
appropriate treatments are not ideal process of care variables. For
example, lung protective ventilation for ARDS using one protocol
prescribes the tidal volume and a target plateau pressure. The
physician has complete control over setting the tidal volume, however,
the resulting plateau pressure reflects a complex interaction between
the process measure (tidal volume) and patient fac- tors like thoracic
compliance. Ideally, the quality measure would capture the attempt of
the physician to respond to the plateau pressure and titrate the tidal
volume, but this is difficult to measure. There is nothing wrong with
including physiologic targets of evidence-based processes like plateau
pressure, central venous saturation, or sedation scores as quality
measures, however, they lack one of the basic advantages of process
measures, specifically, insensitivity to patient factors and risk
adjustment. Therefore, if an ICU looks bad because their patients tend
not to achieve some physiologic targets, this might be due to failure
to adequately implement the process of care or it might be due to age,
obesity, severity of illness, or any of a number of patient factors. If
physi- ologic targets of evidence-based process measures are included
in qual- ity assessments, some thought should be given to the need to
 2. Differences in case mix may lead to differences in the estimate of
the SMR. Even though risk-adjusted models are supposed to deal
with different patient characteristics, they are still far from
perfectly calibrated. In fact, changing the severity of the case mix
leads to differences in the SMR even when there are no real
differences in observed outcome per category. In one study, the
SMR was catego- rized by mortality risk, with a cutoff of 10%
risk.137 Patients with lower risk had SMRs above 2, while those
with higher predicted risk had SMRs close to 1. Obviously, units
with higher percentage of low-risk patients may look worse than
units that care only for sicker patients. This effect is also
expected with different popula- tions where the model may
calibrate differently in different patient subsets. Therefore, even
though risk-adjustment models were devel- oped to allow for
comparisons of different groups of patients, their imperfect
calibration makes this use challenging.

Nevertheless, it seems inappropriate to completely ignore the infor-

mation that may be present in risk-adjusted mortality data. The main
concern is that the SMR and changes in it over time should prompt
appropriate investigations. Hospitals with SMRs that indicate low
mor- tality and good quality of care should not be overly confident that
quality is excellent anymore than hospitals with poor SMRs should be
punished for an isolated value.
Recent years have been marked by an increasing interest in nosoco-
mial infections such as VAP and catheter-related blood stream
infection (CR-BSI). Hospital-acquired infections are an exciting topic
for many stakeholders. They are thought to be preventable and
causally linked