One of the major trends in patient safety in a variety of
venues has been a push toward early mobilization of patients. Early
mobilization has become part of numerous guidelines for a variety of medical
conditions (for example see our December 2010 What’s
New in the Patient Safety World column “The
ABCDE Bundle”).
Early mobilization in acute stroke patients theoretically
makes a lot of sense and several studies have demonstrated positive outcomes
from early mobilization in stroke patients. Patients with acute stroke and significant
limb weakness are obviously at risk for venous thromboembolism and pressure
ulcers among other complications. And the “deconditioning” that occurs with
bedrest is likely detrimental to a number of physiologic systems. But the great
unknown is how much activity is best and when should it be started. The logical
assumption is that the earlier it is started, the better the outcomes are
likely to be.
AVERT (A Very Early
Rehabilitation Trial for Stroke) was undertaken to answer those
questions. AVERT was a randomized (single blinded) controlled trial involving
stroke patients (including both ischemic stroke and intracerebral hemorrhages)
in 56 acute stroke units in 5 countries (Bernhardt
2015). The very early intervention group began therapy and mobilization
within the first 24 hours after stroke (median time to first mobilization 18.5
hours), almost 5 hours on average earlier than those patients in the “usual
care” group.
Much to the surprise of the investigators, the primary
outcome of the study (a good functional outcome based on a modified Rankin
Scale score of 0-2 at three months) was actually worse in the group receiving very early mobilization. And there was
no evidence of accelerated walking recovery.
Interestingly, there was no difference in complications
between the very early intervention group and the usual care group in AVERT.
That includes no difference in the incidence of venous thromboembolism. There
was also no statistically significant difference in mortality between the two
groups.
Subgroup analysis did not reveal a better outcome in any
subgroups in the very early intervention group. But there was some evidence
that patients with more severe ischemic strokes and intracerebral hemorrhages
might be especially prone to worse outcomes with the very early intervention.
The author posit a number of physiologically plausible possible explanations
for the worse outcomes in the very early intervention period.
Overall, the outcomes for all patients in the study were
relatively good. Complication rates were low in both groups. And the “usual
care” group actually was getting mobilization quite early (median time to first
mobilization was 22 hours in the “usual care” group).
The investigators plan to further analyze the data to
determine whether any dose-response relationship exists.
Will the study results change the approach to early
mobilization in stroke patients? Unfortunately, it may be years before more
definitively is known about the optimal time to begin and intensity of such
mobilization. But the AVERT results would certainly suggest that very early,
intensive mobilization may be detrimental in stroke patients.
The study is a reminder that sometimes things that make a
lot of sense may not always translate into clinical benefit and may, in fact,
have unexpected consequences. The investigators should be commended for
undertaking this important study.
One very useful outcome of AVERT is that it demonstrates
that randomized controlled trials (RCT’s) can be used to evaluate
rehabilitation interventions in a manner similar to how we evaluate medication,
surgical or procedural interventions. However, it did take the investigators
almost 8 years to accumulate enough patients to have a study powered adequately
enough to address the questions asked.
References:
Bernhardt J, Langhorne P, Lindley RI, et al. for the AVERT
Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015; Published Online April
17, 2015
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960690-0.pdf
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2015 Too Much of a Good Thing? Very Early Mobilization in Stroke”
We’ve done many
columns on the impact of frailty on surgical outcomes (see list at the end of
today’s column). There exist multiple tools for assessing frailty and there has
been continued interest in simplifying those tools. A lot of attention in the
past several years has been given to gait speed as a parameter easy to
assess and highly predictive of outcomes.
Now there has been renewed attention on another component of
many frailty indices: grip strength.
And it turns out that grip strength not only predicts surgical complications
and outcomes but also predicts risk for stroke, MI, cardiovascular and
all-cause death.
In an analysis of 351
consecutive patients undergoing major intra-abdominal operations Revenig and colleagues (Revenig
2015) found that “shrinking”
and grip strength alone hold the same prognostic information as the full
5-component Fried Frailty Criteria for 30-day morbidity and mortality. When
combined with American Society of Anesthesiologists (ASA) score and serum
hemoglobin, they form a simple risk classification system with robust
prognostic information.
Shortly after that publication, the results of the
Prospective Urban-Rural Epidemiology (PURE) study were released (Leong
2015). This was a longitudinal
population study done on approximately 140,000 subjects in 17 countries of diverse
cultural and socioeconomic settings. Grip strength was measured with a
dynamometer. Grip strength was inversely associated with all-cause mortality (16%
increase for each 5 kg reduction in grip strength), cardiovascular mortality
(17%), non-cardiovascular mortality (17%), myocardial infarction (7%), and
stroke (9%). Grip strength was actually a stronger predictor of all-cause and
cardiovascular mortality than systolic blood pressure.
So what do you do
now with this information? It’s not like we can say “Your cholesterol is
elevated and is a risk factor for heart attack and stroke but we can modify
that risk with medications.” Unanswered is the question regarding whether
improvement in grip strength through physical therapy, for instance, reduces any
of the risks. That is unlikely. Much more likely the reduced grip strength is
simply a marker for patients having multiple comorbidities that collectively
reduce his/her physiologic reserve and make them more vulnerable to adverse
outcomes.
But if you were
doing a pre-op evaluation on an elderly patient and found poor grip strength
you might communicate the increased likelihood of adverse outcomes to that
patient and plan for extended resource use during and after the
hospitalization. You might also consider using a program like the Hospital
Elder Life Program (HELP). A modified HELP intervention, conducted by a trained
nurse and not costly, effectively reduced older surgical patients' functional
decline and delirium rates by hospital discharge (Chen
2011).
Some of our prior
columns on preoperative assessment and frailty:
References:
Revenig LM, Canter DJ, Kim S, et
al. Report of a Simplified Frailty Score Predictive of Short-Term
Postoperative Morbidity and Mortality. J Am Coll Surg 2015; 220(5): 904-911
http://www.journalacs.org/article/S1072-7515%2815%2900116-7/abstract
Leong DP, Teo KT, Rangarajan S, et al. Prognostic value of grip strength:
Findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet 2015; DOI:10.1016/S0140-6736(14)62000-6.
Abstract
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2962000-6/abstract
Chen CC, Lin MT, Tien YW, et al. Modified hospital elder
life program: effects on abdominal surgery patients. J Am Coll
Surg 2011; 213(2): 245-52
http://www.journalacs.org/article/S1072-7515%2811%2900342-5/abstract
Print “June
2015 Get a Grip on It!”
We’ve done a couple
previous columns highlighting the problems that patients with Parkinson’s
Disease run into when they get hospitalized for any reason (see our What’s
New in the Patient Safety World columns for August 2011 “Problems
Managing Medications in Parkinson’s Disease” and December 2012 “More
on Hospitalized Parkinson’s Disease Patients”). Patients with
Parkinson’s typically require specific timing of their medications in order to
minimize the “on-off” phenomenon and to avoid hyperkinesias.
This results in their requiring multiple dosing throughout the day and often at
unusual times. Meeting this very
precise timing of doses is problematic for most hospitals and hospital units
because they are used to their own standardized times for medication dispensing
and administration. And most anti-Parkinsonian
medications are available only in oral form so it is especially problematic
when the patient is NPO or is otherwise unable to swallow. Some anti-Parkinson’s
formulations are also of the extended-release variety and should not be
crushed. Moreover, drugs that worsen extrapyramidal function are often used in
the hospital and these may significantly worsen Parkinsonian
features. Patients with Parkinson’s also seem to get temporary declines in
function when they get a systemic problem, like an infection.
ISMP has recently
done another column on this very problem (ISMP
2015). They provide two case examples that illustrate some of these
critical problems. In one case, there was a several hour delay in getting the
patient’s medications even though she informed hospital staff immediately about
the doses and times. The hospital then scheduled her medication administration
for the standard hospital medication administration times. As a result several
hours went by in which the patient failed to receive her medications. This led
to accentuation of difficulty talking and communicating, increased tremor and
difficulty walking. She then became confused and agitated and was given
haloperidol, which further worsened her Parkinsonian
state.
In the second case,
a Parkinson’s patient did not receive his anti-Parkinsonian
medications when his wife was not present at the bedside. He, too, was given a
contraindicated medication when he developed hallucinations and lost the
ability to communicate until his medications were readjusted to the schedule he
used at home.
In our December 2012
What’s New in the Patient Safety World column “More
on Hospitalized Parkinson’s Disease Patients”) we noted a study from
The Netherlands (Gerlach 2012)
found that 21% of Parkinson patients admitted to a hospital experienced
deterioration of motor function and 33% had one or more complications.
Moreover, 26% received incorrect anti-Parkinson medications, which was the most
significant reason associated with clinical deterioration. And somewhat
surprisingly, the researchers found the situation no better in those patients
admitted to neurological wards rather than other wards. This simply suggests an
overall relative lack of understanding of Parkinson’s disease in healthcare
workers who work primarily in inpatient settings. It also reflects some of the
rigid medication administration practices we have in most hospitals.
Interestingly, in the new ISMP column the first patient scheduled a subsequent
elective admission to a hospital where her neurologist worked but she ran into
all the same problems even under that arrangement.
ISMP goes on to
provide a list of important actions that should be undertaken for inpatients
with Parkinson’s Disease:
We encourage you to
read the ISMP article for details under each of the above bullet points.
It’s tough enough to
manage Parkinson’s Disease as an outpatient.
Recognizing these vulnerabilities when patients with Parkinson’s are admitted
to hospitals is a first step in preventing complications, minimizing hospital
lengths of stay, and avoiding functional deterioration.
References:
ISMP (Institute for Safe Medication Practices). Delayed
administration and contraindicated drugs place hospitalized Parkinson’s disease
patients at risk. ISMP Medication Safety Alert! Acute Care Edition. March 12,
2015
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=103
Gerlach OHH, Broen
MPG, van Domburg PHMF, et al. Deterioration of
Parkinson's disease during hospitalization: survey of 684 patients. BMC Neurology 2012, 12: 13 (8
March 2012)
http://www.biomedcentral.com/1471-2377/12/13
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2015 More Risks for Parkinson Inpatients”
Over the last decade
there has been increasing evidence of the potential harms associated with blood
transfusions. Transfusions have been associated with increased risk of
infections, SIRS (systemic inflammatory response syndrome), and other
complications. While clinical factors need to be considered in any decision
about whether to transfuse, use of a hemoglobin (Hb)
threshold or trigger is still commonly used. Studies have demonstrated that use
of more restrictive Hb triggers (8 g/dL) do not adversely impact patient outcomes and this has
been reflected in multiple new guidelines regarding transfusion (see our April
2012 What’s New in the Patient Safety World column “New
Transfusion Guidelines from the AABB”).
Now a new study from
Johns Hopkins (Ejaz 2015), which has been a leader in improving
transfusion practices (see our June 2013 What’s New in the Patient Safety World
column “Hopkins
Blood Ordering Initiative”), shows that substantial variation in
transfusion practices persists, with potentially inappropriate transfusion
practices leading to considerable consumption of resources. Ejaz
and colleagues looked at PRBC transfusions in patients undergoing major
abdominal surgery at Johns Hopkins over almost a 4-year period. They defined
“liberal” Hb trigger as transfusion of PRBCs for an
intraoperative Hb level of 10 g/dL
or greater or a postoperative Hb level of 8 g/dL or greater. Overall, they found that 11.4% of units
were transfused using a liberal trigger. They then calculated the estimated
costs of such “liberal” transfusions, using an acquisition cost of $220/unit
and an activity-based cost of $760/unit (the latter representing the mean cost
from another study that calculated the cumulative costs for each step involved
in delivering 1 unit of PRBC’s from a donor to a recipient, including
technical, administrative, and clinical costs). They estimated that the total
overall PRBC transfusion costs may have been reduced by $27,360 to $94,516 per
year by adhering to the more restrictive transfusion triggers.
Note that the current study only assessed the acquisition
costs of the blood and the estimated costs involved in getting the blood to
patients (technical, administrative, and clinical costs). It did not include
any additional costs that might have resulted from complications of the
transfusion (eg. surgical complications, infection,
longer length of stay, etc.). Patients in their study who received transfusions
had more perioperative complications and longer lengths of stay even after
adjusting for multiple clinical variables. So, given what we know about the
potential downsides of unnecessary transfusion, the costs in the current study
may be an underestimate of the true total cost of unnecessary transfusion.
The Ejaz study also revealed that
the use of “liberal” transfusion varied significantly by type of surgery and by
individual surgeon. Significantly, of the 92 participating surgeons the 9
surgeons least compliant with their institutional guidelines accounted for 80%
of the total overall estimated excess transfusion costs.
We’ll bet your organization has a similar opportunity to
improve both patient outcomes and the financial bottom line by instituting the
more restrictive transfusion guidelines and auditing adherence to them.
Prior columns on
potential detrimental effects related to red blood cell transfusions:
References:
Ejaz A, Frank SM, Spolverato G, et al. Potential Economic Impact of Using a
Restrictive Transfusion Trigger Among Patients Undergoing Major Abdominal
Surgery. JAMA Surg
2015; Published online May 06, 2015
http://archsurg.jamanetwork.com/article.aspx?articleid=2277732
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2015 Economics and Blood Transfusion”
Print “June
2015 What's New in the Patient Safety World (full
column)”
Print “June
2015 Too Much of a Good Thing? Very Early Mobilization in Stroke”
Print “June
2015 Get a Grip on It!”
Print “June
2015 More Risks for Parkinson Inpatients”
Print “June
2015 Economics and Blood Transfusion”
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