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Over the years, weve done many columns on the question about the impact of
resident work hours on patient safety. The debate has always been Would you
rather be cared for by a tired resident who knows you or a wide awake one who
doesnt know much about you?. Of course, at this time
we dont have an unassailable answer to that question. Studies to date have had
mixed results, some showing fewer errors in residents with more restricted work
hours and others showing no change or even more errors.
It is indisputable
that physiological changes and circadian rhythm disturbances in healthcare
providers, such as fatigue and inattention, make errors more likely. There are
plenty of studies now demonstrating deterioration in cognitive and physical skills
with sleep deprivation or extended work shifts. For example, one recent study (Persico 2018) evaluated the cognitive performance
(processing speed, working memory capacity, perceptual reasoning, and cognitive
flexibility) of emergency physicians after a night shift of 14 hours (H14) and
after a work shift of 24 hours (H24) and to compare it with tests performed
after a rest night at home (H0). No cognitive ability was significantly altered
after H14 compared with H0. But three of 4 cognitive abilities performance
(processing speed, working memory capacity, and perceptual reasoning) were
impaired at H24 compared with H0. Cognitive abilities were not different
between residents and staff physicians (except for perceptual reasoning) and
were not affected by the amount of sleep during the night shift.
Studies like these
showing cognitive and performance deterioration with long shifts, and some well
publicized incidents such as the Libby Zion case, led to the restriction of
work hours for physicians in training. The Bell Commission, which developed the
original residency workhour restrictions in New York State in the 1980s, cited
the more frequent occurrence of hospital incidents at night and on weekends as
a sign of work-related fatigue. Back then, we pointed out to that commission
that those are also times when there is more cross-coverage of patients and the
covering physicians generally have less knowledge about the patients they
cover. So the debate has ensued as to which is worse:
errors related to fatigue or errors related to handoffs. It is fairly clear we must avoid fatigue as much as possible by
adherence to workhour restriction rules. And we also need to focus on
improvement of handoffs and other communication issues to improve patient
safety.
Following the Bell
Commission report in New York State, some states placed restrictions on the
total number of work hours per week and number of consecutive work hours
residents could work. Later, the ACGME developed similar guidelines restricting
resident work hours to no more than 80 hours per week and no more than 16
consecutive hours. Then, in 2017, ACGME did backpeddle
somewhat and allowed more flexible hours (shift of 24-28 consecutive hours were
allowed).
In prior columns, we
expressed our hope that 2 trials, the FIRST (Flexibility in Duty Hour
Requirements for Surgical Trainees) trial and the iCOMPARE
(Individualized Comparative Effectiveness of Models Optimizing Patient Safety and
Resident Education) trial would provide clear cut answers to the fundamental
question as to whether more restricted resident work hours had an impact one
way or the other on patient safety and patient outcomes. Of course, the other
important outcome anticipated from these studies was the impact on resident
well-being.
We discussed the iCOMPARE trial in our April 2019 What's New in the Patient Safety World column iCOMPARE
Study on Resident Work Hour Rules. iCOMPARE involved 63
internal-medicine residency programs that were randomized to a group with
standard ACGME duty hours or to a group with more flexible duty-hour rules that
did not specify limits on shift length or mandatory time off between shifts
(but still complied with the 80 hour per week restriction). The primary outcome
measure, change in 30-day mortality, was not significantly different between
the two groups (Silber
2019). Differences in changes between the flexible programs and the
standard programs in the unadjusted rate of readmission at 7 days, patient
safety indicators, and Medicare payments were also not significantly different.
A companion paper from the iCOMPARE
trial looked at the effects of flexible scheduling vs. strict scheduling on
sleep, sleepiness, and alertness of medical trainees (Basner 2019).
The researchers found no significant difference between the groups in total
sleep duration (as measured by actigraphy) or sleepiness (as measured by the
Karolinska Sleepiness Scale). But noninferiority of the flexible group for
alertness (as measured by the brief computerized Psychomotor Vigilance Test)
was not established.
They concluded that there was no more chronic sleep loss or
sleepiness across trial days among interns in flexible programs than among
those in standard programs. But both those measures were averages over time.
Those in flexible-hour programs averaged 2.23 hours less sleep during night
calls and the average was increased by sleeping more hours on days off. Also,
those in flexible programs reported less alertness and more sleepiness after
extended night shifts than during day shifts.
A third paper from the iCOMPARE
trial (Desai 2018)
found no significant between-group differences in the mean percentages of time
that interns spent in direct patient care and education nor in trainees
perceptions of an appropriate balance between clinical demands and education.
Scores on in-training examinations also did not differ significantly between
groups. But a survey of interns revealed that those in flexible programs were
more likely to report dissatisfaction with multiple aspects of training,
including educational quality (odds ratio 1.67), overall well-being (OR 2.47),
and how the program affects their personal lives with friends and family (OR,
6.11).
We discussed the FIRST trial in our March 2016 What's New in the Patient Safety World column Does
the Surgical Resident Hours Study Answer Anything?. In the FIRST trial (Bilimoria
2016), more flexible resident work hours were not associated with an
increased rate of death or serious complications or residents perception of educational value but residents had more
negative feelings about the impact on their personal lives with the more
flexible hours
The FIRST (Flexibility in Duty Hour Requirements for
Surgical Trainees) trial had found no significant difference in resident
satisfaction with overall well-being and education between flexible and
standard duty-hour policies after 1 year. Followup
analysis in 2017 showed a decrease in negative perception of flexible duty-hour
policies a year later. A survey of residents participating in the FIRST trial (Yang
2017) found that as PGY level increased, residents had increasing concerns
about patient care and resident education and training under standard duty hour
policies, but they had decreasing concerns about well-being under flexible
policies. When given the choice between training under standard or flexible
duty hour policies, only 14% of residents expressed a preference for standard
policies. Khorfan et al. (Khorfan
2020) recently reported 4 year follow up to the FIRST trial. They
found that, over time, there was a trend toward fewer 80-hour work week
violations in the flexible arm (19.8% vs. 17.0%) and increased satisfaction
with flexible duty-hours. Well-being decreased over time
but this was seen in both arms. Residents in flexible duty-hour programs
reported significantly fewer lapses in continuity than standard policy
residents until all programs transitioned to flexibility in 2018.
So, did we have answers to our fundamental questions? Both
the FIRST and iCOMPARE trials showed flexible resident
work-hour policies have similar patient outcomes and resident educational
values compared to the strict ACGME policies. Thats
reassuring. It pretty much answers the question that we raised from the
beginning: the issue of fatigue vs. increased handoffs/discontinuity appears to
be a wash.
But, wait a minute! A
new study (Landrigan
2020) compared two schedules for pediatric resident physicians
during their intensive care unit (ICU) rotations: extended-duration work
schedules that included shifts of 24 hours or more (control schedules) and
schedules that eliminated extended shifts and cycled resident physicians
through day and night shifts of 16 hours or less (intervention schedules).
Resident physicians made more serious errors during the intervention schedules
than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53). The number of serious errors unitwide were likewise higher during the intervention
schedules (181.3 vs. 131.5 per 1000 patient-days;
relative risk, 1.56). Those results are contrary to what the researchers would
expect.
Aha, you say! Those who espouse the less knowledge/more
handoffs theory will say this supports their position. But not so fast! There
was considerable variation between results at participating hospitals. The
patient demographics and complexity of illness could not explain the
differences. Though the characteristics of the patient population were similar
in the 2 arms of the study, the number of patients per resident was not. Those
hospitals with the highest resident physician workloads had the most negative
results with the intervention. In fact, residents in the intervention (limited
hours) group had more ICU patients per resident than those in the control (24
or more hours) group (mean 8.8 vs. 6.7). Once the results were adjusted for the
number of patients per resident physician as a potential confounder,
intervention schedules were no longer associated with an increase in errors.
And, of course, we cant discuss resident work hours without mention of
handoffs. But well simply refer you to our many
columns listed below. The researchers in the Landrigan study did discuss the possibility that an increase
in handoffs may have played a role in producing more errors. Handoffs did increase
in number at all participating hospitals. However, only three sites had worse
patient safety outcomes with the intervention schedule than with the
extended-shift schedule, and one had substantially better safety outcomes with
the intervention. The authors felt that suggests that the increase in handoffs
overall was unlikely to account for the results.
The Landrigan study shows us 3 important things:
Finding the sweet
spot between resident fatigue and well-being vs. patient safety and patient
outcomes probably still requires further tweaking of both scheduling and
workload. And, as John Birkmeyer pointed out in an
editorial accompanying the FIRST trial results, we also need to factor in that much
of the work formerly done primarily by residents is now done by others (Birkmeyer
2016). There has been
increased involvement of intensivists, attending physicians and mid-level
providers as part of interdisciplinary teams, and hospitalists often attend to
many of the non-surgical aspects of patient care in surgical patients.
Some of our other columns on housestaff
workhour restrictions:
December 2008 IOM Report on Resident Work Hours
February 26, 2008 Nightmares: The Hospital at Night
January 2010 Joint Commission Sentinel Event Alert: Healthcare
Worker Fatigue and Patient Safety
January 2011 No Improvement in Patient Safety: Why Not?
November 2011 Restricted Housestaff
Work Hours and Patient Handoffs
January 3, 2012 Unintended Consequences of Restricted Housestaff Hours
June 2012 Surgeon Fatigue
November 2012 The Mid-Day Nap
December 10, 2013 Better
Handoffs, Better Results
April 22, 2014 Impact of Resident Workhour Restrictions
January 2015 More Data on Effect of Resident Workhour
Restrictions
August 2015 Surgical Resident Duty Reform and
Postoperative Outcomes
September 2015 Surgery Previous Night Does Not Impact
Attending Surgeon Next Day
March 2016 Does
the Surgical Resident Hours Study Answer Anything?
April 2019 iCOMPARE
Study on Resident Work Hour Rules
Read about many other
handoff issues (in both healthcare and other industries) in some of our
previous columns:
May 15, 2007 Communication,
Hearback and Other Lessons from Aviation
May 22, 2007 More
on TeamSTEPPS
August 28, 2007 Lessons
Learned from Transportation Accidents
December 11, 2007 Communication
Communication
Communication
February 26, 2008
Nightmares
.The
Hospital at Night
September 30, 2008 Hot
Topic: Handoffs
November 18, 2008 Ticket
to Ride: Checklist, Form, or Decision Scorecard?
December 2008 Another
Good Paper on Handoffs.
June 30, 2009 iSoBAR:
Australian Clinical Handoffs/Handovers
April 25, 2009
Interruptions,
Distractions, Inattention
Oops!
April 13, 2010 Update on Handoffs
July 12, 2011 Psst! Pass it on
How a kids game can mold good handoffs
July 19, 2011 Communication Across Professions
November 2011 Restricted Housestaff
Work Hours and Patient Handoffs
December 2011 AORN Perioperative Handoff Toolkit
February 14, 2012
Handoffs
More Than Battle of the Mnemonics
March 2012 More on Perioperative Handoffs
June 2012 I-PASS Results and Resources Now Available
August 2012 New Joint Commission Tools for Improving Handoffs
August 2012 Review of Postoperative Handoffs
January 29, 2013 A Flurry of Activity on Handoffs
December 10, 2013 Better Handoffs, Better Results
February 11, 2014 Another Perioperative Handoff Tool: SWITCH
March 2014 The Reverse Perioperative Handoff: ICU to
OR
September 9, 2014 The Handback
December 2014 I-PASS Passes the Test
January 6, 2015 Yet Another Handoff: The Intraoperative
Handoff
March 2017 Adding
Structure to Multidisciplinary Rounds
August 22, 2017 OR
to ICU Handoff Success
October 2017 Joint
Commission Sentinel Event Alert on Handoffs
October 30, 2018 Interhospital
Transfers
April 9, 2019 Handoffs for Every Occasion
November 2019 I-PASS Delivers Again
References:
Persico N, Maltese
F, Ferrigno C, et al. Influence of Shift Duration on Cognitive Performance of
Emergency Physicians: A Prospective Cross-Sectional Study. Ann Emerg Med 2018; 72(2): 171-180
https://www.annemergmed.com/article/S0196-0644(17)31769-9/fulltext?code=ymem-site
Silber JH, Bellini LM, Shea JA, et al. Patient Safety
Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med 2019; 380: 905-914
https://www.nejm.org/doi/full/10.1056/NEJMoa1810642
Basner M, Asch DA, Shea JA, et al.
Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2019; 380: 915-923
https://www.nejm.org/doi/full/10.1056/NEJMoa1810641
Desai SV, Asch DA, Bellini LM, et al. Education Outcomes in
a Duty-Hour Flexibility Trial in Internal Medicine. N Engl
J Med 2018; 378: 1494-1508
https://www.nejm.org/doi/full/10.1056/NEJMoa1800965
Bilimoria KY, Chung JW, Hedges LV, et al. National
Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; 374: 713=727 published online first
February 2, 2016
https://www.nejm.org/doi/full/10.1056/NEJMoa1515724?query=TOC
Yang AD, Chung JW, Dahlke AR, et al. Differences in Resident
Perceptions by Postgraduate Year of Duty Hour Policies: An Analysis from the
Flexibility in Duty hour Requirement for Surgical Trainees (FIRST) Trial. Journal
of the American College of Surgeons 2017; 224(2): 103-112 Published online
November 4, 2016
https://www.journalacs.org/article/S1072-7515(16)31591-5/abstract
Khorfan R, Yuce
TK, Love R, et al. Cumulative Effect of Flexible Duty-hour Policies on Resident
Outcomes, Annals of Surgery 2020; 271(5): 791-798
Landrigan CP, Rahman SA, Sullivan
JP, et al. Effect on Patient Safety of a Resident Physician Schedule without
24-Hour Shifts. N Engl J Med 2020; 382: 2514-2523
https://www.nejm.org/doi/full/10.1056/NEJMoa1900669?query=TOC
Birkmeyer JD. Surgical Resident
Duty-Hour Rules - Weighing the New Evidence (editorial). N Engl
J Med 2016; 374:783-784 published online first February 2, 2016
https://www.nejm.org/doi/full/10.1056/NEJMe1516572?query=TOC
Print August 2020 New Twist on Resident Work
Hours and Patient Safety
In multiple columns we have highlighted the dangers of
long-acting and/or extended-release opioids. These formulations are not
intended for use as first-line agents in opioid-naοve patients. The newer
opiate formulations are either more potent or designed to produce a longer peak
action, two characteristics that lead to some of the greatest dangers. These
have been designed to be used in patients who are opioid-tolerant and have pain
of a chronic nature that has not been controlled with more conventional
opiates. They were not intended to be used for treatment of acute pain nor to
be used as first line agents in patients with pain. But in practice they are
often being (mis)used in that way. And, unfortunately, these preparations
became a prime driver of the opioid epidemic in the US.
One of those extended release opioid preparations is the fentaNYL patch. Weve discussed problems with these
patches in our Patient Safety Tip of the Week for September 13, 2011 Do
You Use Fentanyl Transdermal Patches Safely? and our What's New in the Patient Safety World columns for May 2012 Another
Fentanyl Patch Warning from FDA, March 2013 Try
Googling Fentanyl Accidents,
September 2013 ISMP
Outreach on Fentanyl Patch Safety, and February 2020 The FDA and Long-Acting Opioids.
ISMP recently reported on a bothersome potential trend (ISMP
2020). They noted an uptick in prescriptions for fentaNYL
patches in elderly opioid-naοve patients discharged from hospitals or emergency
departments. ISMP, of course, reiterates that fentaNYL
patches, like other long-acting or extended release opioids, are not
appropriate for opioid-naοve patients. They do note some factors that may have contributed
to physicians inappropriately prescribing these. One obvious one is not
understanding they should not be used in opioid-naοve patients. But another was
physicians not understanding what the terms opioid-naοve or opioid-tolerant
mean. ISMP provides a definition of opioid-tolerant from the prescribing information
for fentaNYL patches. Another contributing factor
was mistaking an opioid side effect as evidence of an allergy to a specific
opioid, which apparently led at least one prescriber to think a fentaNYL patch was the only option. Lastly, a patient
request for an opioid patch may have also played a role in one case.
ISMP has some suggestions to help prevent such inappropriate
prescribing of fentaNYL patches. They recommend interactive
alerts requiring confirmation that the patient is opioid-tolerant and experiencing
chronic pain at the time healthcare professionals are entering orders or prescribing
fentaNYL patches (and this should include the
emergency department). Hard stops could be used if the patient does not meet
criteria for being opioid-tolerant. They also recommend creating a daily list
of discharge prescriptions and transfer orders for fentaNYL
patches generated from the order entry system. Hospital pharmacists should then
review the orders and prescriptions to verify that the patient is
opioid-tolerant and has chronic pain.
ISMPs second recommendation has to do with distinguishing
between true allergies and drug intolerances. (Youll recall we just discussed
this issue in our July 21, 2020 Patient Safety Tip of the Week Is This Patient Allergic to
Penicillin?). ISMP recommends that, when allergy information is
collected, include prompts to obtain and document in a standardized manner the
reaction type (e.g., side effect, intolerance, toxicity, immune response) and
description (e.g., rash, pruritus, swelling, anaphylaxis). Before prescribing
medications, allergy information without a documented reaction type and
description should be reconciled with the patient or caregiver so crucial
medications are not avoided simply due to mild intolerances.
Of course, there are lots of other issues associated with opioid
transdermal patches.
They are also now frequent causes of accidental overdoses, including those for whom they were not
prescribed such as children and pets that are attracted to the shiny wraps. And
transdermal patches can lead to burns if a patient wearing one undergoes
an MRI scan. Another problem is failure to remove the old patch when a
new one is put on, resulting in excessive fentanyl levels.
Now is a good time for all hospitals (and other healthcare
organizations) to review their clinical decision support (CDSS) tools to see if
they can help avoid inappropriate use of fentanyl patches or other long-acting
or extended release opioid formulations. A very bothersome occurrence was noted
recently in which a vendor included in an EHR CDSS alerts that actually steered
providers to inappropriately order certain extended-release opioids (Taitsman
2020).
Our prior articles pertaining to long-acting and/or
extended release preparations of opioids:
References:
ISMP (Institute for Safe Medication Practices).
Inappropriate FentaNYL Patch Prescriptions at
Discharge for Opioid-Naοve, Elderly Patients. IMSP Medication Safety Alert!
Acute Care Edition 2020; July 2, 2020
Taitsman JK, VanLandingham
A, Grimm CA. Commercial Influences on Electronic Health Records and Adverse
Effects on Clinical Decision-making. JAMA Intern Med 2020; 180(7): 925-926
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2764862?resultClick=1
Print August 2020 Fentanyl Patches in the
Crosshairs Again
Anything we can do to reduce the risk of alarm fatigue is
welcome. The most obvious one weve discussed is
eliminating unnecessary telemetry monitoring. But, perhaps the next most obvious
one is reducing pulse oximetry alarms that are not clinically important.
Continuous pulse oximetry monitoring is commonly performed in
hospitalized children. An expert panel, utilizing the best evidence in the
literature plus their own experience, recently utilized a modified Delphi
Method to evaluate the need for continuous vs. intermittent pulse oximetry
monitoring in a variety of conditions in hospitalized children outside the ICU
(Schondelmeyer
2020).
For children with mild or moderate asthma, croup, pneumonia,
and bronchiolitis, the panel recommended intermittent vital sign or oximetry
measurement only. For those with severe disease in each respiratory condition
as well as for a new or increased dose of intravenous opiate or benzodiazepine,
the panel recommended continuous monitoring.
Children receiving supplemental oxygen should have
continuous oximetry monitoring, but they should be transitioned from continuous
monitoring to intermittent monitoring within 1 hour of achieving stable oxygen
saturation levels of at least 90%.
Weve, of course, done many columns on the dangers of respiratory
depression by opioids or sedating agents. The panel recommends that intravenous
opioid or benzodiazepine therapy requires continuous cardiorespiratory and
oximetry monitoring only when there is a new medication or an increased dose of
a current medication. Intermittent monitoring is otherwise sufficient.
Were
not so sure about the latter recommendation. Hypoxemia is a relatively late
manifestation of drug-induced respiratory depression. Hypercapnia occurs before
there is a significant reduction in oxygen saturation in most instances. Its probably more appropriate to be using capnography
to monitor patients receiving drugs that may depress respiration, such as
opioids and benzodiazepines. Weve certainly seen
patients become obtunded while they still had good oxygen saturations, even on
continuous pulse oximetry monitoring. If capnography is not available in such
circumstances, wed still feel more comfortable using
continuous rather than intermittent pulse oximetry.
The panel did acknowledge there is a relative dearth of high quality evidence in the literature, which consists
primarily of observational study designs, and that there was little or no
evidence for some of the respiratory conditions.
Overall, the panel recommended that intermittent vital sign
assessment is appropriate for most mild-moderate forms of childhood respiratory
illnesses. For patients weaned from oxygen, transitioning to intermittent
oximetry within one hour is appropriate.
Theres no question these new
guidelines would significantly reduce alarms on pediatric units and, thus,
reduce the risk of alarm fatigue.
Some of our previous
columns on opioid safety issues in children:
Prior Patient Safety
Tips of the Week pertaining to alarm-related issues:
Other Patient Safety
Tips of the Week pertaining to opioid-induced respiratory depression and PCA
safety:
References:
Schondelmeyer AC, Dewan ML, Brady
PW, et al. Cardiorespiratory and Pulse Oximetry Monitoring in Hospitalized
Children: A Delphi Process. Pediatrics 2020; e20193336
https://pediatrics.aappublications.org/content/early/2020/07/15/peds.2019-3336
Print August 2020 Pulse Oximetry in Children
Most of us have always thought about laparoscopic procedures
for non-malignant gynecological conditions to be relatively benign procedures.
But data from a recent randomized controlled trial at a tertiary
university-affiliated center showed some surprising results (Dior
2020). Surgical site infections (SSIs) occurred in 16.3% of cases, with organ
or space infection in 6.6% and port-site infection in 10.2%.
The study was actually a randomized
controlled trial (RCT) looking to see if there was a difference in SSI rates when
using different skin disinfectants. 221 patients were randomized to have their
skin prepared preoperatively with water-based povidone-iodine, 220 were
randomized to alcohol-based povidone-iodine, and 220 were randomized to
alcohol-based chlorhexidine. Patients were blinded to the solution used to
clean their skin. The researchers found that no skin preparation solution
provided an advantage compared with the other solutions in reducing infection
rates. But the somewhat surprising finding was the relatively high rates of
SSIs regardless of the skin preparation used. The authors conclude that further
research efforts are needed to find ways to reduce these SSI rates.
We wonder how many hospitals even know what their SSI rates are
for these laparoscopic procedures. Do you know your rates?
References:
Dior UP, Kathurusinghe S, Cheng C,
et al. Effect of Surgical Skin Antisepsis on Surgical Site Infections in
Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind
Randomized Clinical Trial. JAMA Surg 2020; Published online July 08, 2020
Print August 2020 Surgical Site Infections and
Laparoscopy
Print August
2020 What's New in the Patient Safety World (full column)
Print August 2020 New Twist on Resident Work
Hours and Patient Safety
Print August 2020 Fentanyl Patches in the
Crosshairs Again
Print August 2020 Pulse Oximetry in Children
Print August 2020 Surgical Site Infections and
Laparoscopy
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