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What’s New in the
Patient Safety World
August 2020
New Twist on
Resident Work Hours and
Patient Safety
Over the years, we’ve 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
doesn’t know much about you?”. Of course, at this time
we don’t 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 1980’s, 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. That’s
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 can’t discuss resident work hours without mention of
handoffs. But we’ll 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:
- bigger patient workloads
likely lead to more errors
- we need to focus not just
on work hours, but also on workload
- studies to address this critical question are very difficult to design
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 kid’s 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
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