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Human Factors Contributions
to Healthcare in Canada and
Around the World -
Everything you wanted to know but didn’t
Kathy Momtahan, RN, PhD
Current Lead for the
Canadian Human Factors in
Healthcare Network
My HF beginnings in healthcare . . .
The audibility and the identification of 23 auditory alarms in the intensive care unit (ICU) and 26 auditory alarms in the
operating rooms (ORs) of a 214-bed Canadian teaching hospital were investigated. Digital tape recordings of the alarms
were made and analysed using masked-threshold software developed at the Université de Montréal. The digital
recordings were also presented to the hospital personnel responsible for monitoring these alarms on an individual
basis in order to determine how many of the alarms they would be able to identify when they heard them. Several of
the alarms in both areas of the hospital could mask other alarms in the same area, and many of the alarms in the
operating rooms could be masked by the sound of a surgical saw or a surgical drill. The staff in the OR (anaesthetists,
anaesthesia residents, and OR technologists) were able to identify a mean of between 10 and 15 of the 26 alarms
found in their operating theatres. The ICU nurses were able to identify a mean of between 9 and 14 of the 23 alarms
found in their ICU. Alarm importance was positively correlated with the frequency of alarm identification in the case of
the OR, rho = 0.411, but was not significantly correlated in the case of the ICU, rho = 0.155. This study demonstrates
the poor design of auditory warning signals in hospitals and the need for standardization of alarms on medical
equipment.
Ergonomics. 1993 Oct;36(10):1159-76.
Audibility and identification of auditory alarms in the operating
room and intensive care unit.
Momtahan K1, Hétu R, Tansley B.
Poor alarm design and management has led to a new area of research …
Alarm Fatigue!
‘Human Factors’ Definition
Ergonomics (or human factors) is the scientific discipline
concerned with the understanding of interactions among humans
and other elements of a system, and the profession that applies
theory, principles, data, and other methods to design in order to
optimize human well-being and overall system performance.
- International Ergonomics Association (IEA)
The Human Factors and Ergonomics Society (HFES) is the
North American affiliate of the IEA
There are many depictions in the literature describing ‘Human Factors’. This is mine ….
The Environment (e.g. hospital)
Human
Cognitive Processes
Perceptual Processes
Physiology
Motor Processes
Affective Processes
Capabilities & Limitations
Training
Teamwork
Technology
Computer-based Systems
Devices (e.g. infusion pumps)
Networks
Technology Design
Organizational Structure
Works Systems
Business Processes
Work-related Stressors
What do HCPs already know about Human Factors?
- Most healthcare professionals (HCPs) by now have heard of
Human Factors Engineering / Psychology in the context of patient safety,
human error, the Swiss Cheese Model, the design of medical technologies,
the design and use of electronic health records, usability testing etc.
- The CPSI and the WHO have modules on Human Factors
- Now that many clinicians already know the basics of Human Factors (HF),
what else is there to know?
- This introduction is meant to celebrate past successes, with an
emphasis on Canadian contributions to the science of HF and
to provide an overview of Human Factors applied in
clinical practice today as well as ongoing research
Why we will always need to be vigilant about
Human Factors in healthcare
- The human condition is relatively stable (although amazing!)
- But healthcare technologies continue to grow at a fast pace
Remember what it was like when . . .
- You had to go to the library to look something up?
- You spent time counting drips on an intravenous infusion?
- Being ‘social’ meant going out somewhere?
- You hadn’t even thought about working with a robot?
“At my own hospital, in 2013 we gave a teenager a 39-fold overdose of a
common antibiotic. The initial glitch was innocent enough: A doctor failed to
recognize that a screen was set on “milligrams per kilogram” rather than just
“milligrams.” But the jaw-dropping part of the error involved alerts that were
ignored by both physician and pharmacist. The error caused a grand mal seizure
that sent the boy to the I.C.U. and nearly killed him.
How could they do such a thing? It’s because providers receive tens of
thousands of such alerts each month, a vast majority of them false alarms.
In one month, the electronic monitors in our five intensive care units,
which track things like heart rate and oxygen level, produced more
than 2.5 million alerts. It’s little wonder that health care providers
have grown numb to them.”
https://www.nytimes.com/2015/03/22/opinion/sunday/why-health-care-tech-is-still-so-bad.html?mcubz=3
Why Health Care Tech Is Still So Bad
- March 21, 2015 Article in the NY Times by Robert M Wachter, physician, professor
and well-known patient safety advocate and author
Introducing the Canadian Human Factors in
Healthcare Network
A group of us have formed a network to provide current information on human
factors activities in healthcare.
Purpose:
To provide human factors expertise to healthcare organizations through consultation,
knowledge transfer and exchange activities, and the promotion of partnerships
between healthcare organizations, industry, and academic institutions to promote the
delivery of safer, more effective care to patients.
Members include:
- HF engineers and psychologists, information technology experts, designers,
and clinicians who are involved in patient safety with a human factors focus
- Many of the network members have worked on projects together,
have supervised graduate students together, and otherwise educate
students in various faculties regarding human factors
Our HF Network Information is now online!
http://www.patientsafetyinstitute.ca/en/toolsResources/Human-Factors-
Network/Pages/default.aspx
http://www.patientsafetyinstitute.ca/fr/toolsResources/Human-Factors-
Network/Pages/default.aspx
Other than our current HF Network members, here are a few
Canadian Patient Safety champions whose work has a HF focus
- Pat Croskerry, MD, PhD
- Clinical decision-making
- Cognitive errors
- Lead for the ‘Halifax’ series of patient safety conferences
- Kaveh Shojania, MD
- Medical error
- Patient safety leader and educator
- Ed Etchells, MD, MSc, FRCPC
- Medical errors
- Patient safety leader and educator
And Around the World …
Here are a list of resources outside of Canada:
United States
https://psnet.ahrq.gov/, includes https://psnet.ahrq.gov/webmm
http://www.hopkinsmedicine.org/armstrong_institute
• United Kingdom
http://chfg.org
https://www.england.nhs.uk
http://www.nottingham.ac.uk/research/groups/human-factors-research-group/
• Australia
http://www.ahhfg.org/
There are many other Human Factors resources in Canada and
around the world, both public and private. The list above is only a sample.
Dr. Gianni D’Egidio
Defibrillator Design and Usability
May be Impeding Timely
Defibrillation
Disclosure
• All funding was provided in conjunction
between the University of Ottawa
Department of Medicine Patient Quality and
Safety research grant and The Ottawa
Hospital division of Critical Care.
Delayed Defibrillation
Delayed Defibrillation
• Patients who experience delayed defibrillation:
o Less likely to survive to hospital discharge (22.2%
when defibrillation was delayed versus 39.3% when
defibrillation was not delayed).
• Even amongst those who survive:
o Lower likelihood of having no major disabilities in
neurologic status (odds ratio, 0.74).
o Lower likelihood of having no major disabilities in
functional status (odds ratio, 0.74).
Delayed Defibrillation
Delayed Defibrillation
• Limited data is available regarding
the system-related factors and the
patient-related factors that are
associated with a higher probability
of delayed defibrillation.
Hypothesis
• We hypothesize that flaws in
defibrillator design contribute to a
delay in timely defibrillation.
• We aim to identify such flaws via
high fidelity usability testing in a
simulated hospital environment.
Usability Testing
• A technique in which users interact with a
product under controlled conditions and
behavioral data is collected.
This information is then applied to better
understand:
Human performance capabilities.
Human performance limitations.
How product design can be modified to
meet these needs.
Thought to be an essential
component of safety engineering in
other fields, usability testing has
been reported to be underutilized
in the health care system
Methods - Design
• Qualitative and quantitative
prospective usability study
evaluating the use of a manual-mode
defibrillator in a simulated hospital
environment.
• Study protocol was approved by the
Ottawa Health Science Research
Network Board.
Methods - Setting
• TOH is an academic quaternary care
regional referral center with over 1,100
inpatient beds.
• Operated in conjunction with the University of
Ottawa and TOH, the uOSSC is the largest
medical simulation center in Canada.
• Simulation was conducted in a high-fidelity
clinical exam room.
• Tasks were performed using a full size
Human Patient Simulator.
Methods - Participants
• Twenty-two internal medicine resident’s
post graduate year (PGY) 1-3.
• All participants were certified in Advanced
Cardiovascular Life Support (ACLS) and
had completed ACLS certification training
within the preceding 12 months.
• Senior residents (PGY2 – PGY3) are
cardiac arrest team leaders at our
institution while junior residents (PGY1) are
member of the cardiac arrest team.
Methods - Intervention
• Participants were asked to perform two
simulated tasks typical of in-hospital cardiac
arrest care:
o DEFFIBRILLATION- “Attach the defibrillator
device to the patient, perform a rhythm check,
confirm the presence of ventricular fibrillation,
and then deliver 1 defibrillation.”
o SYNCHRONIZED CARDIOVERSION- “Attach
the defibrillator device to the patient, perform a
rhythm check, confirm the presence of an
unstable atrial tachyarrhythmia, and then deliver
2 synchronized cardioversions.”
Outcomes
• Primary Outcome(s) -
i. Time to defibrillation.
ii. Proportion of participants able to
deliver a defibrillation within 2
minutes.
• Secondary Outcome(s) -
i. Objective observer evaluations.
ii. Participants perceived usability of the
manual-mode defibrillator.
iii. Thematically coded qualitative
participant feedback on usability.
Results
• Time to defibrillation:
o Average time to defibrillation was 4 minutes
21 seconds ± 138 seconds.
o Average time to defibrillation for senior
trainees was similar to that of the group as a
whole at 3 minutes 56 seconds ± 138
seconds.
o Only 9.1% of participants were able to
perform a simulated defibrillation within 2
minutes.
o Average time to synchronized cardioversion
was 1 minute 55 seconds ± 59 seconds.
Objective Observer Evaluations
CORE FUNTION PROPORTION OF PARTICIPANTS
WITH DIFFCIULTY COMPLETING
TASK (%)
Ability to turn on the defibrillator. 27.3
Ability to attach the defibrillator pads. 77.3
Ability to select an appropriate display. 54.5
Ability to deliver a defibrillation. 4.5
Ability to deliver a synchronized
cardioversion.
13.6
Objective Observer Evaluations
Objective Observer Evaluations
CORE FUNTION PROPORTION OF
PARTICIPANTS WITH
DIFFCIULTY COMPLETING TASK
(%)
Ability to identify the pads. 17.6
Ability to identify the adaptor cable. 88.2
Ability to toggle the cable locking
mechanism.
82.4
Ability to attach the pads to the skin. 0.0
Objective Observer Evaluations
CORE FUNTION PROPORTION OF PARTICIPANTS
WITH DIFFCIULTY COMPLETING
TASK (%)
Ability to identify the pads. 17.6
Ability to identify the adaptor cable. 88.2
Ability to toggle the cable locking
mechanism.
82.4
Ability to attach the pads to the skin. 0.0
Results
POST-EXPOSURE
QUESITONARE
VERY DIFFICULT (1) –
VERY EASY (9)
How would you rate the ease or
difficulty in completing task 1?
3.9 ± 2.1
How confident are you in your
ability to effectively utilize this
defibrillator to complete task 1 in
a real world environment?
4.8 ± 2.2
How would you rate the ease or
difficulty in completing task 2?
4.8 ± 2.6
How confident are you in your
ability to effectively utilize this
defibrillator to complete task 2 in
a real world environment?
5.3 ± 2.4
How would you rate the overall
usability of this
defibrillator?
4.2 ± 1.8
Results
POST-EXPOSURE
QUESITONARE
VERY DIFFICULT (1) –
VERY EASY (9)
How would you rate the ease or
difficulty in completing task 1?
3.9 ± 2.1
How confident are you in your
ability to effectively utilize this
defibrillator to complete task 1 in a
real world environment?
4.8 ± 2.2
How would you rate the ease or
difficulty in completing task 2?
4.8 ± 2.6
How confident are you in your
ability to effectively utilize this
defibrillator to complete task 2 in a
real world environment?
5.3 ± 2.4
How would you rate the overall
usability of this defibrillator?
4.2 ± 1.8
Results
• Qualitative participant feedback was analyzed and
grouped according to theme:
o Negative participant feedback focused predominantly upon
the process of attaching the hands-free defibrillator pads
to the defibrillator.
o All 22 participants commented upon at least one aspect of
this core function in the post-exposure questionnaire.
o Descriptors of the process included “unintuitive”,
“inconvenient”, and “awkward”.
Discussion
• Participants in our study are educated predominantly senior trainees with a high
degree of familiarity with the Philips HeartStart XL defibrillator and ACLS protocol.
• Despite this, the average time to defibrillation was greater than two-times that
which is recommended by the American Heart Association.
• Based on these results, it appears likely that delay in defibrillation are at least
partially resultant of poor defibrillator design and lack of usability.
• Even the most expert of users may make continue to make errors when confronted
with a device that is illogical and poorly designed.
Discussion
• Expert observer evaluation and qualitative
participant feedback were largely congruent in
regards to which aspects of defibrillator design
do not suit the end-user.
o Inability to attach the hands-free defibrillator pads
to the defibrillator.
o Inability to select an appropriate display.
Hands-free Defibrillator Pads
Cable Locking Mechanism
Default Display
• The Philips HeartStart XL defibrillator has
the capability to display information from
multiple inputs including ECG leads,
hands-free defibrillator pads, and hand-
held defibrillator paddles.
• The default display is that of ECG lead II.
• When using either the hands-free
defibrillator pads or hand-held paddles the
input must be changed manually to that
of the desired component.
Discussion
• Modification of future defibrillator
design may result in more timely
defibrillation.
o Engineering hands-free defibrillator
pads as a single component.
o Modifying the default display.
o Re-locating the cable locking
mechanism to a more accessible
location.
Validity
• Largely dependent upon obtaining
behavioral data from actual users of the
device in the environment for which it is
intended to be used.
o Attempted to replicate many of the
environmental factors typical of a hospital
environment through high-fidelity simulation.
o Physicians are responsible for defibrillator
use during cardiopulmonary resuscitation
at most large tertiary care centers. As such,
we elected to evaluate physician usability of
the manual-mode defibrillator which had not
been studied previously.
Validity
• It remains somewhat unclear as to why so many
of our participants were unable to compete a
simulated defibrillation within 2 minutes.
o Intuitively, we would have expected defibrillation to
occur more rapidly in a simulated environment.
o Role for improved training and education as the
time to synchronized cardioversion was significantly
less than that of defibrillation likely as a result of
learning and recency.
o Given the relatively low incidence of cardiac arrest it
is impractical to train users frequently enough to
maintain such proficiency.
Discussion
• Our study has several limitations:
o Single center trial with a relatively
modest number of participants.
o Generalizability of our results to other
defibrillator models is uncertain
(given the discrepancy between real-
world and simulated time to
defibrillation at our institution relative to
that of The National Registry of
Cardiopulmonary Resuscitation).
Discussion
• Our study has several limitations:
o Participants were recruited on a
voluntary basis raising the possibility
of selection bias.
o The definition of “difficulty” completing
a specific function used in our study
has not been externally validated.
Nonetheless, we think it is reasonable
that a delay greater than one-half of
the total time allocated for a task is
significant.
Summary
• Most participants in our study were unable to
perform a simulated defibrillation within 2 minutes.
• This delay in defibrillation was likely at least partially
resultant of poor defibrillator design and lack of
usability.
• Expert observation and qualitative participant
feedback were largely congruent in terms of which
aspects of defibrillator design do not suit the end-
user.
• Modification of future defibrillator design may result
in more timely defibrillation and subsequently
improved outcomes for patients.
References
1. Eisenberg, M., & Mengert, T. Cardiac Resuscitation. The New England Journal of Medicine
(2001); 344(17), 1304-1313.
2. Girotra, S., et al. Trends in Survival after In-Hospital Cardiac Arrest. The New England
Journal of Medicine (2012); 367(20), 1912-1920.
3. Neumar, R., et al. Part 1: Executive Summary 2015 American Heart Association Guidelines
Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.
Circulation (2015); 132(18).
4. Chan, P., et al. Delayed Time to Defibrillation after In-Hospital Cardiac Arrest. The New
England Journal of Medicine (2008); 358(1), 9-17.
5. Herlitz, J., et al. Very high survival among patients defibrillated at an early stage after in-
hospital ventricular fibrillation on wards with and without monitoring facilities. Resuscitation
(2005); 66, 159-166.
6. Spearpoint, K., McLean, P., & Zideman, D. Early defibrillation and the chain of survival in
‘in-hospital’ adult cardiac arrest; minutes count. Resuscitation (2000); 44, 165-169.
7. Peberdy, M., et al. Cardiopulmonary resuscitation of adults in the hospital: a report of
14720 cardiac arrests from the National Registry of Cardiopulmonary Resuscitation.
Resuscitation (2003);58(3), 297-308.
8. Godbout J., et al. Innovative Use of AED by RNs and RTs During In-Hospital Cardiac
Arrest: Phase II. CJEM. (2015);17(Supp 2):S5 (Abstract).
9. Chan, P., et al. Hospital Variation in Time to Defibrillation After In-Hospital Cardiac Arrest.
Archives of Internal Medicine (2009); 169(14), 1265-1273.
10. Peberdy, M. A., et al. Survival from In-Hospital Cardiac Arrest During Nights and
Weekends. The Journal of the American Medical Association (2008); 299(7), 785-792.
11. Wichansky, A. Usability testing in 2000 and beyond. Ergonomics (2000); 43(7), 998-1006.
References
12. Karsh, B.-T., & Scanlon, M. When Is a Defibrillator Not a Defibrillator? When It’s Like a Clock Radio .
. .. The Challenge of Usability and Patient Safety in the Real World. Annals of Emergency Medicine
(2007); 50, 433-435.
13. Justin, R., & Hallbeck, S. The ergonomics of “Code Blue” medical emergencies: a literature review.
IIE Transactions on Healthcare Systems Engineering (2011); 1(4), 197-212.
14. Gosbee, J. Who Left the Defibrillator On? Joint Commission Journal on Quality and Safety (2004);
30(5), 282-285.
15. Fairbanks, R., et al. Usability study of two common defibrillators reveals hazards. Annals of
Emergency Medicine (2007); 50(4), 424-432.
16. Facts and Figures. (n.d.). Retrieved July 24, 2016, from uOSSC website: http://uossc.ca/about-
us/facts-and-figures/
17. Adams, B., Anderson, P., & Stuffel, E. ‘‘Code Blue’’ in the hospital lobby: Cardiac arrest teams vs.
public access defibrillation. International Journal of Cardiology (2006); 110, 401-402.
18. Gosbee, J. Human factors engineering and patient safety. Quality and Safety in Healthcare (2002);
11(4), 352-354.
19. Sawyer, D. Do it by Design: An Introduction to Human Factors in Medical Devices. U.S. Department
of Health and Human Services (1997).
20. Wiklund, M. Eleven Keys to Designing Error-Resistant Medical Devices. Medical Device and
Diagnostic Industry (2002); 24, 86-102.
21. William, K., et al. When minutes count—the fallacy of accurate time documentation during in-hospital
resuscitation. Resuscitation (2005); 65, 285-290.
22. Cordell, W., et al. Does anybody really know what time it is? Does anybody really care? Annals of
Emergency Medicine (1994); 23, 1032-1036.

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Human Factors Contributions to Healthcare in Canada and Around the World - Everything you wanted to know but didn’t

  • 1. Human Factors Contributions to Healthcare in Canada and Around the World - Everything you wanted to know but didn’t Kathy Momtahan, RN, PhD Current Lead for the Canadian Human Factors in Healthcare Network
  • 2. My HF beginnings in healthcare . . . The audibility and the identification of 23 auditory alarms in the intensive care unit (ICU) and 26 auditory alarms in the operating rooms (ORs) of a 214-bed Canadian teaching hospital were investigated. Digital tape recordings of the alarms were made and analysed using masked-threshold software developed at the Université de Montréal. The digital recordings were also presented to the hospital personnel responsible for monitoring these alarms on an individual basis in order to determine how many of the alarms they would be able to identify when they heard them. Several of the alarms in both areas of the hospital could mask other alarms in the same area, and many of the alarms in the operating rooms could be masked by the sound of a surgical saw or a surgical drill. The staff in the OR (anaesthetists, anaesthesia residents, and OR technologists) were able to identify a mean of between 10 and 15 of the 26 alarms found in their operating theatres. The ICU nurses were able to identify a mean of between 9 and 14 of the 23 alarms found in their ICU. Alarm importance was positively correlated with the frequency of alarm identification in the case of the OR, rho = 0.411, but was not significantly correlated in the case of the ICU, rho = 0.155. This study demonstrates the poor design of auditory warning signals in hospitals and the need for standardization of alarms on medical equipment. Ergonomics. 1993 Oct;36(10):1159-76. Audibility and identification of auditory alarms in the operating room and intensive care unit. Momtahan K1, Hétu R, Tansley B. Poor alarm design and management has led to a new area of research … Alarm Fatigue!
  • 3. ‘Human Factors’ Definition Ergonomics (or human factors) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data, and other methods to design in order to optimize human well-being and overall system performance. - International Ergonomics Association (IEA) The Human Factors and Ergonomics Society (HFES) is the North American affiliate of the IEA
  • 4. There are many depictions in the literature describing ‘Human Factors’. This is mine …. The Environment (e.g. hospital) Human Cognitive Processes Perceptual Processes Physiology Motor Processes Affective Processes Capabilities & Limitations Training Teamwork Technology Computer-based Systems Devices (e.g. infusion pumps) Networks Technology Design Organizational Structure Works Systems Business Processes Work-related Stressors
  • 5. What do HCPs already know about Human Factors? - Most healthcare professionals (HCPs) by now have heard of Human Factors Engineering / Psychology in the context of patient safety, human error, the Swiss Cheese Model, the design of medical technologies, the design and use of electronic health records, usability testing etc. - The CPSI and the WHO have modules on Human Factors - Now that many clinicians already know the basics of Human Factors (HF), what else is there to know? - This introduction is meant to celebrate past successes, with an emphasis on Canadian contributions to the science of HF and to provide an overview of Human Factors applied in clinical practice today as well as ongoing research
  • 6. Why we will always need to be vigilant about Human Factors in healthcare - The human condition is relatively stable (although amazing!) - But healthcare technologies continue to grow at a fast pace Remember what it was like when . . . - You had to go to the library to look something up? - You spent time counting drips on an intravenous infusion? - Being ‘social’ meant going out somewhere? - You hadn’t even thought about working with a robot?
  • 7. “At my own hospital, in 2013 we gave a teenager a 39-fold overdose of a common antibiotic. The initial glitch was innocent enough: A doctor failed to recognize that a screen was set on “milligrams per kilogram” rather than just “milligrams.” But the jaw-dropping part of the error involved alerts that were ignored by both physician and pharmacist. The error caused a grand mal seizure that sent the boy to the I.C.U. and nearly killed him. How could they do such a thing? It’s because providers receive tens of thousands of such alerts each month, a vast majority of them false alarms. In one month, the electronic monitors in our five intensive care units, which track things like heart rate and oxygen level, produced more than 2.5 million alerts. It’s little wonder that health care providers have grown numb to them.” https://www.nytimes.com/2015/03/22/opinion/sunday/why-health-care-tech-is-still-so-bad.html?mcubz=3 Why Health Care Tech Is Still So Bad - March 21, 2015 Article in the NY Times by Robert M Wachter, physician, professor and well-known patient safety advocate and author
  • 8. Introducing the Canadian Human Factors in Healthcare Network A group of us have formed a network to provide current information on human factors activities in healthcare. Purpose: To provide human factors expertise to healthcare organizations through consultation, knowledge transfer and exchange activities, and the promotion of partnerships between healthcare organizations, industry, and academic institutions to promote the delivery of safer, more effective care to patients. Members include: - HF engineers and psychologists, information technology experts, designers, and clinicians who are involved in patient safety with a human factors focus - Many of the network members have worked on projects together, have supervised graduate students together, and otherwise educate students in various faculties regarding human factors
  • 9. Our HF Network Information is now online! http://www.patientsafetyinstitute.ca/en/toolsResources/Human-Factors- Network/Pages/default.aspx http://www.patientsafetyinstitute.ca/fr/toolsResources/Human-Factors- Network/Pages/default.aspx
  • 10. Other than our current HF Network members, here are a few Canadian Patient Safety champions whose work has a HF focus - Pat Croskerry, MD, PhD - Clinical decision-making - Cognitive errors - Lead for the ‘Halifax’ series of patient safety conferences - Kaveh Shojania, MD - Medical error - Patient safety leader and educator - Ed Etchells, MD, MSc, FRCPC - Medical errors - Patient safety leader and educator
  • 11. And Around the World … Here are a list of resources outside of Canada: United States https://psnet.ahrq.gov/, includes https://psnet.ahrq.gov/webmm http://www.hopkinsmedicine.org/armstrong_institute • United Kingdom http://chfg.org https://www.england.nhs.uk http://www.nottingham.ac.uk/research/groups/human-factors-research-group/ • Australia http://www.ahhfg.org/ There are many other Human Factors resources in Canada and around the world, both public and private. The list above is only a sample.
  • 13. Defibrillator Design and Usability May be Impeding Timely Defibrillation
  • 14. Disclosure • All funding was provided in conjunction between the University of Ottawa Department of Medicine Patient Quality and Safety research grant and The Ottawa Hospital division of Critical Care.
  • 16. Delayed Defibrillation • Patients who experience delayed defibrillation: o Less likely to survive to hospital discharge (22.2% when defibrillation was delayed versus 39.3% when defibrillation was not delayed). • Even amongst those who survive: o Lower likelihood of having no major disabilities in neurologic status (odds ratio, 0.74). o Lower likelihood of having no major disabilities in functional status (odds ratio, 0.74).
  • 18. Delayed Defibrillation • Limited data is available regarding the system-related factors and the patient-related factors that are associated with a higher probability of delayed defibrillation.
  • 19. Hypothesis • We hypothesize that flaws in defibrillator design contribute to a delay in timely defibrillation. • We aim to identify such flaws via high fidelity usability testing in a simulated hospital environment.
  • 20. Usability Testing • A technique in which users interact with a product under controlled conditions and behavioral data is collected.
  • 21. This information is then applied to better understand: Human performance capabilities. Human performance limitations. How product design can be modified to meet these needs. Thought to be an essential component of safety engineering in other fields, usability testing has been reported to be underutilized in the health care system
  • 22. Methods - Design • Qualitative and quantitative prospective usability study evaluating the use of a manual-mode defibrillator in a simulated hospital environment. • Study protocol was approved by the Ottawa Health Science Research Network Board.
  • 23. Methods - Setting • TOH is an academic quaternary care regional referral center with over 1,100 inpatient beds. • Operated in conjunction with the University of Ottawa and TOH, the uOSSC is the largest medical simulation center in Canada. • Simulation was conducted in a high-fidelity clinical exam room. • Tasks were performed using a full size Human Patient Simulator.
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  • 27. Methods - Participants • Twenty-two internal medicine resident’s post graduate year (PGY) 1-3. • All participants were certified in Advanced Cardiovascular Life Support (ACLS) and had completed ACLS certification training within the preceding 12 months. • Senior residents (PGY2 – PGY3) are cardiac arrest team leaders at our institution while junior residents (PGY1) are member of the cardiac arrest team.
  • 28. Methods - Intervention • Participants were asked to perform two simulated tasks typical of in-hospital cardiac arrest care: o DEFFIBRILLATION- “Attach the defibrillator device to the patient, perform a rhythm check, confirm the presence of ventricular fibrillation, and then deliver 1 defibrillation.” o SYNCHRONIZED CARDIOVERSION- “Attach the defibrillator device to the patient, perform a rhythm check, confirm the presence of an unstable atrial tachyarrhythmia, and then deliver 2 synchronized cardioversions.”
  • 29. Outcomes • Primary Outcome(s) - i. Time to defibrillation. ii. Proportion of participants able to deliver a defibrillation within 2 minutes. • Secondary Outcome(s) - i. Objective observer evaluations. ii. Participants perceived usability of the manual-mode defibrillator. iii. Thematically coded qualitative participant feedback on usability.
  • 30. Results • Time to defibrillation: o Average time to defibrillation was 4 minutes 21 seconds ± 138 seconds. o Average time to defibrillation for senior trainees was similar to that of the group as a whole at 3 minutes 56 seconds ± 138 seconds. o Only 9.1% of participants were able to perform a simulated defibrillation within 2 minutes. o Average time to synchronized cardioversion was 1 minute 55 seconds ± 59 seconds.
  • 31. Objective Observer Evaluations CORE FUNTION PROPORTION OF PARTICIPANTS WITH DIFFCIULTY COMPLETING TASK (%) Ability to turn on the defibrillator. 27.3 Ability to attach the defibrillator pads. 77.3 Ability to select an appropriate display. 54.5 Ability to deliver a defibrillation. 4.5 Ability to deliver a synchronized cardioversion. 13.6
  • 33. Objective Observer Evaluations CORE FUNTION PROPORTION OF PARTICIPANTS WITH DIFFCIULTY COMPLETING TASK (%) Ability to identify the pads. 17.6 Ability to identify the adaptor cable. 88.2 Ability to toggle the cable locking mechanism. 82.4 Ability to attach the pads to the skin. 0.0
  • 34. Objective Observer Evaluations CORE FUNTION PROPORTION OF PARTICIPANTS WITH DIFFCIULTY COMPLETING TASK (%) Ability to identify the pads. 17.6 Ability to identify the adaptor cable. 88.2 Ability to toggle the cable locking mechanism. 82.4 Ability to attach the pads to the skin. 0.0
  • 35. Results POST-EXPOSURE QUESITONARE VERY DIFFICULT (1) – VERY EASY (9) How would you rate the ease or difficulty in completing task 1? 3.9 ± 2.1 How confident are you in your ability to effectively utilize this defibrillator to complete task 1 in a real world environment? 4.8 ± 2.2 How would you rate the ease or difficulty in completing task 2? 4.8 ± 2.6 How confident are you in your ability to effectively utilize this defibrillator to complete task 2 in a real world environment? 5.3 ± 2.4 How would you rate the overall usability of this defibrillator? 4.2 ± 1.8
  • 36. Results POST-EXPOSURE QUESITONARE VERY DIFFICULT (1) – VERY EASY (9) How would you rate the ease or difficulty in completing task 1? 3.9 ± 2.1 How confident are you in your ability to effectively utilize this defibrillator to complete task 1 in a real world environment? 4.8 ± 2.2 How would you rate the ease or difficulty in completing task 2? 4.8 ± 2.6 How confident are you in your ability to effectively utilize this defibrillator to complete task 2 in a real world environment? 5.3 ± 2.4 How would you rate the overall usability of this defibrillator? 4.2 ± 1.8
  • 37. Results • Qualitative participant feedback was analyzed and grouped according to theme: o Negative participant feedback focused predominantly upon the process of attaching the hands-free defibrillator pads to the defibrillator. o All 22 participants commented upon at least one aspect of this core function in the post-exposure questionnaire. o Descriptors of the process included “unintuitive”, “inconvenient”, and “awkward”.
  • 38. Discussion • Participants in our study are educated predominantly senior trainees with a high degree of familiarity with the Philips HeartStart XL defibrillator and ACLS protocol. • Despite this, the average time to defibrillation was greater than two-times that which is recommended by the American Heart Association. • Based on these results, it appears likely that delay in defibrillation are at least partially resultant of poor defibrillator design and lack of usability. • Even the most expert of users may make continue to make errors when confronted with a device that is illogical and poorly designed.
  • 39. Discussion • Expert observer evaluation and qualitative participant feedback were largely congruent in regards to which aspects of defibrillator design do not suit the end-user. o Inability to attach the hands-free defibrillator pads to the defibrillator. o Inability to select an appropriate display.
  • 42. Default Display • The Philips HeartStart XL defibrillator has the capability to display information from multiple inputs including ECG leads, hands-free defibrillator pads, and hand- held defibrillator paddles. • The default display is that of ECG lead II. • When using either the hands-free defibrillator pads or hand-held paddles the input must be changed manually to that of the desired component.
  • 43. Discussion • Modification of future defibrillator design may result in more timely defibrillation. o Engineering hands-free defibrillator pads as a single component. o Modifying the default display. o Re-locating the cable locking mechanism to a more accessible location.
  • 44. Validity • Largely dependent upon obtaining behavioral data from actual users of the device in the environment for which it is intended to be used. o Attempted to replicate many of the environmental factors typical of a hospital environment through high-fidelity simulation. o Physicians are responsible for defibrillator use during cardiopulmonary resuscitation at most large tertiary care centers. As such, we elected to evaluate physician usability of the manual-mode defibrillator which had not been studied previously.
  • 45. Validity • It remains somewhat unclear as to why so many of our participants were unable to compete a simulated defibrillation within 2 minutes. o Intuitively, we would have expected defibrillation to occur more rapidly in a simulated environment. o Role for improved training and education as the time to synchronized cardioversion was significantly less than that of defibrillation likely as a result of learning and recency. o Given the relatively low incidence of cardiac arrest it is impractical to train users frequently enough to maintain such proficiency.
  • 46. Discussion • Our study has several limitations: o Single center trial with a relatively modest number of participants. o Generalizability of our results to other defibrillator models is uncertain (given the discrepancy between real- world and simulated time to defibrillation at our institution relative to that of The National Registry of Cardiopulmonary Resuscitation).
  • 47. Discussion • Our study has several limitations: o Participants were recruited on a voluntary basis raising the possibility of selection bias. o The definition of “difficulty” completing a specific function used in our study has not been externally validated. Nonetheless, we think it is reasonable that a delay greater than one-half of the total time allocated for a task is significant.
  • 48. Summary • Most participants in our study were unable to perform a simulated defibrillation within 2 minutes. • This delay in defibrillation was likely at least partially resultant of poor defibrillator design and lack of usability. • Expert observation and qualitative participant feedback were largely congruent in terms of which aspects of defibrillator design do not suit the end- user. • Modification of future defibrillator design may result in more timely defibrillation and subsequently improved outcomes for patients.
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