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Total systems engineering evaluation of invasive pediatric medical therapies conducted in non-clinical environments
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Total systems engineering evaluation of invasive pediatric medical therapies conducted in non-clinical environments
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Content
TOTAL SYSTEMS ENGINEERING EVALUATION OF INVASIVE PEDIATRIC
MEDICAL THERAPIES CONDUCTED IN NON-CLINICAL ENVIRONMENTS
by
Joshua Lukman Gray
A Dissertation Presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the Requirements for the Degree
DOCTOR OF PHILOSPHY
INDUSTRIAL & SYSTEMS ENGINEERING
December 2019
ii
Dedication
This doctoral dissertation is dedicated to three generations of my family. First and
foremost, it is dedicated to my deceased grandmother Rosa M. Gray who was the first person in
my family to earn a college degree. She then became an educator in the segregated south for
generations of African Americans as a teacher in schools and churches to inspire them to pursue
a college degree with the belief that higher education would provide them with a prosperous path
to pursue their purpose in life.
It is also dedicated to my recently deceased father Jimmie L. Gray who was the first
person to introduce me to systems engineering. He was the caretaker of my grandmother and
grandfather, Daniel D. Gray, as they aged in their 90s, to inspire me to explore home health care
as a dissertation research topic. Additionally, my personal interest in studying the human factors
of medical devices has been motivated by my father’s dependence on implanted medical devices
to maintain his cardiac function as well as his dependence on the CADD 6101 parenteral
nutrition device evaluated in this research study.
Lastly, this dissertation is dedicated to my deceased eldest brother Aki-Bua C. Gray who
I never had the opportunity to meet. He was the first child of my father and mother Benita M.
Gray who was born premature with breathing complications before pediatric mechanical
ventilation technology became commonly available in America. Although he died a month after
birth, his spirit is with me as he was the motivation for me to conduct this research and complete
this dissertation.
iii
Acknowledgments
Various institutions, organizations, individuals, and scholars deserve acknowledgement
for their involvement in my desire to pursue a doctorate degree and finalize this dissertation
research. Institutions include the Florida Agricultural & Mechanical University and Florida
State University College of Engineering who initiated my academic interest while studying for a
Bachelor of Science Degree in Industrial Engineering. Rensselaer Polytechnic Institute’s
College of Engineering, who enhanced my applied research interest while pursuing a Master of
Science Degree in Industrial & Management Engineering. The University of Southern
California Viterbi School of Engineering for granting me the opportunity to earn a Doctor of
Philosophy Degree in Industrial & Systems Engineering.
Organizations and individuals also contributed to the completion of this dissertation.
Organizations such as United Technologies and General Electric provided funding and
experience to explore theory as well as application during the initiation of my professional
career. The National Society of Black Engineers and National Action Council for Minorities in
Engineering for providing moral and financial support throughout my academic pursuits. The
Institute of Industrial & Systems Engineering and the Human Factors & Ergonomic Society have
also provided professional development and academic support for my interests in conducting
applied research to enhance Health Systems Engineering. Individuals including my godparents
Dr. James and Judy Ammons also deserve acknowledgement for providing the encouragement to
explore scholarly research at the doctorate level. Mentors Dr. Stan Settles and Dr. John
Slaughter, who provided support with admission and retention throughout the challenging
industrial and systems engineering (ISE) doctoral process. Trustees Dr. Wanda M. Austin and
Mr. Daniel J. Epstein, who provided guidance and funding to complete the ISE doctoral degree.
iv
Appreciation is also due to the Viterbi Engineering School and the Epstein Industrial &
Systems Engineering Department as well as the diverse dissertation committee members who
provided advice along this character-building research journey. External Committee Members
Dr. Glenn Takata and Dr. Mary Lawlor were respectively the Principal Investigators (PI) and
Co-PI of the Clinical & Translational Science Institute Funded Children’s Hospital Los Angeles
Study on Patient Safety who granted the research assistantship used to collect the qualitative data
analyzed within this dissertation. Dr. Andrew Imada, former Human Factors & Ergonomics
Society President, and Dr. Jim Moore, former Institute of Industrial & Systems Engineering
President, graciously contributed their respective industry expertise and academic advice to
provide support personally and professionally. Lastly, Advisor and Chair Dr. Najmedin
Meshkati has been fundamental in overcoming various challenges throughout the rigorous
process of screening, qualifying, and defending diverse scholarship and novel research for this
doctorate.
v
Abstract
In 2010, approximately 12 million Americans received home health care or care in a non-
clinical environment due to the growing cost and capacity constraints of hospital health care
(Basics Statistics about Home Care, 2010). According to the National Research Council (NRC),
human factors could assist with improving the alignment of environments, tasks, and people
involved in home health care to provide increased safety, effectiveness, and efficiency (Olson,
2010). This dissertation explores how the application of a sociotechnical systems model,
participatory ergonomics techniques, and human factors components could be used to align
people, tasks, and technology in non-clinical environments to ensure pediatric patient safety.
The aims of this study are threefold:
1. Identify home health sociotechnical model work system and process components of
invasive medical therapies in home health environments that contribute to undesirable
outcomes.
2. Understand participatory ergonomic application rationale for pediatric patient
families to become lay engineers and the tools modified by caregivers to develop
customized solutions.
3. Develop invasive therapy evaluation techniques with human factors considerations
for pediatric medical devices to minimize undesirable outcomes in non-clinical
settings.
Qualitative research methods were used for this study to understand experiences that have
been both understudied and undertheorized. This dissertation draws on data collected from a
larger qualitative study, so the narrative research approach was primarily used to address aim (1),
vi
the phenomenology research approach was partially used to address aim, (2) and the case study
approach was mostly used to address aim (3). This dissertation used three distinct and
complementary theoretical frameworks to study how the practical application of sociotechnical
systems, participatory ergonomics, and human factors conceptual models could improve
pediatric patient safety in non-clinical environments.
This dissertation provides novel insight into three key National Research Council (NRC)
recommended home health care focal areas. First, this study assesses how environment, people,
process, task, and technology components contribute to undesirable outcomes for pediatric
patients on invasive medical therapies with lay caregivers in non-clinical environments. Second,
it provides the participatory ergonomic rationale and tools used by pediatric patient caregivers
when developing custom solutions for invasive therapies in non-clinical environments to avoid
undesirable outcomes. Third, this dissertation rates the impact of human factors consideration on
the safety and effectiveness outcomes of invasive therapy devices use on pediatric patients in a
non-clinical environment.
vii
Table of Contents
Page
Dedication ....................................................................................................................................... ii
Acknowledgments ......................................................................................................................... iii
Abstract ............................................................................................................................................v
List of Tables ...................................................................................................................................x
List of Figures ..................................................................................................................................x
Chapter 1: Dissertation Topic Introduction .....................................................................................1
Chapter 2: Research Problem Overview ..........................................................................................6
Section 2.1: Dissertation Topic Significance .............................................................................. 6
Section 2.2: Qualitative Research Approach .............................................................................. 8
Section 2.3: Theoretical Framework Overview ........................................................................ 11
Section 2.4: Research Study Questions .................................................................................... 13
Section 2.5: Dissertation Study Limitations ............................................................................. 14
Chapter 3: Sociotechnical System Framework ..............................................................................17
Section 3.1: Invasive Technology Introduction ........................................................................ 17
Section 3.2: Sociotechnical Model Literature ........................................................................... 20
Section 3.3: Narrative Research Approach ............................................................................... 28
Section 3.4: Study Design Overview ........................................................................................ 30
Section 3.5: Sociotechnical System Analysis ........................................................................... 33
Section 3.6: Research Variable Discussion .............................................................................. 38
Chapter 4: Participatory Ergonomic Application ..........................................................................44
Section 4.1: Participatory Ergonomic Introduction .................................................................. 44
viii
Section 4.2: Participatory Design Literature ............................................................................. 47
Section 4.3 Phenomenology Research Approach ..................................................................... 50
Section 4.4 Research Design Overview .................................................................................... 52
Section 4.5: Participatory Ergonomics Analysis ...................................................................... 57
Section 4.6 Technique Application Discussion ........................................................................ 61
Chapter 5: Human Factors Components ........................................................................................67
Section 5.1: Human Factors Introduction ................................................................................. 67
Section 5.2: Invasive Device Literature .................................................................................... 70
Section 5.3: Case Study Approach............................................................................................ 76
Section 5.4 Research Design Overview .................................................................................... 79
Section 5.5: Invasive Device Evaluation .................................................................................. 84
Section 5.6: Rating Outcome Discussion.................................................................................. 87
Chapter 6: Conclusions and Implications ......................................................................................91
Section 6.1: Dissertation Topic Findings .................................................................................. 91
Section 6.2: Research Study Conclusions ................................................................................. 94
Section 6.3: Alternatives and Explanations .............................................................................. 98
Section 6.4: Impact and Learnings.......................................................................................... 101
Section 6.5: Future Research Implications ............................................................................. 103
References ....................................................................................................................................106
ix
List of Tables
Page
Table 3.1: Literature Review of Research Projects Using SEIPS 2.0 Model ............................................. 34
Table 3.2: Synthesis of Narrative Research Method for Sociotechnical Systems Applications ................. 42
Table 3.3: Dissertation Research Sociotechnical System Component Variables ....................................... 43
Table 3.4: Dissertation Research Sociotechnical System Component Findings ......................................... 46
Table 4.1: Historical Participatory Ergonomics Examples ......................................................................... 59
Table 4.2: Literature Review of Participatory Design Applications in Healthcare .................................... 62
Table 4.3: Synthesis of Phenomenology Research for Participatory Ergonomic Application ................... 63
Table 4.4: Participatory Ergonomic Rationale Categories and Inspiration Descriptions............................ 67
Table 4.5: Participatory Ergonomic Technique Descriptions ..................................................................... 68
Table 4.6: Participatory Ergonomic Rationale and Inspiration Findings .................................................... 70
Table 4.7: Participatory Ergonomic Technique Findings ........................................................................... 71
Table 5.1: Overview of Human Factors Advocacy Organizations ............................................................. 79
Table 5.2: Overview of Medical Device Advocacy Organizations ............................................................ 82
Table 5.3 Relevant AAMI/FDA Medical Device Summits ........................................................................ 83
Table 5.4: Priorities Identified by Summit Participants .............................................................................. 85
Table 5.5: Research Projects Related to Human Factors Considerations for Home Healthcare ................. 86
Table 5.6: Synthesis of Case Study Method for Human Factors Application ............................................ 90
Table 5.7: Human Factors Consideration Input Rating Structure ............................................................... 93
Table 5.8: Medical Device Outcome Score Structure ................................................................................. 94
Table 5.9: Parenteral Nutrition Human Factor Consideration Ratings ....................................................... 96
Table 5.10: Mechanical Ventilation Human Factor Consideration Ratings ............................................... 97
Table 5.11: Home Parenteral Nutrition Human Factors Findings .............................................................. 99
Table 5.12: Home Mechanical Ventilation Human Factors Findings ....................................................... 100
x
List of Figures
Page
Figure 3.1: Recreation of SEIPS 2.0 Sociotechnical Systems Model ........................................................ 32
Figure 3.2: Recreation of Human Factors Model for Health Care in the Home ........................................ 36
Figure 5.1: Recreation of FDA Device User Interface Operational Context ............................................. 80
Figure 5.2: FDA Medical Device Human Factors Consideration Model .................................................. 87
Figure 5.3: HPN Medical Devices Curlin 4000, Curlin 6000, CADD 6101 Respectively Displayed ....... 95
Figure 5.4: HMV Medical Devices HT50 and HT70 Respectively Displayed .......................................... 97
Figure 5.5: HMV Medical Devices LTV950 and LTV1150 ...................................................................... 97
Figure 6.1: Process, People, & Technology Framework for Invasive Therapy in Non-Clinical Settings.113
Figure 6.2: Comprehensive Conceptual Framework for Invasive Therapy in Non-Clinical Settings ...... 115
1
Chapter 1
Dissertation Topic Introduction
In 2010, approximately 12 million Americans received home health care or care in a non-
clinical environment due to the growing cost and capacity constraints of hospital health care
(Basics Statistics about Home Care, 2010). That volume was more than 50% higher than the
2008 National Association for Home Care & Hospice (HAHC) estimates and given this trend,
there could be approximately 30 million Americans receiving home healthcare today (Medical
Device Home Use Initiative, 2010). As a result, there is a comparable increase of medical
technologies being used in home health care generating a growing $70 billion market and the
Food & Drug Administration (FDA) admits that “many medical devices that are currently used
in the home were not designed for use by lay caregivers or outside of a controlled clinical
environment” (Medical Device Home Use Initiative, 2010, p. 2). Home Mechanical Ventilation
(HMV) as well as Home Parenteral Nutrition (HPN) are invasive therapies that use medical
devices referenced above by the FDA and are the primary focus of this dissertation study.
HMV is a healthcare therapy involving a medical device used on patients with chronic
respiratory illness mostly for long-term care. In 2010, almost 48,000 Medicare patients
throughout the United States were on some form of HMV, which was driven partially by the fact
that the hospital care cost would be approximately $21,570 as opposed to $7,050 per month for
home care cost (King, 2012). Given that hospital care costs more than three times home care
costs also resulted in the 2010 European HMV population exceeding 27,000; hence, this is a
phenomenon with global applicability (King, 2012). HMV is often preferred by patients as well
due to its ability to improve their quality of life through increased mobility, improved
2
independence, and enhanced nutrition, but the medical device could experience technical failures
that result in hospital readmission or patient mortality. According to King’s article, Long-Term
Home Mechanical Ventilation in the United States, typical HMV device failure causes included
mechanical failure, improper caregiver use, and caregiver tampering (King, 2012). In 2010,
these failures resulted in over 150 adult and pediatric deaths, which validate the FDA’s concerns.
HPN is the use of a mechanical pump in the home to provide nutritive fluids to the
patient via a catheter placed in a vein. It is highly invasive and involves a deep insertion, as well
as an intravenous catheter to infuse nutritional fluids into a patient with intestinal failure. HPN
patients have chronic rare conditions including congenital enteropathy, intestinal pseudo-
obstruction, and short gut syndrome (National Organization for Rare Disorders [NORD], 2014).
HPN patients are at risk of central venous catheter infections, electrolyte or water imbalance, and
overfeeding (Elfassy et al., 2013).
Unfortunately, data on the national population of children on HMV does not exist, but in
1996, the user population in Utah was 5 per 100,000 and in 2004 it increased to 6.3 per 100,000
(Gowans, Keenan, & Bratton, 2007). Likewise, data on the national population of children on
HPN does not currently exist. However, we know that for Italy in 2005 the adult and pediatric
population was 5.7 per 100,000 (Pironi et al., 2007). HMV and HPN involve complex methods
and mechanisms for pediatric patients due to their small size and delicate bodies, which increases
their risk of harm.
Invasive medical technology is a challenge when it comes to patient safety and can cause
harm such as an abnormal symptom or disease that could result in a life-threatening condition,
hospitalization, medical/surgical intervention, disability, or death (Health & Human Services
3
[HHS], 2007). In the medical field, patient safety harm or undesirable outcomes are often
described as Near Misses (NM) or Adverse Events (AE). A NM is an unintended event
involving error that does not result in harm but has the potential to result in an adverse event and
may require intervention (King, 2012). Similarly, an AE is an unintended harm or injury to the
patient resulting from medical management due to an act of commission or omission rather than
the underlying patient disease or condition (King, 2012).
Over the past decade, there has been an increased emphasis on the need for more systems
engineering involvement in health care delivery including home healthcare. In 2013, the
National Academy of Engineering (NAE) and the Institute of Medicine (IOM) reported that a
system engineering approach to health care can improve outcomes and lower cost by helping the
industry design and integrate people, processes, and organizations. Their discussion paper,
Bringing a systems approach to health, states that systems engineering “approaches can be
useful for all levels of the health system—patient-clinician interaction, health care unit,
organization, community, and nation—with different tools available for the needs at different
levels and across levels” (NAE, 2013, p. 1). NAE and IOM specifically state that human factors
engineers are needed “to spot safety, quality, and reliability challenges by understanding how
humans interact with technologies and processes” (NAE, 2013, p. 1).
In 2014, the President’s Council of Advisors Science and Technology (PCAST) reiterated
this declaration by suggesting that healthcare leverage the systems approach utilized in other
industries “to improve productivity, efficiency, reliability, and quality… by using tools such as
alerts, redundancies, checklists, and systems that adjust for the human factor” (PCAST, 2014, p.
8). The council defines systems engineering as “an interdisciplinary approach to analyze, design,
manage, and measure a complex system with efforts to improve its efficiency, productivity,
4
quality, safety, and other factors” through the methods and tools such as industrial engineering as
well as human-factors engineering (PCAST, 2014, p. 9). In their report, the council recommends
that the United States improve health care by employing systems engineering to achieve six
goals: (1) align payment with outcomes (2) increase data access (3) provide technical assistance
(4) involve communities in improvement (5) share lessons learned (6) train health professionals
(PCAST, 2014).
According to the National Research Council (NRC), human factors could assist with
improving the alignment of environments, tasks, and people involved in home health care to
provide increased safety, effectiveness, and efficiency (Olson, 2010). NRC believes that more
human factors engineering is needed to address health care in the home environment and
recommended more focus on health care technologies, care givers in the home, residential
environments for health care, as well as research and development (Olson, 2010). Human
factors methods, theories, and concepts have been partially leveraged to improve patient safety in
the hospital environment, but there is an even greater opportunity to expand its impact on quality
of care to include patient-centered care in the home environment.
The University of Wisconsin (UW) at Madison Center for Quality and Productivity
Improvement’s (CQPI) Director believes that the application of ergonomics facilitates the
discovery of best practices for combining environments, people, organizations, and technologies
to optimize work system outcomes (Carayon, 2012).
The director recommends the socio-
technological approach to identifying risk in health care. This approach assesses the person,
task, technology, environment, and organization domains of a work system that serve as inputs to
the care process that generates organizational outcomes as well as individual outcomes of patient
safety and quality of care. Invasive medical technology in the home creates additional
5
complexities to the health care equation, so additional social, physical, and technical
environmental considerations are required. As a result, home health care involves a
collaborative effort of professional providers and lay caregivers that lead to existence of
cognitive, physical, and macro ergonomic related risk (Carayon, 2012).
This dissertation study applies qualitative research methods to provide insight on
sociotechnical components of invasive medical therapies that can be used to help pediatric
caregivers and healthcare providers understand and control risk factors in non-clinical
environments. It also develops an understanding of potential participatory ergonomic
applications to translate tools for pediatric caregivers to leverage in avoiding undesired outcomes
of invasive medical therapies. Lastly, this study provides insight on the human factors
considerations for invasive medical devices in non-clinical environments for later investigation
as this research is preliminary. Thus, the aims of this study are threefold:
1. Identify home health sociotechnical model work system and process components of
invasive medical therapies in home health environments that contribute to undesirable
outcomes.
2. Understand participatory ergonomic application rationale for pediatric patient
families to become lay engineers and the tools modified by caregivers to develop
customized solutions.
3. Develop invasive therapy evaluation techniques with human factors considerations
for pediatric medical devices to minimize undesirable outcomes in non-clinical
settings.
6
Chapter 2
Research Problem Overview
This chapter provides an overview of the research problem within five sections. The first
section describes the rationale and significance that justifies the need for this study. The second
section reviews the theoretical framework for this study. Section three defines the problem
statements investigated. The fourth section then outlines the research questions and the fifth
section explains the study limitations.
Section 2.1: Dissertation Topic Significance
In the 2014 National Academies Press publication, Healthcare Comes Home: The Human
Factors, the National Research Council (NRC) identified recommendations related to healthcare
technology and medical devices, care recipients, and caregivers, as well as healthcare in
residential homes (Olson, 2010). Their home healthcare technologies recommendations were
related to consumer healthcare technology regulation, information technologies usability
guidance, medical device labeling standards, and device adverse event reporting. For home
health caregivers, the NRC recommended the development of certification credentials and
training standards. The recommendations for residential healthcare environments included
existing housing modifications and new home accessibility designs. The NRC also provided the
following research and development recommendations related to this study:
7
A. Home Health Care Team and Coordination: Provide strategies for improving
coordination among providers of home health care and communication among the
care recipients and caregivers.
B. Characterizing Caregivers, Care Recipients, and Home Environments: Provide
insight on the attributes of home health caregivers and better information about the
home health-care environments.
C. Tools for Assessing Home Health Care Tasks and Operators: Provide medical
device and system designers with information on the demands associated with home
health care and the capabilities needed for non-clinical caregivers to perform
successfully.
The NRC provided these recommendations based on their belief that sufficient core
knowledge exists supporting the theory that human factors could improve safety of home
healthcare. They believe the current problem is ineffective translation of theoretical knowledge
into the practical design of product and services for unique end users (Olson, 2010). Hence, this
study offers novel significance because it evaluates the practical application of theory based
sociotechnical system models in home environments, participatory ergonomic techniques for
pediatric patients, and human factors components on home care devices.
Previous sociotechnical systems model research studies aimed at identifying applications
for improving safety in clinical environments, but this study aims at identifying applications for
improving safety in non-clinical environments. Likewise, previous participatory ergonomic
technique research has focused on industrial professionals, but this study aims to identify
applications for common caregivers. Lastly, most human factors component research focus on
hospital devices as described in the literature review sections of this dissertation, but this study is
8
the first that aims to identify applications for invasive pediatric home care devices including
HMV and HPN.
Section 2.2: Qualitative Research Approach
Qualitative research methods were used for this study to understand experiences that have
been both understudied and undertheorized. The novelty of these research questions requires
exploratory methods and inductive analysis of the study population, which has a small sample
size. Qualitative research methods are less common within medicine and engineering, but are
necessary to address the first aim of this study: Identify home health sociotechnical model work
system and process components of invasive medical therapies in home health environments that
contribute to undesirable outcomes.
According to the Sage Handbook for Qualitative Research, hospitals, health care
institutions and clinics have used qualitative research methods since the 1950s (Denzin, 2011).
Prior to that time, quantitative research was the primary method in medicine and engineering
using clinical trials and statistical analysis to prove the efficacy of medical procedures and
pharmaceutical products. Over the past 30 to 40 years, qualitative research methods have
increased in use and respect within the medical community of practitioners. Since the 1990s,
psychiatry and family medicine have increasingly used qualitative research and mixed methods
designs (Denzin, 2011).
Currently, qualitative studies are “taking place in all areas where health care is
administered: in hospitals, and nursing homes; in clinics, schools, and workplaces; and in the
community – on the streets, in the parks and at people’s homes” (Denzin, 2011, p. 403).
9
Qualitative methods enable researchers to gain the caregivers perspective regarding their
interactions with patients. It also gives context to cultural perspectives of healthcare within the
increasingly diverse communities of the United States of America. According to the Sage
Handbook, qualitative research has contributed to various areas in healthcare, such as patient
education, healthcare evaluation, and clinical profession evaluation (Denzin, 2011).
John W. Creswell of the University of Nebraska Lincoln is a leading scholar in research
methods and is considered an expert on qualitative research methods. Creswell’s (2013) book,
Qualitative Inquiry and Research Design: Choosing among Five Choices, was often referenced
to guide the research philosophies and qualitative methods used for this study. Creswell
thoroughly describes five qualitative approaches, which are Narrative Research, Ground Theory,
Phenomenology Research, Ethnographic Research, and Case Study. Narrative Research is used
to understand individual experiences and sequences, Phenomenology describes people who
experienced a phenomenon, Grounded Theory develops theory from field data, Ethnography
studies context or culture, and Case Studies discover an organization, individual, entity, or event.
Based on the context of this study, narrative research approach was used to address aim
(1) Identify home health sociotechnical model work system and process components of invasive
medical therapies in home health environments that contribute to undesirable outcomes.
Narrative research methods ware used during data collection for this aim because it is best for
exploring aspects of home caregivers’ experience with pediatric patients on invasive medical
therapies. For this approach, data was primarily collected through initial and follow-up family
interviews.
10
Alternatively, phenomenology research approach was used to address aim (2) Understand
participatory ergonomic application rationale for pediatric patient families to become lay
engineers and the tools modified by caregivers to develop customized solutions.
Phenomenology research approach was selected to collect data for this aim because it is best for
capturing the essence of participatory ergonomic application rationale inspiring home health
caregiver to become lay engineers and the phenomenon of modifying techniques to develop
customize solutions. For this approach, data was collected primarily through home observations
and caregiver interviews with families caring for pediatric patients on invasive medical therapies
at home.
Lastly, the case study approach was used to address aim (3) Develop invasive therapy
evaluation techniques with human factors considerations for pediatric medical devices to
minimize undesirable outcomes non-clinical settings. Case study approach was selected to
collect data for this aim because it is best for providing an in-depth understanding of a case or
cases. For this approach, data was collected through multiple sources, such as interviews,
observations, and documents as well as artifacts, and data was analyzed through description of
the case and themes of the case as well as cross-case themes. These research methods provide
different qualitative approaches to unique sociological scenarios that individuals or groups
experience while performing invasive medical therapies on pediatric patients in non-clinical
environments.
11
Section 2.3: Theoretical Framework Overview
This dissertation used three distinct and complementary theoretical frameworks to study
how the practical application of sociotechnical systems, participatory ergonomics, and human
factors conceptual models could improve pediatric patient safety in non-clinical environments.
For this study’s first aim, Drs. Carayon and Smith’s Systems Engineering Initiative for Patient
Safety (SEIPS) sociotechnical framework was used to evaluate home health care team and
coordination. For the second aim, Drs. Noro and Imada’s participatory ergonomics framework
was used to characterize caregivers and care recipients in non-clinical environments. For the
third aim, Drs. Redmill and Rajan’s user interface framework was used to develop tools for
assessing devices used in home health tasks and operations.
Drs. Carayon and Smith originally developed the SEIPS sociotechnical model framework
based on the Balanced Theory of Job Design in 1989 (Carayon, 2006).
According to the National
Institute of Health (NIH) Publication describing the sociotechnical model framework, SEIPS has
been used in projects related to quality of care delivery and overall safety, clinical work and
workflow evaluation and design, medical devices and health information technology, as well as
family and patient engagement. The quality of care and patient safety projects using SEIPS
model have occurred primarily in hospitals and outpatient centers with doctors and nurses
treating adult patients through surgery or radio-therapy. Most of the health technology and
medical device projects have focused on electronic health records or computerized order entry.
The novelty of this study is in the use of SEIPS sociotechnical model framework to discover
applications in home environments, with lay caregiver treating pediatric patients dependent on
invasive therapy medical devices.
12
Dr. Kageyu Noro at Waseda University in Japan and dissertation committee member Dr.
Andrew Imada at the University of Southern California in the United States partnered to author
the book Participatory Ergonomics (1991). The majority of participatory ergonomic design
application literature focuses on industrial organizations and professional employees. The book
includes numerous examples that focus on physical office work environment, small enterprises
in developing countries, decision groups in developing countries, United States automotive
plants, West Germany developments, technology work in organizations, policies, and practices
in Sweden (Noro & Imada, 1991). Participatory ergonomics have been researched to design
family rounds for pediatric patients in clinical environments with health information technology
(FDA, 2016). Participatory design has also been used within geriatric care settings, so the
novelty of this research is in the application of participatory ergonomic for pediatric home care
with invasive medical devices.
FDA human factors considerations traditionally focus on clinical settings and invasive
medical devices historically developed for clinical users. The FDA Perspectives on Human
Factors in Device Development presentation highlights these prior deficiencies in a review of
“Device Use Errors” with transdermal patch products, which is a non-invasive device in non-
clinical environment (Story, 2012). Likewise, it described “Use-Related Risk” of invasive
medical devices in a clinical environment, so the novelty of this research is in the application of
human factors considerations for invasive medical devices used by lay caregivers in non-clinical
environments.
13
Section 2.4: Research Study Questions
The NRC seeks to provide strategies for improving coordination among caregivers
involved in home-based health care and communication among the care recipients and
caregivers. Sociotechnical system frameworks could enhance home care coordination, but
current sociotechnical models for understanding attributes of care primarily focus on hospital
settings with adult patients and clinicians. Without understanding the sociotechnical attributes of
home health, the occurrence of undesired outcomes will rise as the use of home health increases.
Hence, this study seeks to identify the sociotechnical attributes of lay caregivers administering
invasive medical therapies on pediatric patients in non-clinical environments contribute to
undesired outcomes.
Additionally, the NRC desires to provide insight on the attributes of home health
caregivers and better information about the home health-care environments. Participatory
ergonomic applications by lay caregivers could provide insight on attributes of home care;
however, most participatory ergonomic applications are currently focused on industrial
environments with professional employees. Without participatory ergonomic strategies for
improving coordination in home health, there will be limitations to caregiver innovation in
solution development. Hence, this study seeks to understand participatory ergonomic
applications for family caregivers using invasive medical therapies in non-clinical settings.
Lastly, the NRC seeks to provide medical device designers with information on the
demands of home health care and the capabilities needed for non-clinical caregivers to perform
successfully. Human factor considerations for invasive medical devices could provide designers
with home care insight, but current human factors considerations for medical devices focus on
14
the non-invasive technology interface with clinicians. Without human factor considerations for
invasive medical device interfaces in the non-clinical setting, the occurrence of undesired
outcomes will rise as the use of home health devices increase. Hence, this study seeks to
develop human factors consideration recommendations for invasive medical devices used by
pediatric caregivers in non-clinical settings. Thus, three research questions arise:
Sociotechnical System Components: What sociotechnical work system components in
non-clinical environments with lay caregivers might contribute to undesirable outcomes
for pediatric patients on invasive medical therapies?
Participatory Ergonomic Techniques: What participatory ergonomic techniques are
used by pediatric patient caregivers when developing custom solutions for invasive
therapies in non-clinical environments to avoid undesirable outcomes?
Human Factors Considerations: What human factors considerations impact safety and
effectiveness outcomes of invasive therapy devices use on pediatric patients in the non-
clinical environment?
Section 2.5: Dissertation Study Limitations
Children’s Hospital Los Angeles (CHLA) Principal Investigator Dr. Glenn Takata was
awarded pilot study funding from the Southern California Clinical & Translational Science
Institute (CTSI) Grant # UL1 TR000130 that graciously provided a research assistantship to
collect data relevant to this study. Data collected by the interdisciplinary research team within
the CHLA CTSI pilot study through family interviews, observation images, and field notes were
15
used within this dissertation study to provide a micro-ergonomic foundation focused on patient
family centered perspectives. In the larger study, occupational therapy, quality improvement,
and human factors members of the team provided both within group and across group
perspectives. This pilot data was built upon to provide a macro-ergonomic context focused on
the medical equipment as an additional focus.
Data accessibility was a secondary limitation for this research study. The HPN as well as
the HMV pediatric patient populations were limited and the volunteer caregiver participation in
the CTSI Study was moderate, which resulted in a somewhat small sample size. Additionally,
there was scarce access to medical equipment distributors for data collection and minimal
involvement interest from home healthcare vendors due to legal liability and public relations
concerns related to pediatric patient safety risks identified. Lastly, there is limited documented
data on home healthcare sentinel events because there are no federal reporting requirements or
formal reporting structures in place during the timeframe of this study. This led to innovative
data collection methods, which included subject matter expert interviews and online archive
document review to supplement the limited sample size of equipment distributor interviews
conducted virtually. Hence, although a mix of qualitative and quantitative method were
originally proposed for this dissertation, data constraints result in only qualitative methods being
used for this study.
Time constraints also created limitations for this study. I gained the fortunate opportunity
to become part-time faculty at Georgia Institute of Technology and a full-time consultant at
Cognizant Technology Solutions while completing this dissertation study. The USC Viterbi
College of Engineering kindly provided tuition for required continuous enrollment for
dissertation and understandably restricted my timeframe for completion. These employment
16
opportunities and academic constraints limited the time available to collect additional data as
well as conduct further data analysis, but provided numerous post doctorate research
opportunities discussed in the final chapter.
17
Chapter 3
Sociotechnical System Framework
This chapter provides an assessment of a sociotechnical system framework for homecare
teamwork and coordination within six sections. The first section introduces the invasive medical
technologies used in home settings. The second section reviews the prominent sociotechnical
model used within health systems. The third section provides an overview of the
phenomenology approach for this research and the fourth section is an overview of the study
design. The fifth section describes the work system results and the sixth section discusses the
systems components impacting patient safety within this study.
Section 3.1: Invasive Technology Introduction
Of invasive medical technologies used in non-clinical environments, HMV and HPN are
among the most high-risk to pediatric patients. HMV is the use of a specialized machine in the
home to breathe for the patient through a tracheostomy or a surgically created opening in the
neck that connects to the lungs. HMV is used for patients with chronic respiratory failure due to
rare chronic diseases such as congenital muscular dystrophy, congenital central hypoventilation
syndrome, and infantile spinal muscular atrophy (Edwards, Kun, & Keens, 2010; National
Organization for Rare Disorders [NORD], 2014). It is one of the most advanced home health
care treatments.
HPN is the use of a specialized device in non-clinical environments to pump nutritional
formulation through a catheter to treat or prevent malnutrition and/or dehydration. Patients are
18
usually prescribed this invasive medical treatment because of chronic or acute intestinal failure
that cannot be addressed by oral or other feeding methods (Staun et al., 2009). Gastrointestinal
diseases that result in HPN treatment are “inflammatory bowel disease, complications following
surgery, mesenteric vascular disease, radiation enteritis, and chronic small bowel disease with
severe malabsorption and dysmotility syndromes” (Staun et al., 2009, p. 469).
Patient safety harm for HMV usually occurs in the form of tracheostomy tube or
mechanical ventilator complications and for HPN occurs in the form of mechanical, microbial, or
metabolic complications. For HMV patients, tracheostomy tube related complications could
include mucous plugging, tracheal bleeding tracheal infection, accidental decannulation,
granulation formation, irritation, or abrasion (Edwards et al., 2010). Mechanical ventilator
related complications could include circuit breaking/leaking, low/dead battery, part malfunction,
setting errors, display errors, alarm confusion, improper equipment, improper adapter,
insufficient oxygen, improper assembly, or improper humidification (Elfassy et al., 2013).
Mechanical, microbial, or metabolic complications could be the following: catheter infection,
sepsis, venous thrombosis, catheter blockage/displacement, low blood sugar, cholestatic liver
disease, nephrocalcinosis, or osteopenia (Elfassy et al., 2013).
For HPN patients, catheter related complications such as vein thrombosis and sepsis are
often a challenge (Staun et al., 2009). Additional, metabolic issues such as bone or liver disease
and nutritional imbalance can cause complications for these patients (Staun et al., 2009). These
types of complication could lead to undesired and often avoidable readmission into the hospital.
They can be prevalent in pediatric patients due to their dependence on others for care, which is
partially why this study chose to focus on this unique population.
19
The risk of harm due to error for pediatric patients on invasive medical technology in
non-clinical environments is potentially greater and possibly fatal, but a very limited amount of
data or literature exists studying this phenomenon. For instance, catheter infection rates in adult
HPN patients below 1 per 1,000 catheter days are possible (Cotogni et al., 2013). In comparison,
the CHLA pediatric parenteral nutrition catheter infection rate is 4.85 per 1,000 catheter days,
but in the home may be 2-7 times above the inpatient rate (Merritt et al., 2011). Additionally,
adolescent pediatric patients could be at “risk for another type of harm: the loss of dignity and
respect” (NAE, 2013, p. 2).
Despite the lack of pediatric home health care data, recent hospital studies reveal that
pediatric patients on invasive technologies are experiencing fatal harm. According to the clinical
journal Chest, in America there are 360,000 cases of respiratory failure per year due to
respiratory failure or device complications and 36% of these patients five years or older die
during hospitalization (Behrendt, 2000). Additionally, the error rate in critical care mechanical
ventilation is 4 per 1,000 ventilator days in the hospital setting compared to 5.39 per 1,000
ventilator days in the home (Auriant et al., 2002).
Between 2006 and 2010, it is estimated that between 3,000 and 5,000 children were on
HMV nationally. Additional documentation exists showing that children have died after being
on HMV for 5-16 years due to clinical issues such as cardiac arrest or respiratory failure and
others have died specifically due to equipment issues such as ventilator alarm malfunctions
(King, 2012). CHLA studies suggest that patient safety harm is not always due to equipment
failure, indicating sociotechnical factors should be considered (Srinivasan, 1998).
20
Section 3.2: Sociotechnical Model Literature
According to the July 2013 National Institute of Health Public Access Author Manuscript
on Work entitled Sociotechnical systems approach to healthcare quality and patient safety,
Chapanis and Safren conducted one of the first human factors studies on patient safety and
medical errors in 1960 (Carayon, 2012). Clayton and Stoelwinder later leveraged the
methodology at an Australian hospital in 1978. Ziegenfuss then conducted a comparative
analysis healthcare organizational model using a sociotechnical approach in 1983 (Carayon,
2012). Five years later, Dr. Pascale Carayon earned her PhD in Industrial Engineering from the
University of Wisconsin (UW) in Madison and became a founding faculty member of the Center
for Quality and Productivity Improvement (CQPI) (2006). Within CPQI, Carayon and Smith
developed the Systems Engineering Initiative for Patient Safety (SEIPS) Model based on the
Balanced Theory of Job Design in 1989 (Carayon et al., 2006).
The novelty of this study is that it investigates the sociotechnical work systems
components that impact the safety of invasive medical therapies used on pediatric patients from
the lay caregivers’ perspective in their non-clinical environments throughout Southern
California. Reiter and Pernath conducted a similar study in Germany focusing on the Pediatric
Home Mechanical Ventilation to investigate the clinical risk factors for morbidity and mortality
(Reiter et al., 2011). This study revealed that pediatric patients using invasive medical therapies
experience more complications, hospitalizations, and deaths than patients using non-invasive
medical therapies. Their research differs from this study because it involved invasive as well as
non-invasive ventilation interface modes, it did not include other invasive technologies such as
home parenteral nutrition, nor did it use the SEIPS model.
21
Figure 3.1: Recreation of SEIPS 2.0 Sociotechnical Systems Model (Holden et al., 2013)
This study is a novel application of the SEIPS 2.0 model in Figure 3.1 (Holden et al.,
2013), which displays the interaction of the work system components involved in this
sociotechnical framework. It uniquely uses the SEIPS 2.0 model to identify human factors risks
for pediatric patients using invasive medical devices by lay caregivers in non-clinical
environment. Previous research projects that used the SEIPS model focused on patient safety,
clinical workflow, health technology, and family engagement. Hence, a literature review of
those projects was conducted to compare the SEIPS work system components of this study to
those previous research projects. Table 3.1 outlines the outcomes of the literature review based
on the work system components of environment, organizations, people tasks, and technologies
involved in the project listed by focal area.
The projects listed in Table 3.1 were referenced in Holden’s (2013) NIH article entitled
SEIPS 2.0: A human factors framework for studying and improving the work of healthcare
professionals and patients. A literature review of articles on these projects was conducted to
determine if the environment as well as people work system components involved were clinical
or non-clinical and if the patient population involved were pediatric, adult, geriatric or all of the
above. This literature review also determined if those SEIPS research project’s organizations
22
involved were healthcare or non-healthcare and if the technologies involved were invasive or
non-invasive.
As shown in Table 3.1, the NIH article segmented previous research project using the
SEIPS model into the four categories: Safety and Quality of Care, Workflow Evaluation and
Design, Health Technology and Medical Devices, as well as Patient and Family Engagement.
Most of the SEIPS research projects in the NIH article aligned with Safety and Quality of Care
Delivery segment involved invasive technology, but many of the projects focused on clinical
environments and only one of them addresses pediatric patients. Similarly, all the previous
Clinical Work and Workflow Evaluation research projects that used the SEIPS model focused on
clinical environments; only three of those projects involved invasive medical devices and just
two of them focused on pediatric patients. Likewise, much of the Health Technology and
medical device projects were in clinical environments; only two include invasive medical
devices and only one addresses pediatric patient needs.
The Overall Safety and Quality of Care Delivery research projects were somewhat
relevant to the first aim of this dissertation study. Of these studies, only the Patient Safety in
Nursing Homes Project was conducted in a non-clinical environment and involved a Non-
Healthcare organization. All of these projects involved clinical caregivers, but the Patient Safety
in the Intensive Care Unit (ICU) Project was the only study involving pediatric patients. Five of
the eight projects involved invasive technology, which included tasks related to general surgery,
radiotherapy, and intensive care.
23
Table 3.1: Literature Review of Research Projects Using SEIPS 2.0 Model (Holden et al., 2013)
The Workflow Evaluation and Design research projects were less similar to this
dissertation study because they were all in clinical environments and involved clinical
caregivers. Only the Workload and Performance Obstacles among ICU Nurses Project and the
Evaluation of Lean in Healthcare Project involved pediatric patients; in addition, these projects
24
as well the Analysis of Critical Care Work Systems Project involved invasive medical
technology. The tasks within these projects mostly focused on Hospital Management, but also
included Test Follow-up, Electronic Communications, Intensive Care, and Emergency Care,
which are irrelevant to the focus of this dissertation study.
The Health Information Technology and Medical Device projects were minimally
relevant to this dissertation project. Most of them were focused on clinical environments with
the exception of the Health Information Technology-Supported Care Management in Community
Setting Project and the Health Information Technology in Home Care Nursing Project that took
place in community as well as residential settings respectively. All of the projects used clinical
caregivers and only the Tele-ICU Project involved pediatric patients. Only the Tele-ICU Project
and the Smart Infusion Pump Project included invasive technology, but their tasks focused on
Tertiary and Intensive Care respectively. The other projects focused on Technology
Implementation, Care and Medication Management, Primary Care, Order Entry and Home
Nursing.
The Patient and Family Engagement Projects are the most relevant to this research study
because all of them include non-clinical caregivers. The Human Factors in Homecare project is
the most salient because it takes place within a home environment, but it differs because it
focuses on geriatric patients and involves non-invasive technology. The comparable Patient and
Family Self-Care project takes place in a community environment, but it also excludes pediatric
patients and invasive technology. The Engaging Families in Bedside Rounds project is similar to
study because it focuses on pediatric patients and non-clinical caregivers, but it differs because it
takes place in the clinical environment and involves non-clinical technology.
25
The clinical research with the greatest alignment to this study was published in 2016 by
the American Thoracic Society, which was conducted to develop Clinical Practice Guidelines
[for] Pediatric Chronic Home Invasive Ventilation (Sterni et al., 2016). The data collection
methods for this research included a panel of clinical experts and patient representatives,
literature reviews, and evidence synthesis to address four clinical questions related to homecare
requirements, discharge standards, caregiver training, and equipment requirements. The
advantages of this research are that it was the most comprehensive study of invasive ventilation
clinical risk factors and it led to the development of nine recommendations for clinical
professionals to apply as pediatric patients transition from inpatient to outpatient care. The
disadvantages of this study’s approach are that it mostly focused on the clinical provider
perspective and produced results with very low quality of evidence. Additionally, it only
focused on one type of invasive medical therapy and lacked a sociotechnical system approach to
understanding the human factors components that lead to undesired outcomes in the
patient/caregiver’s homecare environment.
Figure 3.2: Recreation of Human Factors Model for Health Care in the Home (Czaja and Nair, 2006)
26
The existing sociotechnical model for home health care was created by Czaja and Nair in
2006. It addresses the following human factor components of home health care: the person
involved, the task engaged, the equipment/technology used, and the environment surrounding.
As shown in Figure 3.2, this model focuses on the interaction of the person, task, and equipment,
within the context of the health policy, community, social, and physical environment.
There are numerous benefits and limitations of applying this model to identify risk
factors for pediatric patients on invasive medical technology in non-clinical environments. The
benefits are that it incorporates a user-centered design approach to system design and
participatory ergonomic approach to evaluation. For example, the model takes into consideration
the cognitive, perceptual, and physical capacity of the people involved (i.e., patient, caregiver,
etc.) as well as the comparable demands of the equipment/technology (i.e., monitor, device, etc.)
and the task (i.e., diagnosis, monitoring, etc.).
The limitation is that this model does not incorporate interactions with macro ergonomic
components of the health system such as the organizations involved in the home health care of a
patient on invasive medical technology. These organizations would include the clinical provider
responsible for diagnosis and follow-up, the insurance company involved with technology
selection and coverage, the prescribing pharmacy responsible for technology setting, and
solution formulas, as well as the technology vendor for technology involved with training and
maintenance.
There are advantages and disadvantages to applying the SEIPS model for identifying risk
factors of invasive medical technologies in non-clinical environments. The primary advantage is
that it incorporates the interactions of the person, task, and technology/tools environment as well
27
as the organization within the work system. The secondary advantage is that it includes a
feedback loop from the process and outcome components to indicate that it is cyclical rather than
linear. Both advantages are extremely important for risk identification and mitigation for
invasive medical technology in non-clinical environments.
The disadvantage of the SEIPS Model is that it was not created for, and has not been
applied to, pediatric patients on invasive medical technology in non-clinical environments.
According to CQPI, it has mostly been used to analyze Health Information Technology and
Health Operations Logistics but has also been used to analyze pediatric family involvement
rounds in the clinical environment and non-invasive technology in the home environment.
Hence, this model is potentially applicable to pediatric patients on invasive medical technology
in non-clinical environments and will be leveraged for this research study.
In summary, the UW Madison CQPI is a leader in health systems engineering and
recommends the SEIPS model for human factors analysis for patient safety risk. Previous
projects have used this sociotechnical framework to conduct similar research mostly with
clinicians using non-invasive medical devices on adult patients in clinical environments, so this
is a truly novel application of the SEIPS model. The Czaja Human Factors sociotechnical model
could have been used for this study, but SEIPS 2.0 is the most comprehensive sociotechnical
framework for understanding risk factors of invasive medical devices in non-clinical
environments because it incorporates the process component and the outcome results which are
the fundamental focus of this patient safety focused study. Given that this sociotechnical model
has been used for similar projects involving risk factor evaluation, the advantages of using it for
this project outweigh any disadvantages.
28
Section 3.3: Narrative Research Approach
Creswell’s Qualitative Inquiry and Research Design states that narrative research “might
be the phenomenon being studied, such as narrative of illness, or it might be the method used in
study, such as the procedure of analyzing stories told” (Creswell, 2013, p. 70). It also defines
narrative research as “a specific type of qualitative design in which narrative is understood as a
spoken or written text giving an account of an event/action or series of events/actions
chronologically connected” (Creswell, 2013, p. 70). Typically, data is collected by capturing
stories or reports of individual’s experiences and chronologically ordering them as life course
stages. The methodology is rooted in history, sociology, anthropology, and medicine as well as
education and has been used to study organizational orientation and human development.
There are multiple modes of narrative research, which could include a collection of
individual’s stories about their lives collectively constructed by the individual and the researcher.
The narratives should reflect how the individuals view themselves through a collection of
interviews, documents, and observations. They often include turning points that shift the
individual’s experience of a situation. Biographical narrative studies are where the researcher
“writes and records the experiences of another person’s life” and autoethnography narrative
research is “written and recorded by the individuals who are the subject of the study” (Creswell,
2013, p. 72-73). Life story narratives “portray an individual’s entire life” and oral history
compiles “personal reflections and their causes and effects from one individual or several
individuals” (Creswell, 2013, p. 73).
Narrative research starts with deciding if the research question aligns with this research
methodology. Next, the researcher selects people who have experiences or stories and schedule
29
time with them to capture their perspective. The primary challenges with this this methodology
involve the need to collect extensive participant information. Additional challenges involve
questions related to “Who owns the story? Who can tell it? Who can change it? Whose version
is convincing? What happens when narratives compete? As a community, what do stories do
among us?” (Creswell, 2013, p. 76).
Table 3.2: Synthesis of Narrative Research Method for Sociotechnical Systems Applications (Creswell, 2013)
A synthesis of these narrative research characteristics and sociotechnical system
applications relevant to the aims of this dissertation study are outlined in Table 3.2. The
narrative research approach was selected to understand home health care teams and coordination
of pediatric invasive medical therapy and identify home health sociotechnical model work
system as well as the process components of invasive medical therapies in home health
environments that contribute to phenomenon of undesirable outcomes. As a result, interview
questions were constructed and asked in an open-ended method to allow family caregivers to
30
comfortably express their experiences caring for children on HPN or HMV as well as instances
of NM and AE outcomes. Hence, the historically derived SEIPS 2.0 sociotechnical model was
used to evaluate the various aspects of homecare teams to improve coordination of pediatric
invasive medical therapy providers.
Section 3.4: Study Design Overview
Data collection for this dissertation study segment included identifying a purposeful
sampling of pediatric patient family caregivers who volunteered to be interviewed after the
occurrence of an undesirable outcome involving invasive medical therapy in the non-clinical
environment. Patient families experiencing undesirable outcomes where identified through the
Pulmonology and Gastrointestinal clinical staff at a prominent pediatric hospital in Southern
California during a Clinical and Translational Institute (CTSI) interdisciplinary study. This work
was supported by the NIH/NCRR SC-CTSI Grant Number UL1 TR000130. Its contents are
solely the responsibility of this author and do not necessarily represent the official views of the
NIH. The USC Health Science Campus (HSC) Internal Review Board (IRB) approved the CTSI
Study HS-14-00678 be conducted under the leadership of the IP at CHLA.
That CTSI study was led by dissertation committee members Dr. Glenn Takata and Dr.
Mary Lawlor as well as Dr. Greg Placencia: the study included interviews with families
administering care in non-clinical settings of five parenteral nutrition and six mechanical
ventilation patients. Patient families were consented for interviews as well as permission to
collect photographic images of equipment and aspects of the caregiving environment to be used
for research. Initial interviews were scheduled with parental caregivers to take place in the
31
pediatric hospital or at patient homes when permitted and were expanded to include multiple
participants present in home during interview. Follow-up interviews with these families were
also scheduled, but unfortunately, follow-up interviews with two parenteral nutrition families
were not completed due to logistic challenges.
After family caregivers were consented for participation in a larger CTSI study, initial
interviews with 11 families of pediatric patients on invasive medical therapy and follow-up
interviews with nine pediatric invasive medical therapy were scheduled, recorded, and
transcribed. Caregiver interviews included parents as well as grandparents, siblings, and
relatives of pediatric patients present during home interviews. The recordings were transcribed,
then the transcriptions were de-identified and stored on a secure server to protect participant
identities. In turn, the CTSI study transcripts documented the individual perspectives of eight
home parenteral nutrition and nine mechanical ventilation caregivers regarding their shared
experience of conducting invasive medical therapy in home health environments. With the
generous permission of the CTSI study PI and Co-PI’s, these transcripts were then analyzed for
the aims of this dissertation.
The narrative research approach was then used to evaluate the experience of these family
caregivers to identify the system components of invasive medical therapies in non-clinical setting
that contribute to undesirable outcomes by open coding the occurrence of near misses and
adverse event on transcripts. The near miss code category was then selected for the central
theme of the process because most undesirable outcomes identified in the transcribed interviews
were unintended events that did not result in harm to the pediatric patient. The dissertation
researcher conducted axial coding of CTSI interview transcripts for each unintended event to
label the work system and process components involved in the event for this study as defined by
32
the SEIPS 2.0 sociotechnical systems framework, which included person(s), organization(s),
environment, task, technology, and process.
The dissertation research sociotechnical system component variables displayed in Table
3.3 were developed for this study’s analysis. In that the aim of this study was to address the
NRC’s recommended research area of “Home Health Care Team and Coordination,” the SEIPS
2.0 sociotechnical system components were segmented by the NRC research variables of Care
Team, Coordination, and Home Health. The SEIPS Environment and Technology components
with the NRC’s Home Health variable, SEIPS Organization and People components were
aligned with the NRC’s Care Team variable, and the SEIPS Task and Process components with
the NRC Coordination variable.
Table 3.3: Dissertation Research Sociotechnical System Component Variables
Applicable binary coding categories or Doctor of Philosophy (PhD) components were
created for the context of this dissertation within each work system and process category or
SEIPS component to further segment the sociotechnical components involved in the undesirable
outcomes of invasive medical therapies. The Environmental system component was segmented
into Internal components including lighting, noise, and vibration, as well as temperature; and
33
External components such as societal, economic, ecological, and policy influences. Likewise,
the Technology component was segmented into Ventilation including ventilation pumps and air
circuit as well as equipment power; and Nutrition including nutrition pump, fluid circuit, battery
power, and the like.
Additionally, the Organization component was subdivided into Healthcare Organizations
including clinical providers as well as pharmaceutical distributors; and Non-Healthcare
Organizations such as a community groups, churches, families or schools. Similarly, the person
system component was subdivided into Clinical individuals such as respiratory therapist for
HMV patients and pharmacists for HPN patients and Non-Clinical individuals such as family
member and community contributors. Likewise, Task component was subdivided into Simple
tasks that include non-clinical tasks involving bathing as well as clothing; and Complex tasks
such as clinical task involving pumps as well as circuits. Lastly, the Process component was
segmented into Physical procedures requiring body, material, matter, or energy; and Mental
procedures requiring the mind, knowing, or perceiving.
Section 3.5: Sociotechnical System Analysis
In that this study focused on the patient and caregiver perspective, the definition of
undesirable outcome was based on their perspective as well. Haldar’s paper Scared to go to the
hospital focused on the patient’s perspective of undesired events as well as outcomes and defined
undesirable event as something that: “was a small or big concern, was unpleasant or caused
harm, and could have been avoided” (Haldar et al., 2016, p. 610). Based on this definition,
undesirable events from the patient or caregiver perspective would involve mismanagement, not
34
being heard, equipment malfunction, natural causes, improper medication, or lack of empathy
(Haldar et al., 2016). Similarly, undesired outcomes would include negative health impact,
pain/discomfort, taking action/giving information, additional care/readmission, provider change
or delayed care (Haldar et al., 2016).
These undesirable outcomes were segmented into NM defined as unintended event
involving error that does not result in clinical treatment and AE defined as unintended
harm/injury to the patient led to clinical treatment for the purpose of this study to clarify
delineation in non-clinical settings. Hence, if an interviewee described an undesired event that
resulted in the patient being treated immediately by a clinical professional via an emergency
medical vehicle, taken to an outpatient health center, or admitted into a hospital facility to
resolve an issue involving the HMV or HPN therapy, it was coded as an AE. Otherwise, if an
interviewee described an HMV or HPN undesired event that did not result in professional
clinical treatment, it was coded as a NM.
The aim of this dissertation chapter is to generally focus on sociotechnical components
involved in undesirable outcomes of pediatric patients on invasive therapies rather than the
specific technology involved to provide insight for future research. The CTSI study interviews
used for this analysis were narratively structured to understand the family caregiver’s overall
experience with caring for a pediatric patient on HMV as well as HPN, so interviewees would
describe their experience with undesired events within this context. Hence, the HMV and HPN
incidents narratively discussed by family caregivers on CTSI interview transcripts were
aggregated and coded as previously described within Nvivo software. Coding analysis revealed
that of the 143 undesirable outcomes identified, 114 of them, or 80% of the undesirable
outcomes in non-clinical settings, were NM. This calculation was based on thorough review of
35
the transcripts to code for unintended events involving errors that did not result in harm to the
pediatric patient. An aggregate analytical overview of the sociotechnical SEIPS and PhD
components involved in undesirable events that narratively emerged during patient caregiver
interviews is displayed in Table 3.4.
Table 3.4: Dissertation Research Sociotechnical System Component Findings
The outcome calculations shown in Table 3.4 was determined by coding each time a
family care mentioned an unintended incident involving error that did not result in clinical
treatment the on the CTSI study interview transcript as a NM and by coding an incident
involving unintended harm/injury to the patient led to clinical treatment as a AE within the
NVivo software. NVivo counted the number of NM and AE labels coded on the initial and
follow-up interviews uploaded into the software for analysis to calculate the 114 NM and the 29
AE figures shown in the count column of the table. The figures in the percentage column were
calculated for the NM incidents by dividing the 114 count by the total undesired events
(114+29=143) which rounds up to 80% and for the AE incidents by dividing the 29 count by 143
which rounds off to 20%. This completed the open coding phase of the analysis.
Next axial coding was completed in NVivo by labeling each open coded unintended
incident with a binomial PhD component for each SEIPS work system component (i.e.,
36
environment, technology, organization, people task, and process) involved in the undesirable
outcome identified in the CTSI study caregiver interview. For instance, a NM could have been
coded with Internal Environment, Nutrition Technology, Healthcare Organization, Clinical
People, Simple Task, and Mental Process PhD component labels if the SEIPS components
involved aligned with the descriptions provided for the components in Table 3.4. In addition, an
AE could have been coded with an External Environment, Ventilation Technology, Non-
Healthcare Organization, Non-Clinical People, Complex Task and Physical Process labels if the
SEIPS components involved aligned with the descriptions provided for the components in the
table.
NVivo totaled the number of PhD Components used to code the undesired incidents
labeled on the CTSI caregiver interview transcripts to calculate the figures in the Count column
of Table 3.4. The count of PhD Component Binomial Option A and Binomial Option B were
added and the Percentage column was calculated by dividing the count for each PhD Component
by the total calculated for its SEIPS Component. For example, the figure in the Percentage
Column for Internal Environment was calculate by dividing the figure in its count column by the
sum of the figures in the count column for the Environment SEIPS Component (i.e., 50/ (50+93)
= 35%.
As outlined in the top four rows of Table 3.4, the environment and technology
components involved with undesired outcomes identified within the CTSI interview transcripts
were coded to understand how they could contribute to the NRC Home Health variable for
family caregivers with pediatric patients on invasive medical therapies in non-clinical settings.
Axial coding of the undesired outcomes labeled through open coding in NVivo revealed that 93
of the undesired outcome references, or 65% of them, involved external environment
37
components as opposed to 50 event references, or 35% of undesired outcomes, involved internal
environment components. Additionally, there were 103 undesired event references, or 73% of
undesired outcomes, involved ventilation technology components as opposed to 39 event
references, or 27% of undesired outcomes, involved nutrition technology.
The SEIPS organization and people components involved with undesired outcomes
identified on interview transcripts were also coded to understand how they contribute to the NRC
Care Team variable for family caregivers with invasive medical therapies on pediatric patients in
non-clinical settings. Coding analysis revealed that there were 76 undesired event references, or
that 54% of undesired outcomes involve non-healthcare organizational components as opposed
to 66 event references, or that 46% of undesired outcomes involved healthcare organizations.
Additionally, there 84 undesired event references, or 59% of undesired outcomes involve non-
clinical people as opposed to 58 event references, or 41% of undesired outcomes involved
clinical people components.
The task and process components involved with undesired outcomes were coded as well
to understand how they contribute to the NRC Coordination variable for family caregivers with
pediatric patients on invasive medical therapies in non-clinical settings. Coding analysis
revealed that there were 99 undesired event references or that 69% of undesired outcomes
involve complex task components as opposed to 44 event references or 31% of undesired
outcomes involved simple tasks. Additionally, 77 undesired event references or 53% of
undesired outcomes involved physical process components as opposed to 68 events or 47% of
undesired outcomes involved mental process components.
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Section 3.6: Research Variable Discussion
As described in Section 3.4, because the aim of this study was to address the NRC’s
recommended research area of “Home Health Care Team and Coordination,” the SEIPS 2.0
sociotechnical system components were segmented by the NRC research variables of Care
Team, Coordination, and Home Health. The SEIPS Environment and Technology components
with the NRC’s Home Health variable, SEIPS Organization and People components were
aligned with the NRC’s Care Team variable, and the SEIPS Task and Process components with
the NRC Coordination variable. Additionally, the SEIP Outcome component was aligned with
the Patient Care as outlined in results shown in Table 3.4.
The Patient Care findings of this sociotechnical system analysis revealed that 20% of the
undesired outcomes resulted in unintended harm or injury to the patient that led to
hospitalization. Unfortunately, the lack of publicly available data on home care AE and NM
with invasive medical devices does not allow for benchmarking, but the findings of this study
will serve as a starting point for future comparison. This issue reiterates the NRC’s
recommendation for the FDA to improve its adverse event reporting systems to increase lay
device users’ awareness of its existence, access to the system and ability to use it to report
undesirable events including near misses. By addressing this recommendation, the FDA would
also improve medical device company’s ability to reactively conduct root cause analysis on
current products and proactively develop future products.
The Home Health NRC variable findings related to environment and technology
sociotechnical components were interesting. The discovery that external environment
components were more often involved in undesirable outcomes revealed that ecological and
39
policy related elements more often contributed to patient care outcomes. This was due to
increases in presence of seasonal illnesses such as pneumonia and changes in pharmaceutical
policies with the pumps and circuits they service and supply respectively. Likewise, the
technology component findings in Table 3.4 communicated that ventilation devices were more
often involved in undesirable outcomes because more HMV patient families volunteered to
participate in the CTSI interviews than HPN patients. The aim of this dissertation chapter was to
generally focus on sociotechnical components involved in undesirable outcomes of pediatric
patients with invasive therapies rather than the specific technology involved to provide insight
for future research. The aim of chapter five focuses more so on the human factor components of
specific HMV and HPN devices to provide further insight on invasive medical devices used in
non-clinical environments based on FDA guidelines.
The findings related to organizations and people concur with the opinions of various
clinical professionals. Validating that non-healthcare organizations such as family teams and/or
school groups were more often involved in undesirable outcomes suggested the need for
enhanced education of family members or communication with school assistants to improve care
of pediatric patients on invasive therapies. Similarly, confirming the prevalence of non-clinical
people components such as parental caregivers or pediatric patients’ involvement in undesirable
outcomes reiterated the need for additional platforms and structures for caregiver and patient
support in the non-clinical environments. For caregivers, these platforms could be virtual, such
as social media groups as well as more online videos or call centers and for patients these
structures could be tangible such as mechanisms designed to keep circuits sanitary and secure on
pediatric users. The aim of chapter four focuses more so on the participatory ergonomic
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techniques of HMV and HPN family caregivers to provide further insight on the rationale and
tools used to develop innovative methods and products to address this issue.
Moreover, these findings show that the coding results for the organization components
was close in count and percentage calculation regarding their involvement in undesired
outcomes. Healthcare organizations contributed to nearly half of undesired events suggesting
that equipment distribution and pharmaceutical companies were almost equally involved in
undesired outcomes. At times, this was due to numerous organizational problems such as supply
chain management issues that resulted in defective devices and incorrect circuits being sent to
patient family homes. On other occasions, this was due to issues with the timing, amount, or
method in which supplies were shipped or delivered.
Likewise, these findings display that coding results for the clinical and non-clinical
people were almost equally involved in the undesired outcomes identified during the CTSI
study’s narrative interviews. Clinical people also contributed to nearly half of the undesired
events, which suggests that home nurses and respiratory therapists were almost equally involved
in undesired outcomes. At times, this was due to various staffing problems such as insufficiently
trained home health assistants that resulted in inappropriate insufficient responses to patients’
clinical needs. Occasionally, this resulted in patient families going through numerous references
to find trustworthy support or caregivers not allowing home resources such as home nurses and
health assistants to handle pediatric patients’ clinical care or invasive therapies.
The Coordination findings related to task and process components were also interesting.
Complex tasks, such as circuit alterations and dressing changes from the caregiver’s perspective,
were more often involved in undesirable outcomes, which reveal the need for the caregiver to
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gain more instructed preparation for complex tasks before discharge and supervised practice after
discharge. Furthermore, physical procedures involving medical devices or circuit connections
were more frequently involved in undesirable outcomes due to the caregiver or patient
accidentally disconnecting the circuit from the pump or dislodging the circuit from the person.
Additionally, the Coordination related findings also communicate that the coding results
for the process components were close in count and percentage calculation in regards to its
involvement in undesired outcomes. As shown in table 3.4, the mental processes PhD
component contributed to nearly half of undesired events suggesting that the caregiver’s
knowledge and/or patients’ perception were almost equally involved in undesired outcomes.
CTSI interview transcript analysis revealed instances when the caregiver would forget the
methods they were taught prior to discharge when they initially arrived home while trying to care
for their child as they learned while in the hospital. Transcripts also included instances when the
pediatric patient would not realize that they are dependent on the invasive device for survival and
disconnect the circuit for attention or humor.
Coordination also involved transporting pediatric patients on invasive medical therapies.
Given the volume of equipment and supplies involved with invasive medical therapies,
automobile transportation with enough space for multiple devices and various supplies was an
important consideration for some patient families. As a result, coordination of therapy and
utilization of supplies as needed during transport was a challenge, as it often required an
additional person to support monitoring the child while another person drives to clinical
appointments. Various types of supplies (e.g., sanitary wipes, catheter tubes, etc.) and method
(e.g., homemade packets, prepackaged kits, etc.) are used when transporting pediatric patients
with invasive medical therapies to ensure quick accessibility during travel.
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Transition between vehicles and facilities was additionally complicated for caregivers of
pediatric patients on invasive medical therapy who were unable to walk independently because a
stroller with the space for supplies and strength to carry equipment would be necessary. These
types of strollers are similar to wheelchairs based on the materials used, such as metal rods to
insure structural integrity needed to transport equipment and the features included such as
additional straps to provide safety. They included more space for transporting medical devices
with the patient for invasive therapy to occur during transport, as well as extra posterior cushion
to absorb vibration and headrest to minimize movement when traveling over rough terrain to
minimize the possibility of circuits becoming dislodged.
In conclusion, this study confirmed the narrative research approach as a useful method
for analyzing of the SEIPS work system components impacting the safety of pediatric patients on
invasive medical therapies in non-clinical environments. This approach also provided insight on
the sociotechnical work system components that lead to undesired outcomes such as near misses
and adverse events. Hence, this study was effective at addressing the NRC’s research
recommendation related to Home Health, Care Teams, and Coordination. The SEIPS model
analysis of the CTSI study’s pediatric patient families revealed that the NRC’s Home Health
research variable was more so impacted by external environment and nutrition technology work
system components. Additionally, it found that the NRC’s Care Team research variable was
more so impacted by the non-healthcare organizations and non-clinical people work system
components. Lastly, it discovered that the NRC’s Coordination research variable was more so
impacted by complex task and physical process work system components.
As a result, the preliminary findings of this chapter’s analysis were influential in the
discovery of future research opportunities. For instance, future analysis of work system
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component interactions as well as specific elements within each binary response may be
enlightening and provide greater support for these conclusions. Additionally, future analysis
stratified by HMV versus HPN would be enlightening. The Care Team finding led to the fourth
chapter’s aim that focuses on the NRC’s recommendation for “Characterizing Caregivers, Care
Recipients, and Home Environments.” In addition, the Home Health findings influenced the
fifth chapter’s aim focusing on the NRC’s recommendation to develop “Tools for Assessing
Home Health Care Tasks and Operations.” These findings are significant contributions to the
limited body of knowledge on pediatric home health patient safety.
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Chapter 4
Participatory Ergonomic Application
This chapter provides an evaluation of participatory ergonomic applications for
characterizing caregivers, care recipients, and home environments within six sections. The first
section introduces participatory ergonomics used in industrial settings. The second section
reviews the participatory ergonomic design within health systems. Section three provides an
overview of the phenomenology research approach for this study and section four is an overview
of the research design. The fifth section describes the participatory ergonomic analysis and the
sixth section discusses technique applications impacting patient safety.
Section 4.1: Participatory Ergonomic Introduction
In 1991, Dr. Kageyu Noro at Waseda University in Japan and dissertation committee
member Dr. Andrew Imada at the University of Southern California in the United States
partnered to author the book Participatory Ergonomics. In this book, Dr. Imada communicates
that ergonomics can play a critical role in improving safety as well as quality, and has “extended
beyond the simple matches between humans and machines to cognitive area such as software
design, decision making and decision facilitation” (Noro & Imada, 1991, p. 30). He explains that
there has been an evolution of ergonomics from the first generation focus on dials and knobs, to
a second level focus on human cognition, and a third-generation incorporation of human machine
matching.
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Noro and Imada initially introduced the term participatory ergonomics in 1984 as a
Macro ergonomic perspective under the conceptual premise that ergonomic limitations are
determined by the degree of human involvement in technology creation. Hence, participatory
ergonomics “requires that end users (the beneficiaries of ergonomics) be vitally involved in
developing and implementing the technology” (Noro & Imada, 1991, p. 30). Dr. Imada justifies
participatory ergonomics based on the following reasons:
1. Ergonomics in and of itself is an intuitive science.
2. Ownership in ideas enhance the likelihood of implementing ergonomics successfully.
3. End-user participation in developing technology creates a flexible problem-solving
tool. (Noro & Imada, 1991, p. 31)
The need for participatory ergonomics was globally fostered as division between
technology developers and end users grew through the industrial revolution. In alignment with
the hierarchical Taylor Management Model, technical leaders then believed they required
minimal involvement with or contributions from individuals utilizing the technology.
Additionally, the concept of ergonomics shifted to be a profession that deviated from its amateur
beginnings of being driven by love or passion for the trade. The term amateur acquired negative
connotations as being crude or less scientific and professional disciplines became “more
complicated and removed from the potential beneficiaries they were intended to serve” (Noro &
Imada, 1991, p. 34). To counter this perspective, “participatory ergonomics proposes to make
the end user a vital part of [the] scientific methodology” of technological development (Noro &
Imada, 1991, p. 34).
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Participatory ergonomic interventions could be nationally, organizationally, or
operationally inspired, so respectively, there are socio-psychological, organizational, and
technological reasons for groups or individuals to pursue this interactive approach to problem
solving. Socio-psychological rationale include social motivation and psychological satisfaction,
grass roots small wins, communities creating change, and environmental stress as well as
bounded rationality. Organizational rationale involves the nature of business cycles,
international market-place competition, new product demands, human dependent system
reliability, as well as workforce education enhancement. Technological rationale relates to
technology changes and complex human-technology interactions.
Some common participatory ergonomic techniques are Pareto analysis, cause and effect
diagrams, qualitative illustrations, five ergonomic viewpoints, link analysis, checklists, world
maps, round-robin questionnaire, layout modeling and mock-ups, and slides or videos, as well as
learning points and pictorial analysis. Other tools exist and may be more applicable, but the
“tools used to solve the problem are not as important as the effect they have on the [participants’]
mindset” (Noro & Imada, 1991, p. 31). It is more imperative that the tool facilitates the
participants’ understanding of how they can apply ergonomics to their operations to improve
comfort, productivity, and safety. Ultimately, the technique “needs to be simple and directed at
the audience and problems that they are intended to solve” (Noro & Imada, 1991, p. 30).
In industrial organizations, participatory ergonomics involves the ergonomist working
with non-experts on a company-wide basis. Its advantages include efficient utilization and
integration of people and information as well as the ingenious utilization of human information,
skill and experience, artificial intelligence, and knowledge engineering. Participatory
ergonomics generally involves a phased approach that includes: (1) Select a theme, (2) Establish
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a goal, (3) Understand the situation and analyzing factors, (4) Identify problem, (5) Develop and
improve measures to solve problem, and (6) Confirm effect of measures taken. Although the
ergonomist can provide guidance through these phases, they could also get too focused on the
methodology rather than the goal the participants seek to achieve. Thus, the value of
participatory ergonomics is in “enabling people to participate in developing, designing, and
utilizing ergonomics to improve their work” (Noro & Imada, 1991, p. 30).
Section 4.2: Participatory Design Literature
Participatory ergonomics is a form of participatory design with global impact that date
back to the mid-1900s with Swedish economic policies and labor practices that began in the
automotive industry and then expanded into the information technology and service sector.
There are various national and organizational case studies on participatory ergonomic
applications documented by Noro and Imada (1991) that are listed in Table 4.1. These examples
of industrial applications range from participatory design of office space to the utilization of
participatory ergonomics to design manufacturing operations.
The participants within these participatory ergonomics examples were primarily office
employees and production employees seeking to improve quality and safety within their
professional lives. The country-focused projects were inspired by socio-psychological rationale
and company-focused projects were inspired by organizational rationale. Techniques for these
applications often included some form of checklists, round robin questionnaire, and layout
modeling, although occasionally involved world maps and learning points as well as cause and
48
effect evaluation. Essentially, none of these case studies involved home health systems
applications with pediatric patients on invasive medical therapies.
Table 4.1: Historical Participatory Ergonomics Examples
Healthcare participatory design applications began to become more popular in the 1990s
and expanded in the 2000s. A literature review of participatory design applications in healthcare
was conducted in preparation for this dissertation study to determine if comparable projects have
been previously conducted. Previous participatory design healthcare application research
projects were identified and segmented into four age based patient care groups: Geriatric Care,
Adult Care, Pediatric Care, and Generic Care. To create alignment across dissertation studies,
the previous participatory design research project articles identified were reviewed to determine
the PhD work system components involved.
This literature review determined if the research project’s, as well as the participant's
environment, were clinical or non-clinical, the organization was healthcare or non-healthcare, the
technology was invasive or non-invasive, and the type of task associated with the study. As
shown in Table 4.2, a couple of participatory design studies were conducted specific to geriatric
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patients, a few studies focused on adult and pediatric patients, and most of these studies included
the general patient population. Many of these studies concentrated on task related to mental
health, hospital management, and cancer services, but a couple of them focused on tasks relevant
to this study such as neonatal care and gastroenterology care.
Table 4.2: Literature Review of Participatory Design Applications in Healthcare
Previous geriatric participatory design studies included non-clinical and clinical
participants using non-invasive technology, but only one of these studies were conducted in a
non-clinical environment. Similarly, participatory design studies involving adult patients in
clinical settings with non-clinical and clinical participants, but only one included invasive
technology. The pediatric participatory design studies were in clinical environments with
50
clinical as well as non-clinical participants and two of them involved invasive technology. All
the general care participatory design studies were in clinical settings, mostly with non-clinical as
well as clinical participants and a handful of them included invasive technology
The Home-based Design and Pediatric Family Centered Rounds study was the most
relevant to this dissertation study because they respectively involved non-clinical settings and
family caregivers. Both were motivated by socio-psychological rationale, which means they
were inspired by social motivation, psychological satisfaction, grass roots small wins,
communities creating change, and environmental stress as well as bounded rationality. The
Home-Based Healthcare applied the Layout Modeling Mock-up participatory ergonomics
technique and the Family Centered Rounds project used the Round Robin Questionnaire tool.
Neither of these studies focused specifically on family caregivers of pediatric patients on
invasive medical therapies in non-clinical settings. Hence, the finding of this dissertation study
related to participants’ rationale and techniques for applying participatory ergonomics will
provide a novel contribution to the current body of knowledge.
Section 4.3 Phenomenology Research Approach
Creswell’s Qualitative Inquiry and Research Design states a “phenomenological study
describes the common meaning for several individuals of their lived experience of a concept of a
phenomenon” (Creswell, 2013, p. 76). This method is often used to understand what individuals
experience as well as how they experience events, which is why this method is popular in
nursing and the health sciences. Phenomenology philosophy involves exploration of wisdom
and intentionality of conscious but lacks presupposition and subject-object dichotomy.
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Hermeneutical phenomenology describes research as oriented toward lived experiences and
interprets the texts of life, whereas transcendental/psychological phenomenology focuses less on
the interpretation and more on a description of the experiences of the participants.
The procedure for conducting phenomenological research starts with determining if the
research problem requires understanding “several individuals’ common or shared experiences of
a phenomenon” (Creswell, 2013, p. 76). Next, philosophical assumptions are determined, and
insight is acquired from people involved in the phenomenon by interviewing 5-25 individuals.
Participant interviews are typically focused on answering the questions regarding their
experience with the phenomenon and the context that influenced their experiences. After data is
collected, it is analyzed through horizontalization or by identifying statements or sentences that
provide insight into participant’s experience of the phenomenon; meaning clusters are then
developed into themes. These themes are used to form a textural description of what individuals
experience and a structural description of the setting impacting how individuals experienced
phenomenon.
The benefit of phenomenology research is that it provides in-depth insight into collective
individual experiences that could inform counselors, educators, clinicians, politicians, and others
involved in participatory ergonomics. Additionally, this research approach provides much
needed structure to new researchers but too much structure for experienced researchers. A
challenge of this approach is that it requires researchers to understand wide-ranging
philosophical ideas that are difficult to communicate in writing.
A synthesis of the phenomenology research approach and participatory ergonomic
applications relevant to the aims of this dissertation study are outlined in Table 4.3. The
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phenomenology research approach was selected to analyze the characteristics of pediatric
invasive medical therapy caregivers and care recipients in the home environment. Hence, this
study uses this research approach to evaluate the rationale that inspired family caregivers to use
participatory ergonomic techniques to develop customized solutions for pediatric patients on
invasive medical therapies in non-clinical settings as described in the next section.
Table 4.3: Synthesis of Phenomenology Research for Participatory Ergonomic Application (Creswell, 2013)
Section 4.4 Research Design Overview
Data collection for this dissertation chapter also included identifying a purposeful
sampling of pediatric patient family caregivers who volunteered to be interviewed after the
occurrence of an undesirable outcome involving invasive medical therapy in non-clinical
environment. It includes a subset of the patient families experiencing undesirable outcomes
identified through the Pulmonology and Gastrointestinal clinical staff at a predominant pediatric
53
hospital in Southern California during a CTSI interdisciplinary study. This work was supported
by the NIH/NCRR SC-CTSI Grant Number UL1 TR000130. Its contents are solely the
responsibility of the authors and do not necessarily represent the official views of the NIH. The
larger CTSI study patient family interview transcripts and digital images selected for this aim of
the dissertation was based on their willingness to participate in follow-up interviews and consent
for digital images of their non-clinical settings to be taken for use in this analysis.
Although five parenteral nutrition and six mechanical ventilation pediatric patient
families originally consented for interviews, only three parenteral nutrition families agreed to
follow-up interviews and five mechanical ventilation families permitted digital imaged images to
be taken of their home environments. Patient families were consented for interviews as well as
images to be used for research; initial as well as follow-up interviews with eight pediatric
invasive medical therapy families were recorded and digital images participatory ergonomic
applications in non-clinical settings were captured. Recording of caregiver as well as care
recipient interviews were transcribed and digital images of homecare setting of pediatric patients
on parenteral nutrition and mechanical ventilation were de-identified to keep volunteers
anonymous. Transcripts of invasive medical therapy caregivers interviewed in home settings,
digital observation images, and field interview notes were sorted according to patient family and
stored on a secure computer server.
The phenomenology research approach was then used to evaluate why and how family
caregivers of pediatric patients on invasive medical therapies applied participatory ergonomic
techniques to reduce undesirable outcome occurrences and ultimately. These innovative parent
caregivers applying participatory ergonomic techniques could be considered a lifesaver to their
child patients, so will be characterized as “super parents” within the context of this dissertation.
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Open coding of follow-up interview transcripts was conducted to identify instances of the super
parent phenomenon, which is when a family caregiver chooses to use participatory ergonomics
to develop custom interventions in their non-clinical environment to decrease the occurrence of
undesirable outcomes involving invasive medical therapies on their child. These super parent
instances would include a unique procedure implemented or product incorporated into the family
caregivers’ work system that mitigated the risk of a near miss or adverse even. Axial coding
then was conducted on the follow-up interview transcripts to determine the super parent’s
rationale and inspiration for using participatory ergonomics in their non-clinical environment.
Axial coding was also conducted on the home observation images to understand the participatory
ergonomic technique or tool used to develop the procedure or product implemented to reduce the
occurrence of undesirable outcomes.
Table 4.4: Participatory Ergonomic Rationale Categories and Inspiration Descriptions (Noro & Imada, 1991)
As mentioned in Section 4.1, the rationale for individuals or groups to use participatory
ergonomics to develop custom interventions could be based on socio-psychological,
organizational, and technological reasons. In the second chapter of the book Participatory
Ergonomics, Dr. Imada elaborates on these rationale categories and the associated types of
inspiration, which are described in Table 4.4. Socio-psychological based rationale is more
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commonly associated with national problems in which citizens are inspired by social motivation
and psychological satisfaction. Social Motivation inspiration is usually triggered by groups
involved in discussions that determine the outcome, and Small Wins relate to inspiration
generated by the identification of a sub-component of a larger problem that can be readily
addressed by subset of individuals. People Creating Change is inspired by moderate nudges
from grass roots groups to address a problem and Mental Stress inspiration involves
environmental pressure to solve a problem. Bounded rationality inspiration involves perceived
workarounds to handle a problem and self-determination inspiration involves choosing to
directly engage in the development of a solution.
Organizational rationale for using participatory ergonomics is usually affiliated with a
corporation of employees or association of members inspired by the nature of business cycles,
international market-place competition, new product demands, and human dependent system
reliability, as well as workforce education enhancement. Business Nature inspiration often stems
from economic demands to address structural problems, and International Marketplace
inspiration is usually initiated by global competition. Product Technology inspiration is
generated from unique resource requirements, Human Reliability inspiration is based on systems
that rely on human involvement, and Workforce Advancement inspiration is associated with
increases education to enlighten individuals on how to solve problems. Technological rationale
for using participatory ergonomics is often associated with people inspired by Technology
Changes or Matching Humans with complex technology. Technology Change inspiration is
based on the introduction of new technology that leads to involvement in problem solving, and
Matching Humans inspiration develops from the need for humans to solve problems caused by
technological advancements.
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The phenomenology research approach was used to understand the super parent
phenomenon, including their rationale for using participatory ergonomics and their techniques
for applying participatory ergonomics to develop customize solutions that reduce the occurrence
of undesired outcomes. Caregiver interview transcripts were analyzed to capture the essence of
“what” the super parents experienced as inspiration for using participatory ergonomics. The
home observation images were evaluated to capture the essence of “how” the super parents used
participatory ergonomic techniques to improve outcomes. The dissertation researcher coded the
interview transcripts based on the participatory ergonomic rationale and inspiration described in
Table 4.4 within the NVivo software to develop grouping statements related to the rationale
categories of socio-psychological, organizational, and technological perspectives identified by
Noro and Imada.
Likewise, the traditional participatory ergonomic techniques described in Table 4.5 were
used by the researcher for coding interviews and photographs within the NVivo software to
develop grouping statements provided in the Participatory Ergonomics book. These techniques
include Pareto analysis that is a histogram of the vital few that cause 80% of problems as
identified in the previous chapter. Additional techniques included Cause-and-Effect (also
referred to as a Fishbone Diagram because it often includes fins identifying the Machine),
Methods, Materials, Man, Measurements, and Mother Nature. Other tools are Qualitative
Illustrations such as other types of charts used for data analysis, Check-lists that are tasks
itemized to jog one’s memory, and World Maps that requires participants to create lists.
Alternative techniques could be Link Analysis for pinpointing movement of information as well
as people, Five Ergonomic Viewpoints of a participant in their workspace, or Layout Modeling
for participants to simulate workspace for evaluation. Additional options are Round-Robin
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Questionnaire that involves statements for participants to complete, Slides or Videos to visualize
work area for evaluation, and Key Learning Points used to divide problem into smaller pieces.
Table 4.5: Participatory Ergonomic Technique Descriptions
Section 4.5: Participatory Ergonomics Analysis
The dissertation researcher analyzed the CTSI study caregiver interview transcripts by
coding the statements that provided insight on the super parents’ rationale for using participatory
ergonomics to develop innovative procedures or products to reduce the instances of undesired
outcomes. As mentioned in Chapter 3, the CTSI study interviews used for this analysis were
narratively structured to understand the family caregivers’ overall experience when caring for a
pediatric patient on HMV as well as HPN, so interviewees would describe their innovative
approaches for avoiding undesired events this context. Caregiver statements were coded by
tagging them in NVivo with the type of inspiration that best described what the super parent
experienced that led them to develop a custom solution that improved the safety of their child on
invasive medical therapy. The coded statements were counted by type of caregiver inspiration,
58
and the percentage of the total number of statements coded was calculated for each type of
inspiration.
Coding analysis of the data points that emerged from CTSI study caregiver interviews
revealed that only about 10% of super parents’ inspiration to apply participatory ergonomics in
their non-clinical environment was based on organizational rationale, which included a couple
instances relevant to Business Nature and a couple related to Human Reliability as well as
Workforce Advancement as shown in Table 4.6. The Business Nature inspired innovations were
driven by the super parent’s need to develop computerized method for tracking the demand and
supply of frequently replaced equipment parts such as circuits provided by pharmaceutical
vendors. Similarly, the Workforce Advancement inspiration involved super parents creating
methods for collectively timing and tracking the use of those supplies and Human Reliability
inspired methods for conveniently and safely disposing of supplies after use. These are logical
findings because they involve coordination between the internal family organization and the
external vendor organizations.
Coding analysis of caregiver interview transcripts also led the researcher to discover that
almost 90% of super parents’ use of participatory ergonomics techniques that emerged during the
CTSI study’s narrative interviews were inspired by Technological justifications. Calculations
displayed in Table 4.6 are primarily representative of caregiver inspirations voluntarily shared,
so additional undiscussed inspirations could also exist. Evaluation of volunteered inspirations
revealed that 40% of family caregivers chose to use participatory ergonomics because of changes
in the technology required to care for their child in the home setting; almost 50% of caregivers
were motivated by the need to adapt technology to their child’s environment. Generally,
caregivers were inspired to use participatory ergonomics based on their need to incorporate
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clinical equipment into non-clinical environments for invasive medical treatment. Often
caregivers used participatory ergonomics to adapt residential space to accommodate for the
complex supplies and clinical tasks associated with therapies. Otherwise, caregivers used
participatory ergonomics for developing methods to access or transport critical supplies when
and where they were needed.
Significance statements for tools used by caregivers using participatory ergonomics to
improve safety for pediatric patients on invasive therapies in non-clinical settings were also
established. What inspired the caregivers as rationale for using participatory ergonomics and
how they modified industrial tools to develop unique solutions were then aggregated to develop
the essence of the phenomenon. Section 4.6 provides further details on these findings in the
form of tables and figures to display the applications of participatory ergonomics within the
homes of pediatric patients on invasive medical therapies with lay caregivers.
Table 4.6: Participatory Ergonomic Rationale and Inspiration Findings
The dissertation researcher also analyzed home observation images by coding the
photographs that provided insight on the participatory ergonomics techniques super parents used
to develop innovative procedures or products to reduce the instances of undesired outcomes.
Digital images were coded by tagging them in NVivo with the participatory ergonomic
60
techniques that best described how the super parent developed the procedure or product that
improved the safety of their child in their non-clinical environment. The coded images were
counted by type of technique and the percentage of the total number of statements coded was
calculated for each technique. The CTSI study’s digital used for this analysis have been redacted
from the content of this dissertation to comply with HIPPA regulations, and can be requested
from the PI, Dr. Glenn Takata, as needed.
Calculations in Table 4.7 also primarily representative of caregiver techniques voluntarily
shared, so additional undiscussed techniques could also exist. Coding analysis results shown in
Table 4.7 revealed that participatory ergonomics techniques were generally used to create
accessibility, mobility, and structure. The Five Ergonomic Points technique was mostly used to
establish immediate accessibility to equipment or supplies. Likewise, the Five Ergonomic Points
and Mock Layout techniques were used to improve the mobility of equipment as well as
supplies. Lastly, the Learning Points technique was used to establish stability, such as when a
mother developed a custom vest with fasteners to provide stability for circuits on the child’s
body to avoid accidental disconnection.
Table 4.7: Participatory Ergonomic Technique Findings
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When evaluating the participatory ergonomic tools used by super parents in the
residential settings, three techniques defined 80% of the applications. A simplified version of the
Five Ergonomic Viewpoints in which the caregiver evaluated their workstation from five points
of view was used for 44% of the instances participatory ergonomic applications were identified.
Additionally, a modified version of Layout Modeling Mock-ups to evaluate new workstations
and new tools for improvements were used in 20% of the identified participatory ergonomic
applications. Lastly, a lay version of Learning Points and Pictorial Analysis to evaluate tasks by
component parts and user illustrations were used in 16% of the participatory ergonomic
applications identified.
Section 4.6 Technique Application Discussion
The Five Ergonomic Viewpoints technique is very applicable to pediatric invasive
medical therapy in home environments because it focuses on the perspective of the caregiver as
well as the patient with workspace arrangement. The viewpoints are from directly above,
standing eye-level, workstation level, diagonally below and foot level from the user or caregiver
perspective. These viewpoints are especially important in confined areas involving medical
devices for pediatric patients. These situations often involved shelving adjacent to the patient’s
bedside to ensure short distance to the invasive technology given the constraints of the supplies
involved. Identified best practices involved five-tiered shelf adjacent to a baby crib within the
proximity of enough lighting to support caregiver with visibility of supplies to ensure the
accuracy of selections made.
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The Five Ergonomic Tools are a complementary addition to the viewpoints as they
incorporate valuable performance metrics to support continuous improvement within the
workspace over time. The Five Ergonomic tools include Time Analysis, Fault-Tree Analysis,
Non-Injury Assessments, Visual Assessments, and Force Evaluations. For instance, the weight
of the equipment and the volume of the supplies would impact where caregivers locate them in a
multi-tiered arrangement. In the arrangement of one HMV patient, the foot level of the shelving
stored equipment and supply carrying cases that are low priority items; this makes the placement
of straps important to avoid the possibility of caregiver tripping while walking in that area.
Use of the Time Analysis ergonomic tool caused the super parent to place the equipment
at the diagonal level due to its proximity to the mattress level of the patient’s crib as well as the
weight of the technology. The Fault-Tree Analysis ergonomic tool led the caregiver to keep an
extra mechanical ventilation pump next to the functional vent as an emergency backup if the
primary device malfunctions. The Non-Injury Accident Evaluation ergonomics tool could also
be useful in selecting the placement of circuit tubes at this level to avoid getting hooked or
punctured accedintally. The Illustrative Diagrams of People Posture and Object Posture
ergonomic tool resulted in the placement of clinical, sanitation, and technical supplies on the
workstation level on the shelf in multiple volumes to avoid the possibility of them not being
readily available. The Force Ready Evaluation ergonomic tool led to the standing level of this
shelving arrangement being selected to store non-clinical supplies useful for maintaining the
comfort and temperature of the pediatric patient, such as lightweight blankets to avoid physical
strain.
Additionally, the Five Ergonomic Viewpoints were used by caregiviers to configure
sleeping arrangements for a young child on mechanical ventilation on a twin sized bed, which
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also involved custom shelfing due to the unique height and development stage of the patient. In
this instance, because the child was becoming more self-sufficient, the viewpoints were from the
perspective of the pediatric patient; thus, the distance between each level caused complexity with
the application of the Five Ergonomic Viewpoints because of the patient’s short but growing
arm-span. This resulted in shorter, narrower, and adjustable shelves as well as a lower quantity
of equipment and supplies to accommodate the limited space available. Additionally, this
arrangement involved adjustable workarounds incorporating a portable dinner tray as a shelf and
labeled transparent bags pinned a wall to create storage for supplies.
Five Ergonomic Viewpoints were also used to develop mobile solutions for mechanical
ventilation patients that included arm extensions for additional workstation space and cabinets.
Sanitation supplies such as cleaning bins were located at the foot level view, clinical supplies
such as medications were stored at the diagonal level, and technical supplies such as circuit
connector were stored in a drawer below the workstation level. Additional sanitation supplies
that did not fit in the cabinets or drawers were place above the workstation for convenient access
as needed.
Caregivers also used modified versions of the Mock Layout tool as well as the Five
Ergonomic Viewpoints to incorporate equipment supporting the invasive therapy such as air
tanks, humidifiers, and hospital style beds when necessary into a pediatric patient bedroom.
Another best practice for using Mock Layout technique would be to use mobile platforms that
also support continuous improvement over time. Caregivers in this Five Ergonomic Viewpoints
application chose to place bedding supplies like blankets at the foot level viewpoint, bathing
supplies like towels at the diagonal level viewpoint, clinical supplies like medication at the
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workstation level, and sanitation supplies like Pampers at standing level viewpoint to avoid
physical strain.
Coding analysis of CTSI field notes and digital images revealed that other super parents
appeared to be using Mock Layout application that involved mobile platforms such as portable
Intravenous therapy stands to support multiple portable devices such as parenteral nutrition
pumps to reconfigure caregiver workspace to better structure patient care. An additional best
practice would be to apply the Mock Layout technique in environments with extensive space for
movement.
Coding analysis found that the Participatory Ergonomic Learning Points technique was
occasionally used by super parents of toddler-aged parenteral nutrition patients due to the
patient’s frequent movement and excessive exploration. Traditionally, with this tool, a worker
would analyze stress on body parts or joints to develop solutions to their problem; a caregiver
could also use this tool to evaluate stress on component parts of invasive therapies. This
technique involves two components, according to the book Participatory Ergonomics (Noro &
Imada, 1991):
• [Break] the task down into its component parts.
• [Illustrate] in a form that is very common to the culture’s cartoon characters. (p. 46)
One super parent used a version of the Participatory Ergonomic Learning Points
technique to create the pediatric vest with adjustable straps, fasteners, and buttons used to secure
invasive catheter circuits on the child to avoid the catheter from being accidentally dislodged by
the caregiver or the patient. The design involved breaking the task of connecting catheter
circuits into its component parts and using cartoon animals print patterned material, shiny
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fasteners, and bright colored buttons to illustrate the vest’s connector interaction with the
catheter circuit’s connectors. This super parent (a.k.a. parental caregiver applying participatory
ergonomic techniques) even designed the vest to be adjustable so that its fit could be modified as
the patient grows.
Once pediatric patients were able to walk independently, super parents also used the
Learning Points technique to incorporate backpacks into their child’s attire and arrangements to
transport parenteral nutrition pumps with the patient during invasive therapy. Backpacks were
valuable methods for ensuring that the nutrition pump stayed within a short distance from the
catheter circuit’s point of insertion on the patient’s body to reduce the possibility of the catheter
being accidentally dislodged. Additionally, the backpack was used to store supplies associated
with the device to ensure immediate accessibility when necessary and to provide a method for
the pediatric patient to independently carry these items.
In conclusion, this study confirmed that the qualitative research approach of interview
transcript open coding analysis is a useful method for understanding what family caregiver of
pediatric patients on invasive medical therapies experience that inspires the super parent
phenomenon. The axial coding approach also provided insight on how super parents use
participatory ergonomic techniques to improve patient safety and reduce undesired outcomes in
non-clinical environments. Hence, this dissertation study was effective at addressing the NRC’s
research recommendation related to Characterizing Caregivers, Care Recipients, and Home
Environments. The participatory ergonomic application analysis found that most family
caregivers who participated in the CTSI Study’s follow-up interviews were motivated by
technological rationale to become super parents to their pediatric patients. It also found that
super parents were inspired by technology changes required for their child’s invasive medical
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therapy and by the need to better match those devices with their pediatric patient and/or
residential environment, given that most invasive medical devices were designed for use in
clinical environments by clinical practitioners. Overall, this study identified that super parents
more often used versions of the Five Ergonomic Points, Mock Layout, and the Learning Points
participatory ergonomic techniques to develop custom solutions.
As a result, the preliminary findings of this chapter’s analysis were influential in
discovering the characteristics of family caregivers and care recipients in home settings that
could inform future research studies with a larger sample size of patients and caregivers. Future
analysis of specific elements within each inspiration type would be enlightening and could
provide greater support for these conclusions. Future analysis stratified by HMV and HPN
would also be enlightening. This dissertation chapter’s findings influenced the fifth chapter’s
aim focusing on the NRC’s recommendation to develop “Tools for Assessing Home Health Care
Tasks and Operations.” These findings are significant contributions to the limited body of
knowledge on pediatric home health patient safety.
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Chapter 5
Human Factors Components
This chapter provides a review of a human factors component tool for assessing home
health care tasks and operations involving invasive medical devices. The first section introduces
the human factors component focus of medical accrediting agencies. Second section reviews the
professional organizations and clinical associations involved with invasive medical therapy.
Section three provides an overview of the case study approach for this research and section four
is an overview of the study design. The fifth section describes the devise user interface results
and the sixth section discusses invasive device rating outcomes.
Section 5.1: Human Factors Introduction
Human Factors standards for medical devices and healthcare operations are primarily
driven by the three organizations listed in Table 5.1 domestically, and these organizations are
rapidly expanding their impact internationally as the market for Western medicine expands
globally. The Human Factors & Ergonomics Society (HFES) is the primary professional
organization advocating for human factors applications to improve safety of medical devices and
quality of health systems through conferences, publications, webinars, consultants, and
programs. HFES also develops academic and industry standards through partnerships with the
American National Standards Institute as wells as the International Standards Organization.
Additionally, developed HFES standards such as the Guidelines for Human Factors Engineering
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of Software User Interfaces (HFES 200) and the Guidelines for Using Anthropometric Data in
Product Design (HFES 300).
The Joint Commission (TJC) is an independent non-profit organization that seeks to
“continuously improve health care for the public, in collaboration with other stakeholders, by
evaluating health care organizations and inspiring them to excel in providing safe and effective
care of the highest quality and value” (TJC, 2018, para. 2). The TJC primarily focuses on the
clinical organization certification and the hospital operation accreditation, but it has extended its
reach to home healthcare due to increasing growth in this market. A decade ago, its Center for
Transforming Healthcare was created to create “solutions for high reliability health care” that
encourages the application of Human Factors and Ergonomic techniques to improve care quality
of clinical operations and patient safety of medical devices (TJC, 2018).
Table 5.1: Overview of Human Factors Advocacy Organizations
For almost two decades, the Human Factors have been increasing as a priority for
medical device developers’ due to greater requirements by the Food and Drug Administration as
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displayed in Figure 5.1. This began in 1999 with the To Err is Human publications that revealed
that within the United States, almost 100,000 deaths resulted from medical errors in hospitals
that cost the nation almost $30 Billion (Ron, 2011). The following year, the FDA’s Center for
Devices and Radiological Health provided human factors guidance for risk analysis. In 2001, the
Association for the Advancement of Medical Instrumentation then established a Human Factors
Design Process for Medical Devices. Five years later, the International Electrotechnical
Commission provided Collateral Standards for Usability of Medical Electrical Devices.
Figure 5.1: Recreation of FDA Device User Interface Operational Context (Redmill and Rajan, 1997)
In 2016, the FDA released the latest Human Factors and Usability Engineering Guidance
for Medical Devices that enhances focus on diverse user including lay caregivers and inclusive
environments such as residential homes. The FDA also has expanded the focus on the medical
device user interface to heighten the impact of devices inputs, processing/reactions, and outputs
on user information perception, cognitive processing, and control actions as shown in Figure 5.1.
The advantages of these modifications are that they increase device developer’s focus on
tasks such as set up, use, and maintenance as well as interactions with visual, auditory, and
tactile components involved in user use. It also encourages developers to conduct preliminary
human factors analysis through preliminary hands-on studies to assess risk controls for critical
tasks. Developers are expected to validate device risk controls with intended user populations in
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practical environments to develop instructions and training intended to ensure appropriate use by
users.
The disadvantage is that for invasive medical devices, the user interface development and
evaluation would primarily focus on interactions with the infusion or ventilation pump. These
would assist with instructions and training on the circuits and sources connecting the lay
caregiver with the medical device, but could neglect the invasive interface between the pediatric
patient and invasive therapy. The relevant research on invasive medical devices identify patient
device interface and the lay caregiver tasks associated as the interactions that create the greatest
risk.
Section 5.2: Invasive Device Literature
The American Society for Parenteral & Enteral Nutrition (ASPEN), the American
Association for Respiratory Care (AARC), and the Association for the Advancement of Medical
Instrumentation (AAMI) are the three organizations focused on parenteral nutrition, mechanical
ventilation, and medical devices as listed in Table 5.2. Founded in 1976, ASPEN is “dedicated
to improving patient care by advancing the science and practice of clinical nutrition” and
provides various resources such as webinars and programs as well as guidelines and standards
for improving safety of parenteral nutrition (ASPEN, 2018). The AARC was established almost
three decades prior in 1947, and includes over 52,000 “respiratory therapists and allied health
practitioners who are trained at the 2- and 4-year college level to assist physicians in the care of
patients with lung disorders and other conditions” (AARC, 2018).
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Table 5.2: Overview of Medical Device Advocacy Organizations
The AAMI was established in 1967 as the “the primary source of consensus standards,
both national and international, for the medical device industry, as well as practical information,
support, and guidance for healthcare technology and sterilization professionals” (AAMI, 2018).
AAMI additionally has a foundation focused on research in the relevant areas of Infusion
Therapy Safety, Complex Healthcare Technology, and Homecare. The AAMI has partnered
with the FDA to host various collaborative summits on invasive medical devices and home
health care with participants ranging from clinical practitioners to device developers to identify
clarion themes for improving patient safety and quality care. The most relevant summits to this
study are listed chronologically in Table 5.3.
The 2010 AAMI/FDA Infusion Device Summit identified five priority themes for
parenteral nutrition therapy the first of which was to “standardize systems and processes for
reporting, aggregating, and analyzing infusion device incidents” (AAMI, 2010, p. 3). The
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second priority was to improve infusion devices integration with information systems and the
third was to mitigate infusion device use errors. The fourth theme was to improve multiple
infusions management and the fifth theme was to resolve infusion device environment issues.
Hence, this summit primarily focused on clinical environments and users, so it was only partially
relevant to this study.
Table 5.3 Relevant AAMI/FDA Medical Device Summits
Alternatively, the 2013 summit entitled A Vision for Anywhere, Everywhere Healthcare
focused on non-clinical environments and users but did not prioritize invasive medical devices.
Summit participants included national academic, industry, medical, and federal thought leaders
as well as patients and identified the top priority as the need to enhance stakeholders’
understanding of device environment variability. Participants secondarily prioritized the need to
advance patient safety by coordinating various care transitions and thirdly prioritized the
opportunity to restructure nonclinical healthcare settings through systems engineering
approaches. The fourth theme was to standardize as well as simplify homecare operations and
the fifth as to design empathically.
Like the inaugural summit, the following year’s topic, Creating a Culture of Safety,
centered on the medical therapy of mechanical ventilation primarily with clinical users in clinical
environments. The top priority of this summit was to improve clinical information by
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developing and advocating for standard ventilator technology terminology; the next priority was
to establish biocompatibility expectation alignment. The third theme involved enhancing
technological as well as clinical proficiencies, and the fourth suggested progression of device-
system integration. The fifth priority was to “leverage human factors engineering to reduce
operational complexity and enhance the safety and effectiveness of ventilators” and the sixth was
to “embrace strong and transparent cooperation, coordination, and collaboration among all
stakeholders” (AAMI, 2014, p. 5).
The 2015 AAMI/FDA Summit was entitled Making Risk Management Everybody’s
Business; hence, this was the primary priority identified by participants, but it also focused on
clinical environments and users. The secondary priority was to establish a collective
understanding of healthcare technology risks and the tertiary priority was to acclimate systems
engineering’s risk management methodologies, procedures, and techniques. The fourth theme
involved “Engage in a total life cycle approach to risk management of healthcare technology”
and the fifth theme involved creating “new practical tools to continue advancing the field of risk
management for healthcare Technology” (AAMI, 2015, p. 5).
The last summit also involved The Joint Commission, the Center for Disease Control,
and the American Hospital Association; it was entitled Preventing Device-Related Healthcare-
Associated Infections. Participants were segmented into three groups to focus on people
interacting with medical devices, places where equipment is being used, and the things or
technology involved in healthcare. This summit also involved invasive medical and the findings
of these collaborative groups included five people related priorities, seven places priorities, and
nine things priorities, listed in Table 5.4.
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Table 5.4: Priorities Identified by Summit Participants (AAMI, 2016, p. 9-12)
Table 5.5 outlines a literature review of home health research projects featured in the
Spring 2013 Edition of AAMI Horizon’s Publication that focused on human factors
considerations in home healthcare related to usability, labeling, design, and security. The entire
usability project focused on non-clinical environments and users, but none of the involved
invasive technology. Most of the labeling projects aligned with the same profile except for one
project involving invasive infusion pumps in clinical environments and users. All the design
consideration projects included non-clinical environments; only two of them focused on non-
clinical caregivers and only one of them incorporated invasive medical therapy. Lastly, both
security research projects involved non-clinical environments and caregivers, but none of them
focused on invasive technology. In turn, this segment of the dissertation study is novel because
it involves non-clinical environments and users as well as invasive medical technology.
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Table 5.5: Research Projects Related to Human Factors Considerations for Home Healthcare (AAMI, 2013)
The FDA document, Applying Human Factors and Usability Engineering to Medical
Devices, was used in this study to identify human factors consideration and develop sub-
considerations relevant to invasive medical devices. Dr. Molly Story presented an overview of
this document during a RAPS Webinar entitled FDA Perspectives on Human Factors on Device
Development, which generally categorized users based on their professional training and
experience was well as users’ physical capabilities and mental condition. Similarly, this
presentation provided broad categories for use environments such as clinical facilities,
transitional locations, residential settings, community environments. and mobile structures.
Likewise, Dr. Story covered user interface categories that included tasks such as device set-up,
use, and cleaning, as well as input interactions and output features like visual, auditory, and
tactile characteristics.
This study is a novel application of the FDA Medical Device Human Factors
Consideration model in Figure 5.2 that displays the user, environment, and interface inputs that
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impact the safety and effectiveness outputs that impact patient outcomes. It uniquely uses the
FDA Human Factors model to evaluate the human factors risks of invasive medical devices used
by lay caregivers in non-clinical environment. This study aims to use the FDA Medical Device
Human Factors Consideration Model addresses the NRC’s research recommendation regarding
“Tools for Assessing Home Health Care Tasks and Operators.” The dissertation researcher uses
the case study approach to develop a prototype tool for evaluating the FDA human factors
considerations of HPN and HMV devices used by family caregivers on pediatric patients in
home settings.
Human Factors Considerations Medical Device Outcomes
Figure 5.2: Recreation of FDA Medical Device Human Factors Consideration Model (FDA, 2016)
Section 5.3: Case Study Approach
The book Qualitative Inquiry & Research Design, explains that Case Study “research is a
qualitative approach in which the investigator explores a real-life, contemporary bounded system
or multiple bounded systems over time through detailed, in-depth data collection involving
multiple sources of information and reports a case description and case themes” (Creswell, 2013,
p. 97). This approach is a common social science research methodology in anthropology,
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sociology, law, medicine, and political science, and might involve a single or multiple cases
within a study.
Case studies can be descriptive, explanatory, or exploratory; they are defined by several
characteristics and the type of research can be focused either on an individual and group or on a
general process or project. It is important to define the scope as well as the objective of case
studies and to research existing situations to ensure information accuracy. Intrinsic cases are
“composed to illustrate a unique case . . . that has unusual interest in and of itself and need to be
described and detailed” and instrumental cases intend to “understand a specific issue, problem,
or concern and the case or cases selected to best understand the problem” (Creswell, 2013, p.
98).
Good case studies are also characterized as providing a deep understanding of the
scenario by obtaining numerous forms of qualitative data through documents, interviews, and
observations. This qualitative data would then be analyzed within a single case or across
multiple cases for comparison that would involve case description of themes and issues
discovered during research. Additionally, “themes or issues might be organized into a
chronology by the research, analyzed across cases for similarities and differences among the
cases, or presented as a theoretical model” (Creswell, 2013, p. 99). These findings lead to
conclusions about the meaning of these case(s) that can be identified as assertations or
explanations of discoveries made during the research study.
There are various types of case studies based on the research scope as well as participant
involvement. Instrumental case studies focus “on an issue or concern, and then select one
bounded case to illustrate this issue” and a collective case study “the researcher might select for
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study several programs from several sites or multiple programs within a single site” to provide
various perspectives (Creswell, 2013, p. 98). When using multiple cases, researchers are
encouraged to replicate procedures within the study design. Intrinsic case studies focus “on the
case itself because the case represents an unusual or unique situation” (Creswell, 2013, p. 98).
There are multiple steps involved in conducting a case study that starts with deciding if
the problem is best researched through the case study method. The researcher then finds cases
through purposeful sampling after determining the type of case study best for investigating the
problem. Next, data for cases are collected in the form of “documents, archival records,
interviews, direct observations, participant observation, and physical artifacts” (Creswell, 2013,
p. 100). Once collected, that data is evaluated in its entirety or based on certain aspects to
develop descriptions and identify themes within a case or across cases. Finally, findings
regarding common issues or abnormal situations are summarized about the case(s).
A synthesis of case study characteristics and human factors applications relevant to the
aims of this dissertation study are outlined in Table 5.3. The case study research method was
selected to assess home health care tasks as well as pediatric invasive medical therapy operations
and develop invasive therapy evaluation techniques with human factors considerations for
pediatric medical devices to minimize undesirable outcomes of pediatric patients in non-clinical
settings. This method was used to evaluate the psychological and physical human factors
components established as regulatory guidelines by FDA to improved medical device
development for invasive pediatric therapies.
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Table 5.6: Synthesis of Case Study Method for Human Factors Application (Creswell, 2013)
Section 5.4 Research Design Overview
Individual and groups of subject matter experts were identified through clinical staff at
predominant pediatric hospitals as well as through university faculty in Southern California.
Additionally, Clinical & Translational Science Institute (CTSI) investigators and participants
provided information on organizations and individuals involved in invasive medical devices and
clinical therapies. USC Internal Review Board (IRB) reviewed and approved the exemption
application UP-18-00171 for this study as an extension of the CTSI study. As a result, the
sample for this case study consisted of social workers, clinical practitioners, and pharmaceutical
vendor’s interviews and observations, as well as standards organizations and clinical associations
involved with invasive therapy. HPN case interviews included four caregivers, two specialists,
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two vendors, and two organizations; HMV case interviews involved seven caregivers, two
specialist, two vendors, and two organizations.
Unfortunately, most pharmaceutical vendors were resistant to participate in interviews
due to concerns of liability, which limited data collection to document and artifact review of
invasive devices. In turn, data on those vendors as well as other organizations or associations
were collected from public documents and digital artifacts were identified through internet
searches on invasive medical therapy devices. When permitted by participants, virtual
interviews were recorded using the BlueJeans platform, field notes were documented using
Evernote application, and observations were captured with digital images. Caregiver interview
transcripts were stored on secure server, clinician interview recordings and vendor field notes on
secure applications, and device documents and association artifacts on a secure computer.
The CTSI Study’s HPN and HMV cases were used to create a context for mechanical
ventilation devices and to create a context for parenteral nutrition devices respectively. Social
workers and pharmaceutical vendor interviews as well as regulatory organization artifacts and
device manufacturer documents were reviewed in the evaluation of invasive medical device
human factors considerations. Cross-case analysis was used for categorical aggregation to
establish interview themes and observation patterns. Additionally, direct interpretation of the
FDA Medical Device Guidelines Human Factors Considerations in Figure 5.2 were used to
develop naturalistic generalizations for binomial human factors themes relevant to invasive
medical device users, interfaces, and environments.
The FDA Medical Device Human Factors Considerations were used by the dissertation
researcher to establish user, environment, and interface categories shown in Table 5.7 that are
relevant to invasive medical therapies based on themes identified through individual interviews
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and document reviews. Because the aim of this study was to address the NRC’s recommended
research area focused on “Tools for Assessing Home Health Care Tasks and Operators,” the
FDA Medical Device Human Factor Model considerations were aligned with the NRC research
variables of Home Health, Care Tasks, and Operators. The FDA’s Environment consideration
was aligned with the NRC’s Home Health variable, FDA’s Interface consideration was aligned
with the NRC’s Care Task variable, and the FDA’s User consideration with the NRC’s Operator
variable.
The FDA’s User consideration was divided into the binomial PhD considerations of User
Expertise (UE) with factor level options of Low or High and User Capability (UC) with factor
level options of Limited or Extensive. Using the Cambridge Dictionary, the researcher defined
Expertise as level of skill or knowledge and determined that a device requiring Low UE could be
operated by lay people or family caregivers, and one requiring High UE should be operated by a
licensed practitioners or clinical technicians. Capability was defined as ability to use and it was
determined that devices involving Limited UC could be used by individuals with low cognition
or biological challenges, and those involving Extensive UC should be used individuals who are
highly insightful or physically enabled. For safety evaluation purposes, the Low EU and Limited
UC rating for a medical device could range from 0 (minimally challenging) to 1 (somewhat
challenging). Similarly, the High EU and Extensive UC rating could range from 2 (moderately
challenging) to 3 (very challenging).
Similarly, the FDA’s Interface consideration was divided into binomial considerations of
Interface Task (IT) with factor level options of Easy or Difficult and Interface Interactions (II)
with factor options of Simple or Complex Interactions. The Clinical Human Factors Group
defines a Task as a “set of physical and mental actions that are required to deliver, or fulfill a
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function, and achieve a goal” (Ives & Hillier, 2016, p. 4), so the researcher determined that an
Easy IT could involve cleaning equipment or disposing supplies; a Difficult IT would involve
equipment installation and device calibration. No official human factors definition was
identified for interaction, but was defined by the Cambridge online dictionary as when people or
things communicate or react, so it was determined that Simple II would include device interfaces
with moderate screens or alerts, and Complex II would include devices with intricate connections
and knobs. For safety evaluation purposes, the Easy IT and Simple II rating for a medical device
could range from 0 (minimal challenging) to 1 (somewhat challenging). Similarly, the Difficult
EU and Complex UC rating could range from 2 (moderately challenging) to 3 (very
challenging).
Table 5.7: Human Factors Consideration Input Rating Structure
Additionally, the FDA’s Environment consideration was divided into the binomial
considerations Environment Residential (ER) with two factor level options Non-Clinical or
Clinical and Environment Public (EP) with two factor level options Non-Mobile and Mobile.
Cambridge defined Residential as where people live, so the researcher determined that Non-
Clinical ER could be patient homes or caregiver apartments, and Clinical ER would be assisted
living facility or long-term care building. Public is defined by Cambridge as somewhere anyone
can access, so the researcher determined that Non-Mobile EP could include office spaces or
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retail stores, and Mobile EP would include automobiles or planes. For safety evaluation
purposes, the Non-Clinical ER and Non-Mobile EP rating for a medical device could range from
0 (minimal challenging) to 1 (somewhat challenging). Similarly, the Clinical ER and Mobile EP
rating could range from 2 (moderately challenging) to 3 (very challenging).
Lastly, the FDA Model’s Medical Device Outcomes were also expanded to three
segments for this dissertation evaluation that includes Effective and Safe (ES), Effective and
Unsafe (EU), and Ineffective and Unsafe (IU) as displayed in Table 5.8. The ES Device
Outcome means that it has a low risk level, should result in a correct user outcome, and should
probably result in a result in the desirable patient outcome of good health. The EU Device
Outcome means that it has a moderate risk level, could result in a questionable user outcome, and
could possibly result in the undesirable patient outcome of a near miss. The IU Device Outcome
means that it has a high risk level, would result in incorrect user outcome, and would potentially
result in the undesirable patient outcome of an adverse event. The Medical Device Outcome is
determined by the Risk Score calculation range for ES is 0-6, for EU is 7-12, and for IU is 13-18.
The Risk Score Range calculation is determined by adding the Medical Device Human Factors
Consideration Input ratings determined for each device. These scores could be used by the FDA
or Corporations to determine whether a device should be approved, improved, or denied.
Table 5.8: Medical Device Outcome Score Structure (Adapted from FDA, 2016)
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Section 5.5: Invasive Device Evaluation
Family caregiver, social worker, and pharmaceutical vendor interviews as well as user
manuals, vendor videos, and organizational documents for these devices were then evaluated to
analyze the user, interface, and environmental components of the devices. These data sources
were used to determine human factor consideration ratings for the mechanical ventilation and
parenteral nutrition devices in the FDA model areas of user, interface, and environment. The
devices were rated by the sub-considerations for invasive medical devices developed for this
dissertation based on findings within those data sources.
The Curlin 4000, Curlin 6000, and CADD 6101 HPN devices displayed in Figure 5.3
were evaluated by the dissertation researcher for this study. These devices were selected because
they were the primary devices ordered by pediatric gastrointestinal clinicians for family
caregivers to perform invasive medical therapies in non-clinical settings. Cross-case analysis for
HPN device evaluations included interviews with four patient caregiver families, two
pharmaceutical vendor representatives, and a review of ASPEN and AAMI reports. Evaluation
of these devices also included review of Curlin and CADD user manuals and training videos.
Figure 5.3: HPN Medical Devices Curlin 4000, Curlin 6000 and CADD 6101 Respectively Displayed
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Table 5.9: Parenteral Nutrition Human Factor Consideration Ratings (FDA, 2016)
Table 5.9 provides human factor component scores associated with the aforementioned
Curlin and CADD HPN pumps based on the rating structure explained in the previous section. A
thematic review of available HPN data sources revealed that the Curlin 4000 and 6000 only
requires low user expertise and limited user capability, but the CADD 6101 requires extensive
user capabilities due to more challenging physical capabilities required to maneuver the leaver to
change the power sources’ battery. Similarly, the Curlin 4000 and 6000 only involves easy
interface task and simple interface interactions, but the CADD 6101 involves difficult interface
tasks and complex interface interactions due to the difficult contraption used to change the
nutritional fluid circuit. Parenteral nutrition pumps received its best ratings for environmental
considerations due to its small size and portability in non-clinical residential facilities and non-
mobile public settings.
Additionally, the HT50, HT70, LTV950, and the LTV1150 ventilators displayed in
Figures 5.4 and 5.5 were the HMV devices evaluated for this study in that they were the primary
devices ordered by pediatric pulmonology clinicians based for invasive medical therapies by
family caregivers in non-clinical settings. Cross-case analysis for HMV device evaluations
included interviews with seven patient caregiver families and two pharmaceutical vendor
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representatives, as well as review of AARC and AAMI reports. Evaluation of these devices also
included review of HT and LTV user manuals and training videos.
Figure 5.4: HMV Medical Devices HT50 and HT70 Respectively Displayed
Figure 5.5: HMV Medical Devices LTV950 and LTV1150 Respectively Displayed
Table 5.10: Mechanical Ventilation Human Factor Consideration Ratings
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Table 5.10 provides human factor component scores associated with the aforementioned
HT and LTV HMV pumps based on the rating structure explained in the previous section.
Thematic review of HMV data sources revealed that the all the devices permit for low user
expertise and the LTV950, LTV1150, and the HT70 allow for limited user capability, but the
HT50 requires extensive user capabilities due to the physical demands of the weight of the
device. Alternatively, only the HT70 has easy interface tasks and simple interface interactions,
but the HT50, LTV950, and the LTV1150 involve difficult interface tasks and complex interface
interactions. All the HMV devices were appropriate for non-clinical private facilities, and the
LTV devices could be used in mobile public settings, but the size and shape of the HT devices
and circuit connectors are more appropriate for non-mobile public settings.
Section 5.6: Rating Outcome Discussion
The User, Interface, and Environment Human Factor Component Input Variable Ratings
for each HPN and HMV device was aggregated to calculate the Medical Device Outcome Scores
for the Curlin, CADD, HT, and LTV devices. An outcome score between 0-6 meant that the
device had a Low Risk Level, a score of 7-12 meant the device had a Moderate Risk Level, and a
score of 13-18 meant the device had a High Risk Level. A medical device outcome score
calculation and risk level translation for each HPN device is displayed in Table 5.11 and for each
HMV device is displayed in Table 5.12. The Medical Device Outcome Score for each device
was calculated using the following equation:
________________________________________________________________________
UE Rating + UC Rating + IT Rating + II Rating + ER Rating + EP Rating = ES, EU or IU Score
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Table 5.11: Home Parenteral Nutrition Human Factors Findings
Human Factors Component evaluation of the HPN devices revealed that most of the
variation involved the device interfaces of the CADD6101 due to its difficult tasks and complex
interactions. Summation of the Curlin 4000 total User score of 2, total Interface score of 2, and
total Environment score of 1 resulted in an overall risk score of 5: this indicates that it is
appropriate for family caregiver users, invasive device interfaces, and non-clinical environments.
Addition of the Curlin 6000 total user score of 2, total Interface score of 1, and total
Environment score of 1 led to an overall risk score of 4: this indicates that it is also appropriate
for family caregiver users, invasive device interfaces, and non-clinical environments.
Calculation of the CADD 6101 total user score of 3, total interface score of 4, and total
Environment score of 1 resulted in an overall risk score of 8; this signifies it has a questionable
use within these cases, meaning that though it may be effective, it could be unsafe in these
current applications. Hence, this prototype tool would suggest that the CADD 6101 equipment
developer consider improving the device to mitigate the risk of an undesirable near miss patient
outcome.
Alternatively, human factors component evaluation of the HMV devices revealed that the
HT70 was the only device determined to be appropriate for family caregiver users, invasive
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device interfaces, and non-clinical environments. Summation of the HT50 total user score of 3,
total Interface score of 6, and total Environment score of 3 resulted in an overall risk score of 12:
this indicates it has a questionable use within these cases, meaning that although it may be
effective, it could be unsafe for existing applications. Addition of the HT70 total user score of 1,
total Interface score of 2, and the total Environment score of 3 led to an overall risk score of 6:
this means that it is the most safe and effective of the four options. Hence, this prototype tool
would suggest that the HT50 equipment developer consider improving the device to mitigate the
risk of an undesirable near miss patient outcome.
Table 5.12: Home Mechanical Ventilation Human Factors Findings
Finally, human factors component evaluation of the LTV devices revealed that both
involved questionable use due to moderate risk; this means that although they could be effective,
but unsafe. Calculation of the LTV950 total user score of 2, total Interface score of 5, and total
Environment score of 2 resulted in an overall risk score of 9: this indicates it could be
inappropriate for family caregiver users, invasive device interfaces, and non-clinical
environments. Similarly, summation of the LTV1150 total user score of 2, total Interface score
of 5, and total Environment score of 2 resulted in an overall risk score of 9: this also indicates it
could be inappropriate for family caregiver users, invasive device interfaces, and non-clinical
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environments. Hence, this prototype tool would recommend that the LTV950 and LTV1150
equipment developer improve the device to mitigate the risk of an undesirable near miss patient
outcome.
In conclusion, this study confirmed the case study approach as a useful method for
evaluating of the FDA and PhD human factor considerations impacting the outcome of HPN and
HMV devices and users. This approach also provided insight on the factor levels that influence
the risk level of invasive medical devices. Hence, this study was effective at addressing the
NRC’s research request for a “Tool for Assessing Home Health Care Tasks and Operators.” The
FDA model analysis of the CTSI Study’s pediatric patient cases revealed that the NRC’s Home
Health research variable was more so impacted by the Public Environment consideration.
Additionally, it found that the NRC’s Care Task research variable was more so impacted by the
Interaction Interface and Task Interface considerations. Lastly, it discovered that the NRC’s
Coordinator research variable was more so impacted by User Capability consideration.
As a result, the preliminary findings of this chapter’s analysis were influential in the
discovery of future research opportunities. Those opportunities include expanding that sample
size used to evaluate this tool to include additional devices used for invasive medical therapies,
as well as non-invasive devices used in various environments and numerous users. These
findings are significant contributions to the limited body of knowledge on pediatric home health
patient safety.
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Chapter 6
Conclusions and Implications
This chapter includes the conclusions and implications of the study. Section one
discusses dissertation topic findings and section two covers research study conclusions. The
third section shares alternative explanations and the fourth section reveals impact learnings.
Section five predicts future research implications.
Section 6.1: Dissertation Topic Findings
As mentioned in the Chapter 2, there were three questions this dissertation study sought
to answer related to sociotechnical system framework, participatory ergonomic applications, and
human factor components. The initial research question was, What sociotechnical work system
components in non-clinical environments with lay caregivers contribute to undesirable outcomes
for pediatric patients on invasive medical therapies? The answer to this question was discovered
through open coding of CTSI interview transcripts for undesirable outcomes, and axial coding of
those same transcripts for sociotechnical work system and process component affiliation with
those outcomes.
Axial coding described in Chapter 3 revealed that Non-Healthcare Organizations such as
family units or school groups were associated with more of the undesired outcomes identified
through open coding. In other words, Healthcare organizations. such as clinical providers and
pharmaceutical distributors. impacted fewer undesired outcomes. It was interesting to discover
through axial coding of CTSI interview transcripts that clinical people such as home nurses were
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involved in almost as many undesired outcomes as the family members. Hence, these findings
suggest that non-clinical organizations should to improve the training of their staff to enhance
caregiver trust in their ability to address the clinical and technical needs of home healthcare
patients to mitigate risk of their involvement in undesired outcomes.
Sociotechnical system analysis in Section 3.5 also revealed that external environmental
components such as ecological influences, economic status, or policy restrictions, had a slightly
greater impact on undesired outcomes based on calculated estimations derived from coded
complications shared during narratively structured CTSI interviews. Ecological influences often
arose with the prevalence of common diseases, such as the pneumonia or influenza during
certain times of year. Economic status, such as ability to be at home with patient rather than
work or the ability to afford adequate arrangements for childcare impacted patient care, which
was occasionally mitigated by parents becoming certified home nurses to earn income to care for
their child. Policy restriction such as insurance coverage of home nursing support or preferred
equipment models as well as clinical constraints on family caregivers’ ability to create work-
around to suggested caregiver methods were occasional challenges.
As displayed in Table 3.4, CTSI interview transcripts coding revealed that complex
tasks such as clinical activities involving pumps and circuits were associated with more of the
undesired outcomes than simple tasks. This could be attributed to the method of clinical training
received by patient caregivers and/or the amount technical training gained by family members.
This challenge might be addressed by improving and increasing caregiver training or simplifying
device functionality and standardizing supply features, but would need to be validated through
future quantitative research to confirm these qualitative findings. This relates to the revelation
that more undesirable outcomes were affiliated with physical process than were associated with
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mental processes, based on calculated estimations derived from coded complications shared
during narratively structured CTSI interviews. This finding could correlate to the fact that
individuals’ physical capabilities were often impacted by their mental state when performing
tasks, and reiterates the future research opportunity to analyze potential interaction between
sociotechnical system and process components
These sociotechnical systems findings often discussed in the initial caregiver interviews
often led to the participatory ergonomic application discovered during the follow-up interviews
and home observations. Hence, the secondary research question was What participatory
ergonomic rationale and tools are used by pediatric patient caregivers when developing custom
solutions for invasive therapies in non-clinical environments to avoid undesirable outcomes? As
communicated in Chapter 4, the majority of family caregiver ergonomic applications were due to
technological rationale, with most involving environmental arrangements to match the human
capabilities with the technology’s complexity and many involving equipment adaptations to
align with technical changes.
As discussed in Section 4.5, most of the CTSI study super parents’ participatory
ergonomic applications involved the use of Five Ergonomic Viewpoints and Tools for arranging
caregiver workstations to simplify supply access. Other participatory ergonomic applications
included the Mock Layout tool to standardize the equipment placement within patients’
bedroom. Some applications involved the Learning Points tool to evaluate and communicate
tasks by critical steps to ensure consistency among the caregiver team to mitigate risk of an
undesirable outcome occurring.
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These participatory ergonomic application findings from the follow-up interviews and
home observations encouraged the human factor component evaluation of the invasive medical
devices based on expert interviews as well as document review. Thus, the final research
question was What human factors considerations impact safety and effectiveness outcomes of
invasive therapy devices use on pediatric patients in non-clinical environment? The answer to
this question differed slightly for parenteral nutrition and mechanical ventilation devices.
For Parenteral Nutrition devices, the user capability as well as the interface task and
complexity were the greatest challenge for the CADD 6101 because the device involved
complex interface interactions requiring extensive user capability; the device was found to have
questionable use due to moderate risk. For Mechanical Ventilation devices, difficult interface
tasks and complex interface interactions resulted in the LTV950 and LTV1150 receiving a
questionable use rating due to the possibility of moderate risk. Similarly, extensive user
capability and non-mobile public setting requirements caused the HT50 to also receive a
questionable use rating due to possible moderate risk.
Section 6.2: Research Study Conclusions
The narrative research approach was used to successfully identify home health
sociotechnical model work system and process components of invasive medical therapies in
home health environments that contribute to undesirable outcomes. The narrative research was
ideal for this study because it allowed for broad exploration of an extremely novel topic for
systems engineers. It is imperative that systems engineers pursue the charge of the NRC by
embracing less traditional approaches to research to expand the areas of research utilizing
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systems engineers. Thankfully, this multidisciplinary approach included occupational therapy
research experts who could provide effective guidance on the data collection and analysis
methods such as narrative research that are accepted increasingly in the health systems arena.
Narrative research was specifically selected for this aim because it is ideal for exploring
aspects of home caregivers’ experience with pediatric patients on invasive medical therapies.
Understanding healthcare teamwork and coordination was the primary research focus for this
portion of the dissertation study; thus, the narrative research method was the best approach for
achieving this goal. This approach focused on the family caregiver perspective that was one of
the key areas of needed exploration according to the NRC. Hence, it was an effective method for
providing insight on the attributes of home health caregivers and better information about the
home health-care environments.
Narrative research was very applicable because of its roots in history, psychology, and
sociology that are relevant to the aim of this study due to its use of historically derived
sociotechnical model to evaluate the psychological aspects of homecare teams to improve
sociological coordination of pediatric invasive medical therapy providers. The historically
derived SEIPS 2.0 system model was an effective approach for identifying themes associated
with invasive medical therapy. The people and process components were effective at identifying
the physical and mental impact of being a family caregiver. The organization and environment
components also shed light on the sociological aspects of home healthcare that impact
undesirable outcomes.
Alternatively, the phenomenology research was used to understand participatory
ergonomic application rationale for pediatric patient families to become lay engineers and the
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tools modified by caregivers to develop customized solutions. Phenomenology is another
qualitative research method seldom used in systems engineering, but again the novelty of this
research problem required an inductive approach rather than a deductive approach to address the
NRC’s recommended research problem. Although this approach has been rarely used in systems
engineering, its use is growing as health systems and industrial engineering merge to address
safety and quality concerns in the increasing home healthcare industry due to its ability to
increase focus on the perspective of the patient and caregiver.
The phenomenology research approach effectively confirmed that the technological
rationale of technology change and matching humans were the most applicable motivators for
family caregivers to apply participatory ergonomics. Additionally, phenomenology supported
the identification of Five Ergonomic Views, Mock-up Layouts, and Learning Points as the
participatory ergonomic tools family caregivers modified to improve care coordination and
reduce undesired outcomes. Most of all, it effectively provided strategies for improving
coordination among caregivers involved in home-based health care and communication among
the care recipients and caregivers to address the research need identified by the NRC.
Phenomenology was an appropriate approach for this dissertation aim based on
derivation in philosophy, psychology, and education in that it aligned with the need to assess the
philosophical concept of participatory ergonomic and the psychological rationale of caregivers
adapting tools to inform others. Participatory ergonomics was a theoretical concept shaped
during the industrial revolution that challenged the Taylor management model of decision being
best made by formally educated executives who had minimal interaction with equipment or
related tasks. The application of participatory ergonomics in industrial systems traditionally
revealed that innovative ideas could come from informal education of on the job training; in
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health systems, it is currently revealing that creative solutions can come from informally
educated family caregivers.
Case studies were used to develop medical device evaluation techniques with human
factors considerations for pediatric invasive therapies to minimize undesirable outcomes non-
clinical settings. Case study method is becoming a more commonly accepted qualitative
research method in health systems because it is being increasingly used by clinical nurses and
social workers involved in medical research as a more patient centered approach to discovering
best practices in home healthcare. Once again, the novelty of this research aim focused on
invasive medical therapies in home health environments; in addition, the fact that the FDA
Human Factor Components were recently incorporated in the medical device guideline made the
case study approach ideal for this dissertation aim.
Case studies were very appropriate because of its growing acceptance in medicine that is
the focus of this study. Case studies were selected because it is best for providing an in-depth
understanding of a case or cases of undesired outcomes involving invasive medical devices.
Cross case analysis with supplemental archive document analysis supported the identification of
human factors components related to the user, interface, and environment of an invasive medical
device that could lead to an undesirable outcome.
It effectively addressed the NRC’s desire to provide medical device and system designers
with information on the demands associated with home health care and the capabilities needed
for non-clinical caregivers to perform successfully. It revealed that how a family caregiver’s
capability as a user and public or private use of invasive medical devices in mobile or non-
mobile setting could impact the associated risk level. More so, it revealed how task interface
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difficulty and interface interaction complexity of an invasive device could result in an
undesirable outcome for pediatric patients in non-clinical settings.
Section 6.3: Alternatives and Explanations
Regarding the topic of Healthcare Teamwork and Coordination, the NRC states that
“home-based healthcare often involves a large number of elements, including multiple care
givers, support services, agencies and complex and dynamic benefit regulations, which are rarely
coordinated”
(Olsen, 2010, p. 6). The SEIPS 2.0 Sociotechnical model defines these elements as
work system components that include the organization, environment, tasks, technology, and
people that impact the process and outcome. This study shed light on how the effective
management of these components facilitates teamwork and care coordination of invasive medical
therapy in non-clinical environment to improve patient outcomes and care cost.
The relationship between the work system components (x’s), the process (=) and the
outcome (y) could be used to form of a mathematical equation to further explore the interaction
between the variables which would be added, subtracted, multiplied, or divided to increase or
decrease the probability of harm to the pediatric patient on invasive medical therapy. With a
larger sample size, the grounded theory method could be employed to further validate these
findings nationally rather than being constrained by the regional limitations of this study.
Additionally, incorporating more parenteral nutrition patient families or additional types of
invasive medical therapies would further balance the Technology component findings of this
sociotechnical system evaluation.
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The NRC also recommended that the Agency for Healthcare Research and Quality
(AHRQ) “support human factors-based research on the identified barriers to coordination of
healthcare services delivered in the home and support user-centered development evaluation of
programs that may overcome these barriers” (Olsen, 2010, p. 7). Such funding support would
provide resources required for increasing the sample size for grounded theory research. It would
also allow for the inclusion of additional invasive medical therapy within other specialty areas
such as cardiology that uses parenteral methods for heart medication delivery.
Regarding the topic of Characterizing Caregivers, Care Recipients, and Home
Environments, the NRC states that “as delivery of healthcare in the home becomes more
common, more coherent strategies and effective policies are needed to support the workforce of
individuals who provide this care” (Olsen, 2010, p. 7). This study demonstrates why
participatory ergonomic rationale could be an effective approach for characterizing caregivers
and how participatory ergonomic tools could provide efficient strategies for improving care
recipient outcomes in home environments. The family caregiver interviews enhanced the
researcher’s understanding of the caregiver, as well as care recipient characteristics in the home,
and the digital home observations inform product developers and service providers about the
environment in which care is delivered.
The NRC also recommended that federal health agencies “coordinate data collection
efforts to capture comprehensive information on elements relevant to healthcare in the home,
either in a single survey or through effective use of common elements across surveys” (Olsen,
2010, p. 7). The NRC admits there is a shortage of data on home healthcare, which is why the
qualitative research approach was selected for this study, so improved coordination of
government agency sponsored surveys would have been beneficial for this study. Family
100
caregiver and pediatric patient access was limited for this study, which constrained the ability to
develop more robust strategies for providing quality care in home environments.
Regarding the topic of Tools for Assessing Home Healthcare Tasks and Operations, the
NRC states that medical device users “vary considerably in their skills, abilities, attitudes,
experience, and other characteristics, such as age, culture/ethnicity, and health literacy”
(Olsen,
2010, p. 8). The FDA Human Factors consideration model provides a high-level structure for
better incorporating User variation into device design and the user sub-considerations of
expertise; capabilities adds a secondary level of detail for device evaluation. This study’s rating
structure adds a more quantitative method for evaluating the risk level of a device based on user
expertise and capability requirements.
The NRC also admit that “healthcare providers lack the tools needed to assess whether
particular individuals would be able to perform specific tasks at home, and medical device and
system designers lack information on the demands associated with health-related tasks
performed at home”
(Olsen, 2010, p. 8). The FDA Human Factors consideration model
additionally provides a high-level structure for better incorporating Interface and Environment
variation into device design and the sub-considerations of tasks and interactions as well as public
and private settings add a secondary level of evaluation detail. Again, this study’s rating
structure adds a more quantitative method for evaluating the risk level of a device based on
interface tasks and interactions as well as public and private environments.
The NRC recommends that AHRQ collaborate with federal health agencies “to support
development of assessment tools customized for home-based healthcare, designed to analyze the
demands of tasks associated with home-based healthcare, [and] the operator capabilities required
101
to carry them out” (Olsen, 2010, p. 9). The invasive medical device human factors component
assessment tool developed for this study is customized for home-based healthcare in that it
enhances the FDA’s Human Factors Environment. Considerations should include Non-Clinical
Private Facilities as well as Mobile and Non-Mobile Public Settings. Hence, further
development of this tool with AHRQ funding and federal resources would be an ideal future
research route for this portion of the dissertation study that will be elaborated upon in the final
section of this chapter.
Section 6.4: Impact and Learnings
Findings of this dissertation study have confirmed that the SEIP 2.0 sociotechnical model
can be effectively uses to analyze home healthcare work systems and caregiver processes to
improve team coordination. It also confirmed that participatory ergonomic rationale is useful for
characterizing caregivers and tools are beneficial for developing custom solutions for care
recipients in home environments. Additionally, it confirmed that the FDA Human Factors
Consideration model could be efficiently enhanced with applicable sub-considerations and
ratings to develop a tool for assessing invasive therapy tasks and medical device operations in
home environments.
The sociotechnical system, participatory ergonomic, and the human factors models are
theoretical frameworks independently evaluated for home healthcare applications within this
study. Similar data was leveraged and enhanced as needed to evaluate the applicability of each
model to invasive medical therapies performed by pediatric patient caregivers in non-clinical,
102
private facilities. Ideally, these frameworks can be collaboratively used to collectively evaluate
home healthcare as shown in Figure 6.1.
Figure 6.1: Process, People, and Technology Framework for Invasive Therapy in Non-Clinical Settings
The sociotechnical system framework would be used to holistically analyze the process
components that impact the outcomes of home health operations. Similarly, the participatory
ergonomic framework would be used to assess the people characteristics of home health
caregivers. Additionally, the human factors framework would be used to evaluate the
technology considerations of home health devices. When combined, these three frameworks
provide a total system engineering evaluation of invasive pediatric medical therapies conducted
in non-clinical environments by family caregivers.
These learnings are valuable contribution to the limited existing body of knowledge on
home health care that will be useful to three groups of stakeholders. Non-clinical users such as
caregivers and patients will benefit from the findings of the sociotechnical system component
103
findings because it provides strategies for improving coordination among providers of home
health care and communication among the care recipients and caregivers. Clinical organizations
such as providers and payers will benefit from the participatory ergonomic technique findings
because it provides insight on the attributes of home health caregivers and better information
about the home health-care environments. Healthcare organizations such as manufacturers and
distributors will benefit from the human factor consideration findings because it provides
medical device and system designers with information on the demands associated with home
health care and the capabilities needed for non-clinical caregivers to perform successfully.
Section 6.5: Future Research Implications
One of the challenges of the existing models discussed in the last section is that they were
originally designed to be used independently rather than collectively. Currently, those
frameworks lack a feedback look between the pediatric patients as well as the family caregivers
and the product developers as well as the service providers. Hence, from the systems
engineering perspective, there is a disconnection between micro ergonomic level risk
identification from the patients’ perspective and macro ergonomic level risk mitigation from the
providers’ perspective as displayed in Figure 6.2 due to a limited participatory ergonomic
collaboration and communication between device users who can identify risk and the equipment
developer who can mitigate risk.
From the micro ergonomic context, people supply the environmental inputs for the task
process to provide safe outputs for the patient customer. From the macro ergonomic context,
organizations supply the technology inputs for the care process to produce quality outputs for
104
their population of customers. To avoid near misses and prevent adverse events, conceptually
there would need to be a Plan-Do-Check-Act Total Quality Management Feedback Loop
between the micro ergonomic and macro ergonomic level for continuous process improvement.
Figure 6.2: Comprehensive Conceptual Framework for Invasive Therapy in Non-Clinical Settings
To create this feedback loop, information communication improvements would need to
occur from organizations to people on how to effectively use devices being deployed and from
the environment to the technology on how to efficiently design devices being developed.
Likewise, information communication improvements would need to occur from individual
patients to group populations on which innovative solutions are developed and from quality
agencies on which novel methods are deployed to improve patient safety.
This conceptual framework would further support the use of the sociotechnical systems,
participatory ergonomics, and human factors models explored within this dissertation study
because it provides a more opportunities for formal and informal dialog between patients and
providers. It would create a platform for comprehensive identification work system as well as
process components impacting undesired outcomes and collective understanding of participatory
105
rationale, as well as ergonomic tools for impacting desirable outcomes, and collaborative
assessment of human factors impacting device outcomes. Future research would need to be
conducted to validate this comprehensive framework and extend applications to additional
patient populations with different medical devices in other non-clinical settings.
106
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Abstract (if available)
Abstract
In 2010, approximately 12 million Americans received home health care or care in a non-clinical environment due to the growing cost and capacity constraints of hospital health care (Basics Statistics about Home Care, 2010). According to the National Research Council (NRC), human factors could assist with improving the alignment of environments, tasks, and people involved in home health care to provide increased safety, effectiveness, and efficiency (Olson, 2010). This dissertation explores how the application of a sociotechnical systems model, participatory ergonomics techniques, and human factors components could be used to align people, tasks, and technology in non-clinical environments to ensure pediatric patient safety. The aims of this study are threefold: ❧ 1. Identify home health sociotechnical model work system and process components of invasive medical therapies in home health environments that contribute to undesirable outcomes. ❧ 2. Understand participatory ergonomic application rationale for pediatric patient families to become lay engineers and the tools modified by caregivers to develop customized solutions. ❧ 3. Develop invasive therapy evaluation techniques with human factors considerations for pediatric medical devices to minimize undesirable outcomes in non-clinical settings. ❧ Qualitative research methods were used for this study to understand experiences that have been both understudied and under-theorized. This dissertation draws on data collected from a larger qualitative study, so the narrative research approach was primarily used to address aim (1), the phenomenology research approach was partially used to address aim, (2) and the case study approach was mostly used to address aim (3). This dissertation used three distinct and complementary theoretical frameworks to study how the practical application of sociotechnical systems, participatory ergonomics, and human factors conceptual models could improve pediatric patient safety in non-clinical environments. ❧ This dissertation provides novel insight into three key National Research Council (NRC) recommended home health care focal areas. First, this study assesses how environment, people, process, task, and technology components contribute to undesirable outcomes for pediatric patients on invasive medical therapies with lay caregivers in non-clinical environments. Second, it provides the participatory ergonomic rationale and tools used by pediatric patient caregivers when developing custom solutions for invasive therapies in non-clinical environments to avoid undesirable outcomes. Third, this dissertation rates the impact of human factors consideration on the safety and effectiveness outcomes of invasive therapy devices use on pediatric patients in a non-clinical environment.
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Creator
Gray, Joshua Lukman
(author)
Core Title
Total systems engineering evaluation of invasive pediatric medical therapies conducted in non-clinical environments
School
Viterbi School of Engineering
Degree
Doctor of Philosophy
Degree Program
Industrial and Systems Engineering
Publication Date
12/04/2019
Defense Date
12/03/2019
Publisher
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(original),
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Tag
health systems,home health,Human Factors,invasive therapy,mechanical ventilation,medical devices,OAI-PMH Harvest,parenteral nutrition,participatory ergonomics,patient safety,pediatric care,sociotechical models
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English
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Meshkati, Najmedin (
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), Imada, Andrew (
committee member
), Lawlor, Mary (
committee member
), Moore, James (
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), Takata, Glenn (
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)
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jlgconsulting.inc@gmail.com,joshualg@usc.edu
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Tags
health systems
home health
invasive therapy
mechanical ventilation
medical devices
parenteral nutrition
participatory ergonomics
patient safety
pediatric care
sociotechical models