Keywords
clinical decision support - primary care - human-centered design - user needs - falls
Background and Significance
Background and Significance
While most falls are preventable,[1] they present a serious threat of injury and death. Falls are the second leading
cause of unintentional injury deaths worldwide, and adults over the age of 60 experience
the greatest number of fatal falls. Researchers have demonstrated that engaging patients
in the fall prevention process can be effective in reducing falls and injuries in
hospital settings.[2]
[3] Our research team is developing clinical decision support (CDS) to address fall
prevention management in urban and rural primary care settings.
CDS is a tool that makes evidence-based knowledge available to health care providers
at the point of care.[4] CDS can add value in primary care but providers often resist its implementation
due to potential limitations.[5] Health care providers override between 60 and 70% of CDS alerts.[6]
[7] This repeated, unproductive interaction with CDS contributes to alert fatigue and
decreases support for CDS implementation.[8]
[9] While some electronic CDS has been designed for inpatient settings,[10]
[11] there is a significant gap in the literature on the development of fall prevention
CDS for use in outpatient settings.
Objectives
By utilizing a human-centered design (HCD) approach, our team aims to address the
limitations of CDS and enhance usability.[12]
[13] Because input is gathered from participants during every stage of development, HCD
prevents design errors and future usability issues.[14] Design principles include workflow integration, provision of recommendations rather
than commands, and presentation of recommendations in a way that cultivates trust
with users.[15] Embracing a HCD process will aid researchers in designing interventions that meet
the users' unique needs, and therefore enhance adoption.[16] We aimed to involve users in early stages of the development of CDS to support fall
prevention management in diverse primary care settings. Our goal is to design an electronic
CDS tool to identify patients' individual fall risk factors; provide tailored, actionable
recommendations for providers; and help facilitate shared decision-making around fall-prevention
planning. This article describes the end-user needs identified through this process.
Methods
Study Design
This was a qualitative user research study based on principles of HCD. As defined
by ISO 9241–110, a main principle of HCD is that “design is based upon an explicit
understanding of users, tasks, and environments.”[17] In accordance with this principle, our team designed this study to further understand
user needs with the ultimate goal of identifying specific user requirements for our
CDS tool. The principles of HCD define user requirements as the features and functions
that the user requires to accomplish their goals.[18] Previous studies have demonstrated the importance of analyzing user needs while
designing CDS and other electronic tools.[19]
[20]
Study Setting and Context
Primary care team staff (primary care providers, care coordinator nurses, licensed
practical nurses, and medical assistants) and adults aged 60 or older associated with
Brigham & Women's Hospital (BWH)-affiliated primary care clinics and University of
Florida Health Archer Family Health Care (UF) clinic were eligible to participate
in this study. Primary care staff participants at both sites received an emailed or
physical copy of a recruitment letter that described the purpose of the study and
participation details. Primary care staff referred their patients 60 years of age
and older, interested in participating in the study, to the study team. A research
team member contacted these patients by email or in-person and provided them with
the the patient-facing recruitment letter. Due to coronavirus disease 2019 (COVID-19)
restrictions, recruitment largely took place virtually. All participants consented
to participate in the study and received reimbursement in the form of a gift card.
Data Collection
Based on the literature and previous experience, our team of registered nurses, physical
therapists, and usability experts designed a guide for semi-structured and exploratory
interviews with primary care staff and patients. Since both primary care staff and
patients will engage with the CDS tool and its supported recommendations, our team
interviewed both groups of end-users to better understand their goals and needs. The
semi-structured interview guide for primary care staff included questions to elicit
perspectives on what staff need for effective fall prevention and the development
and use of personalized fall prevention plans, and current state practices for addressing
preidentified fall injury risk factors (see [Supplementary Appendix A] [available in the online version]). Our goal was to gain a detailed understanding
of current-state fall prevention practices in clinics so that we may identify the
gaps and needs in those processes and address them in our CDS design. Based on a review
of the literature and previous experience, clinical members of the project team identified
three fall injury risk factors (mobility limitations, fall risk increasing drugs,
and osteoporosis) to be addressed in the CDS tool.[21] Team members examined each risk factor individually to determine which were identifiable
through data extracted from the electronic health record (EHR), with the goal of creating
an electronic tool that could automatically identify individual fall risk factors
and provide personalized recommendations (i.e., discuss starting bisphosphonates medication
for patients with osteoporosis). Our team designed the semi-structured interview questions
to help us understand what direct users, or staff who engage with the decision support,
would require from the tool when addressing these risk factors. The semi-structured
interview guide for patient participants comprised questions to elicit insights from
their personal experiences with falls and fall prevention (see [Supplementary Appendix B] [available in the online version]). Our team designed these questions to help us
understand what indirect users, or the recipients of recommendations supported by
the CDS, would require from the tool.
Our team designed the exploratory interview guide for primary care staff to facilitate
a virtual workflow observation where the provider would demonstrate the activities,
steps, and thought processes involved in fall risk assessment and prevention planning
using their EHR during a patient encounter (see [Supplementary Appendix C] [available in the online version]).
Recruitment continued until we reached thematic saturation. Staff participants completed
a demographic form that included years of experience and self-report of how well they
currently engage in fall prevention. Older adult participants completed a similar
form that included questions about fall history and fear of falling. Participant completion
of the full demographic form was optional.
At BWH, a user experience expert (P.M.G.) conducted all interviews on virtual video
calls. At the UF site, a registered nurse with user experience training (K.S.) collaborated
with the site principal investigator (R.J.L.) (i.e., subject matter expert) to conduct
in-person semi-structured interviews and virtual exploratory interviews. Additional
research team members took notes while observing the interviews. At the conclusion
of each interview, other research staff who were present had the opportunity to ask
questions to clarify any statements or observations. The 30-minute semi-structured
interviews were audio-recorded. The 45-minute to 1-hour exploratory interviews were
video- and audio-recorded. The de-identified audio from each interview was transcribed.
While the reliance on remote technologies to conduct this study produced some barriers
to participant recruitment, it did allow patients to participate in interviews without
needing to travel. Additionally, it allowed our team to review recorded interviews
and make increasingly detailed notes and observations.
Data Analysis
Previous studies have shown content analysis to be an effective method for classifying
and deriving meaning from qualitative data.[22]
[23]
[24] Our team conducted a content analysis to identify user needs for CDS to prevent
falls among urban and rural community-dwelling older adults ([Fig. 1]). At BWH, the first author independently reviewed transcripts to identify key ideas
and develop a preliminary coding system for user needs. The first author and our team's
user experience expert (P.M.G.) met regularly to iteratively review, modify, and validate
the codes and emerging themes. Once they reached a consensus, the first author grouped
and sorted common responses into major themes according to similarity. Throughout
this process, the first author presented their findings to the broader research team
at weekly meetings, where they reviewed, validated, and finalized the codes and their
themes. This process also occurred at the UF site, and their team members validated
and added supporting data to the end-user needs identified at their site.
Fig. 1 Using content analysis to uncover user needs and generate themes.
Results
In total, we completed interviews with 24 primary care staff and 18 patients. We completed
20 semi-structured interviews with primary care staff, including 12 primary care providers,
3 care coordinator nurses, 2 licensed practical nurses, and 3 medical assistants across
both sites ([Table 1]). We completed 8 exploratory interviews with primary care staff, including 7 primary
care providers and 1 nurse. 3 primary care providers and 1 nurse participated in both
a semi-structured interview and an exploratory interview. We interviewed a total of
18 patients 60 years and older from both sites combined ([Table 2]). As a result of content analysis, our team categorized user needs for primary care
staff and patients into 8 themes ([Table 3]).
Table 1
Primary care staff participant demographics
|
Primary care staff participants
|
Gender
|
Male
|
5 (20.8%)
|
Female
|
19 (79.2%)
|
Race
|
American Indian/Alaska Native
|
|
Asian
|
6 (25.0%)
|
Native Hawaiian or Pacific Islander
|
|
Black or African American
|
2 (8.3%)
|
White
|
16 (66.7%)
|
More than one race
|
|
Not reporting
|
|
Provider type
|
Nurse
|
5 (20.8%)
|
Nurse Practitioner
|
3 (12.5%)
|
Physician
|
9 (37.5%)
|
Physician's Assistant
|
3 (12.5%)
|
Medical Assistant
|
3 (12.5%)
|
Self-report: Compared with your peers, how do you rate yourself for helping patients
prevent falling?
|
Above average
|
4 (16.7%)
|
Average
|
17 (70.8%)
|
Below average
|
3 (12.5%)
|
Table 2
Patient participant demographics
|
Patient participants
|
Gender
|
Male
|
5 (27.8%)
|
Female
|
13 (72.2%)
|
Race
|
American Indian/Alaska Native
|
|
Asian
|
|
Native Hawaiian or Pacific Islander
|
|
Black or African American
|
4 (22.2%)
|
White
|
14 (77.8%)
|
More than one race
|
|
Not reporting
|
|
Age
|
60–70
|
6 (33.3%)
|
70–80
|
7 (38.9%)
|
80+
|
5 (27.8%)
|
Self-report: Are you afraid of falling?
|
Yes
|
6 (33.3%)
|
No
|
12 (66.7%)
|
Self-report: Have you fallen 2 or more times in the past year?
|
Yes
|
4 (22.8%)
|
No
|
14 (77.8%)
|
Self-report: Were you injured from a fall in the past year?
|
Yes
|
5 (27.8%)
|
No
|
13 (72.8%)
|
Table 3
User needs and sample quotes from participants
Theme
|
User type
|
Sample quote
|
No increase to workflow burden
|
Primary care staff
|
“Not that I shouldn't [address fall prevention], but the visit is only 35 minutes,
there are probably 5 prescriptions that came up to be refilled, and 2 other questions.
It gets buried among a lot of other stuff.” – Provider 1, BWH
|
Systematic communication between staff, patients, and family
|
Primary care staff
|
“Most of [fall prevention] has been communication, talking with families, and getting
other services involved to help with that.” – iCMP Nurse 1, BWH
|
In-person assessment of patient condition and diagnoses
|
Primary care staff
|
“Usually, when [nurses] walk the patients in that's
when they look [for signs]. Then I always document if they're using any kind of assistive
device. If they're in a wheelchair, if they have a cane then I'll always put that
in my notes.” – Staff 5, UF
|
Patient support network to encourage adherence to fall prevention plans
|
Patient
|
“Well, right now, my partner, he is very involved in doing things and would definitely
help me, as I would him for any type of exercises or things that are needed to do
for improved balance.” – Patient 3, UF
|
Tools to help patients change behavior
|
Patient
|
“I do exercise every day, but I know me, and I wouldn't do anything that takes longer
than 15 minutes…I know that if I were supposed to do 20 minutes, I probably wouldn't
do it.” – Patient 6, BWH
|
Patient understanding of personal fall risk
|
Both
|
“I find it's very difficult, because in the population that I see, which is primarily
older, people are very resistant to accepting that they have a risk for falls.” –
Provider 5, BWH
“I'm probably a big denier when it comes to physical stuff because I think I'm pretty
strong and very active. How could somebody really assess the truth for me…it's self-realization
of [fall-risk] and how do you get someone to really realize that?” – Patient 3, BWH
|
Awareness of individualized fall prevention resources that fit patient characteristics
and strategies
|
Both
|
“Like I said, keeping in mind that some seniors aren't able to because we're individuals,
and everybody is individual—they may have similar ailments, but emotionally and mentally,
we're all a little different.” – Patient 1, BWH
“Well, it depends on the patient. Mobility; there's quite a variety of what a patient
will consider to be reasonable mobility for themselves. If patients aren't driving,
or if they're having difficulty maneuvering just to their mailbox—so it's really gonna
range, I guess. I don't know if I can give you a standardized answer, because it just
is very patient-specific.” – Staff 5, UF
|
Evidence-based, safe exercises and expert guidance to inspire trust and confidence
in fall prevention recommendations
|
Both
|
“I really don't want [patients] trying to do [exercise prescriptions] on their own
because I'm concerned they're going to hurt themselves.” – PA 2, BWH
“Because for that kind of advice, which I get from my physical therapist, I'm totally
compliant. I do the exercises that I do religiously. I'm careful about walking, but
I just follow her directions. I don't think the primary care doctor has the knowledge
to do that or the time that I told you of.” – Patient 7, BWH
|
User Needs for Primary Care Staff and Patients
Workload Burden
Workload burden in primary care is a well-documented challenge for staff.[25]
[26]
[27] Multiple primary care staff participants reported that fall prevention CDS should
not add burden to their patient care workflows. Semi-structured and exploratory interviews
revealed the typical workflow patterns at both primary care study sites ([Fig. 2]). While most primary care staff agreed that fall prevention is an important topic
to cover during an office visit, they are constrained by packed schedules and short
patient visits. Staff also noted that it is helpful to share tasks with other care
staff to reduce individual workload burden.
Fig. 2 Fall prevention management workflow at BWH and UF study sites. BWH, Brigham & Women's
Hospital; UF, University of Florida Health Archer Family Health Care.
Systematic Communication
Because the target population of this study is adults aged 60 years or older, staff
participants reported that many conversations around fall prevention are most productive
when care partners are present. Staff participants noted that because fall prevention
planning often involves behavioral or environmental changes, having family member
support can improve adherence to prevention plans. When family members participate,
it is easier to create fall prevention plans tailored to the patient's individual
needs, barriers, and environmental conditions. Staff reported that systematic communication
between staff and patient care partners would ensure that patients understand their
fall prevention plans, remain well-monitored, and receive quality care.
In-Person Assessment of Patient Condition
Staff noted that they observe a variety of signs to identify patients at risk for
falls. For instance, providers watch patients walk to assess their gait and balance
during a visit. If abnormal, this observation prompts a fall prevention discussion.
During the COVID-19 pandemic, in-person visits became less common and therefore have
made observation more difficult. Many staff members rely on this in-person observation
to signal concern about falls. Without observing these signs, staff are unlikely to
cover fall prevention or act on fall prevention CDS during a visit.
Personal Support Networks
Both primary care staff and patient participants agreed that patients need a support
network to successfully adhere to fall prevention strategies. This could consist of
family members, care partners, neighbors, peers, or others who are regularly present
in the patient's life. Patient participants agreed that they could more easily maintain
behavior changes, such as regular exercise, when others are there to encourage them
or do the exercises together which would hold them accountable. A patient support
network can also be crucial to initiating conversations about fall prevention with
primary care staff. Staff noted that family members or care partners who are present
at a visit, and have observed concerning signs or fall risk factors, often prompt
fall prevention discussions themselves.
Motivational Tools
In addition to a personal support network, patients require sources of motivation
to help them to adhere to fall prevention practices. While these forms of motivation
varied across participants, several spoke of their independence as both an extrinsic
and an intrinsic motivator. Some patients were intrinsically motivated knowing that
fall prevention planning could allow them to remain physically strong and independent.
Staff used independence as a motivator in fall prevention conversations with their
patients. Patients acknowledged that external motivators, such as exercise prescriptions
that are quick and easy to complete, were necessary to encourage engagement in fall
prevention practices. Several noted that knowing that an exercise would be quick,
less than 15 minutes, for example, would be enough to push them to integrate it into
their routines.
Patient Understanding of Fall Risk
Another barrier to successful implementation of fall prevention plans was patients
recognizing their own risk for falling. Staff need patients to acknowledge their own
risk to have productive conversations about fall prevention. Staff found it difficult
to encourage patients to acknowledge their symptoms or diagnoses as risk factors for
falls. For example, if patients believe they are physically strong enough to be safe
from falls, it is difficult for staff to help them understand otherwise.
Patient participants also acknowledged that they would first need to accept that they
are at risk for falls before being willing to engage in a fall prevention discussion.
Many patients reported the fear that admission of fall risk could threaten their independence.
Others noted that because they feel healthy and strong for their age, they do not
believe they are at risk. Several participants mentioned that even though they feel
safe, they know that their fall risk will increase with age and hope to engage in
preventive care so they can remain independent.
Individualized Fall Prevention Resources
Although staff participants generally agreed that it is important to address fall
prevention, several felt ill-equipped to do so. Primary care staff reported a need
for personalized resources to help them provide evidence-based fall prevention advice
and design prevention plans that fit patient characteristics and preferences. Staff
acknowledged that their approach to fall prevention is unique to each patient. Prevention
discussions and plans are based on personal risk factors and barriers, thus requiring
an individualized set of resources. For example, staff participants noted that they
must consider a patient's age, activity levels, cognitive ability, environmental and
social barriers, and other risk factors to provide recommendations that are likely
to be well-suited to the individual patient.
Patient participants confirmed that personalized resources are necessary to address
the variety of individual risk factors. Most patients were quick to note that their
needs are different than those of their partners, neighbors, or friends, making it
difficult to know what any one person would require to adhere to fall prevention recommendations.
Several patients cited individual access to technology as a potential barrier to designing
fall prevention plans. For example, if a patient is less likely to or unable to access
resources electronically, they would need to be printed and shared with the patient
during a visit to fit the patient's preference.
Evidence-Based Safe Exercises and Expert Guidance
While primary care staff participants expressed interest in recommending exercise
to patients, several were concerned about sharing exercises that are not evidence-based
or unsafe for frail patients or patients with poor balance. Exercises to prevent falls
often involve strength, gait, and balance training,[28] which primary care staff worried may be unsafe for patients to complete while unsupported
or unsupervised. Participants agreed that knowing exercise prescriptions are evidence-based
would alleviate these concerns.
In line with staff needs, older adult participants also expressed a desire for evidence-based
exercise recommendations. When asked about their willingness to engage in regular
exercises prescribed by their primary care provider, patients expressed a need for
a trusted clinical expert to instruct them. Trust and an existing relationship were
both reported as important factors to older adults' willingness to engage in fall
prevention interventions. However, some patients reported skepticism in their primary
care providers' knowledge of exercise and were more likely to adhere to recommendations
from a physical therapist.
Discussion
Using a HCD process, our team defined end-user needs to inform the design of a CDS
tool for fall prevention management in urban and rural primary care sites. The main
findings gleaned from our interviews highlight that primary care staff and patient
needs can be categorized into the following themes: workload burden; systematic communication;
in-person assessment of patient condition; personal support networks; motivational
tools; patient understanding of fall risk; individualized resources; and evidence-based
safe exercises and expert guidance. There were no substantive differences between
these findings at urban and rural settings.
Currently, there is a significant gap in the literature on defining end-users' goals
and the requirements necessary for the successful use of fall prevention CDS in primary
care. Our study contributes to the existing literature by identifying user needs for
successful use and adherence to CDS recommendations. Interviews revealed that motivational
tools that inspired behavior change were necessary to encourage patient adherence
to fall prevention practices. While overcoming barriers to staff use of CDS is part
of the solution, another is to ensure that patients follow through with their health
care provider's recommendations. This demonstrates the importance of designing tools
centered around both direct and indirect users. In this case, the primary care staff
who engage with the decision support are the direct users, and the patients who are
recipients of the supported recommendations are the indirect users. In the case of
this study, we discovered that there is a significant overlap between user needs for
primary care staff and patients, thus highlighting the importance of addressing the
needs of both sets of end-users. These results will inform design decisions for a
CDS tool considered useful by all users.
In addition, our study supports previous findings examining primary care staff perspectives
and barriers toward implementing fall prevention practices. Several studies confirm
that resolving patients' ambivalence about fall risk is a requirement for implementing
fall prevention practices.[29]
[30] A systematic review completed by McConville and Hooven found that commonly reported
barriers to fall risk management in primary care are a lack of available resources
and coordination between staff members.[31] This finding validates our finding that standardized resources and systematic communication
constitute user needs for fall prevention CDS. Following the implementation of the
Centers for Disease Control and Prevention's STEADI tool, an electronic tool for fall
prevention in primary care, Casey et al confirmed the importance of building interventions
into pre-existing workflows.[32] Their team also emphasized that gathering user feedback at each stage of the development
process allowed for important improvements in the tool, highlighting the importance
of HCD principles.[32] End-users expressing a need for individualized fall prevention resources also confirms
previous evidence demonstrating that individualized programs can prevent falls and
related injuries.[1]
[33]
[34]
Since identifying these user needs, our team has designed a CDS tool to identify patients'
individual fall risk factors; create tailored, actionable recommendations; and help
facilitate a shared decision-making process between patients and providers. Throughout
the design process, we met regularly with stakeholders to continue to gather feedback
and ensure our design met practice and workflow needs. While we were not able to address
all user needs due to constraints of EHR integration, several influenced the design
of the CDS end-product. For example, we learned that our CDS tool needed to integrate
into pre-existing workflows so as not to increase provider workload burden. In recognition
of this need, our tool preselects risk factors detected in the patient's medical record
and automatically generates tailored recommendations. To address both staff and patient
needs, preidentifying risk factors also allows providers to facilitate a personalized
conversation about fall risk and help patients understand what makes them at-risk.
Identified risk factors are shared alongside talking points that providers can use
to engage the patient in discussion and help them further understand their risk. In
response to staff and patient needs for evidence-based safe exercises and expert guidance,
we included resources throughout the tool that cite the evidence supporting exercise-based
recommendations. Patient exercise handouts include a link to a video tutorial led
by the research team member with physical therapy background who designed each exercise.
We continued to follow a HDC process through the development cycle to test and iterate
on these design decisions.
The results of this study are limited and may not apply in all primary care settings.
We did not explore additional sociotechnical and contextual factors related to fall
prevention management beyond what was reported by our participants, which may vary
across urban and rural primary care settings. While testing at both BWH and UF sites
did reveal user needs at urban and rural primary care clinics, their generalizability
may vary outside of these sites. Although we acknowledge the limitations of interviewing
majority female-identifying patients, we were able to reach acceptable saturation
in our findings and believe that, despite the gender imbalance, our study population
is representative of those most afflicted by falls.[35] Formal inter-observer reliability testing was not completed as a part of this study,
though the research team members responsible for conducting interviews at the UF site
were present at all BWH interviews for the purpose of observing and reproducing similar
methods with UF participants. The testing process for this study was also limited
by the COVID-19 pandemic, which made it necessary to conduct interviews virtually.
Conclusion
Our study defines the primary care team and patient user needs for a CDS tool designed
for fall prevention management in primary care. Our processes highlight the benefits
of following HCD principles in understanding end-user goals while designing CDS tools.
These needs informed the iterative design and formative usability testing of a prototype
CDS tool that aligns with primary care staff and patient needs. Next steps include
a sociotechnical analysis of how primary care staff and older adults are managing
fall risk, integration of a live prototype, and summative testing and evaluation based
on the RE-AIM framework.
Clinical Relevance Statement
Clinical Relevance Statement
There is a lack of CDS to support primary care providers in effective fall prevention
management with their older patients. By following a HCD process, our research team
identified end-user needs important to consider in striving for successful use and
adherence to CDS recommendations. Our findings highlight the importance of identifying
the needs of direct and indirect users and informed the design of a prototype CDS
tool.
Multiple Choice Questions
Multiple Choice Questions
-
Which of the following was a user need identified in this study?
-
Virtual assessment of patient diagnoses and symptoms.
-
Organizational support from local health centers.
-
Access to mobility devices (i.e., cane or walker).
-
Evidence-based, safe exercise recommendations.
Correct Answer: The correct answer is option d. A user need identified in this study was “in-person
assessment of patient condition” making answer choice a similar, but incorrect. While
one could argue that organizational support from other local health centers could
benefit primary care clinics, it is not a need specific to fall prevention or one
identified in this study, making answer choice b incorrect. Mobility devices are proven
to prevent falls but answer choice c was not a user need identified in this study.
Many study participants, both primary care staff and patients, noted their need for
evidence-based, safe exercise recommendations to trust and feel confident in fall
prevention recommendations. This makes answer choice d correct.
-
Which of the following was a method used in this study?
Correct Answer: The correct answer is option c. While answer choices a, b, and d are methods that
can be used to collect qualitative data and user comments, answer choice c is one
of the methods that was chosen for this study. The semi-structured interview guide
for primary care staff included questions to elicit perspectives on what staff need
for effective fall prevention and the development and use of personalized fall prevention
plans, and current state practices for addressing preidentified fall injury risk factors.
Our team designed these questions to help us understand what direct and indirect users
would require from the tool.