Keywords
clinical decision support - usability testing - critical care
Background & Significance
Background & Significance
The most common contributing factor to serious safety events within children's hospitals
is a lack of situation awareness.[1] Situation awareness is the degree to which each team member possesses a common mental
model synthesizing all of the incoming data of the clinical environment.[2] To optimize situation awareness and improve outcomes, clinical decision support
(CDS) systems must combine, summarize, and present the vast amount of clinical data
to the care team in an understandable and usable manner.[3] While well-designed CDS tools can enhance patient care processes, they can also
contribute to harm if they function poorly, contain incorrect information, or are
not properly integrated into workflows.[4]
[5]
[6] To evaluate CDS tools, teams can perform formal usability testing using widely accepted
methods.[7] Usability refers to the system or tool's ability to enable users to safely, effectively,
and efficiently carry out their tasks.[8] Usability testing can improve both CDS tool design and outcomes targeted by CDS
and can be conducted a different point in the CDS lifecycle.[9]
[10]
In the intensive care unit (ICU) setting, CDS tools should facilitate the efficient
review of patient data and enable clinicians to prioritize multiple patients and tasks.[11]
[12] Currently available CDS tools generally do not enhance clinician adoption of desired
practices,[13] and automated tools are not widely implemented or considered beneficial by clinicians
within the pediatric intensive care unit (PICU).[14] We hypothesize that poor usability contributes to these findings. Available recommendations
for CDS design in ICU settings have limited scope and are not specific to situation
awareness tools or to pediatric patients.[11]
[15] Mindful of these recommendations and limitations, we developed, refined, and implemented
the PICU Warning Tool, an automated CDS tool aimed at aiding the identification of
patients at high risk of clinical deterioration and enhancing shared situation awareness
among our PICU care teams.[16]
[17]
[18] The PICU Warning Tool serves as a means to support and sustain our unit-wide system
for identifying and caring for high-risk patients and has contributed to reduced cardiopulmonary
resuscitation events. In this study, we sought to further improve the PICU Warning
Tool through formal postimplementation usability testing.
Objectives
We conducted a usability evaluation of the PICU Warning Tool using a mixed-methods
approach. Our objective was to evaluate the tool's usability by clinicians that encounter
the tool in practice and to identify opportunities for tool improvement.
Methods
Clinical Setting
We conducted our study in the PICU of a large, urban, quaternary, free-standing children's
hospital in the Midwest. Our PICU is a closed, noncardiac, medical-surgical unit with
48 beds and over 2,800 annual admissions.
Clinical Decision Support Tool
The PICU Warning Tool (called the “eWatcher” tool locally) is an embedded CDS tool
that aims to identify pediatric ICU patients at high risk of clinical deterioration
and enhance shared situation awareness by summarizing patient-level high-risk criteria.[16]
[17]
[18] Thirteen high-risk criteria are continuously evaluated based on automated electronic
health record (EHR) rules and users can manually add five additional criteria. The
PICU Warning Tool presents the patient's level of risk (low, medium, and high) on
the user's patient list view through passive alerting, visually emphasizing important
data without interruptions to EHR workflows. By hovering over the column, users can
view the high-risk criteria that the patient meets ([Fig. 1]). Double clicking the icon allows the user to add or remove manual risk criteria.
The presence of the tool on the patient list view allows the user to have situation
awareness of which and how many patients in the PICU are high-risk. Any user in our
system, including physicians, advanced practice providers (APPs), registered nurses
(RNs), and respiratory therapists (RTs), can view and update the PICU Warning Tool.
The color choices (green, yellow, and red), used to indicate the level of risk, align
with local standards and interface design best practices.[19] A second passive alert is displayed within the individual patient chart as a banner
to notify clinicians about risk while the chart is already open and to optimize presentation
within different workflows. The banner contains a link to a report showing the high-risk
criteria met by the patient. Additionally, an alert icon is displayed on the nursing
patient view when a patient meets any high-risk criteria, but the icon does not have
the additional functionality (color, hover display of criteria, and ability to add/remove
criteria) of the patient list column described above and only serves to visually indicate
that a patient is high risk. Our tool has undergone prospective validation within
our single center and, when combined with huddles and mitigation planning, has demonstrated
a reduction in in-hospital pediatric cardiac arrest within the PICU.[18]
Fig. 1 PICU Warning Tool functionality and components. (A) PICU Warning Tool as patient
list column. (B) Hover functionality. (C) Manual entry of risk criteria. (D) Banner
alert in patient chart. (E) Risk criteria report in patient chart. (F) 2023 Epic Systems
Corporation. (The data used in this Figure are fictional and do not belong to real
patients).
In our PICU, the PICU Warning Tool is used daily by providers and nursing and is an
integral part of our situation awareness model.[18] Providers have the column in their patient list, and a patient's status (high-risk
vs. not high-risk) is displayed on the nursing patient view, as noted above. In addition,
high-risk patients are discussed at twice daily safety huddles.
Study Design
We performed a mixed-methods usability evaluation of the PICU Warning Tool. The tool
was first assessed using the system usability scale (SUS), a previously validated
and widely used measure.[20] Additionally, we conducted formal think-aloud usability testing of the PICU Warning
Tool to observe efficiency of tool use and obtain qualitative feedback from users.[21]
Participant Recruitment
We sought input on usability from PICU clinicians who view and interact with the PICU
Warning Tool. We approached PICU clinical staff members during their clinical shift,
including physicians, APPs, RNs, and RTs and invited them to complete the SUS. Our
target was to enroll 50 SUS respondents. For the think-aloud usability assessment,
we separately recruited physicians and RNs via email, aiming to enroll five physicians
and five RNs. Experts recommend a minimum of 5 subjects for usability testing,[22] with groups of 10 subjects being able to identify over 95% of the problems during
testing.[23] All participants were provided with an information sheet containing the principal
investigator's contact information and an explanation of their rights.
Data Collection
We administered the 10-question SUS[24] ([Supplement A], available in the online version) to users of the PICU Warning Tool after providing
a brief review of the tool. Participants reported their role, years of experience
using our EHR (Epic Systems Corporation), and self-assigned level of computer skill
(high, medium, or low).
We performed think-aloud usability testing[21] with participants using realistic patient scenarios in a nonproduction EHR environment
on a laptop computer. The think-aloud sessions were completed in an office for physicians
and in a conference room for RNs; locations were chosen to be convenient for participants.
We recorded the screen and captured the audio of participants. This methodology has
previously proven effective in assessing usability and enhancing user interface.[25] A member of our study team moderated the think-aloud testing, asked qualitative
questions, and served as the primary observer during the sessions. Participants reported
their roles, years in current positions, and years of experience using our EHR. The
moderator explained the think-aloud technique and instructed participants to vocalize
their thoughts as they completed each task. The moderator provided guidance only if
a participant became stuck or completed a task incorrectly.
We developed two simulated scenarios ([Supplement B], available in the online version) modeled on actual PICU patients to assess key
features of the PICU Warning Tool, such as the identification of high-risk factors
for patient deterioration and the addition and removal of user-defined high-risk criteria.
While the wording of scenarios varied slightly for physicians and RNs to reflect their
respective roles, the tested tasks and overall scenarios remained the same. The order
of the scenarios was consistent for all participants. We evaluated the successful
completion and time taken to complete the following tasks: (1) reviewing the reasons
why a patient meets high-risk criteria; (2) adding high-risk criteria for a patient;
and (3) removing high-risk criteria for a patient. The moderator used a structured
observation form ([Supplement C], available in the online version) to track task completion and note any difficulties
encountered by users. Task time was measured using screen recordings, measured from
the time each participant finished reading the task directions aloud until they completed
or gave up on the task.
All participants were asked three questions ([Supplement B], available in the online version) following completion of the scenarios regarding
(1) general feedback on the tool; (2) what they liked about the tool and suggestions
for improvement; and (3) any missing features they felt should be included in the
tool. Nursing participants were also asked about potential enhancements to better
integrate the tool into their workflow. Responses were audio recorded.
Analysis
We followed survey guidelines to assess the SUS scores.[17]
[21] We considered any score above 70 as “passing” with “good” usability, while scores
below this threshold were regarded as “not passing” with “poor” usability. We considered
a score >80 as “excellent” usability. We computed means and standard deviations for
task times, stratified by role.
We performed a content analysis that included a review of audio-recorded responses
and moderator observations during think-aloud usability testing. Main themes were
identified within three a priori identified groups: (1) tool features that work well;
(2) tool features that do not work well; and (3) desired enhancements. The moderator
summarized their observations and categorized them into the first two groups: (1)
tool features that work well; and (2) tool features that do not work well. We grouped
the responses and observations within each category based on the addressed feature
of the PICU Warning Tool. The moderator and PI reviewed these groupings individually
and achieved consensus.
Results
Participant Characteristics
Fifty-one PICU staff members completed the SUS, including 22 providers (attending
physicians, fellows, and APPs), 23 RNs (including 6 leadership nurses), and 12 RTs
(including 4 leadership RTs). Among the participants, the median number of years using
Epic was 7.5 years (range 1.5–16 years), with 39% (n = 20) reporting high computer skills, 53% (n = 27) reporting medium computer skills, and 8% (n = 4) reporting low computer skills.
Ten PICU staff, including 5 providers (3 attending physicians and 2 fellows) and 5
RNs completed think-aloud usability testing. Among the participants, the median number
of years in the current role was 3.5 (range 1 to 24 years) and the median number of
years using Epic was 11.5 (range 4 to 16 years).
System Usability Scale
The overall median usability score across all participants was 87.5 (interquartile
range [IQR]: 80–95) with the majority of responses being strongly agree or agree ([Fig. 2]). Almost all participants (>96%) rated the usability of the tool as “passing” or
“good” ([Fig. 3]). The median usability score by role was similar across roles: 86.3 (IQR: 80–97.5)
for providers (physicians/APPs), 87.5 (IQR: 79–98) for fellows, 85 (IQR: 79–98) for
attending physicians, 88.8 (IQR: 86–94) for APPs, 90 (IQR: 80–95) for bedside RNs,
95 (IQR: 84 -98) for bedside RTs, 87.5 (IQR: 80–95) for leadership RNs, and 90 (IQR
81.9–95) for leadership RTs. There did not appear to be an association between median
usability score and self-reported computer skill level: 87.5 (IQR 78.75–95) for low,
82.5 (IQR 76.25–95) for medium, and 92.5 (IQR 80–97.5) for high.
Fig. 2 System usability scale results by question (n = 51). Negative questions reversed for ease of visualization.
Fig. 3 Usability results by role. Usability scores <70 were considered “poor,” 70 to 80
were considered “good,” and >80 were considered “excellent.” Each point represents
a total usability score and may represent more than one user. Abbreviations: APP,
advanced practice provider; MD, medical doctor; RN, registered nurse; RT, respiratory
therapist.
Think-Aloud Testing Task Completion
We measured success and time to completion for the following key tasks: (1) reviewing
why a patient meets high-risk criteria, (2) adding to the patient's high-risk criteria,
and (3) removing a patient's high-risk criteria. All participants (10 out of 10) completed
the task of reviewing why a patient meets high-risk criteria. The task of adding to
the patient's high-risk criteria was completed 75% of the time (15 out of 20 attempts).
During scenario one, five participants (one physician and four RNs) failed to complete
the task. However, all participants were able to complete the task during scenario
two. The task of removing a patient's high-risk criteria was completed by 80% of participants
(8 of 10), with two RNs failing to complete the task. There did not appear to be an
association between task failure and the number of years using Epic.
[Table 1] shows the means and standard deviations of time to task completion, both in aggregate
and by role. The time to task completion ranged from 2 to 92 seconds, with “Reviewing
high-risk criteria” task being completed the fastest and the “Adding to high-risk
criteria” task completed the slowest. Physicians and RNs had similar task completion
times for the “Adding to high-risk criteria” task but differed in task completion
time for the other two tasks. The total time spent on think-aloud testing sessions
(including responses to qualitative questions) ranged from 11 to 16 minutes per participant.
Table 1
Task completion time
|
Task completion time (in seconds)
|
|
All participants (n = 10)
|
Physicians (n = 5)
|
Nurses (n = 5)
|
|
Task
|
Range
|
Mean (SD)
|
Range
|
Mean (SD)
|
Range
|
Mean (SD)
|
|
Review why high-risk
|
2–41
|
11.8 (13.6)
|
2–8
|
5.2 (2.4)
|
4–41
|
18.4 (17.4)
|
|
Add high-risk criteria (scenario 1)
|
20–92
|
41.2 (27.0)
|
20–92
|
40.6 (30.1)
|
21–88
|
41.8 (27.0)
|
|
Add high-risk criteria (scenario 2)
|
4–27
|
13.2 (8.2)
|
7–17
|
12.8 (4.5)
|
4–25
|
13.6 (11.4)
|
|
Remove a high-risk criterion
|
3–23
|
10.8 (7.1)
|
3–9
|
6.8 (2.3)
|
6–23
|
14.8 (8.2)
|
Abbreviation: SD, standard deviation.
Qualitative Findings from Think-Aloud Testing
Tool Features that Work Well
Participants in the study identified three effective features of the PICU Warning
Tool that met their requirements. They praised the visual indicators on the patient
list, which enabled them to quickly identify high-risk patients. The “hover to discover”
feature was also appreciated as it allowed users to view the high-risk criteria met
by a patient without needing to access the patient's chart. The observations confirmed
that participants easily identified high-risk patients through the visual indicators
on the patient list and utilized the “hover to discover” feature to evaluate high-risk
status. Additionally, two participants emphasized the importance of real-time updates
in the tool to enhance situation awareness of high-risk patients in the PICU.
Based on the results of the think-aloud testing, we found that participants quickly
learned how to use the tool. During the testing, we evaluated the task adding high-risk
criteria in both scenarios. All users demonstrated improved ease of use, navigating
to the pop-up faster and completing the task more quickly in the second scenario.
As a result, the task was completed successfully by all participants in the second
scenario.
Tool Features that Do Not Work Well
Participant responses and the moderator observations identified three tool features
that did not function optimally. All nursing participants noted that the PICU Warning
Tool with full functionality did not appear in their normal clinical workflow. Most
nurses do not use the patient list in their daily work in our PICU; instead, they
use a nursing-specific patient view within the EHR. The nursing-specific patient review
displays an icon to indicate a patient is high-risk, but does not have the hover functionality
or ability to manually add criteria. Observation of nursing participants during the
think-aloud process confirmed this, as all nurses started with the nursing-specific
patient view and required guidance to navigate to the patient list.
Furthermore, there were discrepancies in the selection of high-risk criteria among
user roles, which may indicate a lack of specificity in the user-added criteria. Several
users commented on this lack of specificity. In the first scenario, a patient with
high-volume urine output contributing to vital sign instability was described to participants.
All physician users chose “Other” as the high-risk criteria, while all nurse users
selected “Provider Intuition” as the high-risk criteria for this scenario. Providers
explained that they made this selection because there was a specific reason for considering
the patient high risk. Regarding this feature, some users opted to add a comment within
the tool to explain their selection, while others did not. Adding a comment increased
the time required to complete the task, although three users clarified that if no
comment was added, it became unclear why a specific high-risk criterion was selected.
Finally, when users click on the PICU Warning Tool icon to remove a high-risk criterion,
(the third task that we tested), the tool presents a blank form and does not visually
indicate the previously selected criteria. To remove a criterion, a user must select
“No” for the previously chosen high-risk criterion. Multiple participants paused at
this point in the workflow and openly expressed uncertainty about what to do next.
This feature led to two RNs failing to complete the task. Several users described
this aspect of the tool as nonintuitive with one physician user remarking, “I know
that you have to click ‘No’ here because it's messed me up before. Definitely not
very intuitive.”
Moderator observation alone uncovered a problematic aspect of the tool. Although many
users found the “hover to discover” feature helpful, it caused confusion when users
tried to add to the high-risk criteria. During the observation, more than half of
the users clicked on the pop-up screen that appears when hovering over the icon, instead
of clicking on the icon itself (which is the correct workflow). Six participants (60%)
expressed their confusion by commenting, “Where do I click?.”
Desired Enhancements
Participants offered several recommendations to enhance the usability and effectiveness
of the PICU Warning Tool. Three physicians and three RNs expressed difficulties in
comprehending the reason behind certain high-risk criteria assigned to patients. For
instance, they pointed out that the “other” user-entered criterion lacks helpful information
unless accompanied by an additional comment. However, comments are not mandatory and
are not consistently provided. To address this issue, the participants suggested making
comments mandatory for these nonspecific, user-selected high-risk criteria. Additionally,
multiple providers recommended considering the inclusion of additional user-added
criteria, such as “intubation watcher.”
Other improvements focused on the tool's placement in the workflow and the mechanics
of interaction. All RN participants mentioned that the tool would be more usable and
more frequently accessed if it were integrated into their regular workflow with full
functionality. Some users had difficulty understanding where to click to add criteria
and recommended including additional instruction in the pop-up, such as “Double-click
icon to modify criteria” to alleviate confusion. Lastly, nearly all users expressed
a desire for the previously selected criteria to remain displayed as selected when
revisiting the tool. For example, if a user selected “Yes” to the “High Risk Intubation”
criterion, it should remain visibly selected on the form until another user selects
“No” at a later time.
Discussion
We conducted mixed-method usability testing to evaluate the usability of the PICU
Warning Tool, a CDS tool designed to improve situation awareness and reduce in-hospital
cardiac arrest for critically ill patients in the PICU.[16] While we believe this tool is an example of effective ICU-based CDS as it has demonstrated
impact on patient outcomes with a reasonable alert burden, our aim was to identify
opportunities to further improve usability postimplementation. Overall, users rated
the tool highly on the SUS, indicating good to excellent usability. However, through
observation and participant responses during think-aloud testing, we identified several
pain points and opportunities for improvement, including better integration of the
PICU Warning tool into nursing workflow and redesign of nonintuitive features. Although
most participants successfully completed their assigned tasks, our evaluation highlighted
the need for changes in user interaction with the tool to enhance usability and effectiveness.
These findings underscore the importance of a multimodal approach to usability testing,
which has been demonstrated in other studies.[9]
[26]
[27]
Our study highlights the benefits and drawbacks of postimplementation usability testing.
Postimplementation usability testing can occur in situ with users familiar with the
tool, leading to helpful feedback from repeated use. Postimplementation testing may
be less resource intensive (e.g., easier to recruit users, no need for testing laboratory)
and not subject to the time pressure inherent to the development lifecycle of health
care IT projects. However, a drawback of postimplementation usability testing is potentially
delayed recognize of suboptimal design features that might have been identified during
development before a tool was implemented.
CDS solutions that enhance human activities and improve people-based work processes
are an important focus, leading to improved outcomes.[14]
[28] While examples of effective, automated CDS tools in the PICU setting exist,[29]
[30] the implementation and perceived benefits of currently available automated PICU
CDS tools are limited.[14] It is crucial to note that these limitations extend beyond the PICU, as predictive
algorithms and advanced CDS tools often fall short in successful implementation and
effectively improving patient outcomes.[31]
[32] Several contextual factors play a role in influencing the critical care team's response
to CDS in the ICU setting. For instance, operational and patient-related factors within
the ICU, such as the severity of illness and admission rates, can impact cognitive
function and decision-making of the critical care team when utilizing CDS.[33] These factors introduce additional complexities and cognitive load that may hinder
the integration and acceptance of CDS into their workflow. Furthermore, the design,
implementation, and optimization of CDS tools within the ICU are subject to limitations
imposed by the EHR vendor. The dynamic and high-risk environment of the ICU environment,
coupled with the limitations of CDS pose significant challenges to the effective use
of CDS within the ICU. Overcoming these limitations requires rigorous usability testing
aimed at improving the integration of these tools in workflows, and our research findings
highlight the need for this rigorous testing to be multimodal.
Our multimodal usability evaluation highlights both the effective features of the
PICU Warning Tool and areas that could be improved upon. The tool demonstrates ease
of access without interrupting the workflow, clear display of complex information,
and learnability, which are valuable for informaticians and intensivists involved
in developing ICU-based CDS. However, there are notable limitations to our study.
We included participants with varying levels of experience with the PICU Warning Tool,
which may have resulted in diverse conclusions that may not be broadly applicable
to a new audience. Furthermore, since this tool utilizes passive alerting without
interrupting workflows, the findings may not be generalized to other types of interruptive
alerts which may be more common and concerning to ICU staff. Some of the proposed
enhancements may be difficult to implement secondary to vendor-specific constraints.
The resources required to perform this multimodal usability evaluation, which included
time spent collecting SUS questionnaires, time spent preparing for and conducting
think-aloud testing, and a study member familiar with think-aloud usability testing,
may limit generalizability of the methods used. However, these methods can be reproduced
at minimal cost.
Conclusion
In our postimplementation usability study within the critical care environment, the
PICU Warning Tool aimed at enhancing situation awareness demonstrated good to excellent
postimplementation usability. This tool exhibited important features that enhanced
usability, including learnability and clear display of complex information that is
easily accessible. Opportunities for improvement were identified, including better
integration into nursing workflow. Our study underscores the value of usability testing
in the evaluation of CDS.
Clinical Relevance Statement
Clinical Relevance Statement
Lack of shared situation awareness is the most common contributing factor to serious
safety events in children's hospitals. We describe a mixed-methods usability evaluation
of a clinical decisions support tool design to enhance shared situation awareness
in the critical care setting. The results from our evaluation provide important insights
to pediatricians seeking to improve shared situation awareness through clinical decision
support tools.
Multiple Choice Questions
Multiple Choice Questions
-
What is the most common contributing factor to serious safety events in children's
hospitals?
-
A. Error in medical decision-making
-
B. Lack of shared situation awareness
-
C. Insufficient staffing
-
D. Failure to communicate effectively
Answer: The most common contributing factor to serious safety events in children's
hospitals is a lack of shared situation awareness. While errors in medical decision-making,
communication failures, and staffing insufficiency can contribute to serious safety
events, they are less common. Targeting improved shared situation awareness has the
potential to improve patient safety in children's hospitals.
-
Which of the following was identified through usability testing as a desired enhancement
in the PICU Warning Tool?
-
A. Making comments mandatory for all user-selected high-risk criteria
-
B. Reducing the number of user-selected high-risk criteria
-
C. Improved integration of the tool into routine nursing workflow
-
D. Improved integration of the tool into routine physician workflow
Answer: Mixed-methods usability testing of the PICU Warning Tool identified improved
integration of the tool into routine nursing workflow as a desired enhancement. The
CDS tool is integrated into the patient list, which is part of the workflow for physicians,
advanced practice providers, and respiratory therapists. Bedside nursing tends to
use a different screen for their routine workflow in the electronic health record.
Integration into workflow is critical for the success of any CDS tool. Participants
also noted a desire for additional user-selected criteria and making comments mandatory
for the non-specific user-selected criteria “Other” and “Provider Intuition.”