Presentation
PS12 - Single-Blind Examination of Rural Healthcare Provider Situation Awareness to a Novel Wearable Device for Patient Safety and Care Management
SessionPoster Session 1
DescriptionIntroduction: To heighten clinical trial research participant safety, communication between research and clinical teams is necessary to ensure clinical treatment is aligned with the boundaries of the research protocol and anticipated safety profile of the investigational product (i.e., patient medical alert information). However, current mechanisms, including paper copies and electronic health record (EHR), are inconsistently used and updated, and the safety information is not standardized to include consistently updated base information. Paper copies are easily lost, degraded, or not distributed to each participant or provider (Bhargava et al., 2022). These factors of ineffective communication place a significant burden on trial participants to recall essential information at an initial encounter with a clinical nurse and form a barrier to information transfer if the patient is unresponsive (Schrag et al., 2020).
To enhance effective communication between research-clinical teams, a wearable device with key trial information is proposed for participant daily wear. The initial Prototype was a yellow snap wristband which contained an embedded universal serial bus (USB) at the end of the wristband that contained a shortcut to a web-based platform, TrialWear (Johnson et al., 2021; Johnson et al., 2023). TrialWear included medication and clinical trial safety information, and a link to contact research team. This study was guided by the synergistic application of Feature Integration Theory (FIT) and the Preclinical Nurse-Nurse Communication Framework (Treisman & Gelade, 1980; Johnson et al., 2023). As established by Treisman and Gelade, FIT describes the collective interpretation of different contextual cues, or features, which surround an object or environment, such as color, shape, lettering, and symbols (Treisman & Gelade, 1980). The sum of these features becomes more than their individual parts, supporting the individual in sense-making or schema building. Since the early development of FIT, research has evolved surrounding the pre-attentive and attentive phases of schema building, including the significance of distractors within the environment which detract from accuracy in human interpretation and subsequent action (Wolfe, 2020).
Methods:
The recruitment included 14 female participants, including 9 participants reported highest level of education received as high school/GED or Nursing Assistant (CNA) license, and 5 with bachelor's degrees and registered nursing certificate. 10 out of 14 (71.4%) were white, while the remaining identified as Native American or Asian. Demographic information was missing for 1 pre-licensure nurse.
The in-person simulation took place in well-appointed healthcare delivery research setting with patient actors and patient examination equipment typical to a community-based emergency care facility (Besel et al., 2023). Following completion of written consent and eligibility verification, participants with Tobii Pro Glasses 3 eye-tracking glasses (Tobii Co, Ltd, version 1.19, Stockholm, Sweden) started the simulation to complete a typical initial patient assessment. No information about the wearable was provided to participants prior to the simulation. If the participant asked about the wearable or clinical trial medication, the patient actor or the facilitator was allowed to provide a prompt to the participant to engage to the wearable and the website.
Tobii Pro Lab (Version 1.217) was applied to post-process the eye-tracking data and analyze fixation and saccades data regarding different areas of interest (AOIs) (Holmqvist et al., 2011; Tobii AB, 2024). All participant data were codified and de-identified to uphold privacy and confidentiality. All data were analyzed in R (R Core Team, 2020; RStudio Team, 2020) and Minitab (Version 21.4.2, 2023). Descriptive and inferential statistical analyses (general linear models, One-way ANOVA and Pearson correlations) were performed (Girden, 1992; Freedman et al., 2007; Pearson, 1900). The significance level was set as 0.05 for all two-sided tests.
Results:
Most participants (n=13, 92.9%) had multiple times of visually revisiting on the wearable with 12 interacted with the wearable but only two not receiving prompt. The other two participants interacted with neither wearable nor website with no prompt received. On average, participants had 442.92 seconds conducting the examination before the prompt or the interaction with the wearable with 5.6 seconds visual awareness on the wearable. They spent an average of 102.6 seconds with patients before they became aware of the wearable. For the wearable visual awareness before any interaction or prompt, the total fixation time was significantly positively correlated with the total fixation count (r=0.86, p=0.0002) and the time to first fixation (r=0.67, p=0.0121).
10 participants interacted with the website through the USB port but only one interacted without the prompt. Only 2 participants notified the research team through their interaction with the website, and both interacted with the website after the prompt. On average, participants visually focused on the website over half of the time (134.32 seconds out of 212.70 seconds). For the participant's visual attention on the website, the total fixation time was significantly positively correlated with the total AOI time (r=0.84, p=0.0024) and the total fixation count (r=0.96, p<0.0001).
The utilization of eye-tracking glasses in this study was instrumental in understanding nursing-healthcare provider clinical workflow when encountering an unfamiliar wearable technology upon initial patient assessment. To our knowledge, this is the first single-blind study of nursing clinical workflow pertaining to the identification of clinical trial participation at initial encounter coupled with a wearable device for shared safety information exchange impacting clinical decision-making. The simulation in this study helped us to reveal how the proposed prototype was incorporated into the end-user workflow from both objective and subjective perspective. The eye-tracking analysis revealed that nearly all participants (13/14) noticed the wearable device, although only a small fraction (2/14) interacted with it unprompted during the simulation. Most of the participants attributed their attention to the bright color and the flushing light design of the wearable. However, participants thought the wearable more like as medical alert, fall risk band or smart watch. These insights underscored the wearable's ability to capture nurses' attention and highlighted opportunities for refining future prototypes.
References (select)
Besel, J. M., Johnson, E. A., Ma, J., & Kiesow, B. (2023). Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials. Frontiers in Pharmacology, https://doi.org/10.3389/fphar.2023.1309073
Bhargava, A., Jain, N., Rojan, A., Ngo, P., & Dong, B. (2022). Impact of wallet cards compared to conventional chemotherapy education in patients with newly-diagnosed cancer. Journal of Clinical Oncology, 40(28_suppl), 363-363. https://doi.org/10.1200/JCO.2022.40.28_suppl.363
Croucher, S. M., Kelly, S., Rahmani, D., Burkey, M., Subanaliev, T., Galy-Badenas, F., Lando, A. L., Chibita, M., Nyiransabimana, V., Turdubaeva, E., Eskiçorapçı, N., & Jackson, K. (2020). A multi-national validity analysis of the self-perceived communication competence scale. Journal of International and Intercultural Communication, 13(1), 1–12. https://doi.org/10.1080/17513057.2019.1569250
Johnson, E. A., Rainbow, J. G., & Carrington, J. M. (2023). Clinical Nurses’ Identification of a Wearable Universal Serial Bus Used for Pediatric Oncology Clinical Trial Participant Safety Management. CIN: Computers, Informatics, Nursing, 41(9), 687–697. https://doi.org/10.1097/CIN.0000000000001013
Johnson, E. A., Rainbow, J. G., Reed, P. G., Gephart, S. M., & Carrington, J. M. (2023). Developing a Preclinical Nurse-Nurse Communication Framework for Clinical Trial Patient-Related Safety Information. CIN: Computers, Informatics, Nursing, 41(7), 514–521. https://doi.org/10.1097/CIN.0000000000000968
Johnson, E., & Carrington, J. M. (2021). Feasibility of Wearable Universal Serial Bus Utilization to Support Clinical Trial Participant Safety Management: A Pilot, Qualitative Descriptive Study. CIN: Computers, Informatics, Nursing, 39(10), 563–569. https://doi.org/10.1097/CIN.0000000000000746
Matti, C., Essig, S., Föhn, Z., & Balthasar, A. (2023). The Role of Wearable Sensors in the Future Primary Healthcare – Preferences of the Adult Swiss Population: A Mixed Methods Approach. Journal of Medical Systems, 47(1), 111. https://doi.org/10.1007/s10916-023-01998-1
Tran, V.-T., Riveros, C., & Ravaud, P. (2019). Patients’ views of wearable devices and AI in healthcare: Findings from the ComPaRe e-cohort. Npj Digital Medicine, 2(1), 53. https://doi.org/10.1038/s41746-019-0132-y
To enhance effective communication between research-clinical teams, a wearable device with key trial information is proposed for participant daily wear. The initial Prototype was a yellow snap wristband which contained an embedded universal serial bus (USB) at the end of the wristband that contained a shortcut to a web-based platform, TrialWear (Johnson et al., 2021; Johnson et al., 2023). TrialWear included medication and clinical trial safety information, and a link to contact research team. This study was guided by the synergistic application of Feature Integration Theory (FIT) and the Preclinical Nurse-Nurse Communication Framework (Treisman & Gelade, 1980; Johnson et al., 2023). As established by Treisman and Gelade, FIT describes the collective interpretation of different contextual cues, or features, which surround an object or environment, such as color, shape, lettering, and symbols (Treisman & Gelade, 1980). The sum of these features becomes more than their individual parts, supporting the individual in sense-making or schema building. Since the early development of FIT, research has evolved surrounding the pre-attentive and attentive phases of schema building, including the significance of distractors within the environment which detract from accuracy in human interpretation and subsequent action (Wolfe, 2020).
Methods:
The recruitment included 14 female participants, including 9 participants reported highest level of education received as high school/GED or Nursing Assistant (CNA) license, and 5 with bachelor's degrees and registered nursing certificate. 10 out of 14 (71.4%) were white, while the remaining identified as Native American or Asian. Demographic information was missing for 1 pre-licensure nurse.
The in-person simulation took place in well-appointed healthcare delivery research setting with patient actors and patient examination equipment typical to a community-based emergency care facility (Besel et al., 2023). Following completion of written consent and eligibility verification, participants with Tobii Pro Glasses 3 eye-tracking glasses (Tobii Co, Ltd, version 1.19, Stockholm, Sweden) started the simulation to complete a typical initial patient assessment. No information about the wearable was provided to participants prior to the simulation. If the participant asked about the wearable or clinical trial medication, the patient actor or the facilitator was allowed to provide a prompt to the participant to engage to the wearable and the website.
Tobii Pro Lab (Version 1.217) was applied to post-process the eye-tracking data and analyze fixation and saccades data regarding different areas of interest (AOIs) (Holmqvist et al., 2011; Tobii AB, 2024). All participant data were codified and de-identified to uphold privacy and confidentiality. All data were analyzed in R (R Core Team, 2020; RStudio Team, 2020) and Minitab (Version 21.4.2, 2023). Descriptive and inferential statistical analyses (general linear models, One-way ANOVA and Pearson correlations) were performed (Girden, 1992; Freedman et al., 2007; Pearson, 1900). The significance level was set as 0.05 for all two-sided tests.
Results:
Most participants (n=13, 92.9%) had multiple times of visually revisiting on the wearable with 12 interacted with the wearable but only two not receiving prompt. The other two participants interacted with neither wearable nor website with no prompt received. On average, participants had 442.92 seconds conducting the examination before the prompt or the interaction with the wearable with 5.6 seconds visual awareness on the wearable. They spent an average of 102.6 seconds with patients before they became aware of the wearable. For the wearable visual awareness before any interaction or prompt, the total fixation time was significantly positively correlated with the total fixation count (r=0.86, p=0.0002) and the time to first fixation (r=0.67, p=0.0121).
10 participants interacted with the website through the USB port but only one interacted without the prompt. Only 2 participants notified the research team through their interaction with the website, and both interacted with the website after the prompt. On average, participants visually focused on the website over half of the time (134.32 seconds out of 212.70 seconds). For the participant's visual attention on the website, the total fixation time was significantly positively correlated with the total AOI time (r=0.84, p=0.0024) and the total fixation count (r=0.96, p<0.0001).
The utilization of eye-tracking glasses in this study was instrumental in understanding nursing-healthcare provider clinical workflow when encountering an unfamiliar wearable technology upon initial patient assessment. To our knowledge, this is the first single-blind study of nursing clinical workflow pertaining to the identification of clinical trial participation at initial encounter coupled with a wearable device for shared safety information exchange impacting clinical decision-making. The simulation in this study helped us to reveal how the proposed prototype was incorporated into the end-user workflow from both objective and subjective perspective. The eye-tracking analysis revealed that nearly all participants (13/14) noticed the wearable device, although only a small fraction (2/14) interacted with it unprompted during the simulation. Most of the participants attributed their attention to the bright color and the flushing light design of the wearable. However, participants thought the wearable more like as medical alert, fall risk band or smart watch. These insights underscored the wearable's ability to capture nurses' attention and highlighted opportunities for refining future prototypes.
References (select)
Besel, J. M., Johnson, E. A., Ma, J., & Kiesow, B. (2023). Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials. Frontiers in Pharmacology, https://doi.org/10.3389/fphar.2023.1309073
Bhargava, A., Jain, N., Rojan, A., Ngo, P., & Dong, B. (2022). Impact of wallet cards compared to conventional chemotherapy education in patients with newly-diagnosed cancer. Journal of Clinical Oncology, 40(28_suppl), 363-363. https://doi.org/10.1200/JCO.2022.40.28_suppl.363
Croucher, S. M., Kelly, S., Rahmani, D., Burkey, M., Subanaliev, T., Galy-Badenas, F., Lando, A. L., Chibita, M., Nyiransabimana, V., Turdubaeva, E., Eskiçorapçı, N., & Jackson, K. (2020). A multi-national validity analysis of the self-perceived communication competence scale. Journal of International and Intercultural Communication, 13(1), 1–12. https://doi.org/10.1080/17513057.2019.1569250
Johnson, E. A., Rainbow, J. G., & Carrington, J. M. (2023). Clinical Nurses’ Identification of a Wearable Universal Serial Bus Used for Pediatric Oncology Clinical Trial Participant Safety Management. CIN: Computers, Informatics, Nursing, 41(9), 687–697. https://doi.org/10.1097/CIN.0000000000001013
Johnson, E. A., Rainbow, J. G., Reed, P. G., Gephart, S. M., & Carrington, J. M. (2023). Developing a Preclinical Nurse-Nurse Communication Framework for Clinical Trial Patient-Related Safety Information. CIN: Computers, Informatics, Nursing, 41(7), 514–521. https://doi.org/10.1097/CIN.0000000000000968
Johnson, E., & Carrington, J. M. (2021). Feasibility of Wearable Universal Serial Bus Utilization to Support Clinical Trial Participant Safety Management: A Pilot, Qualitative Descriptive Study. CIN: Computers, Informatics, Nursing, 39(10), 563–569. https://doi.org/10.1097/CIN.0000000000000746
Matti, C., Essig, S., Föhn, Z., & Balthasar, A. (2023). The Role of Wearable Sensors in the Future Primary Healthcare – Preferences of the Adult Swiss Population: A Mixed Methods Approach. Journal of Medical Systems, 47(1), 111. https://doi.org/10.1007/s10916-023-01998-1
Tran, V.-T., Riveros, C., & Ravaud, P. (2019). Patients’ views of wearable devices and AI in healthcare: Findings from the ComPaRe e-cohort. Npj Digital Medicine, 2(1), 53. https://doi.org/10.1038/s41746-019-0132-y
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)