Presentation
DH4 - Clinical Trial Care, Everywhere: Leveraging Mobile, Digital Technology for Effective Communication of Clinical Research Safety Information to Rural Clinical Providers
DescriptionClinical trials are traditionally complex in their designs and objectives, particularly given the lack of concrete safety profiles of investigative therapeutics. Clinical trials’ exploratory objectives may conflict with the aims of clinical care, particularly if an investigational product or treatment is contraindicated to standard of care treatment. To heighten 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). Challenges have been documented in the literature regarding the lack of communication between research-clinical teams and the missed opportunities to engage clinical providers with research investigators when constructing the plan of care for a participant in the clinical setting. Current mechanisms of communication for safety information include paper wallet cards, Dear Provider letters, the informed consent form, and the Electronic Health Record (EHR). However, these mechanisms are inconsistently used/updated, and the safety information is not standardized to include base information (research contact information, prohibited medication lists). Paper cards and Dear Provider letters also are easily lost, degraded, or not distributed to each participant or provider. These factors of ineffective communication place a significant burden on trial participants to recall essential information at time of initial encounter with a clinical nurse and form a barrier to information transfer if the patient is unresponsive.
To decrease patient/caregiver recall burden and to support mobile, effective communication between research-clinical teams, a wearable device with key trial information is proposed for participant daily wear. This concept was proven through Epic's Sijilli project, which included Somali refugees wearing encrypted USB necklaces that were then used for health information exchange between providers. The wearable device utilized for this study has been developed and informed by a pilot study and a secondary study which evaluated situation awareness of emergency and urgent care nurses looking at a photo with the patient wearing the device. Two prototypes of wearables have been developed and tested in simulated initial patient assessments performed by student nurses and clinical nurses. Version 1 was a bracelet containing an integrated USB to allow interfacing with a website containing the patients clinical trial information. Version 2 featured motion/sound activated flashing and replaced the USB with a QR code leading to the same interface. The effectiveness of these prototypes was evaluated through simulated initial patient assessments conducted by nurses with eye tracking glasses. Use of eye-tracking glasses provided insight as to the ability of the clinical nurse to identify the wearable device as significant upon patient assessment as part of an intuitive workflow (using embedded information to inform clinical care). Rapid and fixed eye movements were compiled via the glasses to create areas of visual interest and analyze areas where the nurse was not looking to better understand clinical nurse assessment patterns when a wearable device is incorporated into the nurse’s environment. Qualitative interviewing surrounding the clinical nurse's simulation experience was also conducted.
A total of 35 participants were recruited for this study. 14 were nursing students (SNs) and 21 were registered nurses (RNs). The participants had an average of 2.6 and 14.5 years of experience for the respective groups. During the experiments, 16 of the participants (46%) physically interacted with the wearable with 29 of them (83%, 20 from RNs and 9 from SNs) being visually aware of the device. The average fixation duration on the wearable was 0.36/millisecond for RNs and 0.29/millisecond for SNs. Fifteen of them (43%) extended this interaction to the USB or QR code responsive interface. The average fixation duration on the interface was 0.54/millisecond for RNs and 0.47/millisecond for SNs.
During the post-experiment briefing and interview, the participants were asked to describe features that made the wearable device easy or challenging to identify. 80% of respondents reported that color and/or flashing lights made the device easy to recognize. Problems with identifying the device were attributed to the wristband’s similar appearance to a watch or Fitbit (28% of respondents), similar appearance to a patient ID band (22%), and novelty or unexpectedness (28%). These results imply that a wristband can be an effective method of alerting a nurse to relevant patient information if it is colorful, flashing, or a combination of the two. The wristband must also be differentiable from watches, Fitbits, and patient ID bands. Additionally, knowledge about the program will need to be disseminated through nursing staff so they know to look for the wristband during their check-in workflows.
To decrease patient/caregiver recall burden and to support mobile, effective communication between research-clinical teams, a wearable device with key trial information is proposed for participant daily wear. This concept was proven through Epic's Sijilli project, which included Somali refugees wearing encrypted USB necklaces that were then used for health information exchange between providers. The wearable device utilized for this study has been developed and informed by a pilot study and a secondary study which evaluated situation awareness of emergency and urgent care nurses looking at a photo with the patient wearing the device. Two prototypes of wearables have been developed and tested in simulated initial patient assessments performed by student nurses and clinical nurses. Version 1 was a bracelet containing an integrated USB to allow interfacing with a website containing the patients clinical trial information. Version 2 featured motion/sound activated flashing and replaced the USB with a QR code leading to the same interface. The effectiveness of these prototypes was evaluated through simulated initial patient assessments conducted by nurses with eye tracking glasses. Use of eye-tracking glasses provided insight as to the ability of the clinical nurse to identify the wearable device as significant upon patient assessment as part of an intuitive workflow (using embedded information to inform clinical care). Rapid and fixed eye movements were compiled via the glasses to create areas of visual interest and analyze areas where the nurse was not looking to better understand clinical nurse assessment patterns when a wearable device is incorporated into the nurse’s environment. Qualitative interviewing surrounding the clinical nurse's simulation experience was also conducted.
A total of 35 participants were recruited for this study. 14 were nursing students (SNs) and 21 were registered nurses (RNs). The participants had an average of 2.6 and 14.5 years of experience for the respective groups. During the experiments, 16 of the participants (46%) physically interacted with the wearable with 29 of them (83%, 20 from RNs and 9 from SNs) being visually aware of the device. The average fixation duration on the wearable was 0.36/millisecond for RNs and 0.29/millisecond for SNs. Fifteen of them (43%) extended this interaction to the USB or QR code responsive interface. The average fixation duration on the interface was 0.54/millisecond for RNs and 0.47/millisecond for SNs.
During the post-experiment briefing and interview, the participants were asked to describe features that made the wearable device easy or challenging to identify. 80% of respondents reported that color and/or flashing lights made the device easy to recognize. Problems with identifying the device were attributed to the wristband’s similar appearance to a watch or Fitbit (28% of respondents), similar appearance to a patient ID band (22%), and novelty or unexpectedness (28%). These results imply that a wristband can be an effective method of alerting a nurse to relevant patient information if it is colorful, flashing, or a combination of the two. The wristband must also be differentiable from watches, Fitbits, and patient ID bands. Additionally, knowledge about the program will need to be disseminated through nursing staff so they know to look for the wristband during their check-in workflows.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives