Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

Household and Population-Level Behavioural Changes Due to COVID-19 Pandemic: A Smart Thermostat Based Comparative Data Analysis

The World Health Organization declared the coronavirus outbreak as a pandemic on March 11, 2020. To inhibit the spread of COVID-19, governments around the globe, including Canada, have implemented physical distancing and lockdown measures, including a work-from-home policy. Canada in 2020 has developed a 24-Hour Movement Guideline for all ages laying guidance on the ideal amount of physical activity, sedentary behaviour, and sleep (PASS) for an individual in a day. The purpose of this study was to investigate changes on the household and population-level in lifestyle behaviours (PASS) and time spent indoors at the household level, following the implementation of physical distancing protocols and stay-at-home guidelines. For this study, we used 2019 and 2020 data from ecobee, a Canadian smart Wi-Fi thermostat company, through the Donate Your Data (DYD) program. Using motion sensors data, we quantified the amount of sleep by using the absence of movement, and similarly, increased sensor activation to show a longer duration of household occupancy. The key findings of this study were; during the COVID-19 pandemic, overall household-level activity increased significantly compared to pre-pandemic times, there was no significant difference between household-level behaviours between weekdays and weekends during the pandemic, average sleep duration has not changed, but the pattern of sleep behaviour significantly changed, specifically, bedtime and wake up time delayed, indoor time spent has been increased and outdoor time significantly reduced. Our data analysis shows the feasibility of using big data to monitor the impact of the COVID-19 pandemic on the household and population-level behaviours and patterns of change.

Exploring the Differences in Macrocognition Between Experts and Non-CHD Experts Managing Congenital Heart Disease (CHD)

Background and aims: Children with congenital heart disease (CHD) are at risk of deterioration in the face of common childhood illnesses, and their resuscitation and acute management is often best achieved with the guidance of CHD experts. Access to such expertise may be limited outside specialty heart centers and the fragility of these patients is cause for discomfort among many emergency medicine physicians. An understanding of the differences in macrocognition of these clinicians could shed light on some of the causes of discomfort and facilitate the development of a sociotechnological solution to this problem. Methods: Cardiac intensivists (CHD experts) and pediatric emergency medicine physicians (non-CHD experts) in a major academic cardiac center were interviewed using the critical decision method. Interview transcripts were coded deductively based on Klein’s macrocognitive framework and inductively to allow for new or modified characterization of dimensions. Results: While both CHD-experts and non-CHD experts relied on the macrocognitive functions of sensemaking, naturalistic decision making and detecting problems, the specific data and mental models used to understand the patients and course of therapy differed between CHD-experts and non-CHD experts. Conclusion: Characterization of differences between the macrocognitive processes of CHD experts and non-CHD experts can inform development of sociotechnological solutions to augment decision making pertaining to the acute management of pediatric CHD patients.

Improving Genetics Clinic Efficiency and Capacity Using Design and Human Factors Methods

This quality improvement study focused on developing an understanding of factors influencing the ability of prenatal genetics counsellors (GCs) to efficiently see patients during the COVID-19 pandemic and strategies to improve their workflow using techniques from human factors and design. The demand for Prenatal Genetics Clinics is rising which has increased pressure on GCs to become more efficient. Genetics counsellors can improve access to their services by reducing the time spent on the tasks performed before and after a genetic counselling encounter, thereby increasing the number of patients they see. We were limited to certain methods to understand the differences in workflow before and during the COVID-19 pandemic. This study involved a literature review, archival analysis of workflow studies conducted before the pandemic, stakeholder meetings and mapping, a brainstorming session, as well as documenting time-on-task in a diary and naturalistic observation sessions. A task analysis was developed to identify factors influencing efficiency related to the design of the space, processes and the use of artefacts. Virtual and on-site workflows show that GCs spend at least half of their time on tasks before and/or after the patient’s appointment. Looking at potential inefficiencies or bottlenecks in workflow formed the development of a strategic plan for improving GC workflows at the prenatal Genetics Clinic. Improvements suggested through this analysis were constrained to support the current number of healthcare providers working within the existing space configuration.

Considerations for Translating Medical Devices Under Development From the Clinic to the Home: A Case Study in Providing Chronic Wound Care

A prototype medical device and protocol that work well in a clinic would not necessarily work reliably in the home setting. The goal of this work is to identify factors to consider when translating a device evaluated in a clinic for use by home caregivers providing chronic wound care for persons living with dementia. One must consider the current device, the associated bundle, the protocol and how they may need to be modified. Semi-structured interviews with the research assistants who have applied a prototype device were conducted to generate a list of known issues with the current clinical protocol in terms of ultrasound application The researchers performed a set of specified tasks by following the current device protocol and explaining any difficulties with use\execution. They embellished the descriptions with details about what had happened with actual patients in the clinic. Using thematic analysis, analysts identified themes and subthemes. Issues potentially relevant to translating medical devices to the home are discussed.

Implications for the Physical Design of the Postnatal Care Unit from a Targeted Analysis of Issues With Accessing the Bathroom at Night in the Acute Setting: A Secondary Analysis

Assessing hospital environment conditions is necessary for healthcare providers and patients to coordinate safe care. The aims of this research included: a) identifying patterns in hospital visit feedback transcripts regarding bathroom doors and lights in the hospital room and b) interpreting the results to make recommendations for more enabling clinical environments. The methods used by the research team included organizing transcript data, assigning codes, and conducting an interrater reliability test to assess codebook efficacy. Finally, working with maternal and infant mortality experts, recommendations for the hospital were developed. We identified four possible interventions to address barriers: a) implement low-height, dimmable lighting along the base of the patient room, b) provide personal lights, such as penlights, to staff for nighttime assessments, c) install and improve on existing grab bars in patient room bathrooms and d) replace the standard patient room bathroom door with a different kind of auditory/visual privacy barrier.

Evaluating and Motivating Activation in Long Term Care: Lessons From a Pilot Study

Older adults living in long-term care facilities typically receive insufficient exercise and have long periods of the day when they are not doing anything other than sitting or lying down, watching television, or ruminating (Wilkinson et al., 2017). We developed an intervention called the Experiential Centivizer, which provides residents with opportunities to use a driving simulator, watch world travel videos, and engage in exercise. We assessed the impact of the intervention on residents of a long-term care home in Fredericton, NB, Canada. In this paper, we report on the results observed and highlight the lessons learned from implementing a technological intervention within a long-term care setting. Practical and research recommendations are also discussed to facilitate future intervention implementation in long-term care.

The Patient in Patient Safety: Contemporary Issues, From COVID-19 to Citizen Science

In the 4th panel on the topic of The Patient in Patient Safety, we highlighted topics of current relevance and facilitated a reflection session. The objective was to highlight the ways in which the COVID-19 pandemic has impacted patient ergonomics research and work, with particular focus on safety. After a topic overview, panelists presented their work on overcoming challenges to human subjects research created by the suspension of face-to-face activities during the COVID-19 pandemic. A facilitated reflection and brainstorming session using Miro followed. We used questions to elicit examples of patient and caregiver roles in safety during the pandemic and research strategies and challenges. These questions were also distributed on social media prior to the event. The panel served as an opportunity to share lessons learned.

Using Simulated Handover to Assess Team-Based Competencies in a Virtual Environment

We utilized simulated patient scenarios in a virtual environment to improve students’ communication skills during handovers. To determine how students performed during the scenarios, we assessed several behaviors: structured communication, closed-loop communication, and asking clarification questions. Results revealed that the students’ performance was stronger in the first area (structure communication) and weaker in the second (closed-loop communication) and third (asking clarifying questions) areas.