Critical Care Clinical Trial
Official title:
VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU; Project Phases 1 (System Development) and 2 (Prototype Evaluation)
The VitalPAD is a unified, portable and intelligent device that integrates information from
multiple patient monitors, mechanical ventilators, infusion pumps and clinical information
systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to
continuously monitor and coordinate care of critically ill patients.
This study will use a participatory design process to guide the design of an integrated
mobile device, followed by an evaluation of the proposed device in a simulated ICU setting.
1. Purpose
Critically ill patients in the intensive care unit (ICU) need constant monitoring by
nurses, respiratory therapists, and physicians. To make decisions and plan therapies,
these clinicians must observe and reconcile a vast array of information originating from
devices located at the bedsides of multiple patients. Their efforts are hindered by:
information being physically limited to the bedside; information overload from the
number of devices and separate displays; lack of integration and interaction between
devices; displays which fail to present information in a way that is easy to understand;
alarm fatigue; lacking historical data or clinical context to support clinical decision
making; difficulty locating a team member for consultation or to provide an extra pair
of hands
This project aims to integrate information from multiple monitoring and therapy devices
(multi-parameter monitor, infusion pumps, mechanical ventilator) onto one application,
the VitalPAD, hosted on a mobile device (tablet or smartphone). The VitalPAD will
process information from multiple bedside monitors in an intelligent decision-support
system, and provide an intuitive display of vital signs information, alerts and
reminders to ICU healthcare team members.
Assigning priority of care and early detection of deterioration of critically ill
patients represents an enormous source of preventable morbidity, mortality and cost.
Enhanced efficiency in patient monitoring can help reduce the time to detection of
critical conditions and improve priority assignment, contributing to enhanced patient
safety.
The goal of this project is to demonstrate that a mobile application (VitalPAD) can
provide dynamic, meaningful, integrated information to intensive care clinicians in
real-time. (also see above)
2. Hypothesis / Aims
Part I - Participatory Design. The participatory design process, as proposed by
Holtzblatt, for system development is a mixed-method approach. The aim is to develop a
prototype that is easy to use, supports decision making, improves awareness of the
patient's condition by ICU healthcare team members, and reduces mental workload.
Part II - Simulation Experiment. The hypothesis is that in simulated ICU scenarios,
critical care physicians, nurses, and respiratory therapists will prioritize the care of
critically ill patients more more rapidly and more accurately with the use of VitalPAD
than without it. Specifically, using VitalPAD to triage 5 patients will be 30 seconds
faster (moderate effect) than performing the same task with the control display.
Expected secondary outcomes are a decrease in mental workload as well as an increase in
situational awareness.
3. Justification This research represents a significant opportunity to enhance patient
safety in ICUs in Canada and elsewhere by directly advancing the conceptual, theoretical
and clinical knowledge required to optimize the use of information in the ICU. It will
leverage advances in mobile computing to provide real time support to healthcare
providers on the move and reduce cognitive demands.
This integrated system aims to enhance performance of the clinicians in real-time,
optimize therapeutic interventions, reduce adverse outcomes and ultimately save lives.
The aim is to provide healthcare team members with a one-stop solution for their patient
monitoring needs, which will improve the way work is done in the ICU and will decrease
worker stress, especially for nurses.
4. Research Design Part I - Participatory design: an inter-professional team of nurses,
physicians, designers, engineers, and human factors experts will follow a user-centered
design process to refine the system requirements, and obtain feedback during the rapid
prototyping phase of prototype development.
In Part II - Simulation Experiment: the prototype device will be evaluated in a
simulated ICU setting using a triaging task. Answer accuracy and time taken to complete
task will be measured. Participants will complete questionnaires (NASA-TLX workload
assessment and a PSSUQ usability evaluation).
5. Statistical Analysis Part I - Participatory design: qualitative methods will be used to
analyze and summarize data. Specific themes will be identified and similar themes
merged. Specific obstacles to usability, design preferences, and opportunities for
information integration will be collated and summarized. In the usability experiment,
error rates and task completion times will be used to detail opportunities for
additional usability improvements.
Part II - Simulation Experiment:
- Analysis of Response Time. Mixed linear effect modeling will be used to explore the
effects of display, triaging set, and presentation order, and their interactions.
Differences between groups (increase or decrease in time taken to triage) will be
expressed using the nonparametric Hodges-Lehmann estimator and its 95% confidence limit.
- Analysis of Answer Accuracy. As a secondary outcome, the number of correct responses for
each participant will be recorded. The two proportions will be compared using Fisher's
exact test. False positive and false negative detection rates will be compared.
- Analysis of Workload Scores. The NASA-TLX scores will be analyzed using two approaches:
a Friedman's ANOVA, a non-parametric version of the ANOVA, of each of the 6 individual
sub-scores to test for individual effects; and an analysis of the weighted composite
score using the same statistical test.
- Analysis of Usability Questionnaire. The PSSUQ results will be tabulated and specific
problematic usability issues identified. Friedman's ANOVA will be used to test for
individual effects. Feedback provided by the subjects will be screened for improvement
of both user interface and decision support system rules.
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