Clinical trial NCT04435275: Virtual Assistant for COVID-19 PPE
Official title: Development of an Automated and Scalable Virtual Assistant to Aid in PPE Adherence and Clinical Protocols for Healthcare Worker Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: PPE adherence
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures.

Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device.

A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).


Eligibility criteria: Inclusion Criteria:

* Only anesthesia attending staff are allowed in the phase 1 study.
* Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation.

Exclusion Criteria:

• Unwillingness to enter the study for phase 1 or phase 2.

Primary outcomes:
measure: performance of healthcare workers
timeFrame: 0- 30mins during donning
measure: performance of healthcare workers
timeFrame: 0- 30mins during doffing
measure: performance of healthcare workers
timeFrame: 0- 30mins during intubation
measure: performance of healthcare workers
timeFrame: 0- 30mins during extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: