Virtual Assistant for COVID-19 PPE

COVID-19 Clinical Trial

Official title:

Development of an Automated and Scalable Virtual Assistant to Aid in PPE Adherence and Clinical Protocols for Healthcare Worker Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04435275
• Other study ID #: 20-5399
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2020
• Source: University Health Network, Toronto
• Contact: Rongyu ( Cindy) Jin
• Phone: 416-603-5800
• Email: rongyu.jin[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Virtual Assistant first, then Human Coach
Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).
• Human Coach first, then Virtual Assistant
instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance of healthcare workers	Errors occurred during donning of PPE measured by procedure checklist	0- 30mins during donning
Primary	performance of healthcare workers	Errors occurred during doffing of PPE measured by procedure checklist	0- 30mins during doffing
Primary	performance of healthcare workers	Errors occurred during intubation measured by procedure checklist	0- 30mins during intubation
Primary	performance of healthcare workers	Errors occurred during extubation measured by procedure checklist	0- 30mins during extubation