Virtual Assistant for COVID-19 PPE

NCT04435275 | Unknown DMC

• 1 other identifier: 20-5399
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Keywords

PPE adherence

Outcome Measures

Primary Outcomes (4)

• performance of healthcare workers

  Errors occurred during donning of PPE measured by procedure checklist

  0- 30mins during donning

• performance of healthcare workers

  Errors occurred during doffing of PPE measured by procedure checklist

  0- 30mins during doffing

• performance of healthcare workers

  Errors occurred during intubation measured by procedure checklist

  0- 30mins during intubation

• performance of healthcare workers

  Errors occurred during extubation measured by procedure checklist

  0- 30mins during extubation

Study Arms (4)

Donning PPE using VA then doffing PPE using HC

ACTIVE COMPARATOR

Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing.

Other: Virtual Assistant first, then Human Coach

Donning PPE using HC then doffing PPE using VA

ACTIVE COMPARATOR

Study subjects will receive HC guidance for donning first, then VA guidance for doffing.

Other: Human Coach first, then Virtual Assistant

Intubation using VA then extubation using HC;

ACTIVE COMPARATOR

Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure

Other: Virtual Assistant first, then Human Coach

Intubation using HC then extubation using VA

ACTIVE COMPARATOR

Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure

Other: Human Coach first, then Virtual Assistant

Interventions

Virtual Assistant first, then Human Coach OTHER

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).

Donning PPE using VA then doffing PPE using HC; Intubation using VA then extubation using HC;

Human Coach first, then Virtual Assistant OTHER

instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).

Donning PPE using HC then doffing PPE using VA; Intubation using HC then extubation using VA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, ON M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Rongyu ( Cindy) Jin

CONTACT

416-603-5800; rongyu.jin@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 17, 2020
• Study Start: January 2, 2021
• Primary Completion: March 31, 2021
• Study Completion: May 1, 2021
• Last Updated: January 8, 2021

Record last verified: 2020-05

Locations

CA (1)