Virtual Assistant for COVID-19 PPE

Study Overview
=================
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).

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

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Virtual Assistant first, then Human Coach
* Other: Human Coach first, then Virtual Assistant


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Donning PPE using VA then doffing PPE using HC<br>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<br>* 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).<br>|
| Active Comparator: Donning PPE using HC then doffing PPE using VA<br>Study subjects will receive HC guidance for donning first, then VA guidance for doffing. | Other: Human Coach first, then Virtual Assistant<br>* instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).<br>|
| Active Comparator: Intubation using VA then extubation using HC;<br>Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure | Other: Virtual Assistant first, then Human Coach<br>* 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).<br>|
| Active Comparator: Intubation using HC then extubation using VA<br>Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure | Other: Human Coach first, then Virtual Assistant<br>* instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPE adherence