Virtual Reality on Efficacy of Donning and Doffing PPE

June 21, 2021 updated by: Marc J. Gibber, Montefiore Medical Center

Comparison of a Virtual Reality Versus an E-Module on Efficacy of Donning and Doffing PPE: A Randomized Control Trial

All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2). In-person, hands-on training tends to be preferred, however staff shortages limit feasibility and contamination still occurs (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online (5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2).

Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training.

The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The COVID-19 (Coronavirus Disease 2019) pandemic highlighted concerns regarding personal protective equipment (PPE) utilization in hospitals (10,11). When used correctly, PPE can prevent COVID-19 infection amongst exposed healthcare workers (12,13) . Evidence suggests that up to 90% of doffing procedures are performed incorrectly (14). This failure rate has been linked to healthcare workers being more likely to contract COVID-19 compared to the general community (15). As a result, authorities have turned to increased training as a potential solution (16).

All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2) In-person, hands-on training tends to be preferred, however, staff shortages limit feasibility and contamination still occurs 82% of the time (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online(5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2).

Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training.

The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Einstein Center for Innovation in Simulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Associates affiliated with the Montefiore Medical Center.
  • Medical Students at the Albert Einstein College of Medicine.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Virtual Reality
Participants randomized to the immersive virtual reality study arm, considered the "intervention group" received training on donning and doffing PPE using a program developed by Axon Park Inc. (California, USA)
Other: Virtual Reality
The training included the following in the specified order: (1) A tutorial with an introduction to the program and a overview of the correct donning and doffing sequence, based on Center for Disease Control (CDC) guidelines, (2) a training mode to practice the correct sequences with step-wise feedback, and (3) a testing mode that repeated until the sequence was completed perfectly without any mistakes. A study member was present to assist with the device and record the duration of training.
PLACEBO_COMPARATOR: E-module
Participants randomized to the e-module study arm, considered the "control group" received training on donning and doffing PPE using an e-module containing a video and slide show.
Other: E-module
The instructional video included step-by-step instruction and demonstration of adequate donning and doffing procedures. The 14-slide presentation contained the same content as used by the home institution for competency training, based on Center for Disease Control (CDC) guidelines. Participants were instructed to review the material however they liked and their duration of training was recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Donning and Doffing Performance
Time Frame: Immediately after the intervention
Donning and doffing performance was evaluated using a checklist based on Center for Disease Control (CDC) guidelines. The performance checklist consisted of separate sections for donning and doffing. Scoring for each step was based on (1) completion and (2) correct sequence. All points are totaled for a maximum possible score of 64 points and minimum possible score of 0 points. A higher score indicates a better outcome.
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup analysis
Time Frame: Immediately after the intervention
Subgroup analyses were based on the most common occupations listed. The overall study sample was reduced into three groups: medical students, residents, and all other participants.
Immediately after the intervention
Participant experience
Time Frame: Baseline, pre-intervention and immediately after the intervention
Analysis of survey data compared participants' perceived preparedness, perceived confidence, and degree of distraction during training.
Baseline, pre-intervention and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Farrukh Jafri, MD, Albert Einstein College of Medicine
  • Principal Investigator: Marc Gibber, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2020

Primary Completion (ACTUAL)

January 27, 2021

Study Completion (ACTUAL)

January 27, 2021

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (ACTUAL)

June 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-11936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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