Virtual Reality on Efficacy of Donning and Doffing PPE

NCT04937257 | Completed

• 1 other identifier: 2020-11936
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medical Training

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (1)

• Overall Donning and Doffing Performance

  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 Outcomes (2)

• Subgroup analysis

  Immediately after the intervention

• Participant experience

  Baseline, pre-intervention and immediately after the intervention

Study Arms (2)

Virtual Reality

ACTIVE COMPARATOR

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

E-module

PLACEBO COMPARATOR

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

Interventions

Virtual Reality OTHER

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.

Virtual Reality

E-module OTHER

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.

E-module

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Einstein Center for Innovation in Simulation

The Bronx, New York, 10461, United States

Location

Related Publications (16)

• Occupational Safety and Health Administration. OSHA Best Practices for HospitalBased First Receivers of Victims from Mass Casualty Incidents Involving the Release of Hazardous Substances. US Department of Labor, OSHA 3249-08N; 2005. https:// www.osha.gov/Publications/osha3249.pdf. Accessed July 30, 2020.

  BACKGROUND

• Kang J, O'Donnell JM, Colaianne B, Bircher N, Ren D, Smith KJ. Use of personal protective equipment among health care personnel: Results of clinical observations and simulations. Am J Infect Control. 2017 Jan 1;45(1):17-23. doi: 10.1016/j.ajic.2016.08.011.

  PMID: 28065328 BACKGROUND

• Barratt R, Shaban RZ, Gilbert GL. Characteristics of personal protective equipment training programs in Australia and New Zealand hospitals: A survey. Infect Dis Health. 2020 Nov;25(4):253-261. doi: 10.1016/j.idh.2020.05.005. Epub 2020 Jun 26.

  PMID: 32600965 BACKGROUND

• Kirch DG, Petelle K. Addressing the Physician Shortage: The Peril of Ignoring Demography. JAMA. 2017 May 16;317(19):1947-1948. doi: 10.1001/jama.2017.2714. No abstract available.

  PMID: 28319233 BACKGROUND

• Salway RJ, Williams T, Londono C, Roblin P, Koenig K, Arquilla B. Comparing Training Techniques in Personal Protective Equipment Use. Prehosp Disaster Med. 2020 Aug;35(4):364-371. doi: 10.1017/S1049023X20000564. Epub 2020 May 11.

  PMID: 32390583 BACKGROUND

• L Perna AR, R Boruch, N Wang, J Scull, C Evans, S Ahmad. The life cycle of a million MOOC users. MOOC Research Initiative Conference 5; 2013.

  BACKGROUND

• Samadbeik M, Yaaghobi D, Bastani P, Abhari S, Rezaee R, Garavand A. The Applications of Virtual Reality Technology in Medical Groups Teaching. J Adv Med Educ Prof. 2018 Jul;6(3):123-129.

  PMID: 30013996 BACKGROUND

• Christensen L, Rasmussen CS, Benfield T, Franc JM. A Randomized Trial of Instructor-Led Training Versus Video Lesson in Training Health Care Providers in Proper Donning and Doffing of Personal Protective Equipment. Disaster Med Public Health Prep. 2020 Aug;14(4):514-520. doi: 10.1017/dmp.2020.56. Epub 2020 Mar 30.

  PMID: 32223776 BACKGROUND

• Hung PP, Choi KS, Chiang VC. Using interactive computer simulation for teaching the proper use of personal protective equipment. Comput Inform Nurs. 2015 Feb;33(2):49-57. doi: 10.1097/CIN.0000000000000125.

  PMID: 25521788 BACKGROUND

• McCarthy R, Gino B, d'Entremont P, Barari A, Renouf TS. The Importance of Personal Protective Equipment Design and Donning and Doffing Technique in Mitigating Infectious Disease Spread: A Technical Report. Cureus. 2020 Dec 14;12(12):e12084. doi: 10.7759/cureus.12084.

  PMID: 33489502 BACKGROUND

• John A, Tomas ME, Hari A, Wilson BM, Donskey CJ. Do medical students receive training in correct use of personal protective equipment? Med Educ Online. 2017;22(1):1264125. doi: 10.1080/10872981.2017.1264125.

  PMID: 28178912 BACKGROUND

• Suzuki T, Hayakawa K, Ainai A, Iwata-Yoshikawa N, Sano K, Nagata N, Suzuki T, Wakimoto Y, Akiyama Y, Miyazato Y, Nakamura K, Ide S, Nomoto H, Nakamoto T, Ota M, Moriyama Y, Sugiki Y, Saito S, Morioka S, Ishikane M, Kinoshita N, Kutsuna S, Ohmagari N. Effectiveness of personal protective equipment in preventing severe acute respiratory syndrome coronavirus 2 infection among healthcare workers. J Infect Chemother. 2021 Jan;27(1):120-122. doi: 10.1016/j.jiac.2020.09.006. Epub 2020 Sep 9.

  PMID: 32988731 BACKGROUND

• Karlsson U, Fraenkel CJ. Covid-19: risks to healthcare workers and their families. BMJ. 2020 Oct 28;371:m3944. doi: 10.1136/bmj.m3944. No abstract available.

  PMID: 33115772 BACKGROUND

• Phan LT, Maita D, Mortiz DC, Weber R, Fritzen-Pedicini C, Bleasdale SC, Jones RM; CDC Prevention Epicenters Program. Personal protective equipment doffing practices of healthcare workers. J Occup Environ Hyg. 2019 Aug;16(8):575-581. doi: 10.1080/15459624.2019.1628350. Epub 2019 Jul 10.

  PMID: 31291152 BACKGROUND

• Nguyen LH, Drew DA, Graham MS, Joshi AD, Guo CG, Ma W, Mehta RS, Warner ET, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Sudre CH, Cardoso MJ, Wolf J, Spector TD, Ourselin S, Steves CJ, Chan AT; COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet Public Health. 2020 Sep;5(9):e475-e483. doi: 10.1016/S2468-2667(20)30164-X. Epub 2020 Jul 31.

  PMID: 32745512 BACKGROUND

• Using Personal Protective Equipment (PPE). In: National Center for Immunization and Respiratory Diseases (NCIRD) DoVD, edAugust 19, 2020

  BACKGROUND

Study Officials

• Farrukh Jafri, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Marc Gibber, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome raters were two independent nurse educators, blinded to the study protocol and interventions. An encrypted folder contained outcome videos, each with a unique number, containing no known information that may disclose the study arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 24, 2021
• Study Start: November 16, 2020
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)